chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid arm; Left arm which was hard in between elbow and shoulder; Amr was pink; Sore left armpit; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), INDURATION (Left arm which was hard in between elbow and shoulder), ERYTHEMA (Amr was pink), AXILLARY PAIN (Sore left armpit) and PRURITUS (itchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myeloid leukemia. Concomitant products included ASCORBIC ACID (VITAMIN C ACID) and DASATINIB MONOHYDRATE (SPRYCEL) for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm), INDURATION (Left arm which was hard in between elbow and shoulder), ERYTHEMA (Amr was pink), AXILLARY PAIN (Sore left armpit) and PRURITUS (itchy). The patient was treated with IBUPROFEN (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (covid arm), INDURATION (Left arm which was hard in between elbow and shoulder), ERYTHEMA (Amr was pink) and AXILLARY PAIN (Sore left armpit) outcome was unknown and PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-253150 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2021: contact details of reporter, treatment medication, new events were added
Stroke; Received the first dose at least two months ago, second dose due in Apr2021; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke in February 2021.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the first dose at least two months ago, second dose due in Apr2021). The patient was hospitalized on 30-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the first dose at least two months ago, second dose due in Apr2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication were provided.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's medical history of stroke is a possible confounding factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's medical history of stroke is a possible confounding factor.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 60 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2011, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date in 2012, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: ocular shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the ocular shingles is unknown. Upon internal review, ocular shingles was determined to be medically significant. Additional information has been requested.
Four days after vaccination, I woke up with a lot of eye watering/ leakage that cakes/ goes on to under eye area. And this has been going since then (reporting date March 21, 2021). Did see an optometrist who used a slit lamp and determined an eye infection. Taking antibiotics and eye drops (antibiotics with steroid) but still having issues. Eyes not red but very leaky. This is not clearly a reaction to the vaccination but am reporting as it happened within four days after vaccination and is curious/ not usual at all for me and being ongoing. Drainage made skin on upper cheeks very red and angry.
Hives, itching took Claritin day 1 worsened overnight took Benadryl day 2 not improved
Starting the evening of the vaccination I felt fever and flu like symptoms.  I took ibuprofen to bring down the fever and was able to sleep.  The next day, I still felt ill, little or no fever.  On and off since then, I have felt achiness in my joints and generally tired.  Symptoms similar to cold or flu.
Chest pain rad to LUE about 5 min after vaccine admin assoc w nausea No SOB, swelling, itching, rash
Patient presented to BWH ED on 5/17/21 with SOB and fatigue and found to be covid 19 positive after fully vaccinated.  Patient was appropriately treated for covid 19 and was discharged on 5/20.
I have had low-level tinnitus for a number of years. The day after my second dose Covid vaccine I woke up with the tinnitus GREATLY amplified and at a much higher pitch. The ringing had not subsided and I believe my hearing has diminished. The tinnitus is oppressively loud and much worse than the day before the vaccine.
Case number PHEH2016US022047, is an initial spontaneous report received from a physician on 25 Aug 2016. This report refers to a 35-year-old female patient (out of 6 patients). Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose FLUVIRIN (batch number: 1517501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 25 Aug 2016. No adverse event was reported following this maladministration.
Rash with small vessel type vasculitis on left thigh where shot was given, that progressed to left groin, left trunk, left axilla and left arm. These symptoms started 3 to 4 days, post vax.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (a five inch circle), FATIGUE (extreme fatigue/unusually tired), CHILLS (almost felt was going to get the chills) and FEELING ABNORMAL (something isn't quite right) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (a five inch circle). On 05-Mar-2021, the patient experienced FATIGUE (extreme fatigue/unusually tired). On an unknown date, the patient experienced CHILLS (almost felt was going to get the chills), FEELING ABNORMAL (something isn't quite right), DYSPNOEA (felt was a little short of breath), PYREXIA (felt like I had a slight fever in my body) and COUGH (felt was about to get a cough). On 15-Mar-2021, PAIN IN EXTREMITY (sore arm), RASH (a five inch circle), FATIGUE (extreme fatigue/unusually tired), CHILLS (almost felt was going to get the chills), FEELING ABNORMAL (something isn't quite right), DYSPNOEA (felt was a little short of breath), PYREXIA (felt like I had a slight fever in my body) and COUGH (felt was about to get a cough) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatments were reported.
