chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, injection site pain and general body pain. On an unknown date, the outcome of the influenza-like symptoms, headache, injection site pain and general body pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, injection site pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The reporter is a dentist. He was reporting this event for his wife. The patient experienced body ache, pain at injection site, headache, and flu like symptoms which lasted for total of 3 days. This is one of the 5 cases reported by the same reporter, this case has been linked with case US2018163110 reported by the same reporter for same patient for 2nd dose.
Chills, Body Aches, Fever 100 F Saturday 4/4/2021. Took Advil one time around 8:00 pm, the symptoms were minimized by Sunday.
02/06 I had a tickle in my throat and slight cough. Also experienced diarrhea and wasn't sure if it had anything to do with it.  By the 9th I had resolved to see the doctor because I had strong sneezes and wouldn't let up. There, they did a rapid CoVid test(negative) and a Antigen test.(negative) Was diagnosed with upper respiratory infection and was given prescription for Z-pak and prednisone. Currently on liquid diet and cough still persistent but less often.
Felt fine day of and day after the vaccine, not even a sore arm. Two days in, (Fri. 3/26) noticed a couple of itchy welts in the late afternoon but assumed they were bug bites since I had been dining outside. Woke up in the middle of the night with severe itching and burning. Large red welts pretty much covering my entire body from my scalp down to my calves, especially concentrated around my torso, and inner thighs. My husband took one look at me and said I better go to urgent care. Visited local urgent care (3/27) where Dr. said this was likely a reaction to the Covid vaccine and that I may be allergic to the polyethylene glycol in the vaccine. He prescribed a Medrol dose pack and Benadryl along with
Patient became dizzy and felt faint about 10 minutes after receiving the vaccination. EMT evaluated. Patient was not transported.
Started on 2/14, was full blown by 2/17. Rash covered Full body. (knees, torso, arms) Saw PCP who gave methopredisone. Steroids have helped relieve itching, started those on 3/3/21. Received second dose of moderna on 3/4/21, rash did not worsen after dose, remained the same. Rash is still visible but not as itchy.
Temp of 104, fussy & cranky for 24-36 degrees after injection Lg amt swelling at injection site.
upset stomach                           dizzy                                        right arm hurt                            eye problem  HEADACHE today is 9/23/19 & my right arm is still black and blue where injected!
Second dose of JYNNEOS vaccine received intradermal on right forearm (first dose was received IM). Approximately 30 hours after receiving vaccine, patient felt extremely fatigued and had to lie down. Fever reported- temperature was not measured, but patient "felt very hot and sweaty" for a few hours, then alternating with feeling "cooler and/or clammy" for a few hours. Patient then slept for nine hours straight. That day the site appeared red, raised, hot to touch, and felt very itchy per patient report. These local reactions increased on the next two days. On day two after vaccination, area is extremely uncomfortable- hot to touch, red, hurts, patient reports they feel swelling underneath the skin (similar to what was experienced at the site of the first IM dose of this vaccine in her right deltoid- reports the swelling lasted for many weeks, at least six weeks with first dose). This is very uncomfortable. Patient is tired and upset. Reports she still felt somewhat feverish the night before but so far feels better in terms of temperature today. Local reaction/swelling and redness measures about 4 inches in diameter on day 2, and has since last night. She is upset she was not adequately prepared for this outcome when receiving the second dose, nor did she know if was intradermal until she was at the vaccine site about to receive the vaccine.  Patient also reports some gastrointestinal upset on day one and two and three after receiving second dose, including diarrhea. She took a covid rapid on day two and received a negative result.
