chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VERY FATIGUED; sharp pain in her head like in the back of her eye; HEART WAS BEATING FAST; BLOOD PRESSURE WAS GOING UP; COULD HARDLY OPEN HER EYES; COULD HARDLY SPEAK; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (VERY FATIGUED), HEADACHE (sharp pain in her head like in the back of her eye), HEART RATE INCREASED (HEART WAS BEATING FAST), HYPERTENSION (BLOOD PRESSURE WAS GOING UP) and SOMNOLENCE (COULD HARDLY OPEN HER EYES) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROXYZINE, AMITRIPTYLINE, CAFFEINE, MAGNESIUM SALICYLATE (DIUREX WATER PILLS), OMEPRAZOLE and PROBIOTICS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (VERY FATIGUED), HEADACHE (sharp pain in her head like in the back of her eye), HEART RATE INCREASED (HEART WAS BEATING FAST), HYPERTENSION (BLOOD PRESSURE WAS GOING UP), SOMNOLENCE (COULD HARDLY OPEN HER EYES) and ASTHENIA (COULD HARDLY SPEAK). On 12-Feb-2021, FATIGUE (VERY FATIGUED), HEART RATE INCREASED (HEART WAS BEATING FAST) and SOMNOLENCE (COULD HARDLY OPEN HER EYES) had resolved, HYPERTENSION (BLOOD PRESSURE WAS GOING UP) outcome was unknown. At the time of the report, HEADACHE (sharp pain in her head like in the back of her eye) and ASTHENIA (COULD HARDLY SPEAK) 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.   Patient is on concomitant medicine for her blood pressure, thyroid and pain.  Treatment medicines was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Patient denied further follow up stating they are fine now
Blood pressure went up; Both hands hurting; Left hand hurting; Left arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left hand hurting), PERIPHERAL SWELLING (Left arm swollen), BLOOD PRESSURE INCREASED (Blood pressure went up) and PAIN IN EXTREMITY (Both hands hurting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included LISINOPRIL, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and MAGNESIUM for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left hand hurting) and PERIPHERAL SWELLING (Left arm swollen). On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Both hands hurting). On 21-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure went up). On 13-Apr-2021, PAIN IN EXTREMITY (Left hand hurting) and PERIPHERAL SWELLING (Left arm swollen) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure went up) and PAIN IN EXTREMITY (Both hands hurting) outcome was unknown. Not Provided      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.   Treatment information was not provided.
Persistent abdominal pain, diarrhea, nausea, back pain, fatigue and dizziness starting 4 hours after shot and  still continuing 5 days later.
Pt received Moderna booster on 11/1. On 11/2, presented in new onset atrial fibrillation to the emergency department
Reaction on Left arm.  4" x 10" red and itchy area.  Went from injection site down to elbow and stopped.  Resolved itself by Tuesday afternoon.  Patient did take Benadryl tablets and that helped the itching.
Rash onset of 08/31/2020, Generalized on legs, abdomen, and back. Less than 50 Lesions. Vesicles present as well as Papules. Itchy, mostly macular, papular, and vesicular.  No crusting, lasted for 3 days. Afebrile during this time .
Bloody diarrhea, vomiting, intussusception. Surgical reduction. 10/22/07-records received for DOS 8/22-8/26/07-DC DX: Intussusception, status post resection. C/O abdominal pain and bloody bowel movement, emesis, diarrhea lasting 1 day. Ileocolic intussusception with gangrenous terminal ileum and sweep, terminal ileum, cecum and ascending colon. Laparotomy, end to end ileal process anastomosis.
Information has been received from a registered nurse concerning a 22 year old female with no medical history or allergies who on 15-JAN-2008 was vaccinated IM with a first 1.0 ml dose of RECOMBIVAX HB (Lot # 655566/0659U). There was no concomitant medication. On 16-JAN-2008, one day after vaccination developed a fever of 102 F. The patient self-treated with TYLENOL and the fever resolved on 17-JAN-2008. At the time of report the patient was fully recovered. A product quality complaint was not involved. No further information is available.
