chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 8 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that patient received an expired dose of FLUMIST QUADRIVALENT that day, which started on 12-Mar-2015. The outcome of the event of expired dose of FLUMIST is unknown. The report was considered to be non-serious. Corrected Report 15-Mar-2015: Order of reporters was corrected. Case narrative corrected.
Nausea; Vomiting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
A report has been received from a Health Professional concerning a 7 year old, female subject, who had been receiving FLUMIST (Intranasal) dose and a half. FLUMIST (Intranasal) started on an unknown date. The nurse reported that they inadvertently administered  a dose and a half of FLUMIST to a patient on the same day on 23-Oct-2013. The patient had not experienced any symptoms from the extra FLUMIST. The outcome of the event of patient received dose and a half of FLUMIST is unknown. The report was considered to be non-serious.
left leg was cold/left foot was 79-82 degrees Celsius; blood clots in his left leg/he had three/first one on 02Mar, second one 13Mar and the third one yesterday; he had the Pfizer vaccine on 15Feb and 26Feb; he had the Pfizer vaccine on 15Feb and 26Feb; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation; tafamidis (VYNDAMAX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient took the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Feb2021 at age of 77 years old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A patient taking Vyndamax medication who stated that he had experienced blood clot in his left leg. Clarified that he had the Pfizer vaccine on 15Feb2021 and 26Feb2021. Clarified that on 02Mar2021 that he had blood clots in his left leg. Stated that he had three. Stated that he had the first one on 02Mar2021, second one 13Mar2021 and the third one yesterday (15Mar2021). Stated that he was told left leg was cold. Stated that he took his temperature with a thermometer and his left foot was 79-82 degrees Celsius. Stated that the right foot is 95-96 degrees Celsius. Stated that he filled it out for the Covid vaccination. Stated that he reported Vyndalink when it asked what other medications that he took. The action taken in response to the events for tafamidis was unknown. The outcome of events was unknown.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 24-JUN-2015, the patient was vaccinated with an improperly stored doses of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
(1 week 2010) I felt unbalanced, I felt like I could fall flat without being dizzy. I felt super tired, fatigued all of the time. I swore now that I knew for sure in 2011 it is the flu shot I'll never again in my life have another one if I live through it as in 2010. The same symptoms in 2011 as well, I can't remember them now. (2 weeks long 2011).
Pt was 19 yr old female who came to clinic for Hepatitis B vaccination needed for nursing school. Had had titer drawn and was not showing immunity from previous childhood vaccinations per her report. Per vaccine insert information dose was given based off her age of 19 years and she received recommended pediatric dose of 0.5 ml or 10 mcg. After insurance denied payment upon further investigation found that the immunization dose should have been 1 ml or 20 mcg based off of a booster dose and different recommendations for persons 11 years and up to receive adult dose of 1 ml. No adverse reaction.
pain is ramping; Every joint in body/large and small joints were painful/shoulder, neck and hip hurt the most; Deep muscle pain; She was "nonfunctioning"/could not do anything; Was in so much pain; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events she was "nonfunctioning"/could not do anything (immobile), was in so much pain (pain) every joint in body/large and small joints were painful/shoulder, neck and hip hurt the most (arthralgia), deep muscle pain (myalgia), pain is ramping (pain worsened)  The patient's medical history was not provided. Allergies included hay fever. No relevant concomitant medications were reported.  On 23 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (lot: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the events the patient received the second of two planned doses of mRNA-1273 (lot: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient reported that she was nonfunctioning. She could not do anything. She was in so much pain. She had pain in every joint in her body. She stated that her large and small joints were painful. She had deep muscle pain as well. Her shoulder, neck and hip hurt the most. She took acetaminophen and ibuprofen. The patient went to orthopedist for the pain. The X-rays were normal for age. She was given meloxicam and a steroid pack (methylprednisolone) and she started feeling better. On 25 Jan 2021, a few days later, she reported that the pain came back. The pain was ramping and was still ongoing.  Treatment medications included: acetaminophen, ibuprofen, meloxicam, and methylprednisolone.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.   The outcome of the events, was in so much pain/pain came back/pain is ramping/pain,"nonfunctioning"/could not do anything, every joint in body/large and small joints were painful/shoulder, neck and hip hurt the most, deep muscle pain, was unknown.; Reporter'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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-032919:Case with first dose
Stronger dyspnea/have difficulties to deep breath; chest pain/discomfort; chest pain/discomfort; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 16:00 as DOSE 2, SINGLE for covid-19 immunisation (Age at vaccination 60 Years). Medical history and concomitant medications were not reported. No known allergies and other medical history. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 60 Years) and it was reported that strong dysnea for 3 days after 1st dose starting first night, disappeared. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Then the patient experienced on 05Mar2021 stronger dysnea & chest pain/discomfort after 2/3 hours of 2nd application and never left (slowly improving, but never left). It was reported, can perform sports and regular activities, however, have difficulties to deep breath (at times patient can't deep breath) and chest discomfort yet today. Doctors diagnosed by discard emotional stress. They ruled out and did not further investigated for myocarditis and heart issues. Would like her case to be reviewed by Pfizer as the coincidence with the shots are too direct. The patient underwent lab tests and procedures which included blood test: ok in 2021, Contrast chest CT scan (computerized tomogram thorax): negative in 2021, electrocardiogram: negative in 2021, oxygen saturation: ok % in 2021, Covid 19 rapid diagnostic test (sars-cov-2 test): negative on 13Apr2021 Nasal Swab, spirometry: normal in 2021, x-ray: negative in 2021. The patient did not receive any treatments. The patient visited Urgent Care, Primary doctors, Pulmonologist. The clinical outcome of the events was recovering and chest discomfort was not recovered.  Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
30 minutes after receiving a Hep B vaccine this pt developed tachycardia (112-128/min) elevated BP (130/90) diaphoresis and felt SOB. Lungs were clear to ascultation.
