chrisvoncsefalvay/vaers-outcomes huggingface dataset:
45 year old female patient after administering the second dose of Moderna she went to the observation area and when she went to register, she was asked if she was feeling okay and she started to cry. The head nurse was notified and patient was taken to the area of observation. Patient asked to sit for evaluation. At 9:40am vital signs were 98% saturation, 16 respiration, 97 pulse and 140/90 BP. Later the patient reported having a panic attack and was asked to do breathing exercises. Later we spoke with the patient and she said she was feeling scared about the vaccine. At 9:51am vital signs were 130/80BP, 87 pulse, 98% saturation, clear lungs on auscultation and 16 respirations.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 50 years old male patient who had severe shoulder pain for a year after he's had his flu shot, while he received FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date and dose in series was not reported) via intramuscular route in the arm NOS. On an unknown date, following the vaccination the patient experienced shoulder pain for a year. (Other relevant tests included no lab test). Final diagnosis was severe shoulder pain for a year after he's had his flu shot. It was not reported if the patient received a corrective treatment. The outcome of the event was unknown. List of documents held by sender: none.
Information has been received from a advanced practiced registered nurse concerning a 66-year-old female with herpes simplex type II, hyperparathyroidism and breast cancer who on 14-AUG-2007 at 14:50 hours was vaccinated subcutaneous in the left upper upper arm with her first dose of zoster vaccine live (Oka/Merck) (lot # 657767/0740U). There were no illnesses at the time of vaccination. Concomitant vaccine administered on 14-AUG-2007 included her first intramuscular dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) administered in the left deltoid (lot # U2155CA). Concomitant therapy included (MSD), (DIOVAN), vitamin D (unspecified), calcium (unspecified), and vitamins (unspecified). On 20-AUG-2007 the patient thought they had "mosquito bites" five to six days after vaccination the patient developed an itchy rash over trunk rapidly spreading with about 30 lesions on their trunk with less central papules on a 2 cm erythematous base. The patient started acyclovir on 21-AUG-2007. No diagnostic labs were performed. At the time of the report the patient's status was unknown. Additional information has been requested.
Fainting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 07Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (Dose 3; unknown manufacturer), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 08Jun2022 at 09:30, outcome "recovering", described as "Fainting". Therapeutic measures were taken as a result of syncope.  clinical course: Fainting outcome: She's better now, she is not diabetic and does not have low blood sugar but she drank some orange juice and that helped, she has not eaten breakfast. She verified there has been no relevant testing, treatment or medical interventions to report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Whole body convulsing all day; Not doing well after her Moderna vaccine; Tongue began to spasm  and hasn't quit/bad shape; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Whole body convulsing all day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Whole body convulsing all day) (seriousness criterion medically significant), MALAISE (Not doing well after her Moderna vaccine) and MALAISE (Tongue began to spasm  and hasn't quit/bad shape). At the time of the report, SEIZURE (Whole body convulsing all day), MALAISE (Not doing well after her Moderna vaccine) and MALAISE (Tongue began to spasm  and hasn't quit/bad shape) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2021: No specific follow-up information recorded. On 12-Jan-2021: No specific follow-up information recorded. On 12-Jan-2021: No specific follow-up information recorded. On 15-Jan-2021: No specific follow-up information recorded.; Reporter'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.
Took flu shot in 12 hrs running106 temp didn't knowwho I was for three days; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional via Social Media.  This case involves a patient unknown age who "took flu shot in 12 hrs running106 temp didn't know who i was for three days" (pyrexia), while he/she received vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concurrent condition and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received influenza vaccine (lot number and expiry date) at unknown dose via unknown route at unknown administration site for prophylactic vaccination.   On an unknown date, (latency unknown) after administering suspect vaccination therapy, Took flu shot in 12 hrs running106 temperature didn't know who patient was for three days (pyrexia) said never take flu shot again. No patient was not allergic to chickens eggs or feathers my sun , same why so want take it.  No lab data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, outcome was unknown.  There will be no information available on the batch number for this case.
Headache, cough, runny nose, lethargic starting on 8/29/21
The next morning, severe headache, vomiting, chills, sweating, passed out hit my head and now have a black eye and cheek bone swallon. extemely tired, light headed nausea .
Had shingles after getting the shots/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles after getting the shots/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that his or her friend as suggested received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR054617:Same reporter
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 66-years-old male patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 09-JUL-2009, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the prophylaxis.  In October 2019, subsequent to the patient vaccination, he was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages, other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. At the reporting time, the outcome of the event was unknown.  The reporter considered the events of shingles to be related to zoster vaccine live (ZOSTAVAX).
