chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reactions; she developed herpes breakouts again but this time it appeared outside her mouth/around her mouth; she felt the endometriosis pain again.; She said her whole lower half is inflammed and bloated; She said her whole lower half is inflammed and bloated; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included second degree endometriosis, the pain of her endometriosis started when she was 16 years old and it was treated until she was 23, she had 3 exploratory surgeries, and the endometrial area was cauterized years ago. The patient was previously vaccinated with the first dose of BNT162B2 at the age of 67-year-old for Covid-19 immunization and developed herpes breakout inside of her mouth and the upper part of her mouth turned into a blister. With the second dose of the vaccine, she developed herpes breakouts again but this time it appeared outside her mouth, it was around her mouth on an unspecified date. She felt the endometriosis pain again and her whole lower half was inflamed and bloated on an unspecified date. She was reading an article about mast cells which are part of the reaction in allergies involvement in the reaction of the Pfizer COVID-19 vaccine. She said the mast cells in a reproductive disorder increases the activation release of mediators. The patient was convinced that she was experiencing allergic reactions. She was surprised that she had these reactions since she said that she was in great shape and she was not overweight. She wanted to know if Pfizer has more information about how long the adverse events that she was experiencing would occur. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
feeling tired; Ear ache; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear ache) and FATIGUE (feeling tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038621A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced EAR PAIN (Ear ache). On an unknown date, the patient experienced FATIGUE (feeling tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear ache) and FATIGUE (feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (abnormal) high 102 degree. On an unknown date, Heart rate: high (High) Heart rate > 100 beats per min. On an unknown date, Ultrasound scan: normal (normal) normal.         patient had external temperature of 102 but orally it was normal. This case was linked to MOD-2021-073554, MOD-2021-073554 (Patient Link).
Patient tested positive for COVID on 05Sep2021; Patient tested positive for COVID on 05Sep2021; This is a spontaneous report from a contactable other healthcare professional. A 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0175) via intramuscular on 15May2021 (12-year-old at the time of vaccination) as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0175) via intramuscular on 05Jun2021 (12-year-old at the time of vaccination) as dose 2, single for covid-19 immunization. Medical history included the patient was infected with COVID 19 in December 2020 and unknown if ongoing. The patient's concomitant medications were not reported. The patient was fully vaccinated. The patient had covid prior to vaccination. The patient was tested since vaccination. On 05Sep2021, the patient was tested positive for COVID. The patient underwent lab tests and procedures which included COVID test positive on 05Sep2021. The outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected. Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate
PATIENT SAID THAT HER THROAT WAS CLOSED UP WHEN SHE WAS SITTING AT THE WAITING AREA, OFFERED BENADRYL  LIQUID BUT SHE SAID SHE ALLERGIC TO BENADRYL AND SHE ALREADY TOOK ALLEGRA, SHA ASKED TO CALL 911, PARAMEDICS CAME AND TOOK HER VITAL SIGNS, EVERYTHING WAS NORMAL, SHE SAID SHE FELT BETTER THAN BEFORE. SHE DRANK MORE WATER . PARAMEDICS LEFT, ASKED HER TO SIT FOR ANOTHER 5-10 MINUTES. PATIENT TSAID THAT SHE IS ALLERGIC TO FLU VACCINES IN THE PAST.
broke out in a rash; the pimples were not connected areas; lt shoulder, back, under chin, forehead, side & back sides of torso; nothing on arms or legs;
Severe headache pain 2 days after shot administered, Ibuprofen not relieving pain.
This spontaneous report as received from a nurse and physician refers to a 18 year old male patient with no allergies. The patient had no pertinent medical history. On 04-JUN-2015, the patient was vaccinated with the first dose of GARDASIL lot # K014191 (expiration date and dose were not provided), intramuscular. There were no concomitant medications. In June 2015, the patient experienced chronic fullness and discomfort on the left side of his chest. The patient felt fuller and bloated after eating a minimal amount, like he had just eaten a three-course meal. The discomfort was limited to the chest area and not the abdomen. The patient visited physician and as treatment, the patient was prescribed an unspecified muscle relaxer which did not help his symptoms. On 02-JUL-2015, the patient had a chest x-ray which was negative for any abnormalities. On 02-JUL-2015, the patient was vaccinated with the second dose of GARDASIL lot # K016966 (expiration date and dose were not provided), intramuscular, which is less than the 2-month interval between the first and second doses of GARDASIL. The outcome of chest discomfort was reported as not recovered/not resolved. Additional information has been requested.