Two weeks after getting the Moderna shot I started to get shot of breath when walking. I also would wakeup at night gasping for air. After 3+ weeks I got to the point where I could not lay down and fall asleep, as soon as I fell asleep I would wake up gasping for air. It was exactly one month to the day I had the shot I was in the ER at .Hospital.
I had a sore right arm and I also experienced severe diarrhea after receiving the vaccine. I did not see a doctor for these symptoms. I had acute diarrhea for the whole day until I ran out of steam. I continued to hydrate. Sunday over night, I did not awaken to go to the bathroom, and it evacuated in bed. I still had diarrhea the next morning but that was the end of the process. I am still feeling under the weather. We went on a cruise the following week and my symptoms were severe enough for me to get tested for COVID-19 which was negative. I took IMODIUM at the airport as I was concerned about something else happening. I was fine for the cruise. 3 weeks after this I was hospitalized for a UTI. This was on about October 04, 2022. I got a real high fever with nausea and vomiting on October 05, 2022. I went to the hospital via ambulance since I had severe chills, vomiting and fever of about 103. My fever had been running around 101. I was admitted on October 5, 2022, because they indicated I was septic. They determined it was an E. coli infection. They treated me with broad spectrum antibiotics. I was given a different antibiotic to treat the E. coli infection. I believe it was LEVAQUIN. I took the antibiotic for a month. I started to feel better in about a week, and I did not feel better for about a week. I feel like I have recovered from the diarrhea and the UTI.
Pt developed right eye symptoms including blurred vision, itching/burning, and foreign body sensation on 10/30/22. She saw her optometrist on 11/2/22 and an inferior branch retinal artery occlusion of the right eye was diagnosed. ASA 81 mg daily was restarted at that time (pt had previously taken daily ASA but PCP had discontinued it at her annual wellness visit of 10/17/22). Pt returned to the optometrist for follow up on 12/13/22 and was still having blurred vision and a feeling of heaviness in the right eye and optometrist wrote in the visit note that the vision change was likely to be permanent.
dose two less than 4 weeks after dose one; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose two of Shingrix doses less than 4 weeks after dose one, which led to shortening of vaccination schedule. The reporter did not wish to complete report. The reporter did not provide lot number or expiration date. The reporter did not consent to follow-up.
Information has been received from a physician concerning a female who "about 3 years ago", in approximately 2004, was vaccinated with a subcutaneous single dose of varicella virus vaccine live (Oka/Merck). On 17-JUN-2007, the patient developed breakthrough chickenpox rash of about 40 lesions on the trunk and neck. The patient also developed a low grade fever of 99 degrees fahrenheit for a day. No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 24-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
First shot one month prior, no issues at all. Soreness at the injection site.   Second shot: Next day, high fever, chills, severe muscle and joint pain.  Two days after, violent vomiting. increased joint pain, fever, trouble thinking clearly.  Three days after, numbness in my left hand, and loss of sensation in my entire right foot. As of 6-16, loss of feeling still continues.  1 week after, chest and lung pain, I think my heart is hurting, almost like random stabbing pains through it, random waves of muscle and joint pain. Issues sleeping. Issues with thinking clearly.   I have felt run down since receiving my second shot. Loss of appetite and foggy brain.