Information has been received from an office manager, physician, and medical assistant concerning a female patient over 50 years old who on 12-FEB-2008 was vaccinated with a dose of pneumococcal 23V polysaccharide vaccine (Lot #658449/0989U) intramuscularly into the deltoid of the left arm. Subsequently, the patient developed redness and swelling at the injection site. The patient recovered from the redness and swelling on an unspecified date. The physician stated that these reactions had not occurred at the office before and would like a lot check of pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U). This is one of three reports from the same source. One of the patients also received the flu vaccine in the other arm. A standard lot investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and research and was released. No additional information is expected.
Pt. arrived just prior to the clinic at 4:00pm  for her scheduled vaccination.  While there she informed the educator and the vaccinator that she had unknown environmental allergies and indicated that she had a history of anaphylaxis.  She and the nurse reviewed the ingredients in the fact sheet and the patient stated that she was not aware/did not have any allergies to the ingredients to the Moderna vaccine.  She stated that she had had other vaccinations Flu and pneumonia with no issues.  After discussing with the nurse, she decided to proceed with getting the vaccine.  0.5 ML of Moderna vaccine was administered to her right Deltoid at approximately 4:00 pm.  She was informed that she would need to stay and be evaluated for 30 due to her history of anaphylaxis.  At 4:17 patient reported to the monitors that she was starting to feel like her throat was tightening and that she was having difficulty breathing.  At 4:19 pm she began pulling out her epinephrine to draw it up.  RN took over for her as she was struggling and administer 0.5 mg SQ to her right lower abdomen. BP was 180/80 at 4:19 pm.  911 was called.  Pt. continued to have difficulty breathing  and talking.  At 4:27 pm 50mg Benadryl IM was administered to her right deltoid.  She was still having difficulty breathing and her respirations were rapid.  At 4:28 pm  Epinephrine 0.5mg SQ was administered to her lower left abdomen.  BP at 4:28 pm was 150/100, Pulse was 154.  At approximately 4:33 pt. reported some relief, her respirations were not noted to be as rapid but she reported continued difficulty breathing.  At approximately 4:35 EMS was on scene.  EMS intubated patient in the EMS and transported to Hospital.  Pt. is in critical condition in the ICU.  This RN called to check on patient on 03/24/2021 and it was reported by her nurse that she coded multiple times through the night and was made a DNR and will be placed on comfort care and it was anticipated she may pass in the next day or two.
Began with fever to 102 deg F and vomiting within 12 hrs. of immunizations. Treated with home oral hydration. Diagnosis possible early gastroenteritis.
Erythema, induration at (L) deltoid injection site. Severe arm pain, pain with ROM x 3 days after injection. 12/9/11 Flu like sx - severe joint aches.
suspected vaccination failure/received the Shingrix vaccine last Summer, still got it this third time; shingles, three times had them internally; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 2 times before Shingrix vaccination).   On an unknown date, the patient received Shingrix. In August 2021, less than 2 years after receiving Shingrix, the patient experienced pain. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the shingles vaccine last summer and experienced shingles for the 3rd time. All the three times he/she had them internally. The patient experienced the pain since early August 2021. The patient could totally sympathize. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Client was fully vaccinated with Pfizer vaccine for Covid on April 16 and May 7, 2021.  Client exhibited Covid symptoms on 7/23, 2021: nasal congestion and night sweats.  Tested for Covid with PCR on 7/25: positive.  Submitted VAERS report as this is a case of breakthrough Covid illness in a client who was previously fully vaccinated for Covid.
extreme dry heaves/retching, extreme  diffuse body pain, severe headache, malaise, couldn't eat, could only lie down for 24+ hrs.
