chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle pain for several days after then stomach problems(not diagnosed gas problem) since culminating in my trip to the ER and immediate surgery to remove my gallbladder on June 29. Stomach problems are not fully resolved as of yet.
This spontaneous report as received from a medical assistant refers to a 20 year old patient. On an unknown date the patient was vaccinated with PROQUAD lot # M012986, expiration. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Staff member added 1.3 ml of normal saline dilutant to a vail of COVID 19 Pfizer 5-11y Bivalent that had 0.2ml of pure vaccine with drawn from it. Leaving 0.5ml of pure vaccine remaining in the vial.  Once the 1.3ml of dilutant was added this resulted in an over dilution of vaccine. The staff member then drew up 0.2ml of the diluted solution and administered the 0.2ml dose in the RA of the child. There have been now reported symptoms or side effects at this time.
came in for a Moderna Shot.  We screened her for sickness , allergies and eligiblity except for age.  She received the Moderna shot that is approved for 18 and older.  She is 16 years old.
(R) facial droop nausea for 2-3 DAys - onset about 3 DAys after vaccination
Initial misuse report received from a healthcare professional on 02 August 2013. A 13-year-old patient received a dose of ADACEL vaccine earlier than needed. No more information was provided. No adverse event was  reported. List of documents held by sender: none.
I had severe diarrhea and abdominal pain and it was so bad that I had to get rehydrated twice that week. That started on the weekend 3/13, but on 3/15 it really went crazy. On the 3/16/2021, I may have went to the doctor and may have gotten rehydrated on the 17th and 19th. They did some imaging and they decided it was not bacterial. When they did the imaging, they decided it was viral because it didn't culture for bacterial and it said that a massive infection that big must have been viral. They saw a big mass of infection in the imaging they did. The only treatment was the IV hydrations. This lasted for about 5 days. I don't think it was the vaccine because I had a strange feeling in the intestines a couple days before hand. Vaccine must have just worn me down and the problem took the opportunity.
Started feeling unwell & very drowsy at 9pm ( 4 hours after shot) Fell asleep but was awake most of the night with headache, body aches , nausea.  At 6am developed migraine & fever of 100° Sinus pains too. By then feeling extremely unwell Took Ondenestron for nausea , Hydrocodone for body ache?s & migraine , Maxalt for migraine
child was administered an expired dose of adcel vaccine/No AE; Initial information was received on 18-Feb-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4-year-old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  On 13-Feb-2020, the patient received concomitant medications included MMR, IPOL and "Afluria", a Flu vaccine (no dosing details reported) .  On 13-Feb-2020, the patient received a 0.5 mL second dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5367AA, expiry date: 30-Jan-2020] via an intramuscular route at the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I prayed for death, my whole body was in terrific pain; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (I prayed for death, my whole body was in terrific pain) 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 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN (I prayed for death, my whole body was in terrific pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Jun-2021, PAIN (I prayed for death, my whole body was in terrific pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.   Reporter did not allow further contact
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple myeloma (diagnosed in December 2009). On 7th March 2019, the patient received the 1st dose of SHINGRIX. On 8th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On 9th March 2019, the patient experienced localized erythema and skin warm. On 11th March 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the localized erythema and skin warm were recovering/resolving. It was unknown if the reporter considered the pain in arm, localized erythema and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On the second day after receiving the vaccination, the patient's arm was very sore. She described that it was sore to the touch and noticeable with movement. On 9th March 2019 (Saturday), 2 days after receiving vaccination, the patient noticed a red area below the injection site. The area was red and slightly warm. It was located two inches below the injection site. On 10th March 2019 (Sunday), the red area got large and was larger on 11th March 2019. The red area was five inches long and three inches wide. On 11th March 2019, soreness was resolved. The patient did not consent to follow-up.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a consumer via a company representative through social media concerned a 6-decade old male patient of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, one total for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, as per the reporter, "Johnson & Johnson tons of vaccinated people have gotten Covid. I have several family members and I lost a cousin in his 50's just a few days ago" (suspected clinical vaccine failure, and suspected covid-19 infection). On an unspecified date, the patient died from suspected covid-19 infection. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20211214582. This report was associated with a product quality complaint: 90000205685.; Sender's Comments: V0:20211214240- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected COVID-19 infection. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).   20211214240- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
This is a spontaneous report from a contactable consumer (patient). This consumer reported for himself and his wife. This is the second of two reports. A male patient of an unspecified age received, on 18Feb2019, PREVNAR 13 at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On 18Feb2019, the patient experienced a little bit of pain at the injection site. The patient recovered from the event on an unspecified date, in 2019. The information on the lot number has been requested.