Patient is a 22 y.o. male with no previous cardiac history, no known cardiovascular risk factors, and no significant past medical history.  2 days ago he received his second dose of the Maderna Covid vaccine.  Yesterday he reported flulike symptoms with fever to 102 degrees, generalized myalgias, and fatigue.  He awoke at 2 AM this morning with sharp somewhat diffuse substernal pain unrelated to activity, inspiration, exertion, position, without radiation or associated symptoms.  He took Tylenol which eventually caused the pain to decrease in intensity.  He called his family, discussed it with his girlfriend, did some online research, and came to the ER for evaluation where his EKG demonstrated anterior T wave abnormalities and his high-sensitivity troponin came back elevated at 16,072.  His pain is now fully resolved, he is being admitted to the hospitalist service, and cardiology consultation was requested. June 6, 2021
It started as just a sore arm at injection spot. Its been 2 weeks. for the last week my arm and shoulder hurts every time i lift my arm. it comes and goes but is painful
Rash/hives to limbs and trunk 8-10 hr after vac. 50 mg Benadryl PO; Pepcid 40 mg PO; Prednisone 30 mg PO
This spontaneous report as received from a other health professional refers to a patient of unknown age. In 2017, the patient was vaccinated with VAQTA lot # N005274 with expiry date 03-APR-2018, lot # N005796 with expiry date 26-MAY-2018 for prophylaxis. On 2017 the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1708USA013258: US-009507513-1708USA009399: US-009507513-1708USA013257.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) 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 considered EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) to be not applicable.    No concomitant medication was provided No treatment received by the patient
Mother reported elevated temperatures of 104.0 degree F the morning after vaccines, also mentioned extreme fussiness and slight decreased appetite.  All symptoms resolved within 8 hrs of first report.
Left forearm became edematous, red and warm after vaccination. No fever. Given Benadryl and Tylenol in clinic. Called family 06/17/04: Child better, on Keflex for 10 days.
3 y/o received vaccines on 8/16/08.  Parents noticed erythema around injection sites that evening.  Father denies fever or other diffuse rash.  Pruritus is present.  Injection sites were examined and mild erythema noticed around sites, non tender.  Treatment: cool compress around injection site.  Erythema measures 4 cm in diameter (x1) then 2 cm diameter on 2 other sites.
Patient woke up next day with an injection site reaction. Arm was red from shoulder to elbow and had an "egg sized" knot. Patient has not completed an treatment as of reporting day.
Pt cried for 2-3 hrs, mom couldn't control pt; pt was irritable for 2-3 days; pt felt hot but mom did not take temp; had pain & swelling in legs;
Seven days after the injection, my arm started itching at the injection site. Day eight, today, the injection site is itchy as well there is a 2 inch round and red hard bump. A round  red rash that is raised, hard, and itchy at the injection site.
Spoke with patient via telephone on 4/20/21. Patient reports brief syncopal episode 4/15/21 at 6pm; reports he went to urgent care then to hospital. Reports he had CT scan and that multiple blood clots and pulmonary embolism were diagnosed. Reports he was transferred via ambulance early am on 4/16/21 to more advanced hospital. States thrombectomy was performed and he was discharged home on 4/17/21. States he is recovering at home and was advised he still has a blood clot in the leg. Reports he is on blood thinning medication at this time.
Pt states she got her second Moderna COVID19 vaccine in her LUE yesterday 1/26/21.  She developed a low grade fever and nausea last night. Today, 1/27/21,  around 0800, pt states that she fainted, fell on her left side and injured her L elbow. She states that her husband found her and said it appeared as if she was having a "mini seizure". Husband states pts fainting/seizure episode lasted for 15-20 seconds. Pt states that her L elbow pain was 7/10, but is currently 2/10 and she is now experiencing some tingling in her L third and fourth fingers. Pt denies any hx of a seizure and is currently able to get up and walk around. Pt speaking in full and coherent sentences while on call. Pt advised by triage RN and PCP to go to ER for an evaluation
Per hospital reporting system "patient was given FLuAD (high dose) instead of Flulaval. Patient is only 63 years of age. Provider and patient made aware.:
Fever, chills, stiff and painful joints, sore throat, increased pain in perianal area, abdominal distress; symptoms lasted more than 2 weeks.
