chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 14 Apr 2010: This patient was enrolled in study, a phase 3b, open-label, randomized, parallel-group, multi-center study to evaluate the safety of Novartis MENVEO when administered with routine infant vaccinations to healthy infants. The patient received the first dose of study vaccine on 15 Feb 2010. On 27 Feb 2010, the patient suffered fever, irritability, abdominal pain and diarrhea. On 28 Feb 2010, the patient was admitted to hospital as symptoms continued. The patient underwent laboratory tests for sepsis, an echocardiogram and lumbar puncture. The patient diagnosed with Kawasaki's disease. The patient was treated with DENVAR and Acetaminophen. On 08 Mar 2010, the patient recovered from the event with sequelae and was discharged from hospital the same day. The investigator did not suspect a relationship between the event and the study vaccine. Follow-up received on 17 Jun 2010: The patient received the concomitant vaccines, INFANRIX and PREVENAR. During hospitalisation the patient received gamma globulin (13g intravenously). Following discharge, an echocardiogram performed on 22 Mar 2010, revealed dilation of the coronary artery. The patient was discharged with 150mg aspirin every 6 hours. An echocardiogram control was performed on 26 Apr 2010, and a decrease of the coronary artery dilation was observed. The patient's aspirin dose was changed from 150mg every 6 hours to 25 mg per day. The patient was in good clinical condition and was considered to have made a complete recovery from the event on 08 Mar 2010. The patient remained in the study. Case correction on 08 Oct 2010 following DMC monitoring board discussion: Despite the investigator's causality assessment of not suspected. Novartis considers the Kawasaki's disease as possibly related to the study medication as it occurred with 6 weeks of vaccination.
Swollen arm- red , warm and hard.  Looks like COVID arm. Covers  1/3 of upper arm
Pt recvd 2 doses of Hep B vax on 27SEP91 & 11NOV91 & exp no noted problems; on 7APR92 recvd 3rd dose of vax & immed following exp allergic reaction; became apprehensive w/pruritis, breathing difficulties & a rash over entire body; to ER;
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 02-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in freezer and refrigerator where temperature dropped to : Frozen Vaccine 47Minutes -13.79 C, Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses, Lot no 027B21A 100 doses, Lot no 030B21A 100 doses and Lot No 02B21A 140 doses
1. . throat felt thick, and difficulty swallowing 2. arm was sore within 2 hours and could not lift it.  had large red swollen bump with red lines that looked like a spider web.  became hot, hard and really red. 10 days later still hard, hot , red and painful.  came into the clinic to see pcp.  8 x 10 cm or erythema and heat at vaccine site
Woke morning after, 1/4/21 with nausea and headache; by 10:30 a.m. body aches, chills and temp 100.3; Tylenol at that time; To bed at 11:30 a.m. Woke at 5pm with body aches, chills and fever 102.4; Motrin at that time; Morning of 1/5/21 temp 100 most of date with headache, body aches and fatigue; Afebrile by that evening; Morning of 1/6 woke with headache and fatigue; shortness of breath and tachycardia with exertion. Normal HR w/rest. Morning of 1/7 woke with headache that resolved w/Motrin - worked all day
Diagnosed with pharyngitis on 4/12/2021 and started amoxicillin. Developed left sided facial numbness and diagnosed with Bells Palsy at ER on 4/13/2021.
Fever 101 degrees (axillary), swelling and erythema of left arm (5x6 area).
11 hrs p/vax pt exp erythema & swelling of upper thigh from hip to knee proximate to inject site & fever 103 according to parent; local react rx'd w/cold compresses; MD visit next AM; swelling subsided; fever subsided w/in 48 hrs;
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 79-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 79-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
One week post-vaccine, I developed redness, swelling, itching, and what felt like a large mass at the vaccine site (upper left arm). That evening, I also Experienced facial itching with some hives that resolved with Benadryl. The next day, the facial itching was gone however the mass on my arm had grown larger and I was experiencing arm soreness. I have now had this ?Covid arm? phenomenon  for four days and it seems to be slowly fading from the center, however the edges have continued to expand and remains quite large (approximately 1/3 of my arm). The itching , soreness, and redness have decreased each day.
severe GI issues; throwing up for approximately 6hrs; minor symptoms (muscle aches); This spontaneous case was reported by an other health care professional and describes the occurrence of GASTROINTESTINAL DISORDER (severe GI issues), MYALGIA (minor symptoms (muscle aches)) and VOMITING (throwing up for approximately 6hrs) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Apr-2023, the patient experienced MYALGIA (minor symptoms (muscle aches)). On 13-Apr-2023, the patient experienced GASTROINTESTINAL DISORDER (severe GI issues) and VOMITING (throwing up for approximately 6hrs). On 13-Apr-2023, VOMITING (throwing up for approximately 6hrs) had resolved. At the time of the report, GASTROINTESTINAL DISORDER (severe GI issues) and MYALGIA (minor symptoms (muscle aches)) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered GASTROINTESTINAL DISORDER (severe GI issues), MYALGIA (minor symptoms (muscle aches)) and VOMITING (throwing up for approximately 6hrs) to be related.    No concomitant medications were reported. No treatment medications were reported.  Patient was throwing up for 6 hours.
