chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had received their first dose of their Covid-19 vaccine. They were sitting in our waiting area like they were asked. Patient states that she started to feel lightheaded and dizzy. She then starts to walk up to the counseling window to notify the pharmacist, even after being advised to not leave her chair, when she fainted. The patient may have hit her head on the floor when she fainted, unknow to the pharmacist. Patient came to in less than 2 seconds from fainting with complete consciousness. Patients feet were elevated for a few moments and bp was checked while in this position with a bp of 161/101 and a pulse of 89. Patient was then moved back to the chair where she remained until EMS arrived. Patient was also given a snack and water to make sure that her blood sugars were not part of the cause of the fainting. Once EMS arrived they assumed controls of the situation and the patients health. We both were assuming it to be a vagovasal response.
Vaccine leaked onto patient/syringe malfunctioned; Vaccine leaked onto patient; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEVICE MALFUNCTION (Vaccine leaked onto patient/syringe malfunctioned) and UNDERDOSE (Vaccine leaked onto patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On 05-Mar-2021, the patient experienced DEVICE MALFUNCTION (Vaccine leaked onto patient/syringe malfunctioned) and UNDERDOSE (Vaccine leaked onto patient). On 05-Mar-2021, DEVICE MALFUNCTION (Vaccine leaked onto patient/syringe malfunctioned) and UNDERDOSE (Vaccine leaked onto patient) 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 did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.; Sender's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot # unknown), reporting (device malfunction and underdose) without any associated adverse events. The outcome of the events is reported as resolved.
erythema surrounding inj site that is spreading to elbow;hot & painful to touch;+edema 20x 15cm;
right arm is still in a lot of pain/Arexvy site still painful; could not lift her right arm; This non-serious case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number JC7Z5, expiry date 01-FEB-2025) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID VACCINE).   On 18-SEP-2023, the patient received Arexvy (right arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: right arm is still in a lot of pain/Arexvy site still painful) and injected limb mobility decreased (Verbatim: could not lift her right arm).The patient was treated with paracetamol (Tylenol), ibuprofen, non-drug therapy (Ice Pack (No Medication)) and non-drug therapy (Heat (Non-Drug Therapy)).The outcome of the pain in arm was not resolved and the outcome of the injected limb mobility decreased was unknown.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Arexvy.   It was unknown if the company considered the pain in arm and injected limb mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-OCT-2023 The case was reported by the patient.  She stated that she received Arexvy in right arm and Covid vaccine in left arm.  She stated that her left arm was fine but her right arm was still in a lot of pain.  She could not lift her arm.  She was tried, ice, heat, salon pas patches, Tylenol and Ibuprofen without success.  She stated that Arexvy injection site still painful.  The reporter consented to follow up.
I felt that I had an increased heart rate 30 min after the vaccination for 30 min. That evening I felt like I had a fever and felt fatigued. One week later I developed a 1 inch diameter hives rash at the injection site.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up received and contains dose 2 information and action taken updated. Event (missed dose) deleted.
Mother states diarrhea started one day after immunizations.  Started having bloody diarrhea, went to MD, stool was sent off for testing and results did not show anything.
Uncontrollable crying, stomach pain, head ache, itchy face and eyes, red blotches on face. No fever.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (received Moderna booster shot and just found out the vial expired) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (received Moderna booster shot and just found out the vial expired). At the time of the report, administered expired product (received Moderna booster shot and just found out the vial expired) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Immediately after administering vaccine, patient leaned up against the wall. Patient was pale. Individual that accompanied patient was unable to get a response from him, though his eyes were open. We shouted his name several times. His muscles tensed/clenched/spasmed. This lasted about 30 seconds. After 30 seconds patient responded, and asked for water.
Intense lower stomach pain once a month around the time of menstruation for 4 months, lasts 2-7 hours
Patient started fainting a few minutes after the Janssen vaccine was injected. Patient started fainting in while he was seated. He wasn't very responsive but his eyes were open.  Patient stated that he has a panic attack to the injection of the needle and has had similar reactions in the past from other injections.
patient was scheduled for 2nd covid dose 1 week too early. not found until after patient left and vaccine was documented.
Started with very sore arm at site of injection.  Approximately 36 hours after vaccine administered, I started with very sore muscles all over body.  These flu-like symptoms lasted 48 hours.  My arm has been very sore for the past 2 weeks.  Red and swollen area went to 5.5 inches in diameter.  Today (day 14) can see where red area was-but now have 2 "blisters" (size of quarters) and swollen (size of golf ball).