This literature case concerns a previously healthy 10 year-old male patient. On an unknown date the patient received H1N1 (manufacturer unknown). One week after receiving the vaccine the patient developed bilateral, progressive visual loss over 48 hours. Visual Evoked Response showed markedly delayed p100 bilaterally. MRI (magnetic resonance imaging) scan of the brain and spine showed multiple demyelinating lesions in the brain. Cerebrospinal fluid revealed RBC (red blood cell) 1/mm3, WBC (white blood cell) 14/mm3, and protein 66 mg/dl. Oligoclonal bands were negative. The event outcome was not reported. Reporter's comment: Neurologic complications of H1N1 vaccine are rare, but may occur. Further studies are needed to help clarify the incidence of demyelinating complications related to this vaccine as well as the environmental, genetic and other risk factors of acute demyelination in children.
2 bruises on the arm which showed a round thing; Body was lethargic; Kept misplacing her things; Couldn't sleep for 3days/2nights; Neck pain but was just a little bit now; Swollen tongue; Raw mouth; Throat burning; Gums were peeling; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (2 bruises on the arm which showed a round thing), STOMATITIS (Raw mouth), THROAT IRRITATION (Throat burning), ORAL MUCOSAL EXFOLIATION (Gums were peeling) and LETHARGY (Body was lethargic) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced STOMATITIS (Raw mouth), THROAT IRRITATION (Throat burning), ORAL MUCOSAL EXFOLIATION (Gums were peeling) and SWOLLEN TONGUE (Swollen tongue). On an unknown date, the patient experienced CONTUSION (2 bruises on the arm which showed a round thing), LETHARGY (Body was lethargic), AMNESIA (Kept misplacing her things), INSOMNIA (Couldn't sleep for 3days/2nights) and NECK PAIN (Neck pain but was just a little bit now). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CONTUSION (2 bruises on the arm which showed a round thing), STOMATITIS (Raw mouth), THROAT IRRITATION (Throat burning), ORAL MUCOSAL EXFOLIATION (Gums were peeling), LETHARGY (Body was lethargic), AMNESIA (Kept misplacing her things), INSOMNIA (Couldn't sleep for 3days/2nights), NECK PAIN (Neck pain but was just a little bit now) and SWOLLEN TONGUE (Swollen tongue) outcome was unknown.        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.   Concomitant product use was not provided.
Right arm swollen shoulder to midshaft with erythema. DTaP in left arm 6-14-04.
leg pain from calve down to ankle; felt badly; Headache; fatigue; arm soreness from second shot; pain in shoulders; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness from second shot), FEELING ABNORMAL (felt badly), ARTHRALGIA (leg pain from calve down to ankle), ARTHRALGIA (pain in shoulders) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ALPRAZOLAM (XANAX) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness from second shot) and ARTHRALGIA (pain in shoulders). On 18-Mar-2021, the patient experienced FEELING ABNORMAL (felt badly), HEADACHE (Headache) and FATIGUE (fatigue). On an unknown date, the patient experienced ARTHRALGIA (leg pain from calve down to ankle). On 18-Mar-2021, ARTHRALGIA (pain in shoulders) had resolved. On 19-Mar-2021, FEELING ABNORMAL (felt badly) and FATIGUE (fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness from second shot) and ARTHRALGIA (leg pain from calve down to ankle) outcome was unknown and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood pressure measurement: 98/56 Low. On 19-Mar-2021, Heart rate: 99 Low. On an unknown date, Blood pressure measurement: 82/57 Low.         The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable. No treatment drugs were reported  .
Patient recieved his first Moderna vaccine on 11/11/2021 at the hospital. He received his 2nd primary series shot on 12/4/2021 at Hospital as well. This vaccination was administered too soon and should been administered between 12/5/2021 to 12/9/2021. Troubleshooting: educated scribes at registration and vaccination on allowed time between shots, specifically to Moderna.
