chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker concerning an approximately 13 year old male patient. The patient was vaccinated with first and second dose of 0.5 milliliter (ml) GARDASIL (lot number, expiry date unspecified), intramuscularly in the right arm on 12-JAN-2012 and on 02-JAN-2013 (today) respectively. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Blanch-able pinpoint rash noticed on trunk and continued to spread over the next 2-3 days, cough with rhinorrhea since early morning on 4-10-16 and continuing today with rash noted more on extremities and face, cough, and rhinorrhea.
Client received vaccine on 6-17-10 at 2 PM and reports Sx's started on Friday (6-18-10) evening of feeling run-down, mild pain all over (not at injection site), bruise at injection site only, stomach upset, denies fever or rash. Unable to do anything 4 days after vaccine and took ADVIL for discomfort.
Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, LISINOPRIL, AMLODIPINE, SIMVASTATIN and VITAMINS NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach). The patient was treated with CALCIUM CARBONATE (TUMS ANTACID) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Jan 6, 2021 - on the day of the shot I had arm pain, moderate to severe headache, body aches and  lethargy which continued for the next 3 days.  Then on the 4th day I lost my sense of taste, but only for the day and also experienced shortness of breath going up stairs for the next 2 days.  Jan 26, 2021 @0 Days after my first dose I had an episode of Super Ventricular Tachycardia and went to the hospital because it wouldn't stop. After about 2 hours my heart rate converted on its own. Feb 3, 2021- I received my 2nd dose of the Covid vaccine. Feb 4, 2021- I had a low grade fever of 99.6 with the chills and body aches. Feb 17, 2021- I returned to the ER with SVT that again would  not stop. This time they had to convert my heart rhythm  using Adenosine.  March 4, 2021- had an Echocardiogram to check heart because the  hospital doctor said the chest x-ray they took showed an enlarged heart and  the ultrasound they did showed fluid around my heart.  The echocardiogram  showed a moderate Pericardial Effusion   I am attributing these issues to the Covid Vaccine since I have not had any SVT or other issues since 2008. AND my personal nurse practitioner said she had the same reaction.
He received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap, last Thursday. By Monday he was not feeling well, and he tested positive for COVID; By Monday he was not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 93-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "dialysis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 21Nov2022, outcome "unknown", described as "By Monday he was not feeling well"; COVID-19 (non-serious) with onset 21Nov2022, outcome "unknown", described as "He received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap, last Thursday. By Monday he was not feeling well, and he tested positive for COVID". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller on behalf of her father. He is 93 years old, and he is on dialysis. He received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap, last Thursday. By Monday he was not feeling well, and he tested positive for COVID. Had a dentist appointment and caller's sister noticed the patient was not feeling well, so tested patient. Caller wanted to know if the vaccine can cause COVID.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient reports receiving the 2nd dose of the Pfizer vaccine yesterday around 9:10am. Patient started to noticed mild symptoms about 8 hours afterwards, including a mild headache and backache. She reports then feeling fatigued so she went to sleep early around 8pm.   The patient reports waking up at 11pm having to go the bathroom. She notes feeling weak when walking to the bathroom, though as she was on the toilet voiding she felt nauseous. When she got up to wash her hands she felt that she was going to pass out feeling LH and dizzy. She sat down on the bathroom floor as she has a history of orthostatic hypotension, and eventually needed to lay completely flat on the ground. She reports this is when she felt as though she blacked out.  She was then able to wake up and walk back to bed feeling better, and fell back to sleep.
High fever, onset 10 hours following vaccination, duration of fever and related symptoms 24 hours. Other symptoms include chills, extreme fatigue, and muscle aches, and dry cough. All symptoms besides dry cough resolved at 24 hours after onset.
Initial unsolicited report received from a consumeron 19 September 2016. This case involves a 17-year-old female patient who was vaccinated with a dose MENACTRA (batch number: unknown, expiration date, dose and site of administration were not reported) intramuscularly on 09 August 2016. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was denied. On unknown date, two weeks later following the vaccination, the patient developed platelet count went from 1, 88,000 to 5000. It was reported that cause could not be established. Patient required emergency room or doctor visit. Other lab data was not reported. The patient received unspecified corrective treatment to get her level up. Outcome of the patient was reported as unknown. List of documents held by sender: none.; Sender's Comments: A 17 years old patient experienced Platelet count decreased from 188,000 to 5000 two weeks later vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset in compatible with role of vaccine. However details regarding relevant medical history, investigational result ruling out other etiology, previous vaccination history are needed for complete assessment of the case.