vertigo starting on 31OCT severe on 2NOV94 eval by MD on 3NOV94 rx Lorazepam; dizziness resolved 5NOV94;
Fatigue, Severe naseus (treated with Zofran), Body Aches, Fever (treated with Ibuprofen), Explosive Diarrhoea (treated with pedialyte pops)
Received 2 doses of COVID19 (Moderna) vaccine - 1st dose: 5/6/2021; 2nd dose: 6/3/2021. Presented to hospital Emergency Dept on 6/22 with complaint of substernal non-radiating chest pain of 1 day duration.  Patient reported she was asleep when chest pain began and severity wok her up.  Reports the pain "pressure-like" in quality.  Associated symptoms include nausea, vomiting, and palpitations.    Laboratory tests were performed, including the following: Troponin-I - 6/22/21 09:05 = 1.05; 6/22/21 10:11 = 3.00; 6/22/21 14:09 = 8.00; 6/24/21 12:17 = 8.10; 6/25 06:39 = 7.90 (note: elevated) Coronavirus NAA - 6/22/21 12:15 = not detected  Diagnostics tests performed during hospitalization: EKG - 6/22/21 08:59 = sinus bradycardia Echocardiogram - 6/22 11:23 = normal left ventricular systolic dysfunction, LVEF 55-60%; valves normal  Pt underwent cardiac catheterization for NSTEMI.  No lesions noted.  Right coronary artery small and normal; left coronary artery dominant and normal.  Pt diagnosed with myocarditis and discharged on 6/25 (3 day hospitalization) with MYOCARDITIS and NSTEMI.
This is a spontaneous report from a contactable consumer (patient). A 53-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER2613), at the age of 53, via an unspecified route of administration, in the left arm, on an unknown date, at 10:00, single dose, for COVID-19 immunisation. Medical history included WPW Type A (Wolf Parkinson White syndrome) and benign essential tremors. Concomitant medications included ibuprofen 400mg (each 200mgs x 2 pills) from an unknown date for unknown indication. The patient previously received morphine and experienced hives (drug allergy); cefdinir and experienced throat swelling and hard to swallow (drug allergy). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Mar 7, 2021, at 00:00, patient experienced swelling in the whole body (especially the throat area made it discomfort to swallow), sick-to-stomach, pain in arm and brain fog. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. No therapeutic measures taken as a result of the reported events. The outcome of swelling in the whole body (especially the throat area making it discomfort to swallow), sick-to-stomach, pain in arm and brain fog resolved on an unknown date in 2021. No follow-up attempts needed. No further information expected.
Redness at the injection site; Swelling at the injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: HCP mentioned that patients complained of redness and swelling at the injection site following a dose of Shingrix. The reporter did not consent to follow up.
24 hrs. after receiving flu zone 0.5ml IM. Pt presented with 3.5x2 cm swelling, redness, and pain at injection site (left deltoid). Entire arm was "sore" and felt nausea and hot/cold flashes. Had stinging pain with left arm movement and rad to left hand. Temp 98 degrees. Treated with Keflex and to follow up with PCP or ER.
left arm was warm and a little hot at the injection site; when she went to bed her blood sugar was 140/her blood sugar and it was 40/her blood sugar went up to 60/her blood sugar went up to 80.; woke up in the middle of the night; sweaty; weak; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiry date not reported), via an unspecified route of administration at the left arm on 16Feb2021 08:30 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus (reported as diabetic). Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 for COVID-19 immunization. The patient stated that after her second dose, on an unspecified date in Feb2021, her left arm was warm and a little hot at the injection site. Patient stated thet she ate a regular meal at noon and her afternoon meal consisted of a venison patty, garden salad and vegetable jello. The patient stated that she also had some popcorn in the evening. She stated that when she went to bed her,  blood sugar was 140. She stated that she woke up in the middle of the night and she was sweaty and weak. The patient stated that she checked her blood sugar and it was 40. She stated that she woke her husband up and he gave her 4 ounces of orange juice and this did nothing for her blood sugar so he gave her some snack bars. She stated that her blood sugar went up to 60. She stated that she then drank more orange juice and her blood sugar went up to 80. She stated that she went to back to bed and when she woke up again her blood sugar was 113. Clinical outcome of the events was unknown.  Information on about lot/batch number has been requested.
