chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 120 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Itchy hives on the injection site; Itchy hives on the injection site; Arm hurt for a day; A spontaneous report was received from a consumer who was also a 77-years-old female patient who received Moderna's COVID-19 vaccine and experienced  Pain in arm ,and Itchy hives on the injection site.  Patient's medical history was not provided, and concomitant medicines taken by the patient include Pregabalin, Duloxetine and Spironolactone.  On 12 Jan 2021, approximately 8 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced  Pain in arm ,and Itchy hives on the injection site.   Action taken with mRNA-1273 was not reported.  The outcome of the events, Pain in arm ,and Itchy hives on the injection site is not available.
About a half an hour after injection my lips and tongue started tingling and swelling. Benadryl was able to control this.  An hour after the injection I started to hurt and ache, which was expected. But it soon eclipsed the achy miserable feeling one normally gets with a flu shot. The left side of my body started having fibromyalgia nerve pain that was so severe I had no option but to lay in bed and endure it. The lightest touch felt like touching raw nerve endings similar to  getting sugar into  a severely bad tooth. I experience pain on a daily basis and this was something above and beyond any fibromyalgia pain or nerve pain I have experienced in the past. It was so bad, I would not have wanted to live the rest of my life in that level of pain.  I took a Phenergan like I do for my chronic migraines and it allowed me to get some rest and thankfully in the morning it had mostly abated. I continue to have worse than normal fibromyalgia pain for 5 to 6 days after the injection.
dizziness and weakness, after >4 hrs from time of vaccination in pt with active Multiple Sclerosis diagnosis.  No treatment sought
Received first dose of Pfizer COVID vaccine 1/19/21. Had first seizure of her life 1/24/21. Was taken by EMS to emergency room. Started on Keppra and followed up with Neurology. Cause of seizure undetermined at that time. Second dose of vaccine 2/8/21. No side effects. Third dose of vaccine 11/11/21 at 0745. Had seizure 2125. Did not receive medical care at that time. Followed up with neurologist by phone. It is now felt that both seizures were as a result of the vaccine.
MOC called 4NOV96 stated pt awoke 1NOV96 w/chest pain, severe SOB became progressively worse resulting in visit to hosp ER;per MOC MD on duty flet sx were vax related;
A non-serious spontaneous report of two patients administered expired FLUMIST was received from a health professional concerning a 32-month-old female. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 22-Nov-2010. On 10-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Itching; huge red thing; A spontaneous report was received from a consumer concerning a male  patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching/pruritus, huge red thing/erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the events, itching, huge red thing.  Treatment information include ice and Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itching, huge red thing was unknown.
Patient experienced difficulty breathing following vaccination. Patient Received .3mL of Epi, Right thigh. EMT arrived to continue care of patient.
pt recv vax 20MAR98 rt deltoid area devel swelling redness & pain @ site of inj started 22MAR98;no fever or other sx;
red spots began to appear on both arms and neck; This is a spontaneous report from a contactable consumer, the patient. This 76-year-old female patient that reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 14Feb2021 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 12Mar2021; both via unspecified route of administration as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that on 17Feb2021, red spots began to appear on both arms and neck. She was like that for two weeks and they disappeared (unspecified date). She went for the second dose on 12Mar2021. She got the little spots again last night and the day before (estimated as Mar2021), outcome reported as unknown. The clinical outcome of red spots on both arms and neck was recovered on unspecified date.  No follow-up attempts are possible; no request for batch number will be pursued.
Chill at the night of the second vaccine, that accompanied by fever that lasted to the second day after the vaccination day. After second day of the vaccination day every thing returned to normal (temperature)
The patient had tumors growing in her mouth which was diagnosed as squamous cell cancer in May 2021. Patient had surgery May 17, 2021, they removed the tumor, took a graph from her leg and bone from the leg to reconstruct the jaw. By July 6, 2021, the tumor had grown back and was the size of an almond. Patient had chemo on 8/30/2021, became septic and was back in the hospital. Patient went home one week later, by this time the doctors said she was no longer a candidate for surgery and she had 2 tumors that broke out of the skin on her left side of her face. The tumors were 7 inches by 4 inches by 2.5 inches
Received FLUMIST Wed. 11-19-08. Began coughing that night. On Thursday cough had gotten worse. Thursday night child became pale, had difficulty breathing, was taken to local ED and transferred via ambulance to medical center. Treated with Albuterol, FLOVENT and Prednisolone. Temperature 101.4 (rectal) 1/2/09-ED records received for DOS 11/21/08-Presented with C/O difficulty breathing, fever intermittent for 2 days then began to have clear rhinorrhea/cough times 4 days prior to presentation. Increased respiratory rate, subcostal retraction, occasional wheeze.