Feeling Strange; feel like cold is coming; fever; tenderness at injection spot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling Strange), NASOPHARYNGITIS (feel like cold is coming), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at injection spot) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling Strange), NASOPHARYNGITIS (feel like cold is coming), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at injection spot). At the time of the report, FEELING ABNORMAL (Feeling Strange), NASOPHARYNGITIS (feel like cold is coming), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at injection spot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 100 degree (High) 100 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI FU
On 6/23/21 I was at work and became very tired and felt I needed to lie down on the floor of my office, which is unusual for me. I am not sure if I fell asleep or passed out. I am not sure how long I was there. When I woke up I was confused and had trouble speaking and writing. The nurses I work with at the hospital brought me down to ER. My heart rate was in the 40s. I spent the night in the hospital and many tests were done and came back normal. My metoprolol med was stopped. They suggested I stop taking Ambien. I am wondering if my heart rate drop had something g to do with an effect of receding th Pfozer COVID vaccine
Redness, swelling, warmth and itching from elbow to shoulder beginning about 24 hours after injection.
SMELL DISTURBANCES/SMELLS EGG WHEN EATING OR COOKING OR WITH  THE TAKE OUT; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced weird smell on nose/smeled like egg when eating, cooking, take out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weird smell on nose/smeled like egg when eating, cooking, take out. This report was non-serious.
1 week after receiving the vaccine I developed cellulitis in the injection site.  I went to my primary care, and was prescribed keflex for 7 days.
Client is Deaf.  client wrote down on a peice of paper that he needed his second dose. Client did not have his card.  Client was also listed twice in Database which we were not aware of until after the vaccine was given. .  Client was listed as having first dose of Pfizer in system .
On the evening of May 15th, I developed slight upper chest discomfort, a jittery feeling in the anterior neck bilaterally, a fuzzy sensation in the Eustachian tubes, tachycardia (160-170) and slightly decreased BP (95/60).  Called emergency. Transported to ED while receiving IV hydration. Dx Atrial Fibrillation, new onset. Treated with additional hydration, started on oral anticoagulant and discharged around 0700 on May 16, 2022.
I had numbness and a very cold sensation in my left arm and leg immediately after receiving my first and second Pfizer vaccine. I also had numbness and a cold sensation in my mouth and lips after the first shot, but not the second shot. This sensation lasted for 90 minutes after both shots in my arm and leg. I have also had numbness and a cold sensation occur occasionally in my arm and leg for several weeks since having the first shot and also since having the second shot. I was checked out by a doctor after having the vaccine.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) vaccination, patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown.      Additional information has been requested.
increased overall pain; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:00 (Lot Number: EWO153) as 1st dose, single for COVID-19 immunization. The patient's medical history included COVID-19 from unspecified date. Concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient had heart palpitations and increased overall pain which included hospital emergency stay on 07Apr2021 14:00. The events were treated with steroids, pain meds and flexiril. The events resulted in doctor or healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 3 days. The outcome of the events was not recovered. The patient had nasal swab: negative on 27Apr2021 and COVID-19 test: unknown result on unspecified date.  Information on Lot/Batch number was available. Additional information has been requested.
Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     Patient had no Allergies. Patient never had COVID positive test or diagnosis. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma. On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Slight fever the next day and two only.  My arm was hurting with redness.  Probably the second day, 11/18  is when the site started to itch.  As the days went by, it got itchier.  These are all indicated as side effects but information states for 2-3 days.  I'm reporting this since it's been 5 days and the discomfort increased each day.  As of today, 11/22, the arm is still red, patchy, and it's still itching.
Post giving the vax pt began to cry & hold her breath, p/about 30 secs did not take a breath, her eyes rolled into the back of head back arched & extremities all were drawn into flexed position; Sent to MD for evaluation;
Complaining of extreme fatigue for two weeks post shot,  then had a fall, hospitalized  for 24 hr.  Troponin level normal, EKG with changes.
Injection site swelling and redness; Injection site swelling and redness; Low grade fever; Nausea; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient received bnt162b2 (BNT162B2) (Lot# EJ1686, Exp date 31Mar2021), via an unspecified route of administration, on 05Jan2021, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced injection site swelling and redness, low grade fever and nausea all on 06Jan2021 with outcome of unknown. Therapeutic measures were taken as result of the events and included treatment with a 1000 mg Tylenol. The events were considered related (source of assessment: primary source reporter, method of assessment: global introspection).
pt recv Td instead of PPD vax & exp wide spread redness, itching & pain @ test site;disappeared in 48-72hr p/tx w/cold packs & in some cases topical hydrocortisone cream was applied;
Immediate-tingling sensation, sweating. 1 hr-injection site hot, painful-headache. 2 hr-all over body ache-hives all over. From that time until 10/15/09-injection site hot, pain, headache, all over body ache-massive hives.