Regular tenderness at first but after an hour, swelling had grown, redness, warmth to touch, itching injection site hardened, and was extremely tender to touch. Took Benadryl with very minimal relief. After it seemed to calm down after a few days, would get a ?flare up? with same symptoms. Continues to this day which is 11 days after injection.
soreness; achy all over the whole body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness) and PAIN (achy all over the whole body) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness) and PAIN (achy all over the whole body). At the time of the report, PAIN IN EXTREMITY (soreness) and PAIN (achy all over the whole body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
Shortness of breath, dizziness, chest pressure, started about 5 minutes after administration of vaccine.
Pink tongue; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and TONGUE DISCOLOURATION (Pink tongue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced TONGUE DISCOLOURATION (Pink tongue). At the time of the report, DIARRHOEA (diarrhea) and TONGUE DISCOLOURATION (Pink tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and TONGUE DISCOLOURATION (Pink tongue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced TONGUE DISCOLOURATION (Pink tongue). At the time of the report, DIARRHOEA (diarrhea) and TONGUE DISCOLOURATION (Pink tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Heart is racing on and off this morning; Face is swollen; Diarrhea; Rash; Temperature of 99; Nausea; Had a full blown lupus flare; Face is beet red; A spontaneous report was received from a consumer (patient) concerning a 54-years-old, female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and had a full blown lupus flare (condition aggravated), face is beet red (erythema), temperature of 99 (pyrexia), face is swollen (swelling face), heart is racing on and off this morning (palpitations), really really sick (sickness), rash, nausea, diarrhea.  Medical history included abnormal blood pressure and lupus. The concomitant medications included pantoprazole, hydroxychloroquine and blood pressure medications.  On 12 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: not provided), intramuscularly for the prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient had a full blown lupus flare (medically significant). The patient went to the emergency room. Her face was beet red and swollen and had temperature of 99. The patient stated that she had nausea and diarrhea and a rash.  On 16 Mar 2021, the stated that her heart was racing now on and off. She was really really sick now.  The treatment information included prednisone and epinephrine.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the events of had a full blown lupus flare (condition aggravated), face is beet red (erythema), temperature of 99 (pyrexia), face is swollen (swelling face), nausea, diarrhea, rash, really really sick (sickness), heart is racing on and off this morning (palpitations) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
PT FAINTED A MIN OR LESS AFTER VACCINE ADMINISTRATION. PT SAID DID NOT HAVE ANYTHING TO EAT ALL DAY. 911 CALLED, CAME TO SEE PT AND LATER LEFT. PT WERE NOT TAKEN TO HOSPITAL OR ER.
MODERNA COVID VACCINE #3 GIVEN 11/2/21, LOT #071F; pt in Health and Rehab in city; 1/17/22 pt tested positive for COVID; placed in isolation room; given Dexamethasone, Vitamins C, D and zinc, Regen-COV; O2 supplementation; pt was found deceased in the rehab center
Had a headache and  irregular heartbeat  that lasted about 15 hours.  Next day, I was back to normal.
Throat swelling, throat  muscle tightening. Extremely hard to swallow. Rash on neck and face. Nausea.  ER visit for  IV medications for allergic reaction
Began the same night with fatigue and dizziness. Next day (April 18th) felt fatigue in the afternoon around 1p, then weakness, malaise, and nausea. Arm also began to swell and itch. Next day (April 19th) itchy swollen arm spread to shoulder blade and ribcage near injection site and was warm to the touch, strong chills, weakness, and body aches. Next day (April 20th) itchy swollen arm was still itchy and hot to the touch. The other symptoms were waning: no chills, still a little weak and still a little achy. Craved and ate meat. Next day (April 21st) arm swelling was going down. No more chills, less weak, and less achy. Craved and ate meat. Next day (April 22nd) arm swelling was less, but still swollen around the injection site (no longer on the shoulder blade and ribs), and a little itchy. Craved and ate meat. Next day (April 23rd) attempted a workout and felt super nauseous, fatigued, and weak afterwards (usually not how I feel after these workouts that I do weekly). Next day (April 24th) felt back to normal with mild itch at the injection site only.
In less than a minute: medicinal taste and smell.  Tongue became tingly and slightly numb.  1-2 hours very sore arm, diarrhea, fatigued.  Day 2-4, swollen upper arm, rash the size of a softball on injection site, swollen lymph node in armpit, temp 102F, chills, body aches, severe fatigue, nausea, high BP.  Still not feeling 100% back to normal.
