chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was in his usual state of excellent health until approximately October 14th when he received the live attenuated influenza vaccine, FluMist.  Approximately one day later, he began having fevers of 100.5 degrees.  Subsequently, he became increasingly lethargic.  His mother noted that he was not as active as usual.  He was not able to fully participate in soccer practice.  On approximately October 19th, he developed fever to 101.3 degrees.  That evening, he began having nausea and vomiting. On October 20th, he continued to have fever as well as the persistent nausea and vomiting.  She also noted that he had enlarged lymph nodes in his neck. On approximately October 22nd, he developed a fever to 104.9 degrees.  He was seen by his pediatrician, who performed a rapid strep test that was positive. He was then started on amoxicillin.  On October 23rd, the fevers persisted. He became increasingly weak and lethargic.  At one point, he told his mother he was too weak to walk and asked her to take him to the bathroom.  She did this twice.  Subsequently, he became incontinent of urine.  He went back to his pediatrician's office where he was noted to have persistent nausea and vomiting as well as urinary incontinence.  At that point, he was referred to the emergency room. On arrival in the emergency room, he was initially afebrile.  Subsequently, he developed fever to 38.5 degrees.  His other vital signs were unremarkable.  He became increasingly agitated while in the emergency room.  He demonstrated aggression and restlessness.  He was, therefore, admitted to the intensive care unit. He had a CT scan of the brain performed that was unremarkable.  He then underwent a lumbar puncture; which showed 37 white cells, 7% of which were neutrophils, 93% were mononuclear. The glucose of 52 with a protein of nearly 60.  He was thought to have meningitis or meningoencephalitis.  He was started on empiric antibiotic therapy consisting of ceftriaxone and acyclovir.  An MRI was obtained on October 24th, which was completely unremarkable.  Throughout the day of October 25th, he became less and less responsive and became comatose.  On the evening of October 25th, he developed abnormal pattern respiration.  He is thought to be having seizures and was started on Keppra. Subsequently, his respiratory status improved.
Pfizer when mixed Diluent only 08mL was used instead of the correct 1.8mL. Patient was still given 0.3mL Patient checked on 3 days Later No adverse Reaction Patient is doing Fine
A 36 year old male patient (CS) experienced pain of the left foot and left ankle swelling after immunization with RabAvert, batch no. 334011. The patient received RabAvert pre exposure prophylaxis. Dose and route remain unspecified. The patient received the first does of RabAvert on 06/17/04, after which he noticed pain in the base of the plantar surface of his toes on his left foot. After taking an over the counter unidentified medication, the pain emitted after two days. After the second dose of RabAvert, the patient noted pain and swelling of his left ankle, that persisted for two days. The reporter assessed the events as possibly related to the drug. Follow up received 08/02/04: Both RabAvert doses were received intramuscularly in the deltoid. The reporter stated no additional information regarding outcome, treatment received or resolution dates for reported adverse events was available.
5/13/2021: Flushed face, small red rash bumps on face and chest, extreme fatigue; used Benadryl cream which helped.  5/14/2021: Fatigue, sleeping more than 12 hours each day over the weekend;  5/17/2021 to current: Fatigue, short of breath, light headed, when exercising, walking up steps, unable to complete fitness workouts, unable to catch breath ; self treated with Mucinex decongestant-no improvement;  stamina and fitness ability greatly reduced.
The product was refrigerated on 04NOV2021 beyond expiration date 13Oct2021; The patient received expired dose beyond expiratory date 13OCT2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyond expiratory date 13OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 04NOV2021 beyond expiration date 13Oct2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyond expiratory date 13OCT2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 04NOV2021 beyond expiration date 13Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyond expiratory date 13OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 04NOV2021 beyond expiration date 13Oct2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. The vaccine was stored in refrigerator on 04-Nov-2021, there was no temperature excursion. The patient did not experience any adverse event. No treatment medications were provided.
Two days after my Pfizer booster, my muscles started feeling really sore, and my belly button became swollen and a previous scar started to look infected. I went to the ER and was admitted to the local hospital for 2 days and I was given an IV of antibiotics.
Itching since the second day; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number: Ew0162) via an unspecified route of administration, administered in arm left on 12Apr2021 12:00 PM (age at vaccination was 54 years) as dose 1, single for COVID-19 immunization at Doctor's office/urgent care. Medical history included back issues and blood clot issue. Concomitant medications included blood thinners he did not have the name at the time of reporting. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There were no any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, she was not diagnosed with COVID-19. The patient experienced itching since the second day on 14Apr2021. The patient had received Benadryl as treatment. The patient underwent lab test and procedure included nasal swab: negative on 17Mar2021. Since the vaccination, he has been tested for COVID-19. The outcome of event was not recovered.  No follow-up attempts were needed. No further information was expected.
