chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a certified medical assistant (CMA) in a physician office concerning a 25 year old caucasian female with no prior pregnancies, an allergy to clarithromycin (BIAXIN), and May-Thurner Syndrome (involving obstruction of the iliac vein and obstruction of the inferior vena cava), who on 23-FEB-2007 was vaccinated with the first dose of GARDASIL (lot number 655618/0186U). The patient's last menstrual period was on approximately 23-MAR-2007 (estimated date of delivery "28-DEC-2007"). On 24-APR-2007, the second dose of GARDASIL (lot number 657617/0384U) was administered. The patient had a positive pregnancy test in the office on 30-APR-2007. Follow up information from the CMA indicated that the patient had no complications during her pregnancy, but on 02-MAR-2007, the patient was prescribed ondansetron (ZOFRAN) for nausea. Due to her history of May-Thurner syndrome, the patient required heparin throughout her pregnancy and "numerous" ultrasounds, all with normal results (dates not provided). During labor and delivery, the patient experienced "maternal fever," though on 10-DEC-2007, a normal female infant, weight 5 lb 15 oz, 19 1/2, " was delivered (initial Apgar score of 2/5, details not provided). There were no congenital abnormalities. The outcome of maternal fever was not specified. Additional information is not expected.
1:29PM SYNCOPE - EASED TO FLOOR AND FEET ELEVATED. PT BECAME RESPONSIVE. MOVED TO COT PER WHEEL CHAIR. A/O, PIN W/D, RESP WITH EASE. CRACKERS AND WATER GIVEN. 2PM 'FEELS BETTER NOW'.  WIFE TO DRIVE PT HOME. 4-2-21 10:30AM  TC:PT STATES HE 'FEELS FINE NOW'.
substantial leakage of fluid (she presumes vaccine) from her injection site (no just a drop of liquid BUT a trail of fluid down her arm that wet her sweater); substantial leakage of fluid (she presumes vaccine) from her injection site (no just a drop of liquid BUT a trail of fluid down her arm that wet her sweater); This is a spontaneous report from a contactable physician. A female patient of an unspecified age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that, when she received the vaccine, she noticed that there was a substantial leakage of fluid (she presumes vaccine) from her injection site, not just a drop of liquid, but a trail of fluid down her arm that wet her sweater. The reporting physician asked if the patient needs to assume that this qualified as a non-vaccination and needs to get a repeated dose and follow that with a true second dose in 3 weeks, or needs to assume that she got enough of a dose to call it a true first shot. The event onset date and outcome were not reported.  Information about Lot/Batch number is requested.
Lymphadenitis, neck pain, weakness, unable to stand or walk. Lymphocytosis and new Dx CLL.
Approximately 2 hrs after vaccination, broke out in a full-body rash of tiny blisters and pruritus. Benadryl administered post-reaction. Rash lasted approximately 48 hrs. Patient tried twice prior to enter adverse event into VAERS and  was unable to submit/never received a confirmation email.
RIGHT ARM PAIN FROM SHOULDER TO WRIST, NOW TO ELBOW SOME NECK PAIN. LUMP/THICKNESS AT THE SITE OF INJECTION
When I caught COVID-19 I woke up with a really bad sore throat. It felt like I had strep. Throughout the day I had a sniffle in my nose and it was running. I had a slight cough and a vague headache. The next morning I had a sore throat, runny  nose, cough, and a slight fever.  On June 23, 2022 I did a telehealth visit, and I was prescribed paxlovid. I started the first dose that evening.  My symptoms started getting better the next day. I had a very low grade fever. I was less achy but still not great. That continued, but my symptoms were getting better. Throughout having COVID-19 I was feeling fatigued and tired. On day 10 I finally tested negative, but then a few days later I tested positive again for COVID-19.  My symptoms were back, but they were less acute. I had a sore throat again and I felt achy. When I had negative in-between those times I was still fatigued and resting a lot. Now I currently have no more symptoms after testing negative again for the 2nd time.
fever, chills, body aches, swelling of lymph nodes in left side of neck and shoulder (injection site was left arm), fatigue/sleepiness
pain in the armpit; swelling in the armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (pain in the armpit) and PERIPHERAL SWELLING (swelling in the armpit) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced AXILLARY PAIN (pain in the armpit) and PERIPHERAL SWELLING (swelling in the armpit). At the time of the report, AXILLARY PAIN (pain in the armpit) and PERIPHERAL SWELLING (swelling in the armpit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
7 days post first covid shot, very painful left axilla/side of breast. Pain, tenderness, and achiness not in the middle of axilla but is in the very medial portion of the axilla and extends into side and top of left breast. Very painful to have left arm resting in its normal position, very uncomfortable walking. waking up in middle of night with pain.
Breakthrough case admission after three vaccines ; Moderna 11/22/21 Lot# 034F21A;  Moderna 12/22/21 Lot# 067H21A;  Moderna 6/20/22 Lot# 014B22A
Symptoms of pruritic raised rash on extremities about one day after anthrax vaccination, persisting for four more days.
