chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Thought I was going to die; sick; Sweating; Chills; serious fatigue/fatigue; Lungs hurt 24/7; have to take several naps everyday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster), single (Lot number: FH 8030) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gallstones" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing). None of Known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Batch/Lot number: EO7533, Location of injection: Arm Right), administration date: 26Mar2021, when the patient was 58-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, Batch/Lot number: EWO151, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 58-year-old, for Covid-19 Immunization. The following information was reported: CHILLS (life threatening) with onset 20Nov2021, outcome "not recovered"; PULMONARY PAIN (life threatening) with onset 20Nov2021, outcome "not recovered", described as "Lungs hurt 24/7"; HYPERHIDROSIS (life threatening) with onset 20Nov2021, outcome "not recovered", described as "Sweating"; NEAR DEATH EXPERIENCE (medically significant, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Thought I was going to die"; SOMNOLENCE (life threatening) with onset 20Nov2021, outcome "not recovered", described as "have to take several naps everyday"; FATIGUE (life threatening) with onset 20Nov2021, outcome "not recovered", described as "serious fatigue/fatigue"; ILLNESS (life threatening) with onset 20Nov2021, outcome "not recovered", described as "sick". Nothing had been the same since getting booster. The patient did not have covid prior vaccination. The patient had been covid tested post vaccination. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Mar2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of near death experience, illness, hyperhidrosis, chills, fatigue, pulmonary pain, somnolence.
Pt woke up Saturday morning and after taking a shower, she noticed her arm was red, hot and swollen. It is also painful to the touch. As of today, the injection site is improving but is still red, warm to the touch and sore.
Case previously recorded as MA2009-4216. Initial case report received from a physician via MedCom on 11 NOV 2009. A patient, under the age of 4, was vaccinated with 0.25mL S-OIV FLUVIRIN (batch no. 102046P1) i.m on 10 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008010.
Legs were very heavy; left leg was burning; Very tired on Friday, Saturday, and Sunday; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (left leg was burning), LIMB DISCOMFORT (Legs were very heavy) and FATIGUE (Very tired on Friday, Saturday, and Sunday) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. L14F21A, 030A21A and 032B21A) for COVID-19 vaccination. No Medical History information was reported.On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced FATIGUE (Very tired on Friday, Saturday, and Sunday). On 20-Nov-2021, the patient experienced BURNING SENSATION (left leg was burning). On 21-Nov-2021, the patient experienced LIMB DISCOMFORT (Legs were very heavy). On 21-Nov-2021, FATIGUE (Very tired on Friday, Saturday, and Sunday) had resolved. At the time of the report, BURNING SENSATION (left leg was burning) and LIMB DISCOMFORT (Legs were very heavy) was resolving.    Concomitant medications were not reported.No treatment information was provided.This case was linked to MOD-2021-395727, MOD-2021-395870 (Patient Link).
A few hours after receiving the vaccines his arm became sore, he became nauseous and vomited and began to become sweaty. The patients's wife took him to ER to be checked out.
On 3/2 after receiving the 2nd dose I saw the optometrist again. They did different eye exams. Again ,they did not see anything wrong. He checked pupil dilation and noted that there was a slight delay in the left eye. Upon checking with HCP she said she did not notice any significant delay. I was able to have my vision compensated by my right eye. When my right eye vision became compromised. HCP ordered an MRI which showed a moderate to severe sinus infection and was prescribed antibiotics. The antibiotics did not help. On top of the antibiotics, I also took other medications for the sinusitis. I took the antibiotics from 4/14-4/21. After the antibiotics, on the 4/24 I noticed tingling and numbness on my face particularly from the tip of my nose to my chin and in circular area around my mouth. It is random and comes and goes through out the day, Also, on the same night of the numbness I experienced a bout of off balanced feeling and heaviness. It was a drunk feeling but I do not drink. I had 2 occurrences of this.  It went away in the morning I scheduled another appt because both my left and right eye were consistently blurry. The blurriness would get worse with movement and heat. After that appt she referred me to neurology and gave another dose of antibiotics. I took that from 4/19-4/25. Nothing changed after that round of antibiotics I went to the neurology appt on 6/9, they looked at the MRI and basically confirmed that nothing was wring neurologically. They said they did not have any explanation for the symptoms. My husband asked if there was a chance the vaccine could've caused it. They said they've seen some symptoms in patients but there is no way to confirm it was the vaccine.  I am still currently stuck with my loss of vision. It has prevented me from driving and doing any exercise. Many of the tasks I am able to do have been limited as well.