Client had no issues during 15 minute observation period. States that shortly after observation period, she began with dizziness and nausea. Chills/aches that night. Vaccination was during menstruation and began experiencing heavy bleeding. By Sunday 8/15/2021, had heavier bleeding with clots and was seen at ER ( then admitted. Reported "blood level" (hgb?) 1.9 per client. Client states vaccination caused the clots and that also a tumor was identified on her cervix. Placed on hormone therapy and will require surgery later this month. Her provider advised her to still receive her second vaccination.  Health Department/this writer did administer the second dose on 9/2/2021 with a 30 minute observation period with no incidence.
Moderna COVID-19 Vaccine EUA. blisters around right side of face, burning sensation, numbness tingling sensation
Information has been received from a registered nurse concerning a 13 year old female with no drug allergies and with a history of influenza immunisation on 22-SEP-2007 who on 28-AUG-2007 was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil (Lot # 658556/1060U). "A few days after vaccination", the patient developed joint pain, headache, numbness in face and malaise. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complain was involved. Additional information has been requested.
Patient received flu shot on 9/22/09. A few days later, patient got an abscess. Went to doctor and had abscess drained.
Chest pain with elevated troponin.  Most likely exercise induced elevated troponin.  However, has been a competitive athlete for years and this is first episode of chest pain
WRONG ROUTE OF ADMINISTRATION.  BOTH VACCINATIONS  GIVEN INTRAMUSCLAR INSTEAD OF SUB-Q
Fever, headache, chills, nausea, fatigue, stomach pains that patient states started the day after getting the vaccine and lasted about 1 week. She states the severity of symptoms were to the point that she considered going to the hospital.
Pfizer on 3/19 and 4/18. Positive on 8/24 admitted on 8/24 to current
No adverse reaction.  Mixed dose.  Patient received Pfizer vaccine  on 3/31/2021.
14days p/vax pt exp breakout of approx 8 lesions in the mouth. no further info
A spell consisting of body going limp and eye staring of 20 seconds occurred on 09/14/2005 in the evening.  This was followed by 20 second episode of unresponsiveness.  Tactile fever "real high", often unresponsive episode, patient smiled and fell asleep.
This spontaneous report was received from a nurse via a radiation technician and refers to a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot# N003702, expiration date: 08-NOV-2019 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored for 10.5 hours in the temperature of 63.7 degrees Fahrenheit. The vaccine underwent previous temperature excursion of 48 degrees Fahrenheit for 90 minutes. Digital Data Logger was involved. No adverse symptoms were reported.
Redness and swelling at site of HPV vaccine Redness, swelling, rash surrounding site of varicella vaccine.
Soreness at injection site beginning ~2 hours after administration and lasting ~5 days. Chills beginning ~12 hours after injection and lasting ~12 hours, with low-grade fever. Tachycardia beginning ~16 hours after injection and lasting ~16 hours. Insomnia beginning ~16 hours after injection and lasting ~12 hours. Headache beginning ~16 hours after injection and lasting ~12 hours. Malaise and muscle/joint soreness beginning ~16 hours after injection and lasting ~24 hours. Fever and soreness responded to ibuprofen (800 mg PO every 8?10 hours). All adverse effects with the exception of soreness at the injection site resolved completely within ~24 hours of onset (~36 hours after administration).
Woke up with hives on foot (approx. 20 hours after vaccination), swelling/itch went away with Zyrtec
Headache , fatigue and faintness. Night of the injection I was very cold and had a hard time getting warm. Next day unable to eat very much for most of the day and felt horrible, felt chilled for most of the day, faintness very bad til late that evening. Second day after injection was back to normal.
From telephone contact with reporting physician, it was stated that an 18 year old female pt received a Menomune A/C/Y/W-135 vaccination on 6/27/01. Twelve days later, the pt complained of severe headache. She was hospitalized on 7/9/01. The pt is now at home and the headache has completely resolved.
pt recv vax;unconsolable crying for 5 hrs;tx w/ APAP&Motrin
Mild urticaria & itching developed about 12 hours after receiving the vaccine.    Fever of 102, chills, and body aches are also present.