Continually progressing nerve pain causing stroke like symptoms. Currently suspected as Guillain Barre syndrome
itchy throat, heaviness in throat, headache onset  lungs clear bilaterally, denies SOB or difficulty breathing, BP 136/90
My daughter had started her menstrual cycle a day or two prior to receiving the vaccine.  She has had her cycle since August 2020.  Her bleeding became VERY heavy after receiving the shot, where she was bleeding through super plus and ultra tampons in just a couple of hours.  She is still bleeding like this 6 days later.  It has not stopped.  Her regular periods are quite lite and nothing like this.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  This case pertains to patient number 24 out of 40.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:master case
On Oct 1 @0810am vaccine was administered to employee, the luer lock on needle/syringe became loose. When plunger was activated to administer the vaccine the vaccine spilled out of syringe on patient's arm instead of via needle into patient. Alcohol was used to clean site and then vaccine was re-administered with out issue. On Monday, Oct 3, patient noted a 5mm fluid filled vesicle around same location as injection site along with approximately 10 other pinpoint size papules. Patient did not have any redness, swelling, pain or pruritus noted. By Oct 5, 2022, employee reported the site was clear.
This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 09-SEP-2014 the patient was vaccinated with PEDVAXHIB (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
ON THURSDAY SEPTEMBER 2,2021 AFTER RECIEVING THE VACCINE THAT EVENING AROUND 6PM NOTICED VISION WAS BLURRY EVEN WITH PRESCRIPTION GLASSES ON. DIFFICULTY WATCHING TELEVISION THAT EVENING AND CONTINUES TO BOTHER ME TODAY SEPTEMBER 3, 2021 AND ITS CURRENTLY 1730 IN THE EVENING. VISION IS STILL BLURRY. DID HAVE A HEADACHE DURING THE NIGHT AS WELL.
Patient experienced a headache and nausea/vomiting . Patient advised to take tylenol and increase fluids
Splitting headache; Nauseous; Nauseous was reported as worsened; experience some side effects at the injection site (on her left shoulder area) which was huge hive that were red, hard and hurts; Huge hive that is red, hard, and hurts was reported as worsened.; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported ), dose 1 via an unspecified route of administration, administered in Arm Left (Left shoulder) on 17Feb2021 08:00 as single dose for covid-19 immunisation. The patient medical history was not reported. On concomitant Medication patient initially stated she was in immune suppressant medications. However, when probed for concomitant details stated there were no medications to provide. On 26Feb2021 9:00 AM, she started to experience some side effects at the injection site (on her left shoulder area) which was huge hive that were red, hard and hurts. She also had a splitting headache, and she was nauseous. Found it strange that it started over a week after the vaccine. She was also on immune suppressant drugs and did not know if she should repot this information. She added, she does not feel the COVID Vaccine was administered correctly. She is not sure what happened. The CMA pinched her skin high and then put the shot in. Patient stated that she gives herself weekly shots in her muscle, in the arm, and she is not supposed to pinch the skin. It is supposed to go in the muscle. She was not sure if that had anything to do with it. If due to her immune system. No History of any previous immunizations with the Pfizer vaccine considered as suspect. No additional Vaccines administered on same date of the Pfizer suspect. Patient did not visit emergency Room or physicians Office. Prior Vaccinations within 4 weeks and AEs following prior vaccinations were none. The outcome of the events was not recovered.
4/27/04 client stated symptoms of lightheadedness started shortly after receiving Hep B vaccine on 4/22/04. Over the weekend experienced sneezing, wheezing, weakness and headaches. Client stated "am not feeling well".
Patient developed severe chills and body aches approximately 12 hours after the injection, along with fevers. This resolved 48 hours later, however by that time a site reaction including red, hard swollen upper arm occurred.
Tingling/numbness on left side of face, mostly affecting lips and cheek area, stomach cramps and heartburn, diarrhea, dizzy feeling.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On unknown dates, the unspecified patients were vaccinated with doses of ROTATEQ, (strength, dose, frequency, route and anatomical location were not reported), (lot # J013589, expiration date: 06-JUN-2015), which were improperly stored. It was reported that the temperature excursion for ROTATEQ was supported with in-house stability data. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Covid19 Breakthrough.  1st vaccine received on 06/04/2021.  80 y/o presents with hx of testing + for covid19 2 days ago and now returns with continued c/o sore throat, cough, fever, chills, body aches and syncopal episodes x2 lasting several minutes.  Pt receiving low dose steroids.
Pt recv vax on 8/5/98; on 8/10/98 pt exp seizure-eyes rolled back, drooling.  Mother taking child to primary care.
Started with  body achiness, Fever 99.9, chills about 6-7 hours after injection,  severe headache and head soreness overnight, occasional light headedness; general tiredness; wanting to sleep
TDAP given 2/27/2009. (left deltoid) seen in office 3/4/09 for left delt was erythematous and tender. 4X4 cm area, no lymphadenitis but slightly tender under Lt axilla. Temp 98.0 Pt started on PREDNISONE 3/5/09.
The day after the injection she had a low grade fever, nausea, headache, fatigue and lightheadedness