chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nasal congestion; Dizziness; Explosive diarrhea; Slight cough; weak from spending so many days in bed; Off label use; sore arm / muscle aches; Fever / continues to have fever 102.2; Chills; Headache; Fatigue / Exhausted; This spontaneous case was reported by a nurse and describes the occurrence of NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough) and ASTHENIA (weak from spending so many days in bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknwon) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney transplant in 1998 and Kidney transplant in 2019.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough), ASTHENIA (weak from spending so many days in bed), OFF LABEL USE (Off label use), MYALGIA (sore arm / muscle aches), PYREXIA (Fever / continues to have fever 102.2), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue / Exhausted). At the time of the report, NASAL CONGESTION (Nasal congestion), DIZZINESS (Dizziness), DIARRHOEA (Explosive diarrhea), COUGH (Slight cough), ASTHENIA (weak from spending so many days in bed), MYALGIA (sore arm / muscle aches), PYREXIA (Fever / continues to have fever 102.2), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue / Exhausted) outcome was unknown and OFF LABEL USE (Off label use) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza A virus test: negative (Negative) negative for Flu A. On an unknown date, Influenza B virus test: negative (Negative) negative for Flu B. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The patient had test for Flu A and Flu B on unknown date ,whose result where Negative
Skin redness, swelling, warm to the touch, approximately 2inch in diameter, with the back edge of the inflammation touching the injection site, starting approximately 8 hours after the injection, ongoing as of report. Moderate burning sensation localized in tattooed areas of skin on left shoulder-blade (back) and forearm from approximately 12 hours after injection to approximately 48 hours after injection. Inability to lift elbow above shoulder on injection arm, starting approximately 12 hours after injection, continuing to approximately 36 hours after injection. Severe chills, painful shivering, starting about 12 hours following injection, lasting for less than 2 hours. Not alarming or long-lasting enough to seek treatment. Had severe chills and arm mobility issues with the Pfizer vaccine doses in the first round, expected those symptoms, and Covid Arm is a known possible side effect. --I'm only reporting because I haven't seen anything regarding the shot making your tattoos feel like they're on fire.
Patient started receiving Anthrax vaccinations in 2007 and has had a total of 4 shots.  He has had joint pain, in all joints, feeling "achy" after each injection.  He states the joint pains have gotten progressively worse with each injection to where when he received his last injection prior to deploying, Mar 2008, he had joint pains and stiffness for a total of 3 months.  He has no ongoing history of joint pains, other than occasionally his right wrist would bother him.  Member was seen at  Clinic by Dr on 20 Jan 2009.
Incorrect route of product administration; Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration ) and VACCINATION SITE PAIN (Vaccination site pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Major depression on 01-Jan-1980. Concurrent medical conditions included Drug allergy (CA++ Channel Blockers), Asthma since 01-Jan-1950, Type 2 diabetes mellitus since 01-Jan-2000 and Arthritis (gradually worse with age) since 01-Jan-2006. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 01-Jan-2010 to an unknown date for Asthma, CITALOPRAM from 01-Jan-1987 to an unknown date for Depression, METFORMIN from 01-Jan-2010 to an unknown date, GLIMEPIRIDE from 01-Jan-2015 to an unknown date and INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) from 01-Jan-2010 to an unknown date for Diabetes.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration ) and VACCINATION SITE PAIN (Vaccination site pain). On 01-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration ) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No treatment medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-031651, US-MODERNATX, INC.-MOD-2021-032479 (E2B Linked Report). This case was linked to MOD-2021-031572 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Historical condition and concomitant products were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, vaccination site pain, a causal relationship cannot be excluded. This report also refers to a case of incorrect route of product administration for mRNA-1273, lot # 014M20A   with no associated AEs. US-MODERNATX, INC.-MOD-2021-031651:Crosslinked case: Same reporter (Wife case 1st dose) US-MODERNATX, INC.-MOD-2021-032479:Crosslinked case: Same reporter (Wife case (2nd dose)
Site: Pain at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: After receiving the vaccine, the patient went to sit in observation and immediately noticed her arm had a numb, \"fallen asleep\" feeling. She reported that the numbess and tingly feeling was on the injection arm from the shoulder down to her fingers. She moved her fingers without an issue. After 30 min observation, she said the numbness level did not change. The numbness stayed consistent, did not get worse and did not spread. She opted out of urgent care. She was counseled to go to ER if worsens
severe stomach pain; she became nauseated; she could not breathe / doctor prescribed oxygen; her face turned gray; her lips turned blue; Headache; body rash; fever; Fatigue; Body Trembing; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 12-year-old female patient who received FluLaval Tetra 2020-2021 season) for prophylaxis.   On 7th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 7th October 2020, immediately after receiving FluLaval Tetra 2020-2021 season, the patient experienced stomach pain, nausea, difficulty breathing, pallor facial, blue lips, headache, generalized rash, fever, fatigue and tremor. The patient was treated with oxygen. On an unknown date, the outcome of the stomach pain, nausea, difficulty breathing, pallor facial, blue lips, generalized rash and tremor were recovered/resolved and the outcome of the headache, fever and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, nausea, difficulty breathing, pallor facial, blue lips, headache, generalized rash, fever, fatigue and tremor to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The reporter was the mother of the patient. The reporter stated that her daughter received the vaccine and immediately the patient complained of severe stomach pain, her face turned gray, her lips turned blue, she stated she could not breathe, and she became nauseated. The physician saw the patient while she was in the office that day for the injection. The physician prescribed oxygen for the patient and after one hour allowed the patient to go home. The patient also complained of a headache, had a body rash and a fever between 99 degrees to 106 degrees. The patient had recovered except for the headache, fever and fatigue. The reporter wanted to know if the patient should receive the FluLaval injection next year. The reporter was provided with the Medical Disclaimer and gave her the number to our MI department for her health care provider. The reporter also read the information from the PI in content. The reporter consented to follow up.