1-5 minutes after both shots: sensation of mild swelling in throat, in addition to mild dizziness/faintness which passed after 5-10 minutes (no phobia of needles). Feeling of swelling in throat/difficulty swallowing lasted until about 4 hours after vaccine was given, and was more intense after second dose, though not enough to seek medical attention.  In addition, after the second dose, a feeling of prickling/heat on skin, which began within 1-5 minutes of receiving the vaccine and lasted for about 5 minutes after symptoms began.   No respiratory effects. No other symptoms which resembled an allergic reaction (itchy mouth, rash, adrenaline rush, etc.)
This spontaneous report was received via company representative from a 65 year old non-pregnant female patient (office manager) who was reporting on herself. The patient's medical history included cellulitis after an unspecified tuberculosis injection. Her concurrent conditions and concomitant medications were not reported. On an unspecified date in 2014 (reported as 2 years ago), the patient was vaccinated with the first dose of ZOSTAVAX (subcutaneously; dose, lot # and expiration date were not reported). On an unspecified date, the patient was diagnosed with cellulitis. She sought an unspecified type of medical attention and received unspecified antibiotics as a treatment. The outcome of cellulitis was reported as resolved on an unspecified date. The relatedness between the adverse event and ZOSTAVAX was not provided. Upon internal review, the adverse event of cellulitis was determined to be medically significant. Additional information has been requested.
Pt recv vax on 7/18/97; on 7/20/97 pt exp limp body, eyes rolling up, head thrown back
Feeling "drunk" and unbalanced.  Went to bed early and felt ok next day except for pain in my arm.  I noticed 2 days later there was a rash at the injection site.  As a Practitioner, I I do counseling and  I've noticed 2-3 people have complained of deep depression that started next day of vaccine and still is ongoing.  Concerned about youth, who are already suffering depression, and what this will do to them.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 28-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 672 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
CHILLS; TIRED; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced tired. On 05-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, tired, and headache on 07-MAR-2021. This report was non-serious.
Severe shoulder pain.  Unable to lift my arm. Sever pain and limitation of movement.  Unable to sleep on affected side.
In the evening after clinic, child began having  a rash on his hands, which was reported to RN after she had left the campus.  Child seen by participant MD, who advised oral Benadryl.  The next day (Aug 12) Nurse and mother spoke, and she indicated "he's doing fine now".    On Aug 13  Dr and RN were called to the school area, because a rash had developed on patients face which had not been there a couple of hours earlier.  Child appropriately interactive, had rash across lower jaws and under his eyes (had been wearing a cloth mask).  Also had fine rash developing across his forehead.  Denied any difficulty breathing, or swelling around tongue or mouth/throat areas.  Dr contacted mother who reported she had not changed laundry soap or other factors which might have contributed to a reaction to his mask.  She agreed he could receive 12.5 mg Benadryl that afternoon.  Today mother reports his last dose of Benadryl was given the morning of Aug 14th, and no other interventions needed.
About 3 days later pain started on left arm at site of injection.  It felt like pain was in the bone at the site of injection; within 4 days pain gravitated to shoulder--that is where it has been since. Patient called the clinic when pain gravitated to shoulder. Patient has been to the facility several times since then for follow-up.  Patient has seen, PCP, rheumatologist and currently has appointment with orthopedist.   The pain level has not changed much since it gravitated to shoulder.  Patient has received cortisone shot, a dose of Celebrex, and 2 aspirin; it relieved pain a little bit temporarily. Patient has had shoulder imaging, x-rays, and sonogram.   Patient has not had other symptoms.  Patient has been very active all life, can carry weight when shoulder is down but it becomes unusable as soon as lift it slightly.   Patient has intense pain just when lifting it to grab steering wheel.
After work, she started to feel swelling on the right side of her throat with a lot of pain in her throat. This pain lasted for about a week. She states that her lymph nodes were significantly and noticeably enlarged.  She tried to contact her physician at the hospital but was unable to get in contact with a physician. Headaches from Friday night (1/15/2021) to Tuesday (1/19/2021). Medicine taste in mouth during work then started to get headaches and then throat started to swell. Right now, she doesn't have any headaches, but the lymph nodes on the right side is still slightly swollen and painful to the touch. Not as pronounced as the first few days.