7 patients devel large welt (approx 1 1/2 inches), redness, swelling & pain @ inj site; all pt had negative allergy hx to eggs;
It was reported that an 18 year old male pt was dx'd with an Asymptomatic Arachnoid Cyst, 6 years ago, discovered by chance after an accident. This cyst was smaller at the time and did not need any intervention. Reportedly, the pt received a Menomune A/C/Y/W-135 vaccination on 1/21/00 and several weeks later, the pt developed severe headaches, rating a 10 on a scale of 1 to 10. Neurologist saw pt and had a MRI done which showed the Arachnoid Cyst was enlarged. Vioxx and Biofeedback was tried, which seemed to help slightly but headaches have continued. A Neurosurgeon has suggested possible surgery. From correspondence *received at manufacturer on 5/1/00,* it was reported that the pt continues to be treated with a non-steroidal anti-inflammatory. As of 4/12/00, the pt's headaches have subsided. He is scheduled for a return visit in 6/00 to the Neurologist. *F/UP report on 3/4/03: Amendments in the narrative and add'l PT and responsible MD info was also provided. (also added adverse event coding Aggravation Rx).*
mild case of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (mild case of COVID-19) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COVID-19 (mild case of COVID-19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (mild case of COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This spontaneous case concerns a 82-year-old female patient with no details on relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 5 months after the second dose of mRNA- 1273 vaccine. Clinical manifestations included headache and fatigue. The rechallenge is not applicable due to the nature of the event. Patient´s age is a risk factor for severe COVID-19, but nevertheless the patient experienced mild disease.  The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Drug ineffective was not captured since information regarding the appropriateness of the schedule of vaccination is not available at this moment.
runny diarrhea; This spontaneous report was received from the patient's mother referring to a 4 months old female patient. The patient's concomitant medication, pertinent medical history, drug reactions/ allergies was reported as none.     On 02-DEC-2020, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, strength, lot# and expiration date were not reported) orally for routine vaccination.         On 04-DEC-2020 (reported as today), the patient had runny diarrhea. Lab diagnostics/studies performed was reported as none. Information about treatment and sought medical attention was not provided. The outcome of the event was reported as not recovered.        The relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
102 degree fever; chills; body trembling; headache; joint pain; swollen lymph nodes on left side; This is a spontaneous report from a non-contactable consumer (patient) received via a reporting program. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 08Feb2021 at 01:00 PM (Batch/Lot Number: EL9265) (at the age of 32 years old) as dose 2, single for COVID-19 immunisation in a workplace clinic. The patient has no relevant medical history and has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient was previously administered the first dose of BNT162B2 on 18Jan2021 at 01:00 PM, single (at the age of 32-years-old) (Lot number: EL1283) in the left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021 at 06:00 PM, the patient experienced 102 degree fever, chills and body trembling, headache, joint pain, swollen lymph nodes on left side. All persist even 48 hours after vaccination. The patient underwent lab tests and procedures on 08Feb2021 which included fever: 102 degree. The events did not result to physician office and emergency room visit. The patient did not receive treatment for the events. The patient did not recover from the events on the time of the report.  No follow-up attempts are possible. No further information is expected.
First dose on 29 DEC 2020 and 2nd shot on 21 JAN 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 29 DEC 2020 and 2nd shot on 21 JAN 2021) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028C20A and 025J2019) for COVID-19 vaccination.     The patient's past medical history included Aortic valve replacement in 1993 and Pacemaker insertion (cardiac) in 2016. Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included ALOPURINOL, LOSARTAN, WARFARIN, LEVOCETIRIZINE and GLIPIZIDE for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 29 DEC 2020 and 2nd shot on 21 JAN 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 29 DEC 2020 and 2nd shot on 21 JAN 2021) outcome was unknown.            Patient did not had any reaction to the first and second dose. Treatment information was not provided.   This case was linked to MOD-2022-539494 (Patient Link).
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 11-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
10 minutes after vaccination the entire left hand side of my face went numb as if I'd had a dental procedure (I was injected on the left side). The nurses on site looked me over and said I was ok to go home at the end of my wait time.  The effect faded as the day went on and was gone the next morning. I was vaccinated on a Tuesday morning and on the following Thursday morning I woke up with swelling covering almost my entire bicep area on the side I was vaccinated. The area is about 8 inches by 4 inches. It is swollen, red, hard to the touch, painful and mildly itchy.  As of today (Friday) it has gotten a couple of inches bigger and not improved at all.
Novartis vaccine administered to 3 yo. Manufacturer's insert states to be used for children 4 and older, i.e. as off-label use.
Fever, myalgias, arthralgias, tinnitus, headache, dizziness.