chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he developed multisystem inflammatory syndrome; Big spleen; This is a spontaneous report from a contactable consumer (patient's parent) via a Pfizer-sponsored program.  A male patient (age not provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration, on 18May2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 22May2021, the patient developed multisystem inflammatory syndrome and big spleen. The outcome of the events was unknown.   Information about Batch/Lot number has been requested.
Excursion began on 30Jan and experienced severa excursions until 14Feb2023; No Adverse Event; Excursion began on 30Jan and experienced severa excursions until 14Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion began on 30Jan and experienced severa excursions until 14Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Excursion began on 30Jan and experienced severa excursions until 14Feb2023) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Excursion began on 30Jan and experienced severa excursions until 14Feb2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion began on 30Jan and experienced severa excursions until 14Feb2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion began on 30Jan and experienced severa excursions until 14Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Excursion began on 30Jan and experienced severa excursions until 14Feb2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion began on 30Jan and experienced severa excursions until 14Feb2023) and POOR QUALITY PRODUCT ADMINISTERED (Excursion began on 30Jan and experienced severa excursions until 14Feb2023).    No concomitant drug information was provided.   No treatment drug information was provided.  The case corresponding to one of the two adult patients who had received the vaccine on 6Feb2023 as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710558, US-MODERNATX, INC.-MOD-2023-710839 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710558:Master case US-MODERNATX, INC.-MOD-2023-710839:same reporter US-MODERNATX, INC.-MOD-2023-710849:Same reporter
Vaccine was given the afternoon of 5/13/13. That night mother noted his arm there was no redness. On 5/15/13 redness was noted below the injection site. There was an area of redness and warmth. The arm (upper) was swollen compared to the other arm. No itching, pain or breathing difficulties. No treatment. On 5/17/13 area had mostly resolved.
Patient described feeling light-headed and blurred vision immediately following vaccine administration. POD nurse stated patient appeared pale. Patient was assisted to supine position on floor, did not fall or lose consciousness. Patient was observed by EMS, who continued to monitor vital signs over 35-40min. Patient improved and was released from clinic after 35-40min observation with no treatment warranted.
This spontaneous report was received from a registered nurse via medical assistant and refers to a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 29-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
No adverse event; Nurse reports patient was administered MMR II through a subcutaneous needle in the deltoid intramuscularly; This spontaneous report was received from a nurse referring to an unknown age and gender patient.  The patient's concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 01-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA subcutaneous injection, lot #T028935, expiration date: 26-AUG-2022, administered for prophylaxis through a subcutaneous needle in the deltoid intramuscularly (Incorrect route of product administration) (strength was not provided). No adverse event occurred.
pt recv vax 4NOV98 3PM & exp chest tightness & difficulty breathing during the late evening hours of same day;sx disappeared by next AM but pt left feeling out of it;felt nl day 3;
death;pt vaxed 22NOV95 @ 1045-fever PM 22NOV95 no assoc sx was active & alert placed in bed 930PM on 23NOV95 found dead @ 1015PM was feb-past hx febrile seizure
lt arm hot then tingling & itchy in both arms, diaphoretic, pale, nauseous felt as if would lose control of bowels; seen by MD inf facility; DPH given;
On the day after the first injection, I experienced significant vertigo that affected my daily life. This vertigo lasted for 10 days, each day it was slightly better. Then, when I received the 2nd vaccination injection, the vertigo came back again. It did not last as many days, however it has reappeared randomly and I continue to battle it.
Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also smelled things that were not there. I lost my sense of smell 10 years ago due to sinusitis. I experienced lethargy about 5 days after the shot up to 4 weeks after. I had some tightness in my chest, my albuterol inhaler helped with that. The  tingling in my hand and feet happened on a few occasions. I had numbness that lasted about an hour. I had frequent night sweats that woke me. I had muscle tightness in my leg and abdomen. I also had soreness in my arm, which made it hard to grasp a pen. I did test my reflexes which were normal.
Patient had a UTI; This spontaneous case was reported by a patient family member or friend and describes the occurrence of URINARY TRACT INFECTION (Patient had a UTI) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 25-Mar-2021, the patient experienced URINARY TRACT INFECTION (Patient had a UTI). At the time of the report, URINARY TRACT INFECTION (Patient had a UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs included no treatment drugs included; Sender's Comments: Event is of an infective origin , therefore, based on biological implausibility, causal association between the reported event and the administration of the reported is assessed as unlikely.
PT FELT DIZZY 5 MINUTES AFTER RECEIVNG HIS FIRST PFIZER COVID SHOT , HE WAS SWEATING AND GET SEATED AND WE OFFERED HIM WATER AND JUICE  SINCE HE SAIS HE ONLY HAS COFFEE IN THE MORNING THEN WE CALLED 911 WHO INSTRUCTED US TO HOLD ANY FLUIDS UNTIL THE PYRAMEDICS ARRIVED . PT STAYED COHERENT BUT KEPT HIS EYES CLOSED AND HE WAS TALKING TO 2 TEAM MEMBERS IN SPANISH AND THE PHARMACIST ON DUTY.