Patient was given booster for ages 12-18, no adverse reactions just submitting due to COVID vaccine
patient is late for the second dose / No second dose provided; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose 2 years ago, from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. The pharmacist reported that a patient was late for the second dose. Till the time of reporting, the patient did not received 2nd dose which led to incomplete course of vaccination. No patient's identifiers provided. No LOT number and expiration date provided. No second dose provided. No adverse event was reported. The reporter consented to follow up.
I got Covid over 30 days past my second Pfizer injection. My husband got Covid that same week and died on 3/10/21.
Size 3" to 3 1/2" circle with small bubbles to left arm and hot to touch.
This spontaneous report as received from a registered nurse refers to a 15 year old male patient. The patient's concurrent conditions included intractable headache for 5 months. The patient's other pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 06-JAN-2016 at 18:19, the patient was vaccinated with the first dose of GARDASIL intramuscularly, lot number L019297 (strength, dose, site of administration and expiration date were not reported), which was improperly stored. This is one of several reports received from the same reporter. Additional information has been requested.
Initial report received from a healthcare professional on 27 November 2012. A female patient whose age was not reported, had received an intramuscular dose of ADACEL vaccine (lot number U4421AA, dose number was not reported) in the right deltoid on an unspecified date. The patient was pregnant. The last menstrual period date was 12 April 2012 and the expected date of delivery was reported as "25 January 2012". The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. As of 27 November 2012, the patient did not experience any adverse event. Follow-up information was received on 03 September 2013 from a health care professional. A 35 year-old female patient's last menstrual period was 20 April 2012. The patient relevant illness during pregnancy was reported as polyhydramnios and macrosomia. According to the reporter, the patient experienced no adverse events following vaccination. The patient's pregnancy history included one pregnancy. The end of pregnancy was reported as 18 January 2013. The infant's outcome was normal. No further information was provided at the time of the report. List of documents held by the sender: None.
became completely disoriented; felt drained of all energy; could barely walk/unable to walk much; had a heavy pain behind my left eye; heavy headache; couldn't relax or think; couldn't relax or think; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318) via an unspecified route of administration in left arm on 06Feb2021 09:30 at single dose for COVID-19 immunization. Medical history included high blood pressure, chronic kidney disease. The patient had no known allergies. Concomitant medication included amlodipine, lisinopril, pantoprazole, multi Vitam. No other vaccine was received in four weeks. No Covid prior vaccination. No covid tested post vaccination. The patient thought he had a 72 hour delay reaction to the vaccine. Tuesday on 09Feb2021, about midmorning 10:00 AM, he felt drained of all energy, could barely walk, had a heavy pain behind her left eye and a heavy headache, and became completely disoriented and unable to walk much. He couldn't relax or think. Then overnight it all went away. No treatment was received for events. The outcome of events was recovered on 10Feb2021.
At 12:30, on 7/10/01, spoke to mother who reported "large red lump" on left leg about the size of a 50 cents piece. The pt had been crying earlier but was walking and playing during phone call. No fever or loss of appetite. Told mother that DTAP and Polio were given on left leg. Apply warm, moist pack X 15 minutes, 3 X a day and give Tylenol for age, if symptoms increase ie fever; leg gets more swollen contact physician.
Day after IM Injection in Left Deltoid. Patient experienced pain, swelling and heat in area.
Temperature the evening after vaccines 101. The next day 103.6. Headache and dizziness.
Headache; Body aches; Very very tired; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received an an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 17:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, thyroid disorder and Gastroesophageal Reflux Disease (GERD). The patient was allergic mangoes and pectic. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received codeine and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 19:00, the patient experienced headache, body aches and was very very tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events headache, body aches and very very tired were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated intramuscularly with 0.5 ml PNEUMOVAX 23 (lot # 667912/0933Z, exp. 25-FEB-2012) on 04-SEP-2012. No adverse effect reported. The outcome of patient was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Left arm where 2 vaccines given became slightly swollen. Redness is ~4 inches down arm, warm to touch. No fever. Cold compresses and Ibuprofen.
Fever ranging from 103.8-106.6 for 3 days, chills, body aches, muscle cramping, nausea, severe headache, low back pain, red swollen painful arm at injection site, dizziness, blurry vision, and a large lump/infection under the arm near the armpit on the injection side with redness that extended about 6 inches.