minor nuisance; yeast infection; injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot; pain at the injections site; swelling at the injections site/injection site has swollen back up; low grade fever around 100.2°F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (minor nuisance), FUNGAL INFECTION (yeast infection), VACCINATION SITE PRURITUS (injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot), VACCINATION SITE PAIN (pain at the injections site) and VACCINATION SITE SWELLING (swelling at the injections site/injection site has swollen back up) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GLUCOSAMINE for Joint disorder, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (minor nuisance), FUNGAL INFECTION (yeast infection), VACCINATION SITE PRURITUS (injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot), VACCINATION SITE PAIN (pain at the injections site), VACCINATION SITE SWELLING (swelling at the injections site/injection site has swollen back up) and PYREXIA (low grade fever around 100.2°F). At the time of the report, FEELING ABNORMAL (minor nuisance), FUNGAL INFECTION (yeast infection) and VACCINATION SITE PRURITUS (injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot) outcome was unknown, VACCINATION SITE PAIN (pain at the injections site) and PYREXIA (low grade fever around 100.2°F) had resolved and VACCINATION SITE SWELLING (swelling at the injections site/injection site has swollen back up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2°f (Low) low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other medication included herbal supplements and turmeric. Treatment information was not provided. Patient  scheduled for  second dose on 08-Oct-2021.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of GARDASIL 9 lot # L007560 expiration date 16-JUN-2017 and lot # L016248 expiration date 30-JUL-2017 (indication and dose number were not reported), were given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of the several reports of the same source. Additional information has been requested .
On 10/12/09 patient called indicating that he received 3 immunizations on 10/7/09. Noticed R axillary lymph node swollen on 10/10/09 and R side of the chest. Denies fever, vomiting, nausea, CP or SOB. Denied skin discoloration. Using calamine lotion.
Right upper thigh with 3" X 2 1/2" erythematous area; fever to 102.8F X 2 days and vomiting.
Lump on collarbone appeared on day 2 after the 2nd dose of the vaccine.
Vaccine was given on 1/25/21. Normal arm pain, swelling, redness for 5 days. No other issues. On 2/1/21, felt itching at the injection site and scratched, noticing a "bump" under the skin and rubbed it. Didn't think too much of it. Next day, injection site appeared red and swollen, warm to the touch. Since that time, the area still seems to be red and swollen, only painful if pressed. Redness continues to grow and spread - from about the size of a nickel on 2/2/21 to current size of about 1.5" x 2" inches 2/4/21 (today). Although, the redness seems to be less "red" as it has spread. I have rubbed ointment (Pomada de Arnica) to help with the healing.
6 inches x 10 inches area of redness and pain, severe swelling of right upper arm, systemic itching. Only affected on right arm where PNEUMOVAX was given. No reaction to FLUZONE HD given in left deltoid.
Headache, fever, nausea, difficulty breathing, hoarsness, weakness/dizziness
Patient received Dtpa, IPV, Act Hib, Prevnar and Rotateq on 11/30/06. Patient ran a temperature of 101 degrees for 24 hours. Temperature was 101- 102 degrees. No other symptoms.
Patient received Moderna COVID-19 vaccine on 2/25/2021.  Patient found dead by family the morning of 2/26/2021.   Family requested an autopsy.
Sore shoulder at site of injection all day, but malaise began around 1800 developing into chills and fever which peaked around 2100 on date of injection at 101 F.  I took two(2) ibuprofen OTC tablets shortly after 1800 onset.  I wrapped myself in a blanket with a heating pad to contribute warmth and reduce the shaking from the chills.  Symptoms slowly subsided after 2200 the night of the injection and were completely gone by morning the following day except for lack of energy through the weekend following.
