chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tiredness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            Relevant concomitant medications were not reported.  The treatment information was  not provided.   This case was linked to MOD-2021-302211 (Patient Link).
I was on a vacation (24 people that I know also got sick) from 10/26/22-11/05/22. Once on vacation I started coughing and feeling and I got a Z-pak. I did an at home COVID-19 test both 10/27/22, 10/28/22 both came back negative. I was running a fever, so I went to the doctor. They ran a PCR COVID-19 test that came back negative. They advised me to continue to take the antibiotic, add a cough syrup. I departed on 11/05/22 and continued to cough and feel bad. On 11/23/22 I had a chest x-ray as I had a surgery scheduled and needed to be cleared for surgery. On 11/28/22 we found out that I had pneumonia, I was prescribed a rescue inhaler, Symbicort, doxycycline and prednisone that I finished on 12/02/22. By 12/04/22 I started to cough a little and started to use the Symbicort, by 12/08/22 the coughing increased by 12/12/22 I had facial pressure and the coughing had increased even more, so I called my PCP. She called in a prescription of Augmentin and recommended I go see my pulmonologist. I saw the pulmonologist today and she believes I had pneumonia and bronchitis while on vacation the cough was just a lingering effect. I should be better once I finish my antibiotics.
This spontaneous report was received from a medical assistant refers to a 33-year-old male patient with no pertinent medical history and drug reactions/allergies. On 09-APR-2013 the patient was vaccinated with a dose of M-M-R II (lot# H016192, expiration date 31-AUG-2014, route not reported). Other suspect therapies included Tetanus and Diphtheria Toxoids, Adsorbed (reported as TD vaccine manufactured by the company). The patient stated he had pain around the injection site and had been experiencing headaches since receiving a first dose of M-M-R II, the TD vaccine and a Tuberculosis Skin Test (PPD) on the same date (09-APR-2014). The reporter mentioned the patient's Tuberculosis Skin Test (PPD) was positive. The outcome of the events 'pain around the injection site' and 'headaches' were reported as recovering. Treatment was rendered for the events. Ibuprofen and ice to injection site was given. On an unknown date in 2013, chest x-ray was performed for positive Tuberculosis Skin Test (PPD) results unknown). Causality was not reported. Additional information has been requested.
Patient was unable to move . Unaware of  surrounding. Was taken to ER at 1 am on 9/28/2021
Low grade fever, chills, shortness of breath, body ache, headache, loss of appetite, extreme fatigue, red, swollen injection site, significant painful swelling in neck, upper chest and shoulder area on same side of body as injection.  Had to stay in bed for 2 days, drank lots of fluids,  increased my oxygen from 2 lpm to 3 lpm.  Did not contact my Primary Care Physician because I thought i was just having a 24 hour reaction to the vaccine.  The fever and chills persisted for 2 days, on the 3rd day I was able to get out of bed but was still experiencing fatigue and shortness of breath.  Pain and swelling in my neck and chest lasted for 5 days after the initial injection.  The injection site, 3 days after I received the injection, was red and swollen, very painful.  Area measured approx. 4" high and 7" across on my upper arm.  One month later I can still feel a lump under my skin at the injection site, about 3/4" in diameter.
Very sore arm - 5 days  Body aches - 5 days Very low pulse - resting pulse 41- ongoing (as of today, 10 days)  Cold sweats - 10 days so far, ongoing Extreme abdominal pain - 9 days until present Severe constipation - ongoing (10 days)  High pitched ringing in ears - ongoing, so far 10 days.  Brain fog - ongoing, so far 10 days  Vertigo - dizziness - 7 days Nausea - 5 days  Involuntary twitching  - 10 days (ongoing)  Mixing up words and inability to think of words - ongoing (so far 10 days)
Arrived to ED with slurred speech, potential stroke, was transferred to Hospital  for higher level of care.
