chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (patient did a home test for COVID-19 (disease) on Friday, May 13, 2022; tested positive on Saturday, May 14, 2022 with a PCR test) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. December 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 14, 2022, patient experienced COVID-19 (patient did a home test for COVID-19 (disease) on Friday, May 13, 2022; tested positive on Saturday, May 14, 2022 with a PCR test). At the time of the report, COVID-19 (patient did a home test for COVID-19 (disease) on Friday, May 13, 2022; tested positive on Saturday, May 14, 2022 with a PCR test): resolving. Diagnostic results: On May 13, 2022, SARS-CoV-2 test: results not provided (inconclusive); Results not provided. On May 14, 2022, SARS-CoV-2 test: positive. No concomitant medications reported. Reportedly, patient was fully vaccinated with 2 primary doses and one booster dose of Moderna in Dec 2021, prior to getting COVID-19. He was prescribed Paxlovid. He has not picked up the prescription yet. He started not feeling well on Thursday, May 12, 2022. He did a home test for COVID-19 (disease) on Friday, May 13, 2022, and tested positive on Saturday, May 14, 2022, with a PCR test. On Saturday he felt worse, but started feeling better on Sunday, May 15, 2022; and "even better today." All doses were Moderna. Sender's comments: This is a spontaneous case concerning a 67-year-old male patient with no medical history reported, who experienced the unexpected adverse event of special interest COVID-19 confirmed by PCR test, which occurred approximately 5 months after receiving the third/booster dose of mRNA-1273 vaccine. Patient received 2 doses of mRNA-1273 vaccine, on unknown dates, prior to the third/booster dose. Initially, patient felt unwell and underwent COVID-19 PCR test with positive result. Patient prescribed Paxlovid, however has not picked up the prescription. It was not mentioned if patient took the medication. Patient reported he started feeling better the next day. The benefit-risk relationship of mRNA-1273 not affected by this report.
Pt recv vax on 8/27/98; on same day pt exp rt arm sore to elbow & wrist
On 7/23 he suffered an asystolic arrest, brief VT, ACLS x30 minutes. Resuscitation stopped at the request of his brother whom Dr. reached by phone.
Silver dollar sized red, very sore area; Spread elbow to shoulder; Seen by MD; poss cellulitis; Rx: Keflix;
So on the same day, starting at 11PM, my body started to ache and my bones started hurting a lot. I then became feverish and felt cold. As I tried to sleep, I had difficulty sleeping. The next day, I awoke with a splitting headache and my body aching worse than before including my neck which was impossible for me to look around. Still felt a little cold. Head was hurting a lot. Slept better the second night. Awoke on Sunday with mainly head hurting and body aching a little less.
I had experienced the continual dizziness from the night of 4/10/2021. I went to my PCP first and they went ahead and told me to go to a neurologist department, and was then directed to go to an ENT for a hearing test, Hx of 14% hearing loss in left ear. Passed vertigo test and seems to be more of a vestibular issue per diagnosis, I was then sent to vestibular therapy and have gone twice, and I do at home PT as well. If I am not strapped by the waist during therapy, I can easily fall. Sporadic relief and improvement however everyday 24/7/ I am dizzy.
Immediately after immunization, a burning sensation was felt from shoulder to elbow, followed by copious sweating, faint feeling and dropping blood pressure (70/50 nadir).  Taken by ambulance to nearest ER where bp had risen to 120/86 upon arrival.  ER physician diagnosed a vagal reaction.  Patient reports no other fainting episodes related to blood draws or other immunizations and this "felt different".
Hoarse coughing, difficulty breathing, swollen nasal passages, sore throat, feeling cold.
She reports a rash on her back, that traveled around to the front and her breast felt "full".
Medical Assistant gave patients a dose of Hep A by mistakes. Provider did not order it. Patients sister was getting the Hep A that day and MA got confused.
pt recv vax 14NOV96 & 14 days p/vax pt exp lesions;5DEC96 pt exp a febrile sz @ 3PM & a second febrile sz @ 7PM & was hosp;new pox were still developing @ that time;pt was hosp for 36hr;OM was not thought to be cause of fever;
The patient got her flu shot around 10:00 am on 10/08/18 and then the patient went home after 15 min. Approximately 2 hours after getting the flu shot, the patient said she felt  cold and was shivering. So, she rested until approx 5 pm. Further, the patient had muscle weakness through out that night. She felt a little better from the next day, but it took her almost a week to come back to normal. The patient gets her flu shots regularly, but this is her first time having these symptoms.
There were no initial adverse reactions to the vaccine given on 1/18/21.  No redness and slight soreness at the injection site.  However, a week later, //1/25/21, there was a raised redness at the injection site.  The next day the area of redness had increased substantially and measured  3 inches in length.  The arm feels more tender that it did previously.