Chronic dental infection; This is a spontaneous report from other health professional (dentist) from a Pfizer-sponsored program Pfizer First Connect.  A patient of unspecified age and gender received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced chronic dental infection (non-serious) on an unspecified date with outcome of unknown.
vaccination area was blistery; vaccination area was bumpy; vaccination area was itchy; vaccination area was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (vaccination area was blistery), VACCINATION SITE MASS (vaccination area was bumpy), VACCINATION SITE PRURITUS (vaccination area was itchy) and VACCINATION SITE ERYTHEMA (vaccination area was red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder NOS.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE VESICLES (vaccination area was blistery), VACCINATION SITE MASS (vaccination area was bumpy), VACCINATION SITE PRURITUS (vaccination area was itchy) and VACCINATION SITE ERYTHEMA (vaccination area was red). At the time of the report, VACCINATION SITE VESICLES (vaccination area was blistery), VACCINATION SITE MASS (vaccination area was bumpy), VACCINATION SITE PRURITUS (vaccination area was itchy) and VACCINATION SITE ERYTHEMA (vaccination area was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant medication reported.
Half way towards the date for the second vaccine I started feeling pain in my lower abdomen. The bleeding started a couple of days later and it continued to increase in flow to the point where I lost so much blood that I needed to go to the urgent care, where I was directed to the emergency room. I was NOT examined by an Obgyn and they just gave me Deproprovera in 8 pills. That stopped the bleeding but the pain in my stomach continued for another week.
Pain; arm was sore; arm was sore and uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain, pain in arm and arm discomfort. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain, pain in arm and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the pain, pain in arm and arm discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that after the 1st dose of Shingrix vaccine, pain, arm was sore and uncomfortable. The patient took one Ibuprofen and felt relieved. The reporter did not consent to follow-up. The reporter discontinued the call abruptly so all information was not available. For further tolerance of 2nd dose refer case ID US2020AMR188514.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR188514:same reporter, different dose
Kidney CREAT index jumped from ~1.4 (Feb. 2021) to ~1.7(Aug. 2021). No treatment. It keeps stable since then.
Began to break out in hives. They soon covered his whole body - back, face, legs, arms. Very red and nasty. Fever of approx 101 the next morning. Pediatrician recommended Benadryl every 6 hours 1/4 tsp, and Tylenol every 4 hours as needed.
On Monday 19Jul2021 I tested positive for Covid.; On Monday 19Jul2021 I tested positive for Covid.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Lot Number: En6199) via an unspecified route of administration, administered in Arm Right on 10Mar2021 as DOSE 1, SINGLE and dose 2 (Lot Number: En6208) via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Age at Vaccination 42-years-old) as DOSE 2, SINGLE both for covid-19 immunisation. Medical history included chronic vitamin b12 deficiency, vitamin d deficiency and Known allergies: Sulpha from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient started sneezing and congested on sunday 18Jul2021 at 08:30. On Monday 19Jul2021, she tested positive for Covid. She experienced severe headaches, incessant sneezing, mild to moderate congestion, moderate to severe body aches. While she understood that there was a chance of this with the vaccine, she wanted to report her experience as she was a healthy individual, but she had a chronic B12 deficiency and vitamin D deficiency. She taken doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Covid-19 test was positive on 19Jul2021 (On Monday 19Jul2021 I tested positive for Covid), covic 19 home test was positive on 20Jul2021 (Nasal Swab), Sofia 2 rapid COVID-19 antigen test was positive on 18Jul2021 (Nasal Swab). Therapeutic measures were taken as a result of on monday 19Jul2021, i tested positive for covid with prescriptions of zpack, dexamthasone, fluticasone. The outcome of the events were not recovered.
malaise /is not feeling well; she is having body aches; a dull headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise /is not feeling well), PAIN (she is having body aches) and HEADACHE (a dull headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced MALAISE (malaise /is not feeling well), PAIN (she is having body aches) and HEADACHE (a dull headache). At the time of the report, MALAISE (malaise /is not feeling well), PAIN (she is having body aches) and HEADACHE (a dull headache) outcome was unknown.            No concomitant medications reported.  No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.
Pt was found deceased in his crib on the morning of 12/30/2014. He did have a fever of 102 the night before.
This initial spontaneous report was received on 23-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 30-DEC-2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-OCT-2016, she was treated by a physician/MD at a medical group facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and keratis (as reported) with cornea scarring, a damaging eye condition of zoster infections of the eye. The female patient has been prescribed tramadol (manufacturer not specified) and valacyclovir (VALTREX) for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, Keratis with cornea scarring, a damaging eye condition of zoster infections of the eye was determined to be medically significant. Additional information has been requested.
Patient came at pharmacy and asked for PMEUMOVAX 23 and flu shot, she filled vaccination forms and were asked questions, and she got PNEUMOVAX 23 and FLUZONE High-Dose. 4 days later patient came at our pharmacy saying that she remembered that she had pneumonia shot at a different pharmacy, and she is complaining of injection site reactions.