This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (FLUID RETENTION), PERIPHERAL SWELLING (LEGS, THIGH, CALF ARE SO SWOLLEN), INDURATION (HARD AS A WATERMELON), DISCHARGE (BROKE OUT IN SMELLY DICHARGE) and VACCINATION SITE WARMTH (WARM TO TOUCH) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-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 FLUID RETENTION (FLUID RETENTION), PERIPHERAL SWELLING (LEGS, THIGH, CALF ARE SO SWOLLEN), INDURATION (HARD AS A WATERMELON), DISCHARGE (BROKE OUT IN SMELLY DICHARGE), VACCINATION SITE WARMTH (WARM TO TOUCH) and RASH (BROKE OUT IN SMELLY DICHARGE RASH ALL OVER HIS BODY). The patient was treated with BACITRACIN ZINC, GRAMICIDIN, POLYMYXIN B SULFATE (TRIPLE ANTIBIOTIC [BACITRACIN ZINC;GRAMICIDIN;POLYMYXIN B SULFATE]) (topical) ongoing since an unknown date for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, FLUID RETENTION (FLUID RETENTION), PERIPHERAL SWELLING (LEGS, THIGH, CALF ARE SO SWOLLEN), INDURATION (HARD AS A WATERMELON), DISCHARGE (BROKE OUT IN SMELLY DICHARGE), VACCINATION SITE WARMTH (WARM TO TOUCH) and RASH (BROKE OUT IN SMELLY DICHARGE RASH ALL OVER HIS BODY) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-101565 (Patient Link).
experienced multi flu symptoms over period of five hours--coughing, sore throat, profound shaking chills, headache, vomiting
Patient has had diarrhea multiple times a day since the day after she received the second dose.
Transient ischemic attack. Patient developed right-sided weakness around 1140 on 9/15/21. She called her son who recommended calling EMS. Patient was noted to have right facial droop, and right upper and lower extremity weakness. She denied any prior history of stroke or TIA, or any history of intracranial bleeding. She has not prior cardiac history. In the ED, code stroke was called and patient was evaluated by neurology. Vital signs were stable, CT, CTA, and perfusion study without bleed or signs of perfusion deficit which would be concerning for a large vessel stroke. Neurology discussed risks/benefits of tPA with patient and son, and after discussion it was decided not to give tPA. Patient was admitted for further stroke workup and monitored overnight. Patient given loading dose of aspirin and was started on dual antiplatelet therapy with aspirin and clopidogrel. No telemetry events overnight. Weakness resolved by the following morning.
Recipient stood up after vaccination. After 120 seconds noted that her vision was impaired but felt normal and was responsive. Both pupils were dilated.  Sat her down. Offered water. Assessed breathing. Continued to talk and converse with her throughout episode.  Symptoms lasted about 30 seconds. Same symptoms were reported as repeated in the middle of the night. Lasting about the same amount of time but were less severe.
No additional AE; Improperly stored VARIVAX was administered; temperature -12.48 C for 1 hour 30 minutes; This spontaneous report was received from a medical assistant with a physician on the back line and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 22-AUG-2023, the patient was vaccinated with improperly stored first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X006983, expiration date: 07-MAR-2025, administered subcutaneously (dose and site of administration were not provided) for prophylaxis (strength was not provided). Vaccine was improperly stored for 1 hour 30 minutes 0 seconds in temperature of - 12.48 degrees Celsius (C). There was no previous temperature excursion reported. There was no additional adverse event (AE).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2308USA008988:
Pt reported having a constant medium severity headache starting 4 to 5 hours after receiving vacc. Headache constant. Started taking acetaminophen 650 mg every 4 hrs which helped, Headache is ongoing at present.
Nausea Severe Vomiting Broken capillary blood vessels on face from vomiting Headache Body Aches Chills
Initial report received from a health care professional on 20 January 2012. This case involves 1 of a cluster of 4 patients who had received FLUZONE INTRADERMAL (lot number UT4163AA) and experienced reactions. Information regarding the other 3 patients is captured in case numbers 2011-10556 (serious cases), 2012-00784 and 00785 (both non-serious cases). A 32 year-old female patient had received a right arm dose of FLUZONE INTRADERMAL (lot number UT4163AA) on 27 October 2011 at 9:00 am and 4 days later on 31 October 2011 at 9:00 am experienced extensive swelling of the vaccinated limb. It was not reported whether the patient required any medical evaluation or treatment. The patient recovered on an unspecified date. Documents held by sender: None.