I noticed minor digestive problems before the 2nd shot. Four days after the 2nd shot, I noticed severe digestive problems. Every time I eat or drink anything other than water, I got stomachache. My bowl movement increases from 1 per day before the 2nd shot to 2 ~ 3 per day. I also was having excessive stomach gas. During every bowl movement, my stool was neither hard nor liquid but it was little soft and would come out in many chunks instead of a few large pieces. I started to loose weight very fast. In the nest 10 days (around 3/25/2021), I lost 12 lbs (122 lbs to 110 lbs). This may be because I couldn't digest my food and I was eating much less because of fear. I was feeling much weaker and tired even though I was resting most of the time except going to work full time which wasn't physically challenging.
Tight chest, burns when breathing, reacted with my tattoo and made it raise up and get vumpy
Patient was given 50mcg/0.25mL of adult moderna instead of pediatric moderna vaccine. Patient did not experience any symptoms after vaccine administration.
Patient had previously received PCV 23 in September 2020. Unfortunately State Immunization Information System (IIS) had shown PCV 13 in Sept 2020 and not PCV 23. This was clarified by the agency who administered and it was updated in the system. But because she received an extra dose, her arm became hot, swollen, and red from the shoulder to her elbow.
Information has been received from a medical assistant concerning a 27 year old patient who on 02-NOV-2009 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23. Subsequently, the patient experienced redness, warmth and swelling at the injection site. The patient visited the office for medical attention. No laboratory diagnostics studies were performed. At the time of the report, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
4cm area of tenderness, warmness and itching at site of Yellow Fever immunization on left upper arm.
On 1/26/21 I felt chills, headache, body aches and very weak. These symptom's lasted five days.
A legal complaint was received from an attorney alleging that a female child received Hib-TITER, Tetramune, Acel0Imune, and Recombivax-HB from October 1995 through March 1997. According to the legal complaint, the child "has developed severe neurodevelopmental disorders with associated high mercury exposure levels as a result of the vaccinations she received," due to the cumulative exposure to the mercury preservative thimerosal in the vaccines. According to the legal complaint, the child "has sustained mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." It is also alleged that the child has "suffered serious permanent injury." No further info was available as of the date of this report. The lot number given for Tetramune, 4270840, administered 10/20/95 (as per the legal complaint), is not a valid lot number. This case was serious since these events were considered medically important (OMIC).
Fever, chills, sweats, severe frontal headache, eyes hurt, runny nose, arm swelling and pain at injection site, general fatigue and tiredness which lasted the entire day of Saturday, July 17, 2021 following my July 16, 2021 second injection of the Moderna vaccine.
The Pharmacist is confused about the dosing of the Moderna Covid- 19 bivalent 6th dose which is 0.25 or 0.5 ml.; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT LABEL CONFUSION (The Pharmacist is confused about the dosing of the Moderna Covid- 19 bivalent 6th dose which is 0.25 or 0.5 ml.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received sixth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (The Pharmacist is confused about the dosing of the Moderna Covid- 19 bivalent 6th dose which is 0.25 or 0.5 ml.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL CONFUSION (The Pharmacist is confused about the dosing of the Moderna Covid- 19 bivalent 6th dose which is 0.25 or 0.5 ml.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 assessments were provided for PRODUCT LABEL CONFUSION (The Pharmacist is confused about the dosing of the Moderna Covid- 19 bivalent 6th dose which is 0.25 or 0.5 ml.) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    Concomitant medications details were not reported.  It was reported that the Pharmacist would like to know if the 0.5 or 0.25 could be given as an immunocompromised booster dose. The pharmacist was confused because the bivalent vial said that was for 0.25 or 0.5 ml. However, the vial did not indicate who was getting which dose. They used 0.25 ml for the previous boosters, and that was ingrained in everyone's brains. The pharmacist mentioned that for Pfizer that was easy because the same dosage was used.  No treatment medication was provided.