Mom of client called the clinic today & stated pt started vomiting @ 5PM yesterday & had temp of 104.8 ax @ 10PM; mom states pt vomits up the APAP states pt has not vomited since 9AM today; has temp 102ax today;
After 2nd vaccine.  Night 1 - woke up, hot/cold sweats. Flu-like symptoms. Very sick. Tired. Gassy. Slept a lot. Bloody nose. Day 2 - extremely tired. Hot/cold. Couldn't stay awake. Clammy. Gassy. Slept all day.  Day 3 - eyelid swelling when I woke up. Put a hot towel on the eyes. low-grade fever. Extremely tired. Migraine all day. Body aches. Toe pain (not sure how that even happened). Night 3 - extreme neck pain. Hurt very bad to sleep on it. Eye swelling. Gassy. Tired. Slept a lot. Migraine. Inability to focus. Chest pain. Trouble breathing. Day 4 - mild neck pain. Semi-clammy. feeling much better.
Dull Headache lasting 1 hour 30 minutes Strange taste in mouth - not metallic - lasting 2-3 hours
FLU-LIKE SYMPTOMS; RASH ON THE NECK; This spontaneous report received from a consumer concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021at left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced flu-like symptoms. On 02-APR-2021, the subject experienced rash on the neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on the neck and flu-like symptoms was not reported. This report was non-serious.
Woke up Trembling & Palpitations so bad that I considered going to the ER. Took 1 Librax and went to bed. That helped.
positive effect of your vaccine injections on lesions of my classic Kaposisarcoma cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3302) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "Kaposi's sarcoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "positive effect of your vaccine injections on lesions of my classic Kaposisarcoma cancer".  Follow-up attempts are completed. No further information is expected.
No adverse event; Patient received 0.25 ml of bivalent Moderna COVID-19 vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent Moderna COVID-19 vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent Moderna COVID-19 vaccine instead of 0.5 ml). No concomitant medications were reported. The patient received vaccine from a time period between 01-Sep-2022 to 26-Oct-2022. The reporter asked what to do next after the medication error incident occurred. No treatment information was reported. This case contains information for the second patient out of 20 adult patients as described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-665494 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-665494:Same reporter.
around 6 hours after injection I noticed large amounts of pain at the site of injection.  Pain continued for two weeks.  I then saw my family doctor for treatment.  She recommended ibuprofen plus heat and ice.  This did not work.  She recommended I see a shoulder specialist which I did.  He took an XRay and prescribed anti-inflammatories for one month.  This did not help.  He also recommended exercises to do but this also did not help.  After this, he gave me a cortisone shot which did not help either.
This case was reported by a nurse via patient support programs and described the occurrence of nerve pain in a 88-year-old male patient who received Shingrix for prophylaxis. On 1st October 2018, the patient received Shingrix .5 ml. In October 2018, less than a week after receiving Shingrix, the patient experienced nerve pain and numbness of upper extremities. On an unknown date, the outcome of the nerve pain and numbness of upper extremities were unknown. It was unknown if the reporter considered the nerve pain and numbness of upper extremities to be related to Shingrix. Additional details were provided as follows: The patient was given the vaccine on his left arm. The reporter was unsure if it was given correctly because the patient was having nerve pain and numbness in his left arm and left hand.
Dose was not reconstituted, only the dilatant was given, mother notified via phone and contracted to return for re admin.
rigors, headache, chills, low grade fever (100.2). Was 4 weeks pregnant at time and 9 week ultrasound revealed no growth past 6 weeks and no fetal heart tones.