Weeks later she has tachycardia; you can even might feel her chest, heart is just jumping all around; Her pulse all that was elevated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history included: "oil fish" (unspecified if ongoing); "Oil shellfish" (unspecified if ongoing); "walnut including coconut" (unspecified if ongoing); "She can't even taken like sesame oil" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TACHYCARDIA (non-serious), outcome "unknown", described as "Weeks later she has tachycardia"; PALPITATIONS (non-serious), outcome "unknown", described as "you can even might feel her chest, heart is just jumping all around"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Her pulse all that was elevated". The events "weeks later she has tachycardia", "you can even might feel her chest, heart is just jumping all around" and "her pulse all that was elevated" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that her daughter was 6 years but she got her first dose of the Pfizer vaccine at 5 years. Weeks later she had tachycardia, she could even might feel her chest, heart was just jumping all around. She took her to urgent care and the doctor said, she really did not know what to do. She said, she put her, she checked her pulse all that was elevated. She said get her follow up with her primary care with a (Voice not clear) so that was the result. The patient had lot of allergies like she was allergic to oil fish, oil shellfish, walnut including coconut. She could not even take like sesame oil. She kind of made her ice cream, the patient was getting better with tolerating certain ice creams and she knew, the immune system as well as allergies were similar they had similarities in terms of, what could cause for an allergen to. She did not know exactly what was going on but she wanted her to get the second dose of the Pfizer. She had her on schedule to get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed hives, itchy mouth and throat developed about 10 minutes after receiving her second vaccine. benadryl  50mg IM was given at 11:42AM
swollen tongue, no treatment beside tylenol. After 3 days, still feel tongue is swollen or slightly sore. Feels like tongue is sprained. Symptoms are not severe but are worrisome. Some discomfort in muscles near stomach. Started happening on 2 day. Not happening on day 3.
Moments after receiving the HIB vaccine, the patient had a quarter-sized red lump at the injection sight in his left thigh. The redness lasted for two weeks. As of 5/23/19 the redness has completely subsided, but there is still a dime-sized hard lump at the injection sight.  The lump was hot to the touch for the first week, and cased the patient (my child) discomfort for one week.
Tuesday 2pm-Jansen vaccine administered . Tuesday 8pm-Violent chills for 2hours followed by what felt like hot flashes and sweating, extreme joint and muscle pain.  Wednesday 6am- awake w fever 101.5, horrific headache and body aches. Can barely walk to bathroom to get aspirin. Fever breaks late morning but still feel terrible, Sleep all day.  Thursday am- extreme diarrhea, fever 99.5. Took aspirin and Pepto bismol Fatigue all day Thursday pm- pain and swelling at injection site. Feels  like a Hard mass about 3.5 inches in diameter and raised. Extremely painful, even clothes against it causes pain that feels like a bad burn.  It is now Saturday late Pm and arm is still swollen and extremely painful to The touch. Wondering if I should get it looked at.  Awoke next morning w 101.5 fever Horrific body aches and headache,  Exhaustion  Lasted until evening (slept most of the day) extreme fatigue into following day, diarrhea and 99.5 fever two mornings later.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date (also reported as many years ago) the patient was vaccinated with the first dose of RECOMBIVAX HB (injection, dose1, in the arm, strength, route, lot # and expiration date not reported). Concomitant medications were not reported. The reporter informed that the patient experienced fever, headache and irritability, as well as soreness, redness, heat and swelling of the arm in which she received the first dose of RECOMBIVAX HB. The physician reported that the patient had no received further doses of RECOMBIVAX HB or any other Hepatitis B virus vaccine and wanted to know whether it was safe to attempt revaccination. The outcome of the events was reported as recovered/resolved (also reported as the symptoms lasted about 1 week). Causality assessment was not provided by the reporter. Additional information has been requested.
Patient described a 4 inch ring of swelling and redness around the lower left side of her left arm corresponding to PNEUMOVAX 23 site 2 shots on left side.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema. On 29th July 2018, the patient experienced injection site itching. On an unknown date, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site itching were not recovered/not resolved and the outcome of the injection site pain and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm around 10:30 AM. The patient had denied permission to contact their physician.
4/7 6pm  arm very sore fevered, caused sleepless night, 4/8 headache, body aches, low grade fever, chills, nausea
This spontaneous report as received from a consumer refers to her father a 92 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In approximately September 2015 (date estimated based on "about a month earlier"), the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, route of administration, injection site, lot number and expiration date were not reported). On 20-OCT-2015, the patient received a second injection of PNEUMOVAX 23, 0.5 ml, intramuscularly, (injection site, lot number and expiration date were not reported), which was other that indicated in the prescribing information. The patient did not seek medical attention. No treatment was given for the event. Additional information is not expected as insufficient contact details were provided.