Real throbbing burning pain; Little sore in left arm; Unable to move his right arm and reported pain when he tries to lift it up; Unable to move his right arm and reported pain when he tries to lift it up; Real throbbing burning pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 59-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 21Apr2021 (age at vaccination: 59-years-old) as single dose for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (BNT162B2, PFIZER-BOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration in left arm on 31Mar2021 for COVID-19 Immunization. It was reported that patient received both doses of the Pfizer covid vaccine. He was unable to move his right arm and reported pain when he tries to lift it up. He has had problems ever since the second dose on 21Apr2021. Upon date 20May2021 it was reported that patient had side effects He can't move his arm. He doesn't know who to talk to about it. It has been going on for 3 and a half weeks now and is not getting any better. His unemployment is about to run out. He doesn't know what to do. He can't pick his arm up. He works as a carpenter. Patient was keeps saying if his arm hurts it is usually okay and means the vaccine is working. Can't move his right arm: This happened about 3 or 4 days after the second shot. He got both shots in his left arm. He was a little sore in that area for a couple of days, then after 3 or 4 days his right arm started hurting and has been hurting since. He doesn't know if it might be a blood clot. He doesn't know what is going on, and he can't pick it up. His right arm was good until 3 or 4 days after the second shot. After the first shot he was fine. Then 3 or 4 days after the booster he couldn't move his right arm. It is like a throbbing pain when he tries to pick it up. If he just leaves it down it's fine, but when he tries to pick it up it's a real throbbing burning pain. It is about the same. Little sore in left arm: The soreness was when they stuck the needle, it was maybe 2 or 3 inches. It wasn't bad. His left arm is fine now. It lasted for a couple of days. The outcome for the event Unable to move his right arm and reported pain when he tries to lift it up (Joint range of motion decreased) was reported as not resolved and for remaining events outcome was reported as unknown at the time of this report.   Follow-up attempts are needed. Further information is expected.
At OV today, pt reports that after she left office on day of vacc, at 1/2 hour, started with "hives/itchy bumps" at elbow. She did not call us. Was on CLARITIN, used HCT cream, resolved on its own.
On 12/12/09. Immediately couldn't stop sneezing, chills an hoarseness started on 12/13/09, hives size of a quarter, immediately took over my entire body, I was itching severally on 12/16/09. My eyes, R eye, swelled shut. My work sent me home, hives, muscles, legs, hips, shoulders, back nausea would not go away. On 12/22/09 I was rush to the E/Room by my husband. My mouth, lips, throat was swelling fast, lips looked like I was stung by bees, inside mouth looked like I had just seen a dentist. Face an nose looked as if someone had hitted me. All E/Room reports are available. Still been seen by PCP. Other follow-up visits. Lost a tremendous amount of time from work, lost pay, hours, vacation, need to be reimbursed.
4/17/2021 - New onset of significant pelvic/ abdominal pain, initially thought to be severe, early, out of the ordinary menstrual cramps.  Because I had an IUD, checked to ensure my IUD was in proper position on 4/26.  It was.   A few weeks later, had abnormal bleeding (starting 5/28) not associated with normal menstrual cycle and significant pain starting 6/4.  Transvaginal ultrasound showed cystic fallopian tube  vs hematosalpinx.  Workup has not shown a known cause.  It was not an ectopic pregnancy. There have been no signs/ symptoms/ exam findings lab work  consistent with PID (which would be the main cause with an IUD).   Underwent antibiotic treatment and IUD removal with continued milder intermittent pain.  Will be having a repeat US coming up to determine if it has resolved.
Physician reported on 4/28/2019 that patient presented to hospital and was diagnosed with Transverse Sinus Thrombosis. Was admitted to hospital 4/25/2021. No other information. Hospital wanted the Health Department to report this since the vaccine was given by us.
Received the Pfizer COVID-19 on 21Dec2020. I got Covid from a family member, sore throat, felt like a flu or bad cold,headache, body aches and sinus issue. She now has congestion and cough; Received the Pfizer COVID-19 on 21Dec2020. I got Covid from a family member, sore throat, felt like a flu or bad cold,headache, body aches and sinus issue. She now has congestion and cough; This is a spontaneous report from a contactable health care professional nurse, the patient. A female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020 as a single dose for COVID-19 vaccination. The patient had no known medical history. The patients concomitant medications were not reported. On an unspecified date the patient experienced  I got Covid from a family member.  She reported being symptomatic on 1Jan2021 started with a sore throat, felt like a flu or bad cold. She reported sore throat, headache, body aches and sinus issue. She now has congestion and cough. She had no issue when she got the vaccine.  The patient will be getting the second dose 11Jan2021 and she would like to know  if she is eligible to receive the second dose Pfizer Covid-19 Vaccine. The clinical outcome of the event was unknown   . Information on the Lot number has been requested.; Sender's Comments: The reported "got COVID from a family member" after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
a bad nose bleed from her left nostril; appeared to have a long bloody slimy mucus - like a slug (worm); This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (a bad nose bleed from her left nostril) and SECRETION DISCHARGE (appeared to have a long bloody slimy mucus - like a slug (worm)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced EPISTAXIS (a bad nose bleed from her left nostril) and SECRETION DISCHARGE (appeared to have a long bloody slimy mucus - like a slug (worm)). At the time of the report, EPISTAXIS (a bad nose bleed from her left nostril) and SECRETION DISCHARGE (appeared to have a long bloody slimy mucus - like a slug (worm)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.