Injection site reaction; This spontaneous case was received on 29-Sep-2022 from pharmacist via Communications and concerned an elderly, male patient. At the time of this report, the patient was 69-year-old.  The patient's medical history and concomitant medications were not reported  On unspecified date, last flu season as reported, the patient was vaccinated with Fluad Quadrivalent (2021-2022 formulation) (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed an injection site reaction.  On unspecified date, the patient recovered from the event of 'vaccination site reaction'.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 69-year-old male patient developed an injection site reaction after vaccination as reported. Elapsed time between vaccination and the onset of the event is unknown. Due to lack of information concerning chronology and diagnostic findings, causality for the reported event is unassessable.; Sender's Comments: A 69-year-old male patient developed an injection site reaction after vaccination as reported. Elapsed time between vaccination and the onset of the event is unknown. Due to lack of information concerning chronology and diagnostic findings, causality for the reported event is unassessable.
Patient reports that his arm was swollen around the site of the vaccine and that he was running fever yesterday. No fever or swelling today. He states that he was taking Ibuprofen at home yesterday for the fever.
August 23. 2021. Woke up with right side of face feeling weird. Went to emergency room at hospital. diagnosed as Bell's Palsy.
Myriad of symptoms first dose 12/16/21  runny nose, fatigue, sore throat, chills, and  diarrhea  -negative Covid test day 8 Only one symptom second dose 1/5/21  only severe body aches Beginning March 3, 2021  onset of severe joint arthralgia in wrists, hands, elbows, shoulders, knees, and feet.  This is along with fatigue and inability to walk or move without pain.  This has exacerbated my carpal tunnel to becoming unbearable as well.   This is totally NEW and NEVER had this before.  If I had to describe the pain it is like inflammation similar to description of Rheumatoid Arthritis.   NSAIDS are barely helpful and contraindicated as I have GERD with Barrett's esophagus.   I have heard this reaction has been reported with post vaccination patients.
Mom states client had fever evening of vaccines and the day after. Mom states client developed "spots" that were raised and red 2 days after shots about 8-10 in total on both legs. Says spots multiplied to 30 approximately on the 3rd day after shots with a few (5-8) on his belly. Client fell on 4th day after shots and was taken to ER where she was told by DR that the spots were a vaccine reaction.
Fever, body aches, and tiredness throughout the day on 4/7/21. No medical treatment, only ibuprofen. Tiredness only on 4/8/21.
Only mild tenderness at injection site first two days after first dose Moderna vaccination on Jan 20, 2021.  No other side effects noticed and felt fine.  8 days later on Jan 28, developed a large elongated 4" by 2" itchy red rash at the injection site (upper left arm). As of today Jan 31, 3 days later, I still have the rash and so far not diminishing. Feel fine otherwise, no fever or pain,  just annoying and unsightly rash.
I started  having vesicles all over my body less than 24 hours after my first and second dose. I did go to the clinic to get allergic reaction shot.
My armpit has been swollen and throbbing for the past week on the arm that I was injected.; armpit has been swollen; had a low grade fever for about four days; extreme fatigue; migraines on and off; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Er8733) via an unspecified route of administration in the right arm on 05Apr2021 at 13:15(at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, obesity and penicillin allergy. The patient did not receive any medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ence202) via an unspecified route of administration in the right arm on 09Mar2021 at 13:30(at the age of 29-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 20:30, the patient's armpit was swollen and throbbing for the past week on the arm that was injected in, had a low grade fever for about four days, a week after injection had extreme fatigue and migraines on and off. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events armpit swollen and throbbing, low grade fever, extreme fatigue and migraines was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Moderna COVID-19 Vaccine EUA. Adverse events/side effects:  At about 10pm day of shot, developed severe chills and body aches and pains. Fever was 102F. Uncontrollable chattering of teeth. Sporadic, piercing, sharp pains in head/brain. Very fatigued.  Very sore arm at injection site that lasted days, and obvious red inflammation surrounding injection site extending out 3" all around. Worst of it kept patient from being able to sleep for several hours. By morning, no more chattering of teeth, but bed ridden sleeping/resting for the entire day Friday November 5. Fever dropped to 100.5F. Remained in bed all day Friday, and into the night, with nothing to eat. Just drank water and ginger ale. By Saturday morning  November 6, the worst symptoms had passed. Sporadic piercing pains in head lasted another day.   Nothing done/taken for treatment.
