chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 19 December 2011 from a consumer who is also the patient's parent and additional information was received from a health care professional. A 43-year-old male patient received an injection (route and site not reported) of INFLUENZA VACCINE, Sanofi Pasteur Inc. lot not reported, on 17 November 2011 (also reported as 18 November 2011). The patient had a medical history of increased blood pressure and "Dbj". It was unknown if the patient had any illnesses at the time of vaccination, or had any vaccinations within 4 weeks of the influenza vaccine. The patient's concomitant medications were unknown. It was reported that the patient had no previous influenza vaccines. The parent stated that the patient was seen by her on 18 November 2011 and he had been sick after receiving the influenza vaccine and was having a severe headache and could not eat. The patient had called 911 on Sunday and was taken to a hospital. The patient died on 21 November 2011. The outcome was reported as fatal. Documents held by sender: None.
fever; chills; headache in her eyes; eyes feel glassy and watery; arm started hurting immensely; pain in arm, neck, small of back; pain in shoulders, knees; Knot under the skin; knot higher up on shoulder; Red rash in a circle under where he put the medicine in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), EYE IRRITATION (eyes feel glassy and watery), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), PYREXIA (fever) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), MYALGIA (pain in arm, neck, small of back) and ARTHRALGIA (pain in shoulders, knees). On 03-Feb-2021 at 9:00 PM, the patient experienced VACCINATION SITE PAIN (arm started hurting immensely). On 04-Feb-2021, the patient experienced EYE IRRITATION (eyes feel glassy and watery), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache in her eyes). At the time of the report, VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), EYE IRRITATION (eyes feel glassy and watery), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), PYREXIA (fever), CHILLS (chills), HEADACHE (headache in her eyes), VACCINATION SITE PAIN (arm started hurting immensely), MYALGIA (pain in arm, neck, small of back) and ARTHRALGIA (pain in shoulders, knees) had not resolved.            Treatment for the events included paracetamol and ice on the affected arm.   No concomitant medication were provided.; 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, a causal relationship cannot be excluded.
Dizzy, spacy, light headed,  a little disoriented and, after 10 minutes or so, sleepy.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 13-APR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for  the prevention of shingles (herpes zoster). On 14-SEP-2017, the patient was diagnosed with shingles after experiencing extreme pain and an outbreak of blisters on her legs, arms and ribcage which resulted in medical treatment. This outbreak lasted for at least three weeks. On or about 02-NOV-2017, the patient was diagnosed with a second shingles outbreak. On 25-NOV-2017, the patient was diagnosed with a third outbreak of shingles after reporting to her physician with lesions on her side and a feeling like "something was biting her from inside". The patient continued to have reoccurring shingles outbreaks throughout the end of 2017 and throughout 2018 as a result of the zoster vaccine live (ZOSTAVAX), including extreme pain and numbness in her left leg which all resulted in medical treatment. Pain and tingling sensations in her skin, as a result of zoster vaccine live (ZOSTAVAX), were permanent and continued at the time of the report. It was also specified that the patient suffered serious, progressive, permanent, and incurable disfiguring injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment. the event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Herpes zoster was considered to be disabling due to the severe, permanent and incurable injuries.
Mouth started tingling, throat had feeling of tightness, voice changed. 50mg of liquid Benadryl, EpiPen. Observed in emergency department.
This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid pulse), DYSMORPHISM (drooping face), DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite) and COLD SWEAT (cold sweat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced HEART RATE INCREASED (rapid pulse), DYSMORPHISM (drooping face), DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), COLD SWEAT (cold sweat), HYPERSOMNIA (slept for 13 hours), MUSCULOSKELETAL PAIN (calves and thighs hurt for 4 days), PYREXIA (slightly feverish), ARTHRALGIA (severe join pain) and FATIGUE (fatigue). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at a dose of UNK dosage form. On 21-Mar-2021, HEART RATE INCREASED (rapid pulse), DYSMORPHISM (drooping face), DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), COLD SWEAT (cold sweat), HYPERSOMNIA (slept for 13 hours), PYREXIA (slightly feverish), ARTHRALGIA (severe join pain) and FATIGUE (fatigue) had resolved. On 24-Mar-2021, MUSCULOSKELETAL PAIN (calves and thighs hurt for 4 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took ibuprofen to help with thighs and calves hurting. No concomitant medication information were provided   This case was linked to MOD-2021-073078 (Patient Link).
