chrisvoncsefalvay/vaers-outcomes huggingface dataset:
overall body aches; Chills; 100.4 fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 17:15 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "lung cancer" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 21Oct2023 at 07:00, outcome "recovered", described as "100.4 fever"; CHILLS (non-serious) with onset 21Oct2023 at 07:00, outcome "recovered"; PAIN (non-serious) with onset 21Oct2023 at 07:00, outcome "recovered", described as "overall body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, chills, pyrexia.  Additional information: Patient had no known allergies, no covid prior to vaccination and was not tested for covid post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
The patient received the wrong formulation of Pfizer covid-19 vaccine. He was administered the adult dose instead of the pediatric dose. I notified the mother on 06/05/22 and she said that he has not had any adverse reaction to the vaccination except for soreness in the arm.
On 12/3/21 the worst headache of my life began on the left side of my head along with vomiting. After about two days the nausea went away, but the headache persisted. I ended up in the ER twice on 12/7/21 and 12/8/21, but it was written off as a bad migraine.
Pt noticed itching to right arm 2d after injection came home from school and mom noticed redness and swelling to right arm. TYLENOL, cold compresses and rest.
This patient presented to our pharmacy to get the first dose of pfizer imz, but failed to tell us that he had already received a dose of J and J previously at another pharmacy. When we called and asked him, he stated that he wanted to get the pfizer  because he knew that the J and J did not cover the variants.  We let him know that this was not recommended, and he stated that he was fine and that we were being overly cautious.
Onset of Tinnitus/ a few days of injection.  Right ear only .  No history of ear issues ever .  Hoping it?s just a temporary immune reaction to the vaccine.  Hoping in due time symptom will resolve .
2 days after vaccination, patient reports "heart palpitations and increasing size in my lymph nodes in my armpit, elbow, and left breast. The injection site(left deltoid) is also warm, red, and swollen to the touch. The size in pain in my lymph nodes on the left side have gotten so bad I have limited mobility in that arm. The pain in my left breast wakes me up at night. My heart rate can reach up to 160bpm 6-8 hours following the doses. My vital signs have been within normal limits today and seem to be improving overall". Pt also reported left eye lid swelling after injection and was recommended to go to ED if heart palpitations and swelling persisted. Also educated to use warm compress to help with arm mobility. Patient did not end up going to ED.
Please note: the sticker given to me to put on my card has lot and other information cut off and I am unable to read this information.  My left forearm had an adverse reaction resulting in a painful and occasionally itchy rash.  I noticed it on the Friday afternoon  following my appointment.  My arm was painful to the touch and red.  Please note that redness appeared in places other than the injection site and covered most of my forearm.  By Friday evening my arm felt hot to the touch.  I used an infrared thermoeter on my forearm with the reading of 103.7 and 101 from my forehead.  By Sunday evening the fever was gone.  As of today, 05/20/21, the arm is still itchy and slightly red in some places.    Thank you.
Information has been received from a licensed nurse of practice concerning a 6 month old patient who on 05-JUL-2010 was inadvertently vaccinated with VAQTA IM. The office meant to administer "ENGERIX". Thus the patient missed the dose of "ENGERIX". No known adverse effect. It is unspecified the patient sought medical attention. Follow up information on 26-OCT-2010 has been received from the nurse who reported that a 6 month old male with no illness at time of vaccination, no allergy, no birth defects who on 05-JUL-2010 was vaccinated with the first dose of VAQTA (lot # 666550/1537Y) IM on left arm. Suspect therapy included the third dose of ROTATEQ (lot # 665161/1632Y). Other concomitant vaccines included the third dose of PENTACEL (lot # C31016AH) IM right arm and the third dose of PREVNAR 13 (Pfizer) (lot# E47473) IM left arm. No lab was performed. The patient experienced no adverse reaction to these vaccines. No further information is available.