shingles and blisters on the right lower back; blisters on the right lower back; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in late 1990s).   On 17th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th September 2020, 2 days after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional information was provided as follows: The case was reported by the patient's wife. The patient experienced shingles and blisters on the right lower back after the 1st dose of Shingrix. The reporter mentioned that the shingles and blisters were still currently on her husband's back and that was the same place where he broke out with shingles previously in the late 1990s. The reporter had no lot number or expiration date information to provide. The reporter consented to follow up with HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020188895:Same Reporter US-GLAXOSMITHKLINE-US2020188897:Same Reporter
Breakthrough case admission after 3 vaccines Pfizer 4/8/21 lot# EW0053;  Pfizer 5/6/21 lot# Ew0182;  Pfizer 11/2/21 lot# FH8020;
Transient diplopia lasting approximately 5 - 10 minutes.  Appeared to be related to inability to control right eye - ?palsy
Headache, MYalgia, NauseaVomiting, sour stomach, sore throat sneezing Narrative:
MENACTRA vaccine administered (L) deltoid at doctors office 02/10/15-witih 1/2 hour of vaccine patient felt nauseous and dizzy. One hour post vaccine she developed whole body twitching-worse in the neck. Difficulty in walking due to shaking and spasms. She was taken to local emergency room. (At 10:30 today, pt was at pediatricians office, receiving meningitis vaccine. At 11am she felt nauseous and dizzy, and by 11:30am she developed twitching to her whole body, worse in her neck. No numbness or tingling, but she was having trouble walking due to the shaking and spasms. By 11:45 her neck began twitching to the left uncontrollably which mom called peds office who told her to come to ER. No recent illness. was feeling fine this morning. Denies constitutional symptoms prior to vaccine. No SOB or difficulty swallowing. No rash.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3248), on 11Feb2021 as dose 2, single (Lot number: EN6201), on 18Oct2021 as dose 3 (booster), single (Lot number: FH8020) and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing), notes: CAD with stent placement; "CAD with stent placement" (unspecified if ongoing), notes: CAD with stent placement; "Achilles tendon discomfort" (unspecified if ongoing), notes: Definite familial hyper cholesterol Emil with Achilles tendon xanthoma; "Xanthoma" (unspecified if ongoing), notes: Definite familial hyper cholesterol Emil with Achilles tendon xanthoma; "Mild type 1 Von Willebrand disease" (unspecified if ongoing). The patient's medical history, reported also as family history included: "Familial hypercholesterolemia" (unspecified if ongoing), notes: Definite familial hypercholesterolemia with Achilles tendon xanthoma. Concomitant medication(s) included: EZETIMIBE, start date: 06May2021, stop date: 08Apr2023; ROSUVASTATIN, start date: 06May2022, stop date: 08Apr2023; COLCHICINE, start date: 18Aug2022, stop date: 08Apr2023; MIRABEGRON, start date: 15Apr2020; ACETYLSALICYLIC ACID; TYLENOL; AREDS. Past drug history included: Nitrofurantoin monohyd/m-cryst, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 08Apr2023 to 13Apr2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300165569 same patient different drug/event;
RespDepression chest tightness Narrative:  Pt received 1st dose of COVID-19 vaccine (Pfizer) on 12/27/21, WIthin 10 mins, complained of "know in chest" and some "difficulty breathing." Reported to ED, ECG done and no STEMI. No meds or treatment given, improved on own and discharged home.
Erythematous welt 2-inch in diameter. Slightly pruritus & inflammation, duration lasted for about 2 weeks.
Couldn?t swallow good, itchy ears and throat, blood pressure 170/87 , elevated heart rate, numb lips, bad headache. I received a shot of benedryl and steroids.
Received MMR 5/9/11. On 5/27/11 - woke up with symptoms of mouth soreness & swollen neck in Rt side. Symptoms lasted for 1 week. No fever or other symptoms.
First week to week 4 of cough and SOB. Not relieved by any cough syrup. Was tested for COVID 19 twice within the period. WAs treated by prednisone 10 mg daily x 5days. Week two after the Vaccine noticed a distorted , vibration and echo on high pitchsound on the left ear,  reduced hearing compared when receiving calls between the left and right ear.