This spontaneous report as received from a health professional refers to a 25 year old female patient. The patients medical history included car accident with neck whiplash approximately on an unknown date in February 2013 (reported as few weeks before vaccination). On 06-MAR-2013, the patient was vaccinated with a dose of GARDASIL (lot # H017698, expiry date was 02-JUL-2015, route and dose were not reported). On 06-MAR-2013, the patient became light headed immediately after vaccination. Approximately on 10-MAR-2013 (reported as 4-5 days after vaccination), the patient developed a sore arm and pain radiated into her neck. Laboratory tests performed was none. The patient sought medical attention and fluids were given for the event light headedness. In response to the events GARDASIL was discontinued on 06-MAR-2013. Approximately on an unknown date in MARCH 2013, the patient recovered from all the reported events. Additional information has been requested.
Shingles; he got real sick; This is a spontaneous report from a contactable consumer (patient's wife). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EN6198; Expiration Date: 30Jun2021) as 1st dose, single for covid-19 immunization. Medical history blood pressure and high cholesterol. Concomitant medications included valsartan for blood pressure and simvastatin for high cholesterol The patient got his vaccine on 20Feb2021 and two days later he got real sick and broke out with shingles. The reporter stated that they are still improving. The patient was treated with valacyclovir 1000mg. The patient did not go to hospital. He did not get the second shot that is why the reporter was calling for. She doesn't know if the patient should get the second shot. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
One week post vaccination:  itchiness, redness, warmth, soreness and small bump in/around injection site
SORENESS AT INJECTION SITE, JOINT PAIN,  VERTIGO, LEG SWELLING
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of an unknown age and gender. On an unknown date the patients were vaccinated with MMR II via an unknown route of administration for an unknown indication. Past medical history and concomitant medications were not reported. On an unknown date the patients received MMR that was exposed to 57 degrees F for 10 hours which is an excursion that is unsupported by in-house stability data. No adverse symptoms reported. The healthcare worker was unable to provide states of administration and lot numbers/expiration dates at the time of this report. The outcome of patients received MMR that was exposed to 57 degrees F for 10 hours is unknown. The reporter considered patients received MMR that was exposed to 57 degrees F for 10 hours to be not related to MMR II. Additional information has been requested.
Itchiness on hand, head and feet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchiness on hand, head and feet) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for Product used for unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness on hand, head and feet). The patient was treated with BUSPIRONE HYDROCHLORIDE (BUSPAR) at a dose of 15 mg twice a day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and OMEPRAZOLE at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness on hand, head and feet) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-116535 (Patient Link).
Lower back pain that increased to such severity that I could not walk for a day. I have had PT and pain meds that have not helped the pain.
It started with digestive issues for two weeks that lead to major fatigue. Then intermittent sleep  started with major headaches. I have elevated heart beat with swollen thyroid. I am currently experiencing muscle spasms, pain and burning sensations in my legs. During the past couple of months I never associated my symptoms to the  vaccine but my older sister after taking the first dose of vaccine she started to have similar symptoms as me.
a lot of itching from time to time in the area under the injection and the arm it's red there; a lot of itching from time to time in the area under the injection and the arm it's red there; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS a lot of itching from time to time in the area under the injection and the arm it's red there) and VACCINATION SITE ERYTHEMA (a lot of itching from time to time in the area under the injection and the arm it's red there) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM D BEACONS) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (a lot of itching from time to time in the area under the injection and the arm it's red there) and VACCINATION SITE ERYTHEMA (a lot of itching from time to time in the area under the injection and the arm it's red there). At the time of the report, VACCINATION SITE PRURITUS (a lot of itching from time to time in the area under the injection and the arm it's red there) and VACCINATION SITE ERYTHEMA (a lot of itching from time to time in the area under the injection and the arm it's red there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included application of VapoRub to the area.
Initial report received from a healthcare professional on 25 July 2013. A 7-month-old male patient, whose medical history and concomitant medications were not reported, had received a dose of PENTACEL (batch number: C4483AA, expiry date: 10/04/2014, route and site of administration were not reported) on 24 July 2013 at about 10.00 hours. On 24 July 2013 at 16:45 hours, the patient's mother called to report that the patient had experienced vomiting and had vomited 3 to 4 times. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender: none.