Patient was not feeling well around 9 pm and used ProAir inhaler. Patient began having chills, fever, and nausea around 9:30 pm. Patient woke up at 3 am and was still experiencing these symptoms so took 2 Tylenol which helped decrease the symptoms some. At 4 am the patient had heart palpitations (however, this is not unusual for her.. ) and at 10 am she was still having chills. At 10:15 am the patient took another Tylenol and at 7 pm she was feeling a little better and more energetic.
5-6 days post vax, pt experienced diarrhea and developed a high fever. Pt also developed a rash all over her body. Pt was treated with Benadryl. Pt experienced fatigue and a decrease in appetite. The pt was weak and would sleep the whole day. She had redness in her eyes. The physician insisted that the pt had a virus. Follow up information from a physician reported that on 5/14/99, the pt was vaccinated IM in the left thigh. The pt received 50 Units of the vaccine which is not the recommended dose. On 5/17/99, the physician reports that the pts's mother stated the pt "felt warm." The pt also experienced mild nasal congestion and on 5/15/99 felt dizzy. On 5/27/99, the pt was seen by 10 different physicians and was diagnosed with probable gastroenteritis. The physician noted that the pt recovered competely from her experience. The physician felt that the pt's experience was not related to therapy with Hep A vaccine.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On 16-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS-LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 32F (0 Celsius) for 104 hours; also there were reported temperature of 72F and 52F. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
there was a gap between the needle and the barrel / fluid came out of the gap when trying to inject vaccine in deltoid; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2021, the patient received Shingrix. On 14th June 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional gave a shingrix vaccination, but there was a gap between the needle and the barrel. The fluid came out of the gap when trying to inject vaccine in deltoid, which led to incomplete dose administration. The reporter disconnected the chat prior to providing any information about the patient's experience or if this was a potential product quality complaint. The reporter did not consent to follow up.  No additional data was available except what was presented in this adverse event report.
getting a cut on her foot; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A female patient of (age:90, unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes. The patient's concomitant medications were not reported. The patient was a consumer who is due for her second Covid19 vaccine this Wednesday. But, she received a tetanus shot last Friday, 05Feb2021, after getting a cut on her foot on an unspecified date and because of her history of diabetes. She stated that her doctor told her she must reschedule her second dose of vaccine because of receiving the tetanus shot.  She also called the CDC to get more information, and they were unable to provide information to her. The caller inquired she should reschedule her and if  not reschedule, will it kill her. The patient was advised there are no data to assess the concomitant administration of the bnt162b2 vaccine with other vaccines and referred caller back to vaccination site, let them know when and why she received the tetanus shot, and what their guidance would be.The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
This case involves a 11-year-old female patient who was vaccinated with a intramuscular dose of Tdap (batch number, expiration date, dose was not reported) in left deltoid on 02 February 2016. It was reported that reporter denied Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical condition. Concomitant medications were not reported. On 02 February 2016, same day following the vaccination, the patient experienced redness at the injection site, swelling of left hand and pain in the left arm when patient felt tired. Patient required emergency room or doctor visit. Lab data was not reported. It was reported that ibuprofen was prescribed as corrective treatment. Outcome of event was reported as unknown. List of documents held by sender: none.
This spontaneous case reported by a pharmacist, describes the occurrence of illness (booster yesterday at 9:00 am, I've been sick ever since), oropharyngeal pain (sore throat), myalgia (major body aches) and fatigue in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Nov 22, 2021, at 9:00 am, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 22, 2021, patient experienced illness (booster yesterday at 9:00 am, I've been sick ever since), oropharyngeal pain (sore throat), myalgia (major body aches) and fatigue. At the time of the report, illness (booster yesterday at 9:00 am, I've been sick ever since), oropharyngeal pain (sore throat), myalgia (major body aches) and fatigue: not resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.