Felt pain in my arm; Felt weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt pain in my arm) and ASTHENIA (Felt weak) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Felt pain in my arm) and ASTHENIA (Felt weak). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 PO OD. At the time of the report, PAIN IN EXTREMITY (Felt pain in my arm) had not resolved and ASTHENIA (Felt weak) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant reported wasVitamins used to treat vision. Treatment involved using ice to relieve the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant Follow-up, Events outcome updated
Hypertensive Urgency; I have sharp pains in my chest; heart was pounding out of chest; tachycardia; D-Dimer test came back positive; my headache was excruciating/head pounding; booster dose; booster dose; my blood pressure increased/My normal BP of 120/70 or 75, skyrocketed to 180/100; my body began to hurt like hell; fever; pain at the injection site; nausea; chills; my tongue and mouth tasted horrible; my lymp nodes under my left arm swole with a lump the size of a golf ball, my groin lymph nodes and even behind my knee and ankle on my left side swole.; exhausted; I felt horrible; My vision was blurry; This is a spontaneous report received from consumer (patient) in response to the query mail. A patient of unspecified age and gender received booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 16Sep2021 as dose 3 (booster), single for COVID-19 immunization. Patient decided to get the booster shot because patient donated left kidney to sister in Feb2021. Medical history for the patient included kidney donor [donated left kidney to sister in Feb2021]. Concomitant medications were none. Patient previously received dose 1 and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. On 16Sep2021, patient received booster shot of the Pfizer vaccine, within hours of receiving the vaccine, patient body began to hurt like hell on an unspecified date in Sep2021. The vaccine wreaked havoc on patient's system and one kidney obviously couldn't take it. Patient had a fever, pain at the injection site, nausea, chills, body aches, tongue and mouth tasted horrible and blood pressure increased. Over eight (8) days, post-booster, patient's lymph nodes under left arm swollen with a lump-the size of a golf ball, groin lymph nodes and even behind knee and ankle on left side were swollen, blood pressure continued to rise, headache was excruciating, patient was extremely exhausted and felt horrible on an unspecified date in Sep2021. Normal BP of 120/70 or 75, skyrocketed to 180/100. Patient went to see Primary Care Physician, both the doctor and her nurse confirmed extremely high pressure. Patient left the office and went home to rest and monitored pressure hourly and it remained high. The next day patient went to ER. Patient's vision was blurry, head pounding and blood pressure elevated but a little less than before 154/90. They ran tests, did a CT scan w/o contrast, gave a steroid, headache cocktail and sent patient home. A day later, patient still felt horrible. Now it was Friday, a full 8 days or so post vaccine and patient came back to the ER. Heart was pounding out of chest, had head aching and have sharp pains in chest. Patient was diagnosed with tachycardia and Hypertensive Urgency on an unspecified date in Sep2021. They give patient Valium and ran blood tests, and D-Dimer test came back positive. So, patient stayed in the hospital overnight for observation. Outcome of all the events were unknown.
Blood in her urine; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Blood in her urine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMATURIA (Blood in her urine). At the time of the report, HAEMATURIA (Blood in her urine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Suffocating sensation; Cannot breath deeply, difficulty breathing; Sensation of having an insect in the ear; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SUFFOCATION FEELING (Suffocating sensation), DYSPNOEA (Cannot breath deeply, difficulty breathing) and EAR DISCOMFORT (Sensation of having an insect in the ear) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic shock. Concurrent medical conditions included Asthmatic. Concomitant products included MONTELUKAST for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced SUFFOCATION FEELING (Suffocating sensation), DYSPNOEA (Cannot breath deeply, difficulty breathing) and EAR DISCOMFORT (Sensation of having an insect in the ear). At the time of the report, SUFFOCATION FEELING (Suffocating sensation), DYSPNOEA (Cannot breath deeply, difficulty breathing) and EAR DISCOMFORT (Sensation of having an insect in the ear) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: results not provided Results not provided. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, X-ray: results not provided Results not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient went to emergency room (ER), where a computed tomography (CT) scan, X-Ray diagnosis were made. The patient spoke with different doctors, Clinical, Cardiologist and Pneumologist. She was given medication but symptoms did not subside. She took Montelukast, Prednisone, Albuterol spray and Alprazolam. to treat symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Excessive yawning beginning at 1:30am (16.5 hours after vaccination), that continued for approximately 1-2 hours.
Later that day i began feeling very tired (couldn't stop yawning), began feeling achy. by bedtime i alternated between shivering cold & very warm. never registered a fever. by the middle of the night i couldn't sleep for the muscle aches, sensitive hearing (could hear everything accutely & it hurt my brain!). my whole body hurt! i took some acetaminophen for my headache- didn't think that would get better without help. i think the painkiller helped because by the next day i was feeling somewhat better. much better by mid-day. happy about that!
brown spots on chest; fever; bronchitis; This case was reported by a pharmacist via call center representative and described the occurrence of bronchitis in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number CX5BG, expiry date 18th May 2021) for prophylaxis.   On 31st January 2019, the patient received the 1st dose of Shingrix. On 31st January 2019, less than a day after receiving Shingrix, the patient experienced bronchitis. On an unknown date, the patient experienced skin discoloration and fever. On an unknown date, the outcome of the bronchitis was recovered/resolved and the outcome of the skin discoloration and fever were unknown.   It was unknown if the reporter considered the bronchitis, skin discoloration and fever to be related to Shingrix.  Additional details were provided as follows: The patient experienced bronchitis that lasted for 12 weeks. The patient also had brown spots on her chest and a fever of 103.5 degrees F. The reporter consented to follow up.
Reported fever of 101 degrees F yesterday with joint pains and today diarrhea with continued joint pains. Has had BM five times already. Temp decreased to 100 degrees F. along with diarrhea and joint point
Immediately after inj, there was slight bleeding. A cotton ball was applied. Local site began to swell. Pt was asked how she was feeling. Soon after she felt lightheaded "like fainting". 911 was called. Pt got hot & clammy & "felt like passing out", but remained conscious. EMTs arrived, checked pt - was stabilizing - bp ok- pt signed waiver of release. Dx: 'syncope episode'. Bump at site went down.