Patient complained of local tongue swelling.  No hives or wheezing.  Initially RMA'd but then requested a transport due to feeling weak & tired.  Transported to Medical Center by EMS.
PATIENT CALLED AFTER ABOUT 45 MINUTES TO AN HOUR TO VACCINE SAYING THAT HER THROAT FELT SORE AND TIGHT, BUT HAD NO DIFFICULTY BREATHING. PATIENT WAS TOLD TO GO TO ER. WHEN PATIENT WENT THERE THEY GAVE HER BENADRYL AND STEROIDS, BUT TOLD PATIENT THAT REACTION DID NOT SEEM ANAPHYLACTIC
arm pain; low grade fever of 100; This is a spontaneous report from a contactable nurse.  A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly at the left arm on 20Dec2020 10:30 at a single dose for COVID-19 immunization at a hospital.  Medical history included migraine and asthma. Allergy with only certain nausea medications (unspecified). There were concomitant medications but were unspecified which the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. On 20Dec2020, 22:00, after almost 12 hours, patient had a low grade fever of 100 (unit unspecified) and had an arm pain with no treatment while fever responded to acetaminophen (TYLENOL). The patient recovered from the events on an unknown date.
This spontaneous report was received from a pharmacist and refers to a multiple patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX, lot number M005972, expiration date 02-FEB-2018, lot number M031970, expiration date 30-JUN-2018, by subcutaneous route, (anatomical location and dose number were not reported), for prophylaxis. The vaccines were reconstituted with sterile diluent (lot number as reported K015799, expiration date 19-JUL-2017), however the sterile diluent was stored within the recommended storage range. The VARIVAX was between 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees) during a time frame of 15 minutes. The VARIVAX had a previous temperature excursion. The digital data logger was not involved. No product quality complain was involved. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA007563.
Pain; Swelling; This case was reported by a physician via call center representative and described the occurrence of pain in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were unknown.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain and swelling. The reporter did not have lot or expiration date, as the 1st dose was given elsewhere. The reporter consented to follow up.
Within days, I experienced my first onset of crippling vertigo.  I went to urgent care after being extremely nauseated and still having intermittent bad vertigo.  They discovered my heart rate was 1/2 what it should be and traced the vertigo to a cardiac issue requiring a pacemaker.  Two months later I was walking on the beach and collapsed.  I was experiencing the worst vertigo where moving any part of my body moved my head.  Moving a millimeter increased the intensity of the pain making it intolerable and an ambulance transported me to the hospital.
Tested positive for covid on 4/11/22, admitted for weakness and fatigue, exposure to covid from family members, no acute symptoms of sob, cough, or fever, discharged home with home care on 4/18/22
Approximately 15-20 minutes after receiving vaccine patient reportedly felt dizzy, then "passed out" while driving home - resulted in her rear ending auto in front of her.
Found a lump on left side of my breast.  Diagnostic mammo/ultrasound found a second, more questionable lump in deep left axilla.
A lump swell up right next to the injection site; The area was now slightly red; This is a spontaneous case, reported by pharmacist to Agency (reference number: SEQ19-05124) and initially received on 18-Oct-2019, concerning a 76-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported. It was reported that the patient received Fluad vaccine last year and the year before without any issues.  On 18-Oct-2019, the patient was administered Fluad (TIV) [Influenza vaccine, influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscular, batch number: 261280, expiration date: 30-Jun-2020] for protection against seasonal influenza.  On the same day, during vaccination, the pharmacist noticed a lump swell up right next to the injection site. After the pharmacist pulled the needle out of the patient's arm, she noticed that the swelling had gone down, however, the area was slightly red. Patient did not experience any additional issues.   At the time of initial reporting, the patient was recovering from the event of 'injection site redness'.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Non-significant follow-up reported by other non-health professional from Agency [reference number: SEQ19-05851] on 16-Jan-2020: Additional reference number added. No changes in narrative.  Company comment: The patient developed injection site mass and injection site erythema, associated with administration of the suspect product, Fluad (TIV). Chronology is plausible and causal role of the suspect vaccine is assessed as probably related.; Sender's Comments: The patient developed injection site mass and injection site erythema, associated with administration of the suspect product, Fluad (TIV). Chronology is plausible and causal role of the suspect vaccine is assessed as probably related.