Multiple red spots on his legs; Colors have faded and turned brown; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Multiple red spots on his legs) and SKIN DISCOLOURATION (Colors have faded and turned brown) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-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 ERYTHEMA (Multiple red spots on his legs) and SKIN DISCOLOURATION (Colors have faded and turned brown). At the time of the report, ERYTHEMA (Multiple red spots on his legs) and SKIN DISCOLOURATION (Colors have faded and turned brown) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was provided. No concomitant was provided. Patient took second dose and didn't remember the exact date of vaccination.
I had no complications after receiving the vaccine. I started feeling sick and tested positive for COVID-19 on 12/24/2022. I went online and found out I needed to seek care. I went to the urgent care center, and I received a prescription for PAXLOVID and ZITHROMAX. The PAXLOVID upset my stomach a little in the beginning, but I adjusted to it.
46 y.o. male patient of, MD with history of TBI, depression. Presents with SOB, productive cough.   Acute Hypoxic Respiratory Failure, hypoxic COVID 19 Pneumonia Rule out pulmonary tuberculosis Symptoms present on admission: productive cough, SOB Pfizer COVID vaccine 1/27/2023 Date of covid positive test: 9/21/2023 Out of isolation 10/2 WBC 21k  CTPA:  New diffuse reticulonodular infiltrates, New patchy opacity anteriorly in the right upper lobe and mild patchy right lower lobe opacities  Quantiferon MTB indeterminate, Sputum for AFB x 3 negative  S/P Bronchoscopy 10/2, BAL preliminary negative for TB, final will take 6-8 weeks.   Oxygen requirements on admission 5-6L Current oxygen requirements: RA  s/p paxlovid, s/p CTX and azithro in ED  Completed dexamethasone, remdesivir Pulmonology following  - ok to discharge and out of isolation    Leukocytosis Possible 2/2 steroids Monitor    Hx of TBI Follows with Dr.   Summer of 2022 Residual LUE pain and spacticity, dysarthria NARxCheck 9/29 Continue gabapentin  Cont home baclofen  Neurogenic Bladder D/t TBI  Continue bethanechol   Agitation - Improved Depression Psych consulted-Continue Celexa 20mg qday.Add Atarax 25mg tid prn anxiety.Continue PRN Geodon for agitation Scheduled Atarax 9/29 Continue home Celexa   Tobacco Use Cessation discussed by Agency NRT PRN
Unable to lift treated arm. Unable to lift small items. Range of motion severely limited. I believe it may be SIRVA. I've not been diagnosed yet. Not sure the order of steps to take. I was shared this application online.
Hives that started don left arm near injection site. Then more hives on Right arm, legs, face. Mildly itchy.
6wk migratory polyarthritis treated w/ASA resolved;rheumatologist did full workup (negative) & all he could think of was some post viral event or chronologically relates to hep b vax;
I developed a rash after 4th dose. 2 days later I felt it stronger underneath my arm and back. I was pretty sure it was Shingles and went to urgent care on 5/31/2022. I already started taking gabapentin 100 mg, then they prescribed acyclovir 1 gram twice daily for 1 week. Saw PCP 06/24/2022 and my gabapentin was raised to 300mg daily, valacyclovir HCL 1 gram twice daily I was diagnosed with Herpetic pain.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient, with no pertinent medical history and no drug reactions or allergies, who in November 2008, was vaccinated with a first dose of GARDASIL (lot # 0947X, expire date 05-JUL-2010), 0.5 ml, intramuscularly. Concomitant therapy included vitamins. Subsequently, the patient realized she was pregnant. On an unspecified date, blood test and ultrasound (also reported as: ultrasound) were performed for routine prenatal care. The patient delivered a healthy male on 07-OCT-2009. During delivery, on 07-OCT-2009, the patient required IV and oxygen. In January 2010, the patient was vaccinated with the second dose of GARDASIL (lot # 1423X, expire date 20-JUN-2011), 0.5 ml, intramuscularly. "No adverse symptoms noted". On 11-NOV-2010, she was vaccinated with the third dose of GARDASIL (lot #, expire date not reported), 0.5 ml, intramuscularly. The registered nurse considered IV and oxygen requirements during delivery to be other important medical event. Additional information has been requested.
Initial report was received on 05 January 2012 from a consumer who is also the patient. A female patient who was 27 year-old at the time of vaccination (date of birth not reported) had received an INFLUENZA VACCINE (manufacturer, lot number, route and site of administration not reported) "many years ago, 1976 to be exact" and weeks later had a "horrible reaction" and was finally diagnosed with rheumatoid arthritis. According to the patient, none of the physicians at the time knew to relate the injection with the symptoms and therefore was "misdiagnosed". According to the patient, they  had Guillain Barre syndrome. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Chicken pox vaccine given 2/23/05, child sick (cranky and unwilling to eat) 2/25/05 PM.  2/26/05 AM - runny nose and cough started, still unwilling to eat.  Runny nose, cough and poor appetite continued and she started with a rash that appeared to be chicken pox 3/1/05 (2 or 3 spots), she continued to get more blisters (40 or more total) under her diaper, on her belly and on her face over the next 2 weeks. She was started on Augmentin 3/7/05 for an ear infection and changed to Zithromax 3/14/05.  There have been no new blisters seen since ~3/16/05 and the blisters she still has appear to finally be going away.
covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19 positive) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044BUA) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (covid-19 positive). At the time of the report, COVID-19 (covid-19 positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided.  No treatment information provided.