Swollen lymph nodes under left arm making left breast sore; Swollen lymph nodes under left arm making left breast sore; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration in left arm on 02Mar2021 (Batch/Lot Number: EL3247), at 41 years of age, as single dose for COVID-19 immunization. Medical history was none. The patient didn't receive any concomitant medication and any other vaccine in the previous 4 weeks, she was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On an unspecified date in Mar2021 the patient experienced swollen lymph nodes under left arm making left breast sore. The patient didn't receive any treatment for the events. At the time of the report the events had not resolved yet.  No follow-up attempts are needed. No further information is expected.
Patient presented to pharmacy with redness, itching and pain spreading down the arm, advised to see doctor ASAP
Started developing flu symptoms; Temperature like up to a hundred and one almost/I got like a hundred and one fever; I am aching all over/Achiness; I feel miserable; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: 30125BA), dose 3 via an unspecified route of administration on 11Oct2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took two doses of bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified dates as dose 1, single and dose 2, single for covid-19 immunisation and had no symptoms after first two doses. On 15Oct2021, the patient experienced started developing flu symptoms, temperature like up to a hundred and one almost/i got like a hundred and one fever. On an unspecified date in Oct2021, the patient experienced am aching all over/achiness and i feel miserable. Patient went to went to 'immediate' care center, had covid test and the doctor there felt like or may be just could be related to the vaccine. The patient underwent lab tests and procedures which included body temperature: 101 on 15Oct2021, sars-cov-2 test: negative on 16Oct2021. The events result in physician office visit. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
I am a breastfeeding mother. My son (11 months) nursing baby vomited at 1:15am (12/30)  following my 11:15am (12/29) vaccination. He was uncomfortable crying from hours 1:15-3:30am and threw up. Not like him to do so normally. He vomited again at 9:30am (12/30).
Pain on right leg and hip; Severe muscle aches; starting to feel it in left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on right leg and hip), MYALGIA (Severe muscle aches) and ARTHRALGIA (starting to feel it in left leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O14M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on right leg and hip), MYALGIA (Severe muscle aches) and ARTHRALGIA (starting to feel it in left leg). At the time of the report, PAIN IN EXTREMITY (Pain on right leg and hip), MYALGIA (Severe muscle aches) and ARTHRALGIA (starting to feel it in left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided.  Treatment information was not provided.
One day after administration feel achy, light headed, ill, that night spiked fever with chills, profuse sweating, injection site red, warm 3" x 3" area. Next am temp 100°, shakey, I'll feeling. Next evening went to doctor.
Fever 101, achy, pain, large redness and pain at site (4" x 3"), unable to move arm. No anaphylaxis but SOB with activity. Migraine.
Night sweeting; Night Chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweeting) and CHILLS (Night Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced NIGHT SWEATS (Night sweeting) and CHILLS (Night Chills). At the time of the report, NIGHT SWEATS (Night sweeting) and CHILLS (Night Chills) had not resolved.            No concomitant medication was reported. No treatment medication was reported.
No additional adverse effects reported; both of which were over the age of 12, were administered one dose of PROQUAD each; both of which were over the age of 12, were administered one dose of PROQUAD each; This spontaneous report has been received from a nurse, referring to a 14 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.   On an unknown date in October 2019 (reported as last month), the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, frequency, route, lot# and expiration date were unknown) for prophylaxis (product administered to patient of inappropriate age and product use issue). No additional adverse effects reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA008989:
Per the father, son stated his right arm hurt and looked red and swollen.  Father then transported pt to the local emergency dept for evaluation.  Father stated the diagnosis at discharge was a local infection at the injection site and a Rx for amoxicillin was written.  After speaking with the father on 4/8/15 he stated the arm looked better and his son was feeling better as well.