According to clinic patient received J+J COVID vaccine on 4/5/2021 and again on 9/16/2021 as documented in this report.
administered a vaccine that expired; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (expiry date 30-SEP-2022) for prophylaxis.   On 13-MAR-2023, the patient received Havrix. On 13-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered a vaccine that expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13 Mar 2023 The medical assistant administered a Hepatitis A (Havrix) vaccine to a patient on the day of reporting that expired on 30th September 2022.  The patient had already been notified. The reporter wanted to know what to do. No patient demographics provided. The permission for Safety follow-up not given.  The patient received expired Havrix vaccine which led to expired vaccine used.
A pharmacist reported that he received an injection of Pnu-Imune 23 on 12/8/00. The following day, he developed an injection site reaction characterized by a 8" by 4" area of redness, swelling, warmth and pain. The reporter stated that the symptoms have decreased; however, the pain has "moved down to elbow area". This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23 lot 468148. Follow-up received on 5/30/01, indicated that the pt recovered.
Narrative: 40 YO female who received the 1st dose of COVID-19 vaccine on 3/21/21 and 2nd dose on 4/11/21. Patient reported symptoms to her primary care provider and ID consult was placed. She reported sore arm x2 days, then severe joint pain and stiffness in knees, wrist, and axillary region x5 days. She reports the pain being severe and taking ibuprofen 800 mg daily. At most recent follow-up on 5/5/21, knee pain has resolved but hands and wrists continue to feel tight and  stiff. She also reported a heavy feeling in her sinuses with hypersensitivity in right cheek and numbness in left cheek, which still persisted at follow-up. Per ID consult, no current data supporting association between COVID vaccines and reactive arthritis or facial symptoms. Patient is currently being worked up for  other causes (neurology, arthritis, inflammatory markers, X-rays).
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On 17-AUG-2007, the patient was vaccinated with ZOSTAVAX (strength, dose, anatomical route of vaccination, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and, despite being inoculated with the ZOSTAVAX. Due to the patient's shingles, on 29-SEP-2016, the patient was treated by a healthcare provider. Furthermore, it was reported that the patient suffered serious physical, emotional and economic damages as a result. The patient would continue to suffer ongoing injuries, included 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; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the outcome of emotional distress and pain was reported as not recovered and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. Additionally, the reporter considered herpes zoster, condition aggravated, quality of life decreased, pain, emotional distress and vaccination failure to be related to ZOSTAVAX. The reporter considered the events to be serious due to disabling, life-threatening, hospitalization and medically significant.
Approx. 3 days, after injection, pt complained of muscle weakness, joint pain in right arm and area around injection was approx. 5cm with multiple pustules, itchy and hot to the touch, lasting 3 days.
constant ear ringing (buzz), headache for about 4 days after injection, light nausea for about 3 days
Narrative: N/a. Patient was contacted and has reported no adverse reaction to 2nd dose Moderna vaccine administered today, 9/30/2021 at 0820. Vial was opened on Friday, That opened vial was used for 2nd dose administration.
Patient starting having itching 15 minutes post vaccination, patient forewarned that this would happen as she has had this reaction with the flu shot and pneumonia shot. Patient had already discussed with doctor and he still recommended getting the COVID vaccine. Benadryl 50mg  STAT was administered and patient waited another 15  minutes. She was feeling well other than the itching. Recommended that famotidine could also be administered to help with itching, and hydrocortisone cream if a particular spot was more bothersome than others.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99F) and INJECTION SITE PAIN (Injection site pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (Fever of 99F) and INJECTION SITE PAIN (Injection site pain). At the time of the report, PYREXIA (Fever of 99F) and INJECTION SITE PAIN (Injection site pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details was reported. No treatment medication details was reported.