Stated that he felt fine at first, recovered for the fifteen minutes and returned to class. Then stated that he started to get really tired and his stomach hurt. Returned to clinic site, laid down for forty five minutes on stretcher, vital signs were stable throughout. Was released to go home with his mother.
Current severe episode of major depressive disorder without psychotic features without prior episode. Hospital Admission within 6 weeks of receiving the COVID vaccine.
Arm sore and red and swollen for 5 days or so, then appeared to be getting better.  Day 8, arm red sore and swollen again just like just after the shot.
10/30 extreme tightness, pain all over abdominal region, unable to sleep, mild nausea. Went to Emergency Care, CT scan revealed inflammed appendix.   2:00 pm 10/31 - ambulanced to hospital admitted to ER 5:00 pm. Received IV antibiotics metronidazole for 16 hours.  symptoms relieved, released from hospital 11/1 11 am put on Augmentin.   Follow up with surgeon in 10 days.
Starting 02/12/2022, I felt fatigue that did not feel normal (I had just woken up). I went to the drugstore and got an at home test. I began to have head congestion (which isn't abnormal for me). I had a slight fever (stayed around 99.7). As soon as I took the test at home, it came back positive. I emailed the doctor right away and on that coming Monday he called a steroid into the pharmacy. I began to take it immediately and by the end of the duration of the prednisone, I started feeling normal. I tested myself for COVID-19 numerous times while isolating and I didn't go back outside until I got a negative result (7 days).
From the time of the shot until death 9 day later pt screamed & little butt swelled the size of a soft ball & hard as a rock; mom thinks pt died as result of shot not crib death as stated by hosp & MD:
Covid Breakthrough, vaccine 06/11/21.  Patient complains of SOB x2 days. Patient recently admitted to facility with CAP 12/21/21. History of DM2, liver cirrhosis, CAD, HLD, CKD, anemia, Chronic Lymphadema, morbid obesity, current smoker.
Came into Peds ER with complaints of can't breathe and itching. Placed in Crisis Room. Epi 1:1000 given Benadryl and Solumediol. Pt discharged to home after 3 hour observation.
fever, shortness of breath, shivering, loose stools, loss of appetite, muscle aches, headache, extreme fatigue.
No other AE reported; expired dose of MMR II was inadvertently administered; This spontaneous report was received from a pharmacy technician and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 05-OCT-2020, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Batch#R029224, expiration date reported as 02-OCT-2020, but upon internal validation was established as invalid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. No other adverse events were reported. The reporter would like to know if this was a valid dose. No prior temperature excursions on the product.
body aches; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), FATIGUE (Fatigue) and HEADACHE (Headache) 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 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (body aches), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PAIN (body aches), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatments were reported
Redness at site, soreness through arm, radiating to L eblow that has persisted 4 days later, warmth to the touch.
Chills, sweating, ran a fever, body aches, and headache. Experienced fatigue. Treated at home with Tylenol, fluids, and sleep
1-2 days p/vax itching/watering eyes-nose throat;scratchy-ears itching-sl tightness in chest;face flushed;chills, hot flashes w/sweating;gen feeling bad;ringing in ear;joint pain diff moving; stiff neck;burning urination; muscle tired
Fever started day 1, still with fever on day 3 up to 103F. Rash started day 2 on stomach (8/5/22) and day 3 was full body, covering face, abdomen, arms, legs, back. Rash was maculopapular, non-itchy.
Narrative: Patient became dizzy and expressed headache 15 minutes after administration of vaccine. BP taken, results 133/94. Patient escorted to ED for further evaluation. No LOC, SOB, chest pains experienced.
Low grade fever lasting over 24 hours, chills, body ache, vivid dreams - despite 500mg Tylenol every 4-6 hours and 400mg ibuprofen every 6-8 hours  Extreme pain at injection side lasting 12 hours  Severe fatigue lasting 24 hours Nausea, black-tarry stool, mild diarrhea, abdominal cramping Numbness in finger tips lasting 6 hours
Patient was throwing up in his sleep and continued to throw up multiple times over the course of 48 hours. He was NOT sick before receiving this shot.
Ache at site and over all. Shaky, no fever. Flu like symptoms.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2013, the patient was vaccinated with a single dose of GARDASIL lot # H021861 (route of administration and expiry date were not reported). On 24-MAY-2017, the patient was vaccinated with a single dose of GARDASIL 9 lot # M034195 (route of administration and expiry date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.