heavy menstrual bleeding, passing of clots during period, irregular bleeding during middle of cycle even after having a period 10 days prior, this has happened for 3 months and I'm not sure if my period has returned to normal.  I was previously on birth control and often did not have a period but was consistently regular when I did have a period - it would be at end of birth control pack/placebo pills.  Even on birth control I had this irregularity.  I have since taken myself off birth control to try and get my body back to normal.
Pt. felt tired days following administration. Pt discomfort increased to heaviness, numbness and pain in extremities. "Guillain-Barre syndrome". Treatment - NSAIDS, steroids, pain meds.
Immunocompromised patient received a .25 mL dose instead of his 3 full dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Immunocompromised patient received a .25 mL dose instead of his 3 full dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Immunocompromised patient received a .25 mL dose instead of his 3 full dose). At the time of the report, UNDERDOSE (Immunocompromised patient received a .25 mL dose instead of his 3 full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  The reporter stated that then it was the time for his booster and they wanted to know if they should administer a  0.5 mL or 0.25 mL dose.
Pt has a history of diabetes and diastolic heart failure with preserved ejection fraction.  He is fully vaccinated and has had a booster.   He presented due to hypoxia and was admitted.
Pt reported hives and swollen tongue 2 days after injection. This occurred with exercise and exertion. Pt took BENADRYL that helped with her symptoms. She had recurrent hives 2 more days only with exercise. All relieved with BENADRYL.
This case was reported by a consumer via sales rep and described the occurrence of upset stomach in a 50-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020. Concomitant products included SHINGRIX. On 21st April 2018, the patient received the 2nd dose of SHINGRIX. On 22nd April 2018, 1 days after receiving SHINGRIX, the patient experienced upset stomach, fatigue, contusion and headache. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the upset stomach, fatigue, contusion, headache and pain in arm were recovering/resolving. The reporter considered the upset stomach, fatigue, contusion, headache and pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: For tolerability after receiving 2nd dose of SHINGRIX, refer case US2018078793. The age at vaccination was not reported. The patient received SHINGRIX in the left deltoid. The patient experienced bruising after vaccination. Less than a month after receiving vaccination, the patient experienced arm pain. The expiry date was reported as 4th July 2018 and was corrected to 4th July 2020 as per sales database.
My arm was sore the first two days after receiving the vaccination.  Nothing abnormal the first two days then soreness went away for days 2-7.  On day 8 I woke up and my left arm was very swollen, hard and bright red in a 3-4  inch area around where shot was given.  I took Claritin and 2 ibuprofen the swelling started going down in about 24 hours.  Red color and hard area was present for several days.  By the time my second dose was due on January 26th my arm felt normal.
Worsening Tinnitus  starting about a week of go.  It is  constant.