About two weeks after this first dose of the Covid vaccine, I had a very severe bout of vertigo. It was so bad I couldn?t even crawl. It lasted a little over two hours at that level, then significantly resolved. The next couple of days I felt a little unsteady. After that the vertigo resolved. When the vertigo resolved, I noticed that my ears were ringing.  The ringing has steadily gotten worse and I have noticed that my hearing seems to be affected. I am going to the ENT next week and hopefully will get a hearing test.
itchy swollen and painful after 8 days of covid injection. i was sleeping and felt it in the morning.
About 12 hours after the vaccine I developed a high fever of about 105, shaking, chattering and flu like symptoms which lasted about a day and went away. Then about 6 weeks ago I began getting a numbness in my right leg. I reached out to my Neurologist who scheduled an appointment for an MRI because the numbness progressed and slowly got worse. During that MRI the doctor noticed demyelination was found on my thoracic spinal cord and I was admitted into a local medical center. During that time various testing was performed. After 6 days I was discharged with about 80% of my feeling back, but about 2 days later the numbness returned but this time to my right arm and my various places in my face, nose, mouth and tongue is affected this time and now I am currently sitting in the ER at the medical center awaiting to be seen.
Tiredness; Lack of energy; Foggy; excessive yawning.; Sore arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 15:00 (at the age of 41-year-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient previously took Aspirin and experienced allergy to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included valaciclovir (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN), both for unknown indication and from an unknown date. On 15Apr2021, on the day on vaccination the patient experienced sore arm. On 21Apr2021, the patient had tiredness/lack of energy, foggy, and excessive yawning. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events sore arm, tiredness/lack of energy, foggy, and excessive yawning was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
After 60 minutes from receiving the first shot my face became flush and hot like a bad sunburn.  This only showed on my cheeks and a little on my forehead in color and felt hot to touch.  The rest of my face being warm but not with the red coloring.  The flush coloring faded after 4 hours and my face felt less hot but still warm.  I didn't take anything but water and some food.  A bad headache was included in this feeling and now my face feels and looks closer to normal after 9 hours.  I did not run any fever and I did feel that laying down was the only thing to do.  Yet while resting, lights flashed from my right side to the center (when looking into the darkness) which was very new and different.  I only mention this as I have no clue how that could be related but I've never experienced this...
6hr p/vax pt began to have fatigue & malaise by next morning had t101, chills, body aches, h/a, fever lasted approx 24hr;today is afeb;still has some h/a, body aches gone;
Developed reaction in deltoid area late 11/08.  Tingling, blistering, redness, very uncomfortable.  This has happened with past flu vaccinations, but not other vaccinations.  Thought reaction was related to thimerosol so requested thimerosol free vaccine this year.
Covid19 breakthrough.  1st vaccine received on 12/30/2020.  68 y/o female with PMHx of OSA, COPD, GERD, HTN, DM, Kidney stones, CHF, Dysphagia, complicated UTI with MDRO pseudomonas and ecoli presents from Inpatient rehab with Hypoxia requiring transfer to ICU on bipap at 80% FIO2.  Pt treated with IV ABX, Remdesivir and steroids.
I had very mild adverse events at first (fatigue, headache, muscle aches). On the third day, I felt ?normal? again. However on day four, I had headache/head congestion/felt lightheaded upon standing from a seated position. On day five, I have the same symptoms, but also had some anal bleeding (a hemorrhoid?) but no pain. It was gushing and very bright for about 2 minutes first thing in the morning but then was very spotty and mild throughout the rest of the day.
No adverse effects from the vaccination. Tested positive to COVID 09/02/2022. Very minor symptoms. Runny nose, slight sore throat. Prescribed Paxlovid. Symptoms gone in less than a day. Tested positive again 3 days after final Paxlovid dose. Again, very minor symptoms gone the next day.
About 20  mins after I got the shot my arm was burning, it stopped about 30 minutes later. At the same time the burning started my arm became molded  by the next day it was gone.  About two hours after the injection I started feeling light headed, fatigue and couldn't lift my arm past my shoulders and had a headache. The next day I was tired, body ache and headache, I took Tylenol and was ok. I still wasn't able to life my arm above my shoulder. The next day I was fine.  On the 1/12/21 my arm became extremely red and some hives around the injection site, and swelling. It was so hot to the touch, I took Benadryl and Tylenol. The next morning it was worse, and went to see my Dr. she told me to treat with ice pack, Benadryl, Tylenol and gave me medication.  On the 16th the redness had spread to the inside and outside of my arm.  By 1/26/21 everything went away.
Patient came to the store on 3/9/18 and reported an adverse reaction to the flu shot he received on 1/28/18. He said he woke up the next day with half of the face paralyzed. He went to see his PCP he was diagnosed with Bell's Palsy. We called MD, he said it was unrelated to the vaccine.