Awakened in am and noticed rash, swelling and itching right side of face. Urticaria rt eyelid, cheeks, neck and a few on center left side of face and neck. Skin tingely. Recommended antihistamine and cool compresses. No other adverse side effects. 10/26/09 ED records received from date 10/23/09. DX: Generalized allergic reaction. Presenting SX: pt. states received flu vax 10/21, face swelling, itching 10/22. ER 10/23 for continued swelling. Assessment: (+)facial swelling, right eye swelling. Pt. tx and d/c.
Red and irritable, felt warm and it showed an induratino of 2" x 2 1/2" with noticeable itching. Prescribed Hc 2.5%.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 01/27/2021, 02/24/2021, and 01/06/2022. They tested positive for COVID-19 on 07/08/2022. They died on 07/21/2022. They had co-occurring conditions and complications of: cardiogenic shock, myocardial infarction, ventricular fatal defect, coronary artery disease, COVID-19 pneumonia.
Stomach Bleed; Flu symptoms; From that week on I've had no energy/ Ive felt weak; Dizzy; Short of breath / anything I do I feel out of breath.; Fever for a week.; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA (Flu symptoms), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy), DYSPNOEA (Short of breath / anything I do I feel out of breath.) and PYREXIA (Fever for a week.). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) (seriousness criterion medically significant). On 11-Mar-2021, INFLUENZA (Flu symptoms) and PYREXIA (Fever for a week.) had resolved. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy) and DYSPNOEA (Short of breath / anything I do I feel out of breath.) had resolved.            No concomitant medication was reported. The patient stated that per his doctor, his chest, heart and veins were all tested (type of tests were not specified) and all tests were negative. No treatment medication was reported.  Patient reported that later found out it was a stomach bleed but said not related to vaccine. Is all fine now and does not want to be contacted for follow up.  Company Comment: 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.  Further information to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up added. Added event and upgraded case to serious. Outcome of case updated to recovered.; 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.  Further information to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted.
slight allergic reaction including hives; slight allergic reaction including hives; her face was swollen; face is not as swollen and it is only kind of tingly/ face was swollen, numb, tingling; Felt like it was burning and chills; within 15 minutes injection felt like it was burning; have slight hives on arms/ hives on both arm including around injection site; slight swelling; numbness in face; nasal voice; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA7484), dose 1 via an unspecified route of administration, administered in Arm Right on 01Aug2021 11:30 (age at vaccination: 36 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received other medications Famotidine, Levothyroxine, Zyrtec-D within 2 weeks of vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing 5 to 10 years ago, polycystic ovaries from an unknown date and unknown if ongoing 5 years ago, seasonal allergy from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, mycotic allergy from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO) taken for hypersensitivity from an unspecified start date and ongoing; famotidine (FAMOTIDINE) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine (LEVOTHYROXINE) taken for biopsy thyroid gland abnormal, start and stop date were not reported. Patient didn't had COVID-19 prior to vaccination. Patient was not tested with COVID-19 to post vaccination. The patient experienced within 15 minutes injection felt like it was burning on 01Aug2021 12:00, have slight hives on arms/ hives on both arm including around injection site on 01Aug2021 12:00, slight swelling on 01Aug2021 12:00 ,numbness in face on 01Aug2021 12:00, slight allergic reaction including hives on an unspecified date, slight allergic reaction including hives on an unspecified date, her face was swollen on an unspecified date, nasal voice on 01Aug2021 , face is not as swollen and it is only kind of tingly/ face was swollen, numb, tingling on an unspecified date, felt like it was burning and chills on an unspecified date. No therapeutic measures were taken for the events. The outcome of the events vaccination site pain, urticaria, swelling, hypoaesthesia, dysphonia was recovering, the outcome of the events drug hypersensitivity, urticaria, swelling face, paraesthesia, chills was unknown.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  Follow-up attempts are completed. No further information is expected.
pt recvd vax on 26JAN93 In late Feb93 the pt exp muscle aches, joint pain & numbness & swelling in rt foot; No further details were provided;
Vasovagal response, not syncope. Pt was clammy, pale, and felt like passing out. She was responsive, placed in supine position, given gatorade. VS 110/70, pulse 70, resp 16. Pt had not eaten yet today either. Pt states that she has not been vaccinated ever. Pt is not pregnant. Pt was sent home with spouse driving with instructions to call if there were more questions.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fluid filled blister at injection site-Medium, Error: Wrong Route (SC, IM, etc.)-, Additional Details: Patient presented with fluid filled blister about the size of a dime at the injection site.  The injection site is in an abnormal position on the upper arm, toward the front of the body (not in the center of the deltoid).  It has been 2 days since injection and has not resolved.  Patient states that he is experiencing pain.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 05-JUN-2014, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
10 days after vaccination, injection site became itchy, red, swollen and hard. 7.5cm x 5cm.  Headache and slept most of the time for the next 4 days.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and drug allergies were not reported. Since 31-OCT-2013, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular (lot number and concentration were not reported) that had been improperly stored. No adverse effects were reported. Additional information has been requested.