Dizziness when moving head quickly; Headache; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 01May2021 at 17:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines and allergy to bananas (oral allergy) and raw pineapple (oral allergy). Concomitant medications included omeprazole (MANUFACTUERER UNKNOWN), colecalciferol (VITAMIN D3), folic acid (MANUFACTURER UNKNOWN) and L-theanine (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received loratadine (CLARITIN) and amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient experienced headache everyday from 10May2021 to 18May2021. The patient also experienced dizziness when moving head quickly on same dates as headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab test on 18May2021 which included COVID test via nasal swab and the test result was negative. Therapeutic measures were taken as a result of the events headache and dizziness when moving head quickly which included treatment with acetaminophen (TYLENOL) 500 mg twice a day. The clinical outcome of the events headache and dizziness when moving head quickly were recovered on 18May2021.   No follow-up attempts are needed. No further information is expected.
Two days after vaccine was administered, patient developed a warm, red, firm lump (1inchx3inch) about 1 inch below injection site. Patient describes this as painful like a bruise. Does not report any fainting, fever, chills, or anything else besides redness/pain/swelling.
Narrative:  85 yo male died on 12/03/2021 with hx of niddm, mild ckd, bph s/p TURP, chronic diffuse low back pain, bilat knee pain on chronic opioids, macular deg/glaucoma, left eye enucleation due to MRSA infection. Pt had received covid vaccines on 2/1/21 & 3/4/21 from another site. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Possibly received extra dose. Uncertain if patient is immunocompromised as this was not noted on consent form. Timeline: 1st dose Janssen 03/19/2021, 2nd dose Moderna 04/20/2021 and 3rd dose Janssen 03/15/2022. If patient is immunocompromised this would be an appropriate timeline.
Fever and chills lasting 2 days after both shots. Also, terrible brain fog, headaches, stomach pain (pain not nausea), and extreme bloating,  and fatigue: all these adverse effects lasting acutely for 3 months. After 3 months, still could not concentrate mentally at my best level, also still felt tired. Finally by November, 2021, was really feeling back to my normal self mentally and physically. Another reaction I had was an extremely heavy menstrual period and immediate start of menopause. Even though I was 57, I had still been getting my menstrual cycle every month or every 2 months.
Patient SAID HE IS NOW HAVING PAINS AROUND UPPER LEFT SHOULDER. THINKS IT MAY BE FROM FLU SHOT GIVEN ABOUT A MONTH AGO.
Received shot 11:45 am at 7:45 pm felt a tightness start from my left arm and felt like it reach across my chest. It felt like a blanket wrapped to tight around my chest and my throat. The symptoms persisted. I proceeded to the emergency room and was determined not to have a PE and was told to contact my PCP but if it got worse I could come back. Symptoms continued and contacted a cardiologist who got me into his clinic on the 21. At this point my symptoms were chest burning constantly right in the center, neck tightness, fatigue and taking deep breath even when walking in a pool. I am having a cardiology work up at this point.
pt recvd vax; pt exp stiff neck & HA;1dec95 broke out w/ a pimple like rash on stomach,arms & back;some of them were blistered & red;also exp bump at inject site;
Red rash and hard nodule about 3-4 inches long starting a few inches below injection site. Very tender to touch.
The pt experienced swelling and redness to the left thigh, secondary cellulitis. Pt was given Augmentin. Mom states was better 24 hours post starting antibiotic. Completely resolved in 3-4 days.
Approximately 3 cm diameter of redness with mild edema and discomfort at injection site. Compaint of generalized malaise and arthralgia 24 hours after receipt of vaccine.
Top and bottom lips became tingly and numb, tip of tounge became numb, red demarkation noted above upper lip and nose.
Mom states child went home and took a nap. Child woke up from nap at 16:00 (flushed) with a fever of 104.5F. Mom phoned and was instructed by MD to give cool sponge bath and give child Motrin. Fever continued and child was taken to ER. Symptoms of diarrhea and fever from 21:00 until 12:00 on 8/10/02. Vomited X 1 in AM of 8/10/02. Improved with antibiotic and Motrin given at ER. Was normal and healthy on 8/11/02.
Simple febrile seizure, generalized tonic-clonic shaking, lasted approximately 2 minutes. Brief post-ictal symptoms. Seen in the ED after and returned to baseline with normal exam. Was febrile in the ED.
2 days after vaccination of TRUMENBA, teen told someone his arm was red and slightly swollen. It improved with ice and ZYRTEC. 48 hrs later swelling resolved.
I started feeling ill the sixth day after hot cold then. Then on Monday I start getting severe stomach cramps and then I started having diarrhea and then vomiting Tuesday the 30th I was sick to my stomach all day long. Wednesday the 31st my son took me to the ER and they admitted me into the hospital.  I was also wondering I need help paying for the hospital bill because I am on Social Security disability.
DIZZINESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies and has not had covid or been tested positive for covid. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dizziness. This report was non-serious.
Vaccine admit @ approx 1430 pm on 9/11/19 + next day developed "rash" to upper body shoulder area + intermittent fevers (99.5 - 99.7) fevers resolved 9/14/19 + rash has improved but still present. No other sx. But see ER or UC/ED for urticaria Monday if not resolved.