Information has been received from a nurse practitioner concerning a 20 year old female who on 13-NOV-2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (Lot # not provided). On 13-NOV-2006 the patient experienced nausea, vomiting and decreased appetite. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered from these events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2006. Follow-up information from the nurse practitioner indicated that the patient recovered. Additional information is not expected.
Redness & swelling to left upper arm. Itching present. Site warm to touch - quarter size.
A few hours after the vaccine I started feeling my heart racing and shortness of breath. I have felt this feeling every day since the vaccination.  The day after I was driving and felt my heart racing and then felt dizzy and lightheaded as if I was going to faint while driving on the road.  I started to breathe deeply and pulled over until I felt regulated.  My heart palpitations have not ceased.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult male patient who received SHINGRIX for prophylaxis. On 22nd March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 23rd March 2019, 1 days after receiving SHINGRIX, the patient experienced tiredness and headache. On 25th March 2019, the patient experienced dizziness. On an unknown date, the outcome of the tiredness and headache were recovering/resolving and the outcome of the dizziness was not recovered/not resolved. It was unknown if the reporter considered the tiredness, headache and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left deltoid. 3 days after receiving SHINGRIX, the patient felt better, but when he got out of bed later that night he felt dizzy. The patient did not stand up immediately, but just sat on the end of the bed for a few moments. On the day of reporting, the patient felts a little dizzy. The reporter gave consent to follow up.
Fever, chills, body aches, erythema around injection site and in armpit.
The initial reaction I had after receiving the booster was malaise, a  headache, muscle aches, and congestion that all lasted for about 2 or 3 days. I had took ibuprofen for that. In January of 2022 I had caught covid. I had sinus headaches, muscle aches, nasal congestion, malaise, and an occasional non productive cough, but no fever. I called my doctor and she prescribed me with Dexamethasone.
Patient was inadvertently given a second dose of flu vaccine when she has already received one two weeks ago.
At 5:30 PM vaccination was given. At 6:15 PM I started to notice my lips felt like they were sore. Upon further Viewing, because I was wearing a mask I realized I had hives around my upper lip and underneath my jaw. I then took 25 mg of Benadryl. My lips started to feel better and I drank some water I then realized that my tongue felt weird, my taste was off, and my tongue was itchy. I then took another 25 mg of Benadryl. I was feeling better at about 6:45pm. And left the vaccination site. My eyes did become itchy. But no swelling or redness was noted. Symptoms completely resolved by 8:30 PM.
Massive heart attack; Death; vomiting; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Massive heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and DEATH (Death) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011m20a and 013a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN POTASSIUM (COZAAR) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DEATH (Death) (seriousness criterion death) and VOMITING (vomiting). In March 2021, the patient experienced MYOCARDIAL INFARCTION (Massive heart attack) (seriousness criteria hospitalization and life threatening) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). On 11-Mar-2021, MYOCARDIAL INFARCTION (Massive heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and VOMITING (vomiting) had resolved. The patient died on 11-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Echocardiogram: unknown (Inconclusive) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information also included inhalers, non specified and eye drops non specified. No treatment information was reported.   Based on the current available information and temporal association between the use of the product and the start dates of the events,  a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events,  a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N005096, expiration date 22-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 9 to 25 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. Additional information has been requested.
Severe headache from 4/21 & ongoing Extreme arm / muscle soreness 4/21 & ongoing Chills & sweating 4/22-4/23
Pt recvd 3 doses of Engerix on 26JUL91, 22AUG91 & 26SEP91 & 29OCT91 serology indicated non-responder; no tx was given;
Chills; Headache; Nausea; Muscle aches; Low grade fever 99 degrees F; This case was reported by a consumer via call center representative and described the occurrence of chills in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included rosuvastatin calcium (Crestor) for product used for unknown indication.   On 26th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and Crestor at an unknown dose and frequency. On 27th October 2020, 1 days after receiving Shingrix and Crestor, the patient experienced chills, headache, nausea, muscle pain and low grade fever. On an unknown date, the outcome of the chills, headache, nausea, muscle pain and low grade fever were not recovered/not resolved.   It was unknown if the reporter considered the chills, headache, nausea, muscle pain and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and rosuvastatin generic Crestor and experience chills, headache, nausea, muscle aches, and low grade fever of 99 degrees F and these symptoms improved after 3 to 4 days, but still persist at this time. The reporter consented to follow up and did not had any additional details for this AE.
Started experiencing chest pain, left arm pain traveling to wrist, shortness of breath, fast heart rate, pounding of chest
Seizure-like episode on Sunday 3-18-07. Patient made a noise mom looked at patient and noted staring with head slightly tilted to the right. Slightly pale, body was stiff and teeth clamped down, eyes glassy. Patient was unresponsive - lasted 2-5 minutes.
Received her 2nd Covid Vaccine from Pfizer on 1/7/2021.  She stated that she developed side effects about 2am reporting elevated temp of 101,  dizziness, muscle aches all over, nausea, and just didn't feel well.  She states she developed a knot on her arm at injection site with redness and itching.  She reports this knot was hard initially but next day was better.  She reports these side effects lasted all weekend.