53 yo female just received the Pfizer COVID vaccine around 1100 and around 1130 started feeling light headed and c/o mild throat tightness.  No trouble breathing.  Was taken to exam room.  Pulse ox 100%, Pulse 80's, BP was 152/90.  Lungs were clear on exam.  She was given some juice to drink but continued to c/o tightness in throat.  We gave her some IM Benadryl 50 mg and continued to watch her.
chills, fever, severe weakness, nausea, incontinence - began approcimately 12 hours following the vaccine and were severe for approximately 20 hours
Vaccine - Moderna COVID-19 EUA, dose 1. Patient received the first dose on 2/1 around 6PM PST in his left arm. By 2/2, the patient experienced arm soreness, and  by 9PM, he felt pain in his right ear. On the morning of 2/3, the patient woke up with hearing loss in his right ear, slight dizziness and nausea, but was able to work and eat with normal appetite. On 2/4, the patient woke up with general malaise, dizziness, lightheaded feeling, GI discomfort (minor diarrhea and vomiting), sweating, and chills. The patient still experienced hearing loss. The patient was fatigued, and had no appetite; stayed hydrated and slept most of the day. The patient gradually became less fatigued and  gained appetite from 2/5-2/8. On 2/8, the patient visited urgent care for his ear. The NP on site observed yellow fluid in the patient's right ear and prescribed amoxicillin and flonase generic. The patient took the amoxicillin for 10 days and flonase generic for 14 days. On 2/22 (D21 post vaccine), the patient saw his PCP, still reported hearing loss, but the doctor did not report any findings. The patient received a referral for the ear specialist. To date, 2/23, the patient has hearing loss in his right ear.
Approx. 4 week after receiving ZOSTAVAX, patient developed numbness in feet that progressed up his legs to point he had to walk with walker (previously walked on own fine). Diagnosed in ER with Guillain Barre syndrome, had 5 days of plasmapheresis, admitted due to complications (drop in BP), then to rehab center for 2 1/2-3weeks. On walker expectedly for 4-10 more months.
Mom reports approx 20 chicken pox like spots. No fever. Resolved by 5/19/03.
This spontaneous report was received from a registered nurse concerning a 27 year old female patient. The patient's concurrent conditions, medical history or allergy/drug reactions were reported as none. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9, (strength, dose, frequency, route, lot no. and expiration date were unspecified). Thera was no concomitant medication described. On an unknown date, the patient experienced a significant rash that appeared down side her torso from her nipple line down to her abdomen, 24 hours after the administration of the vaccine. It was also described that the rash was on the same side as the site of the injection and lasted about a week. No treatment was given. There was not a product quality complain involved. There was not laboratory testes performed. At the time of this report, the outcome of the above mentioned event was reported as recovered on an unspecified date. Additional information has been requested.
On the 5th day after the vaccination, I noticed a rash on my right side on my waistline about the size of the palm of my hand in two locations. It is red, a little itchy, under skin (not raised), but doesn't hurt. My right lower arm has a little redness, a little roughness again under skin. I called my doctor's office. They said Benadryl would be OK to take. I have no idea if this is a possible side affect of the vaccine. The nurse at the office  did not know...The rash may be a little less red today.
Burning/Tingling Sensation in both legs, from the kneecaps to the feet.
Information has been received from a physician concerning an 18 year old female patient having mononucleosis previously who in June 2011, was vaccinated with a first dose of GARDASIL (lot# unspecified). The physician reported that, in June 2011 while on GARDASIL, the patient presented with a rash that began at the head and appeared to work its way down her body. The patient also experienced muscle aches, arthralgia and fatigue. The patient had slightly elevated sedimentation (SED) and C-reactive protein (CRP) rates. The patient might have also had a low-grade fever. The patient had sought medical attention and the physician tested the patient regarding additional viral cause of the rash. At the time of report, the patient's condition was resolving. The adverse events were considered to be significant disability or incapacity. Additional information has been requested.
Anaphylaxis, tongue tingling and swelling, lip tingling and swelling, facial tingling and swelling, difficulty breathing, nausea
Initial report received from a health care professional on 27 October 2010. A 73-year-old female patient, with a history of hypertension, hyperlipidemia, anxiety, headache (HA) and osteoporosis, received on 25 October 2010 a right deltoid intramuscular injection of FLUZONE HIGH-DOSE, lot number U3602AA and a left deltoid injection of PNEUMOVAX, MSD lot number 0866Z. The patient's concomitant medications included lisinopril, statins, alendronate, acetaminophen, butalbital, and FIOROCET and alprazolam. The patient had "nothing acute" at the time of vaccination. On 26 October 2010, the patient experienced dizziness, confusion and shaking of the hands. She was not evaluated by a physician and received no treatment. The symptoms were resolving on 27 October 2010. Follow-up information was received from the health care professional on 23 December 2010. The patient continued to have symptoms, but they were described as "usually transient". She had followed-up with her physician, and had undergone a CT scan and other blood work; results were not available at the time of the report. Follow-up information received from a health care professional on 14 March 2011. Per the reporter, they had no further information to provide for this case. No other contact information was provided. Follow-up information received from a health care professional on 21 March 2011. Per the reporter, there are no changes since the last report. The reporter followed up with the patient on 14 March 2011. Documents held by sender: None.