I experienced soreness in my arm feels like I've been stabbed with a needle I now have frozen shoulder and I'm not able to move my arm up and down.
pain/soreness of the injection site for 3-4 days, fatigue/low energy, body aches, back pain, chills, fever, cough, sneezing, runny nose, headache
Patient entered facility for second time to receive second dose of vaccine. Patient reported an incorrect birthday asked for correction. Patient vaccinated.  when questioned about proper dob patients mother admitted she lied to get daughter her vaccine. mother reports daughter needed it for work and that she is fine and she felt daughter was old enough to get vaccinated. mother stated she was aware of age requirement and lied to get daughter the shot. agreed to sign waiver for reporting she will do whatever as long as daughter got her shot. reported.
*Pregnancy: Estimated Due Date- 9/21/2021 (8wks pregnant, 1st trimester) No adverse impact to pregnancy at this time.   Adverse Impact from 1st dose: Sore Arm at injection site, including surrounding muscles into the neck and pectoral muscle (left arm and left pectoral muscle)
Fever, sluggishness, loss of appetite, swelling, redness over injection sight. Tylenol given, kept hydrated.
I am 27 weeks pregnant and have not had any bleeding, anxiety, or complications to date.  As one one week following receipt of my first dose of Pfizer, I have had 3 anxiety attacks (I have never experienced anxiety before), have trouble breathing, and had minor vaginal bleeding.  I spoke with my doctor and will continue to monitor my fetal movement to identify any fetal health concerns.
No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 13-AUG-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (dose, route of administration, anatomical site of vaccination and vaccine scheme were not provided; lot number U013969 has been verified to be valid, expiration date reported and established as 06-FEB-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9°F) during a time frame of 90 hours (product storage error). There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003304: US-009507513-2109USA003305: US-009507513-2109USA003303: US-009507513-2109USA003302: US-009507513-2109USA003301:
pt was seen in office w/a dx of chickenpox;if you need any further info, please contact this office;
Patient received the COVID 19 vaccine and was being monitored for 15 minutes post-vaccination. Approximately 10 minutes after receiving the vaccine patient stated that she felt dizzy and her throat was scratchy. Pharmacist went to assist patient and noted that patient had yellow facial coloring and appeared disoriented. Patient was not responding when pharmacist was speaking to her. Patient was seated in a chair and her eyes were noted to roll back in her head and her body was convulsing. Patient was not conscious. Patient was assisted to floor by staff and assessed by pharmacist and technician.  Approximately 5 to 10 seconds after being set on ground, patient stopped convulsing and regained consciousness. Patient stated she was not having difficulty breathing but was confused, shaking, light-headed and nauseous. A nurse who happened to be on site assisted with treatment. An ambulance was called for the patient and treatment was triaged to emergency responders. Patient was assessed and observed by EMT's and was discharged to home.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 12Oct2021 as dose 3 (booster), single (Lot number: EW0186), in left arm and on 27Apr2022 as dose 4 (booster), single (Lot number: FJ8762), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 virus  test: Positive, notes: Tested positive after Paxlovid treatment and testing negative; Negative, notes: Tested positive after Paxlovid treatment and testing negative; Positive, notes: Now testing positive again. Therapeutic measures were taken as a result of vaccination failure, COVID-19 with Paxlovid from 18Jan2023 to 23Jan2023.
Rash on Lt forearm arm secondary to varicella administration on 10/17/03
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Mild, Additional Details: right arm, injection site, turned red, puffy, and was sore.  Pt states it was hard in the middle of the lump.  She went to the ER for unrelated shortness of breath and had dr look at the arm.  MD thought it could be a possible infection.  Pt was admitted for 3 days for infection and unrelated shortness of breath.  MD drew a line around arm to monitor, did not become worse and has since resolved. Area was cleaned prior per pt with alcohol swab.
Noted anal itching the night after 1st dose. Continued through all 4 pills. Itching continued in anal area, on (L) palm of hand, (L) sole of foot, and along spine called 12/7/12. Still having the itching but is better. 12/11/12 Most itching has stopped.