Received expired Moderna COVID-19 vaccine after 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Moderna COVID-19 vaccine after 30 day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Moderna COVID-19 vaccine after 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Moderna COVID-19 vaccine after 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there was one vial with 10 dose each and from them 2 doses injected past its expiration date. The vial was initially stored in the refrigerator on 24 Jan 2022 and the vial did not undergo any temperature excursions. No treatment information was provided.   This case was linked to MOD-2022-494719 (Patient Link).
rash on my stomach, back, and thighs, was large and splotchy, red, and slightly raised; red rash; It was not itchy, but tender in rash areas; This is a spontaneous report from a contactable consumer, the patient. A 44-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in thr left arm on 20Mar2021 at 18:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was allergic to possibly raw tuna (like sushi). The patient had not received any other vaccines within four weeks prior to the vaccine. The patient did not receive other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 00:00, the patient developed a rash on her stomach, back, and thighs. It was large and splotchy, red, and slightly raised. It was not itchy, but tender in those areas. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did a telehealth visit with her doctor. and the doctor thought it was a histamine response and not an allergic reaction. But the patient had not seen this type of rash listed anywhere. Only a rash at injection site was listed. The patient did not receive any treatment for the reported events. On nights 2 and 3 after vaccination, the patient had rash on her stomach, back, and thighs, it was large and splotchy, red, and slightly raised and tender in those areas. The clinical outcome of the events rash on her stomach, back, and thighs, it was large and splotchy, red, and slightly raised and tender in those areas were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
She couldn't turn her neck and her shoulder and collar bone and her chest hurt and it's getting worse; She couldn't turn her neck and her shoulder and collar bone and her chest hurt and it's getting worse; her right arm was sore from her shoulder to her neck to the top of her chest on the right side / her chest hurt and it's getting worse; right arm was sore from her shoulder to her neck to the top of  her chest on the right side; right arm was sore from her shoulder to her neck to the top of  her chest on the right side; right arm was sore from her shoulder to her neck to the top of  her chest on the right side; This is a spontaneous report from a contactable consumer or other non hcp from United States. The following was Reported by patient herself.   A 59-years-old female patient received bnt162b2 (bnt162b2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Apr2021 15:00 (Batch/Lot number was not reported, Expiry Date: Unknown) as single dose (at the age of 59-years-old) for covid-19 immunization.  The patient previously took first dose on 03APR2021 via an unspecified route of administration, administered in Arm Right (Batch/Lot number was not reported, Expiry Date: Unknown) as single dose for covid-19 immunization. With the first Covid 19 vaccine she just had a sore arm (on 04Apr2021) the day after she received her vaccine. The soreness only lasted a day. Medical history included covid-19 from 11Mar2021 to an unknown date, ongoing arthritis, ongoing type 2 sugar diabetes, ongoing high blood pressure and ongoing lower lumbar sciatica. Patient reported that she had the Covid 19 virus on 11Mar2021. The patient's concomitant medications were not reported. When probing concomitant medications caller reports she takes her regular medications, nothing new has been prescribed. She declines to provide her medications for the report. Patient has no history of prior vaccinations (within 4 weeks). No other events were reported following prior vaccinations. Next day of receiving second dose on, 25Apr2021 her right arm was sore from her shoulder to her neck to the top of her chest on the right side. It's gotten worse since then. She couldn't turn her neck and her shoulder and collar bone (on 25Apr2021). Patient also complained of chest hurt which was reportedly getting worsened. There was no emergency room nor physician office visit for events. The outcome of events was not recovered.  No relevant tests were done. No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Reason for no lot number: The caller reports the vaccine record card does not have an NDC/Lot/Expiry for either dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.