headaches within 4 hours and took two ibuprofen to help, stomache pain, hives behind ear and neck and she took two benadryl, eyelids were swelling and liquid was dropping, hives and rash behind ear and neck, welts on both arms, large rash on left thigh and buttox - went to the urgent care and they gave her a prescription for 5 days of prednisone and continuing benadryl, also recommended to see an allergist
Have not received second dose within 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Have not received second dose within 36 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Have not received second dose within 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Have not received second dose within 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Fatigue (slept for 13.5 hours),  R arm swelling below injection site with some difficulty moving  (12 + hours after injection)
Sweating around neck; Wasn't feeling good on Sunday; Chills; Joint pain; Muscle pain; Nausea; Feeling tired; A spontaneous report from unspecified location was received from a consumer concerning a 66 year elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like chills, joint pain, swelling, muscle pain, nausea, sweating around neck area, Wasn't feeling good on Sunday achy all over and tired.  The patient medical history was not provided.  No relevant concomitant medications were reported.  On 07-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the anatomical location for prophylaxis of COVID-19 infection.  As a effect of first dose as per the patient statement he experienced chills, joint pain, swelling, muscle pain, nausea, sweating around neck area, Wasn't feeling good on sunday achy all over and tired still feeling side effects till 23-JAN-2021.  No laboratory details are provided.  No treatments received details provided.  As per the patient statement till now he experienced all the mentioned adverse events so none of them is get resolved.
burning in her eyes/the feeling you get when you get soap in your eyes; Experiencing itchiness here and there/itchiness around the body; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning in her eyes/the feeling you get when you get soap in your eyes) and PRURITUS (Experiencing itchiness here and there/itchiness around the body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (Experiencing itchiness here and there/itchiness around the body). On an unknown date, the patient experienced EYE IRRITATION (burning in her eyes/the feeling you get when you get soap in your eyes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, EYE IRRITATION (burning in her eyes/the feeling you get when you get soap in your eyes) outcome was unknown and PRURITUS (Experiencing itchiness here and there/itchiness around the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Follow-up information received on 19-Mar-2021, contains significant information. Added new event. and treatment medication updated.
Moderna COVID-19 Vaccine EUA Injection site redness, swelling, itching, discomfort the size of a fist 7 days after injection.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history and concurrent condition were reported. On an unknown date in September 2014 the patient was vaccinated with the first dose in the series of RECOMBIVAX HB (strength 2.5/0.5 DF), intramuscularly and second dose in the series on an unknown date in September 2015 (dose, frequency, lot# and expiration date unknown). The third dose in the series of RECOMBIVAX HB (lot# L019299 and expiration date 14-APR-2017) was on 05-FEB-2016 (inappropriate schedule of drug administration). No adverse effects were reported. The outcome of inappropriate schedule of drug administration was unknown. Additional information has been requested.
Patient states that her lymph nodes under her right armpit were swollen for about 2 weeks after receiving first dose of COVID-19
This case was reported by a consumer and described the occurrence of adverse reaction in a 63-year-old female patient who received Flu vaccine. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. The reporter considered the adverse reaction to be probably related to Flu vaccine. Additional details provided were as follows: This case was reported by an unspecified adverse reaction after receiving a dose of Flu vaccine. The reporter did not provide any further details.
On 20JAN95 pt's mom calls-pt had sore arm & redness around shot area; advise: heat, movement & APAP;
8/9 started taking Typhoid vaccine. 2nd dose on 8/11. Next morning had mild diarrhea, felt itchy and started scratching, broke out in hives around groin, midriff, and back. Called doctor who recommended BENADRYL and followed with a CLARITIN. Medicine took care of hives. Did not take 4th dose. Today has unsettled stomach still. 8/21 develop something like a floater on left eye, read that they form as possible autoimmune reaction. Has follow-up appointment with doctor next week.
I had very very unusual stint of hives that flared up for 3 days. I didn't know what was happening at first. I started out itchy at my ankles, both legs, groin area, and going up my neck underneath my hair (I wear a ball cap / or hard hat at work always). It got itchy that I ended up leaving work because I couldn't get anything done and at that time I wasn't sure what was going on or what could have caused it. Urgent care recommended Benadryl until I could get in to see a dermatologist. I have picture of the huge raised lumps ranging from dime to golf ball size all of me and up my sides. I used topical itch creams and Benadryl to try to relive it. I was off work for 2.5 days. I did go to the dermatologist on April 21st and he told me it was a form of hives. He prescribed me a pill and cream to help and had me take Allegra to help with it. I had another appointment with him about a month after when I still had problems. It was at that point very manageable and I could function normally. Ever since, I still have more itching sensation that I ever had before the event and I now have to continually take Allegra, and occasionally the prescription if it flares up to get the hives symptoms back under control. I had another flare up in November when I got the booster, although it was less severe and more manageable so I could deal with it with the drugs I had.