Expired Dose of Heplisav-B Received; Initial Report Received on 15-NOV-2022  This is a spontaneous report received from a registered nurse in the regarding a 32-year-old female (race and ethnicity not provided) who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 15-NOV-2022, dose 1 of HEPLISAV B (Lot #935845, expiration date 06-NOV-2022, NDC #435528-003-01), route and site not specified, was administered for hepatitis B immunisation.   The HEPLISAV-B dose was 9 days past the expiration date.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
patient says her arm is really sore and bruised. she also noted warm to touch. i have instructed her to mark area around redness/bruising with a pen and to have her go to an er/urgent care if it continues to be warm (although noted it wasn't as of today) and I will follow up with patient tomorrow to see how she is doing.
About a week after my second dose, I developed a lump in my left breast. I went to see my doctor that week. He sent me to a specialty high risk appointment. I have family history of breast cancer. I had a mammogram and an ultrasound completed. They informed me that after the testing, there was no need to worry because it was probably from the vaccine. A couple of months had gone by before I could no longer see or feel the lump.
This spontaneous report as received from a health worker refers to multiple patients of unknown age. On an unknown date those patients were vaccinated with improperly stored ROTATEQ for prophylaxis. No adverse events were reported. Additional information has been requested.
Pain at injection site, swollen lymph node on same side as  injection, head ache, muscle ache, cold sweats, low grade fever, chills,  diarrhea, nausea, fatigue
pt recv vax 5NOV97 & on 10NOV97 began c/o pain in vaccinated arm, shoulder & neck;above sc cont through 14NOV97;
Information has been received from a consumer concerning her 17 month old daughter with no past medical history, a dairy allergy and an antibiotic allergy who on 3/19/01 was vaccinated with MMRII (lot 00150-invalid lot). Concomitant therapy included hyoscyamine (Levsin). In approx. 3/01, the pt developed a fever of 105F, a rash, an ear infection, irritability and insomnia. It was noted that the rash looked like measles and rubella. She went on antibiotics and the effects disappeared within 2 weeks. Unspecified medical attention was sought. Additional information has been requested.
6 yr old female received 0.2cc of vaccine from Purple vial, essentially 20mcg. No adverse reactions noted during time in clinic.
On 15-DEC-2000, (at approximately 2 PM), the pt was vaccinated with the third dose of Comvax IM in the thigh. On the morning of 16-DEC-2000 at approximately 10 AM the pt developed a fever that was noted to be a very toxic febrile reaction. In the evening of 16-DEC-2000, the pt's fever went to 103 to 104 degrees and he was treated with Tylenol liquid. The pt was actually ill with fever, irritability and a decreased appetite. the pt also had erythema at the thigh injection site (dime-size) which subsided over 72 hours. On 17-DEC-2000 the pt was seen by his pediatrician. At this time the pt has a fever of 101 degrees and the child had a bump on his outer thigh at the injection site. A blood count was normal. The pediatrician felt the pt's experience was viral and not related to Comvax. It was reported that the pt recovered on 17-DEC-2000 PM. Follow up information received from the physician indicated that no further adverse sequelae were noted since the third Comvax vaccination. At the time of this report on 29-JAN-2001 the pt had not received any additional vaccines. No further information is available.
Moderna COVID-19 Vaccine  Red rash near injection site, approximately 2 1/2 inches long and 2 inches wide, appeared overnight. Initially itchy. Slightly tender muscle similar to discomfort following injection. Does not feel hot. First noticed at 5:15 am. Slightly less red by 3:20 pm.
This spontaneous report as received from a physician via company representative refers to a 15 year old male patient. The patient had no known pertinent medical history. The patient had no known drug reactions/allergies. On 06-FEB-2014, the patient was vaccinated with the first dose of GARDASIL (lot # J012212, expiry date 18-FEB-2016) injection 120 Y (dose and route not reported). The patient also received a dose of influenza virus vaccine (manufacturer unknown) (lot#, expiry date, dose, frequency, strength and route not reported) concomitantly with the GARDASIL. No concomitant medication was reported. On 06-FEB-2014, the patient fainted and developed tonic clonic movements after receiving the first dose of GARDASIL. The patient went to the physician's office for seek medical attention. No lab diagnostics studies were performed. The patient was treated with ice packs and "alcohol smelling capsules". The patient recovered from the adverse events on 06-FEB-2014. Additional information has been requested.
Flu vaccine on 10/20/23, left arm.   Itching started about 40 minutes after vaccine. Pt thought it was her asthma.  But then saw rash, redness.  Taking Benadryl after work.  Did that for few days, then eyes started to be irritated.  Went to MD on 10/23/23.  Script for Prednisone called in to Pharmacy, had to leave work to get meds.  Pt states Prednisone worked, and rash and itching cleared up. Pt states about 16 years ago had similar reaction. Had bad reaction to COVID vaccine, in bed for 7 days after vaccine. No vaccines or illness 1 month prior to flu vaccine this year.
27SEP recv vax & 28SEP fever, dizzy, didn't sleep well, arm pain, swelling @ site of shot;29SEP muscle spasms in back, pain in neck, back of head hurts, diff breathing because of pain;4OCT neck stiffness improving;pain @ inj site;