Patient received Pfizer Pediatrics vaccine on 2/16/22 that is past beyond use date of 1/31/22
Patient described increased R SCM tone that felt like "toritcollis" (patient is a retired MD) 2 weeks after vaccination, this decreased slightly over the following 2 weeks but at the time he developed concurrent extensor weakness in his neck to the point that he could not consistently keep it elevated. He was seen initially by ortho/PT who referred him to a neurologist. EMG done in January 2020 (i.e., 5 months after vaccination) was suggestive of a myopathic process. His symptoms have been stable for the last 4 months (no improvement or worsening), and he has had no associated pain, sensory alteration, or other axial/bulbar weakness.
No adverse event; patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine).    No concomitant medications was reported. It was reported that patient did not had any adverse events. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654905, US-MODERNATX, INC.-MOD-2022-654910, US-MODERNATX, INC.-MOD-2022-654894 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654905:Patient No -2 US-MODERNATX, INC.-MOD-2022-654910:Patient No -4 US-MODERNATX, INC.-MOD-2022-654894:Patient No-1
Got vaccine on 2/5/2021 started with diarrhea that evening and the next day, Saturday became fatigue continues intermittently, Sunday 2/7/2021 noticed swelling to the left axilla with enlarged lymph node continues with it today 2/8/2021
PATIENT EXPERIENCED RASH ON WRIST AND THEN ABDOMEN, THEN LEFT SHOULDER, BOTH CHEEKS, JAW BONE, ELBOW AND RIGHT INDEX FINGER. PATIENT TOOK ANTIHISTAMINE AND WAS UNABLE TO CONTACT MD OR DERMATOLOGIST SO DENTIST PRESCRIBED 5 DEXAMETHASONE TABLETS. RASH WAS ITCHY AND IS NOW (12/17/21) LESSONED BUT NOT GONE
As previously stated, I received the Pneumovax vaccination on June 6, 2017.  That night, I awoke in the early hours of the morning with an urge to use the bathroom. I could not understand why the muscles in my entire body were so sore and painful when I moved or walked. I thought perhaps I caught a bug.    Unable to move, I remained in bed for two days and had to use a commode.  It was during that time, I realized my urine had changed color, resembling that of black coffee. As a nurse, I became worried and knew this was not just a bug and needed to go to the hospital.   On the third day, my husband and I arrived at the Emergency Room of Hospital, where I was admitted and given IVs throughout the day.  The soreness and muscle pain subsided gradually, and I had expected to be released, however they admitted me and remained at the hospital for a total of five days.   The doctors were extremely concerned regarding my liver enzymes which were elevated. I have never had any medical issue with my liver before and the doctors were trying to find the cause. The medical terms used during my stay were: ? Myositis? inflammation of muscles and muscle damage Transaminitis - refers to unusually high levels of a family of enzymes called transaminases. Myalgia ? mild to sever muscle pain   At the end of five days I was discharged and advised to see Doctor at the same hospital.  I saw him go through my records and requested that I go to the lab again and have blood drawn to check my liver enzymes.  The doctor ordered my blood drawn at regular intervals after that to continue to monitor my liver enzymes.    Over months my liver enzymes eventually stabilized and I was extremely relieved.  He gave me the news over the phone as he had since retired.
Patient passed away five days after receiving Fluarix vaccination.  Per spouse, cause of death is not yet established.
Headache; pain/muscle soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL3248), via an unspecified route of administration in left arm on 03Mar2021 at 09:00 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included allergies with Penicillin. Concomitant medications included Ibuprofen (ADVIL); Cyano-cobalamin (B-12); Cannabidiol (CBD OIL); L-lysine (L-LYSINE (LYSINE)); Sumatriptan and Alprazolam (XANAX). The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 03Mar2021, patient experienced headache (about 6 hours following vaccination), pain/muscle soreness at injection site (about 12 hours following vaccination). No treatment was given for the events. Events recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Soreness at injection site. Muscle pain. Nausea. Chilling. Fever. Headache. Dizziness. Fatigue .
Initially started of as pain in lower abdomen. Went to the family dr after about a week, since pain was still lingering. I was diagnosed with a mild case of Shingles by the Dr. The shingles started to crust by the time I went to the Dr office. No other major symptoms.
Almost a week after receiving the first dose, the vaccination site became sore again and swollen, and then became very itchy.  The site was tender for about a week and a half after that, and I had a rash for that long. I also developed rashes on my right forearm and on my back.
After patient received all four vaccines, pt had vasovagal episode which lasted less than 20 seconds. Skin was pale, clammy and warm to touch. Patient was treated with cool pack behind neck, legs elevated. Once patient was aware of surroundings, patient was given water/food and monitored by RN before being discharged.
Severe body aches; Chills; Fever; Soreness in injection site; Nausea; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 11May2021 at 12:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 23:00, the patient experienced severe body aches, chills, fever, soreness in injection site, nausea and loss of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 severe body aches, chills, fever, soreness in injection site, nausea and loss of appetite was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Flu-like symptoms; Bad headache; fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Bad headache), PYREXIA (fever) and CHILLS (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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 30-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Bad headache), PYREXIA (fever) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Bad headache), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99-100 f 99-100 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-024861 (Patient Link).