This spontaneous report as received from a registered nurse refers to a 32 year old male patient. The patient received a dose of M-M-R II on 04-JUN-2010 (lot and expiration date were unspecified) and had a negative Mumps titer (of 0.19) in early December of 2012 (titer for Measles and Rubella were acceptable). The patient was administered another dose of M-M-R II on 11-DEC-2012, but no titer tests had been done since then M-M-R II dose on 12/11/2012. The nurse stated that the patient might  have received M-M-R II as a child, but there were no vaccination records for the patient as a child. No adverse event reported, other than the negative Mumps titer. The outcome of negative mumps titer was unknown. Additional information has been requested.
Information has been received from a 63 year old female patient with hepatitis C for 50 years and drug reaction to Penicillin who on 18-JUN-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). Concomitant therapy included LEXAPRO. It was reported that "the same day after receiving ZOSTAVAX (Merck)" she started developing severe injection site reaction. Patient reported that she felt sick after a couple of days of the vaccination and then she developed chickenpox on her legs. Patient noted that the chickenpox lasted for two to three weeks. Patient reported that after that, she started experiencing fatigue, muscle aches and headache and she even had to take 6 weeks of vacation just to rest in her bed because of the extraordinary exhaustion. The patient also stated that she also experienced sore throat after receiving ZOSTAVAX (Merck). The patient sought medical attention with the physician. A laboratory test was performed on an unspecified date and she was diagnosed of Epstein Barr Virus. It was reported that the patient had not recovered at the time of the report. Upon internal review Epstein Barr Virus was considered to be disabling due to "she even had to take 6 weeks of vacation just to rest on her bed because of the extraordinary exhaustion". Additional information has been requested.
pt recvd vax & had keloid enlarged; Rt arm became irritated never healed; when healed keloid existed;
Friday evening I started with chills and a fever about 7:30pm, both were relieved by Tylenol. Saturday evening about 33 hours after my second (about 6:30pm on 4/17) vaccine dose I noticed small itchy bumps on my left foot, by 9pm that evening the ?hives? were all over my hands and feet. I put some lotion on them and took some Benedryl, but as of 4/19 I still have the hives- small itchy red bumps  on my hands and feet.
This is a spontaneous report received from a contactable reporter(s) (Physician). A 40-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Systemic lupus erythematosus" (unspecified if ongoing). Concomitant medication(s) included: RINVOQ oral; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE] oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of Covid-19. Clinical Course: Treatment start date, on 26Apr2022 and stop date 26Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Fever (102), chills, nausea, headache, body aches, vaccination site red and sore.
Patient claims her arm is red, warm and has a rash. I called her doctor for her to have her seen. Dr will follow up. 10/12/11.
At approximately 11:09 am, patient began complaining of dizziness, headache, blurry vision and nausea.  Patient states that she had a headache on arrival and took her bp meds this morning.  Patient released by EMS to home with friend on site.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (lot# k010437, expiration dare 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
AFTER PATIENT RECEIVED VACCINATION HE COMPLAINT THREE HOURS LATER OF: SORE THROAT EYE ITCHING; SEVERE HEADACHE  STUFFY NOSE HE WENT TO ER AND WAS TREATED AS AN ANAPHYLACTIC REACTION.  HE WAS GIVEN THE INSTRUCTION NOT TO VACCINATE AGAIN. HE RECOVERED AND INFORMED PHARMACY TODAY 09/28/20.
Tinnitus bilaterally starting approximately 1 week after 2nd dose then getting slightly better within 6 months. Tinnitus became much worse after booster shot (3rd dose), which was also Pfizer batch/lot# FF2590 on 11/3/2021, and continuing until today with very little improvement.
Runny nose and later congestion. And some headache in the back of head because of congestion. For three or four days, I had a fever reaching 100 degrees. I used Tylenol for three days and just before I went to sleep. The symptoms started 10/8/2021 and went away on October 11th in the morning. I had pink eye in my right eye - had this the same day as all the symptoms, too. Doctor prescribed the drops for the eyes - and the the pink eye disappeared almost the same day as my other symptoms.