Patient did not want dinner that evening. Found unresponsive in bed around 7pm. Patient had known severe anemia (HgB6.9) with decision to forgo additional transfusion or GI workup.
08/23/06 pm L arm swollen, painful, 8/24/06 pm increased swelling L deltoid down L arm painful, Temp 100-101 red area deltoid to elbow having muscle spasms, 8/28/06 L deltoid red painful to touch hard.
Within 5-10 minutes of vaccination, the patient became diaphoretic, nauseous, and had a syncopal episode that lasted approximately 5 seconds. EMS evaluated the patient on-site. The patient was hypotensive (64/43) with a FSBG of 108mg/dL. EtCO2 and EKG were normal. EMS administered 1L normal saline and transported the patient to Hospital Emergency Department. In the ED, the patient reported being "anxious for days" about getting the vaccine and remembers hyperventilating prior to syncopizing. Upon assessment, the patient was normotensive (126/79) following fluid therapy. The patient reported improvement in the ED. The physician discharged the patient with diagnose of vasovagal syncopal episode secondary to an anxiety inducing event.
Very sore, swollen arm. Fever: 102, achy, nauseous, dizzy, headache
fatigue; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 05Mar2021 09:30 (Batch/Lot number was not reported) as single dose at the age of 60-year-old for COVID-19 immunisation.  The patient medical history included known allergies not specified. No COVID prior vaccination. The patient was taking concomitant medication but they were not specified as "to many to list". No other vaccine in fourweeks.  The patient experienced fatigue in Mar2021. It was unknown if the patient received treatment for the event. COVID was not tested post vaccination. The outcome of event was unknown.    Information on the Lot/Batch number has been requested.  No follow-up attempts are needed. No further information is expected.
Both of Pts legs were red, swollen and hot to the touch. Pts mom stated that pt may have had a reaction with last set of shots at 6 months of age.
Pain and soreness at injection site beginning approximately 3 hours after the injection.  Chills, shivering, sweating, fever, upset stomach, nausea, beginning approximately 11 hours after the injection (1:30 AM).  Felt tired and weak and had a fever (99.9 degrees F) the morning after the day of the injection.  The low grade fever lasted until approximately 30 hours after the injection.
Patient was administered FLUZONE HD on 10/4/2010 complained of muscle pain to husband later that day. Returned to pharmacy on 11/1/2010 and complained of limited mobility of left arm.
Vomiting, chills, pain in my head neck and back, loss of control of my bladder, fever, and night sweats. Patient has a history of MS and is receiving Ocrevus infusions Q6 months.  Patient reported similar side effects (significant) after most recent vaccine administration (booster) - in chart it also references that she experienced all of these same symptoms with all THREE COVID vaccines.  Following covid shot on Friday (10.29.21) became violently ill. Vomiting, chills, pain in my head neck and back, loss of control of my bladder, fever, and night sweats.  Diagnosed with UTI on 11.22.21.   Reported with 2nd dose (4.21.21);  swelling of face / throat; dizziness/weakness; uncontrollable shaking; loss of bladder function.   Note from patient to PCP in patient chart:  "received my 2nd dose and f the Covid vaccine last night at 6pm. By 9pm I was dizzy and feeling very lightheaded so I decided to go to bed. I woke up at midnight with uncontrollable body shaking and started vomiting. There was so much pressure in my head and my neck hurt so bad. I had a fever of 101.4 and the body shaking became so bad that I wet myself 3 times. My husband almost called 911.  I was able to drink some water and keep that down around 5am and haven't vomited since. I've had 1 shaking episode at 12pm and that lasted about 35 minutes. I have a terrible headache and body aches but all the scary stuff seems to have gone away."