While standing at the sink on the evening of November 6, I was washing dishes. I was neither cold nor hot, just comfortable. The water was equally comfortable, neither cold nor hot. I noticed my hands started to turn a very dark blue and purple, starting with my fingertips. It moved down towards the center of my hands. At first my friends thought it was dye coming from the brush scrubber I was using. We tried putting nail polish remover on my hands to get the color off. Of course that did not work at all. My husband came in and suggested I raise my hands above my head. I did that for about 10 seconds. When I brought my hands back down they had pinked up a bit. But then they started turning that weird color again. This lasted about 30 minutes. A few days later I went to the doctor. He thought it was Reynaud's syndrome. He recommended me to a vascular surgeon. At the time of my initial doctor's visit, my blood clotting was out of range, meaning I was not clotting fast enough. When I went to see the surgeon she re-drew my blood, and the numbers were still the same, out of range. I experienced a couple more episodes of my hands changing color, but none as severe as the initial reaction. The surgeon confirmed Reynaud's syndrome.
Rash appeared on inner right thigh 8/21, approx 18 days after first shot.  Second rash appeared on upper right buttocks 8/22.  Both rashes blistered within 24 hours.  Shingles was diagnosed via doctor visit and Valtrex was prescribed.  At time of reporting, three separate patches of shingles exist.  Inner right thigh, right knee, and upper right buttocks.  Pain of the blistered areas is intermittent and moderate.
THE PATIENT HAD A RED, SWOLLEN, HOT, INFLAMMED AREA ABOUT 4 INCHES WIDE BELOW THE INJECTION SITE TO ABOUT THE ELBOW. HE FELT TIRED, LETHARGIC. HE DID NOT HAVE A FEVER. HE HAD NORMAL RANGE OF MOTION FOR ARM. THIS STARTED SOON AFTER THE IMMUNIZATION.  THE PATIENT WENT TO SEE HIS PRIMARY PROVIDER ON FRIDAY AND WAS TOLD THAT THE DOSE OF VACCINE HAD MOVED DOWN HIS ARM DUE TO GRAVITY. DR. TOLD HIM TO CONTINUE TYLENOL AND IBUPROFEN FOR PAIN AND TO USE ICE PACKS TOPICALLY AND IT SHOULD RESOLVE WITHIN A FEW DAYS.
PARENT CALLED MD ON CALL AND REPORTED PT DEVELOPED "HIVES ALL OVER" "A FEW HOURS AFTER" IMMUNIZATION WAS GIVEN. HE WAS INSTRUCTED TO TAKE BENADRYL. THE NEXT DAY THEY HAD BEEN REPORTED BY PHONE TO BE RESOLVED. THEN CONTACED AGAIN TO REPORT RETURN. PT HAS CONTINUED WITH HIVES EACH AM THAT DO RESPOND TO BENADRYL TO THIS DATE 3/30/18. PREDNISONE FOR 7 DAYS HAS NOW BEEN STARTED WITH REF. TO ALLERGY/IMMUNOLOGY.
I have pain in the testicles and my heart go so fast also i am very tired every day .
Information has been received from a consumer concerning her husband who "many years ago", was vaccinated subsequently with 0.5ml of varicella virus vaccine live (Oka/Merck). Subsequently, on an unspecified date, the patient developed redness, warmth and swelling at injection site. Medical attention was not sought. There was no product quality complaint. Additional information is not expected.
Muscle weakness, tachycardia 120?s resting , fever, extremely tired, freezing cold to the bone, headache, just zero energy felt horrible , slept 11 hours   Still feel weak and now dizzy, heart rate low 100?s testing .  Red hot swollen arm.  That happened with the first shot.  Very sore arm
No adverse reaction.  Pt was given a dose of pediatric covid vaccine that was past the beyond use date.  Parent notified and given CDC recommendations regarding re-vaccination.  Opted to not re-vaccinate at this time.
Dizziness; Fatigue; Weaknezz; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 03Mar2021, the patient experienced dizziness, fatigue and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, fatigue and weakness were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2014US003816 is an initial spontaneous report received from a pharmacist on 21 Feb 2014: This report refers to a 14-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006031A and expiry date: Jun 2014) intramuscularly at a dose of 0.5 ml on 09 Nov 2013. No adverse event was reporting following the administration error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 21 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".