Rec. vaccine on 11/04/2009. First symptoms noted on 12/09/09 with arms numbness. Presented on 12/11/09 to Med. Ctr: Dx: Guillain-Barre.  12/22/09 Hospital records received. Service dates 12/12/09 to 12/22/09. Assessment: Possible Guillain-Barre syndrome. Patient felt something 'tweak' in his back after lifting 100 lb. object. Muscle soreness back of neck and shoulders, numbness and weakness in both legs and upper extremities. Palms and soles numb and tingly. No reflexes. Anxious.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included Wegener's granulomatosis. Concomitant products included folic acid, methotrexate and vitamin D. In February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue, injection site pain, weight loss, injection site erythema, fever and appetite lost. On an unknown date, the outcome of the influenza-like symptoms, fatigue, injection site pain, weight loss, injection site erythema, fever and appetite lost were recovered/resolved. The reporter considered the influenza-like symptoms, fatigue, injection site pain, weight loss, injection site erythema, fever and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient stated that the next day after receiving the SHINGRIX vaccine, she experienced flu like symptoms that lasted approximately 48 hours. She also experienced a fever that peaked at 101.6 F. The patient also experienced extreme fatigue and loss of appetite that resulted in a weight loss of approximately 2-3 pounds. The patient experienced redness and soreness in her arm that started at the injection site and spread down her arm. Patient stated that the red, sore arm lasted longer than 2 days. The patient had denied permission to contact their physician. The patient did not wish to provide her own address. She did not visit the doctor's office, but simply called to report her symptoms.
1st dose in 2020 before Covid get the 2nd now; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (on 2020 the patient received 1st dose of Shingrix.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 09-June-2022 Reporter's Comments: The patient had 1st dose of Shingrix in 2020 right before Covid.  The patient want to know do need to start it over again and get 2 vaccine within 6 month or just the 2nd vaccine. The patient couldn't get the 2nd shot on time due to Covid. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
She had sever swelling on her left arm the size of a baseball, bruised, numb and painful. Treated it with ice, no pressure on arm. Took two days to go down.
1 1/2 yrs p/series vax completed employee not immune according to testing; Waning immunity; Given 5 doses 9DEC88; 16JAN89; 16JUN89; 30NOV90;22MAR91 from lot#s 1893P, 1880R, 1238S; 1 & 2 dose not recorded;
Pt recv vax on 9/4/98; on 9/5/98 pt exp redness of arm, itchy, and warm to touch about 4 in. circumference around injection site.
I started to have a severe anxiety until now today; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration, administered in left arm on 05May2021 at 15:00 (at the age of 50-year-old) at single dose for COVID-19 immunization. No other vaccine received in four weeks. Medical history included bipolar disorder; prior to vaccination, patient was diagnosed with COVID-19; had known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 50-year-old at single dose for COVID-19 immunization and got a little anxiety. After patient received a second one of Pfizer's vaccine on 05May2021, he started to have a severe anxiety from 07May2021 until now 23May2021. Some medications won't help him out as enough. Event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days. The patient underwent lab tests which included Nasal swab: Positive on 11Dec2020; since the vaccination, patient had been tested for COVID-19 with unknown result on an unspecified date. Therapeutic measures were taken as a result of the event included Lorazepam. The outcome of the event was not recovered. This report was reported as serious with seriousness criteria-Caused hospitalization.  Information on the lot/batch number has been requested.
changes in vision; Information has been received from a lawyer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, the patient experienced changes in his vision. The patient did not recover from the event. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The event was disabling.   The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Redness (size of silver dollar), swelling and warm at site of injection.  Started at 24 hours post shot. Lasting 2 days.
redness at the sight; swelling at the sight; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received Shingrix. On 7th February 2020, less than a day 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 details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced redness and swelling at the sight after receiving Shingrix.
Severe dizziness lasting days along with headaches and muscle aches. Inability to do daily tasks because I am so dizzy and my head hurts so bad. I am so tired and exhausted
This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The patient's age at vaccination was not provided. The details of the reaction was not reported. For tolerability after FLUARIX QUADRIVALENT, please see case US2016GSK166610.
Light flu like symptoms, acute local reaction To arm. Redness,acute pain ,swelling from injection site to anticubital with heat and redness. Acute swelling
Panic attack 1 day after receiving vaccine, fast heartbeat, heartburn and digestive tract problems like diarrhea and excess gas that still haven't resolved, decreased appetite
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 09-JUL-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Dizziness, Headache, Myalgia, Fever, fatigue and chills Narrative:
Within 10 minutes of receiving vaccine I experienced a rash that spread very quickly all over my chest and traveled up the left side of my face and ear. Experienced tachycardia as well. I had to stay for an hour and be monitored. Later that evening I started running a fever of 102.7 at home and kept the fever for approx 24 hours.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 , "10PK-0.5ml SD-PFS LLok w Tip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 47 F for 40 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.