Severe vertigo started on 15 Mar 2021. Symptoms include: vomiting; dizziness; unable to walk without falling; etc.
Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asleep most of the whole day; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Arp2021), via an unspecified route of administration on 30Dec2020 at single dose at right arm for Covid virus. Medical history included blood thinner treatment. Concomitant medication included ongoing apixaban (ELIQUIS) for blood thinner treatment. The patient previously took coumadin, warfarin. Patient received the Covid-19 vaccine yesterday. She had been asleep most of the whole day (Dec2020). She had injection site pain, headache, tiredness, muscle pain and chills. She thought she was going to work but that didn't work. She was currently taking Eliquis. She had been on coumadin and warfarin before. She looked at the different medications that needed to be reported. She would also call her physician and make her aware. The start date for "Injection site pain" was 30Dec2020. The start dates for headache, tiredness, muscle pain and chills all were 31Dec2020. The patient also experienced nausea, feeling unwell on 31Dec2020. Investigation assessment was no. The outcome of the event "Injection site pain" was not recovered. The outcome of the other events was unknown.
Information has been received from a physician concerning patients who in approximately 1998 or 1997 were vaccinated with varicella virus vaccine live. Subsequently the patients experienced "breakthrough chickenpox". Unspecified medical attention was sought. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: 2-3 minutes after vaccine administration child complained his head hurt and he felt dizzy. His skin became pale and clammy, lips colorless, and he had slow responses verbally. Breathing and pulse were normal. Patient's condiotion was not improving for approximately 5 minutes so to be safe 911 was called. Paremedics responded and all vitals, reflexes, and blood glucose levels were normal and child's condition slowly started to improve, he was able to return home with parent.
Fever, headache, aching neck, arms and hands. Fingers felt stiff and swollen, hard to move, but still looked normal size. Developed an egg size lump under left armpit that was very painful.
May 5th 2021 Right eye went very blurry for most of day. Recovered sight later evening. May 6th 2021 Right eye went very blurry again most of day. Recovered sight later evening. May 17th 2021 Right eye went very blurry again. Recovered about 5 hours later. Right eye has not completely healed so eye doctor wants to see me again Dec. 3rd. 2021. In the early mornings right eye will be a bit blurry but seems to recover sight within an hour. We are not sure if this is caused by Johnson Covid shot but very suspicous of the timing. I was advised to report this to be safe and to find out what booster covid shot would be safe.
The patient stated that they sat down to wait for 20 minutes after receiving the vaccine. They did not experience any symptoms. When they exited the building and entered the sunlight, they stated their "eyes began flashing." It was described as bright flashing spots. This continued for about 30 minutes before it stopped. They did not experience this before and they have not had symptoms after it stopped. No other symptoms were experienced. It was recommended the patient follow up with an eye doctor to ensure there are no issues. Whether the patient went to see a provider is not known.
This spontaneous case was initially received on 18-DEC-2015. The case report was received from a(n) Health Professional and concerns a(n) 46 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 09-Dec-2015 - 09-Dec-2015, Batch no: U55706, Route of administration: Intramuscular, Dose: 0.5 ml once. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with AFLURIA the patient experienced Pain in her arm/Arm pain (non serious, outcome: not recovered/not resolved). Action taken: discontinued. Event treatment: Rechallenge/Dechallenge Information: For relevant test results see appropriate report section. Reporter's assessment: The reporter assessed the event as non-serious.
woke up being dizzy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (woke up being dizzy ) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (woke up being dizzy ). At the time of the report, DIZZINESS (woke up being dizzy ) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
After patient had been sitting for about 15 minutes (after receiving vaccine) she got up and told a nurse that she was having chest pain that extended into her arm. The nurse had her lie down and called 911. Paramedics took her to the emergency room. She was still having pain as they were leaving. After follow up the next morning, we found that she was released from hospital after a few hours and that she would follow up with primary care physician. She was still having intermittent pain the next morning.
individual has a swollen left lymph node axillary and neck on same side as vaccine (administered tues 12/29/2020)  swelling noted on Friday evening (1/1/2021).  No other symptoms at all.   Visibly swollen upon examination on 1/4/2021.
Information has been received from a physician concerning a female patient who during the week of 17-JUN-2007 to 22-JUN-2007, was vaccinated with a first dose of Gardasil. On 23-JUN-2007, the patient experienced abdominal pain. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Information has been received from a healthcare professional and physician concerning a female patient with no allergies who on 21-JUN-2007, was vaccinated into the left arm with a first dose of GARDASIL. On 21-JUN-2007, the patient went to the emergency room with right sided pain. All exams were negative. The patient was given MOTRIN and released. It was reported that the emergency room physician was unsure if it was a side effect of GARDASIL. The patient has had no previous reactions to other vaccines. At the time of this report, the patient recovered. No product quality complaint was involved. Additional information is not expected.