Patient is a 64 y.o. female patient of  CNP with history of pretension, chronic hypoxic respiratory failure secondary to COPD, obesity, GERD presented with shortness of breath.   Acute on Chronic hypoxic resp failure, 2L at home COVID pneumonia Covid-19 Virus Infection Date of onset of symptoms: 9/2/22 Symptoms present on admission: SOB and cough Date of covid positive test: 9/10/22 Vaccination status: vaccinated x 2 doses Imaging: CXR-bibasilar PNA Oxygen requirements on admission: 4L Current oxygen requirements: She was weaned off to 3 L which she does have home oxygen at the time of discharge Medical therapy: steroids Consultants following: none Anticipated special isolation end date: 9/21/22       Acute COPD exacerbation 2/2 above On 2-4L O2 at home Albuterol inhaler Incentive spirometer Added Symbicort Albuterol every 4 hours MDI Add IS. We will discharge the patient on 5 days of prednisone   OSA CPAP   Hypokalemia  Replaced.
REDNESS,SORENESS, ITCHING AN D RASH  FOR EXTENDED PERIOD OF TIME
chills; fever; joint paint; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Nov-2021 and was forwarded to Moderna on 02-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint paint) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint paint). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint paint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported .   This case was linked to MOD-2021-372805, MOD-2021-372818 (Patient Link).
Sleeplessness; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 18:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included NSAIDs allergy. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 20:00, the patient experienced headache and on 03Apr2021, the patient experienced sleeplessness. The patient did not receive any treatment for these events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event headache and sleeplessness were not recovered at the time of this report.   Follow up attempts are not possible; Information about lot/batch number cannot be obtained.
sore throat, swollen glands, headache, body ache, severe coughing. Doctor pescribed inhaler. Home tests postive for 10 days. symptoms improved in 3 days.
Pain at site of shot.  Severe hives on scalp, base of neck.  Hives at different locations of body.  Treatment.  25mg. of Dipenhydramine HCI every 5 hours for 4 days. After that only mild redness throughout body.  Dipenhydramine HCI as needed.
I had a DVT in leg, then has a stroke 2 months after the DVT.; I had a DVT in leg, then has a stroke 2 months after the DVT.; This is a spontaneous report from a contactable other health care professional (nurse/patient). A 22-years-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EK9231, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 30Dec2020 10:00 as dose 1, single for covid-19 immunization at the hospital. Patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3249, expiration date unspecified), via an unspecified route of administration, administered in Arm right on an unknown date as dose 2, single for covid-19 immunization at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Medical history included systemic Diagnosed with lupus from an unknown date, (APLS) antiphospholipid syndrome from an unknown date. The patient's concomitant medications were not reported. On 16Apr2021 01:0, the patient had a DVT in leg (deep vein thrombosis) and on an unknown date 2 months after DVT in leg the patient had a stroke. The patient was hospitalized due to the event for 6 days. The patient was treated with blood thinners during her stay in hospital. The outcome of the events was reported as recovered. No follow-up attempts are possible. No further information is expected. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event Deep vein thrombosis and cerebral vascular accident and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities and Investigators, as appropriate
Thrombocytopenia and purpura. Diagnosis: idiopathic thrombocytopenic purpura 2 hours to MMR.
Patient received PNEUMOVAX 10/19/13. Had (R) arm pain, redness, and swelling on 10/19 which got worse on 10/20. Patient saw primary doctor 10/21/13. Per pt he said she had (R) underarm lymph node swelling. Doctor prescribed levofloxacin 500 mg daily x 7 days.
A physician reported that a 2 year old female received her third dose of Prevnar on 9/11/01. Subsequently, she was diagnosed with pneumonia and empyema. A blood culture was positive for Streptococcus pneumoniae serotype 19. She recovered. These events were considered medically important. No further info was available at the date of this report. Additional information was received on 4/2/03 from a physician, which provided patient's date of birth and seriousness criteria. Information has been received from a physician regarding a 2 year old female. On 9/11/01, at 6 months of age, she received her third dose of Prevnar. Subsequently, she was hospitalized with a diagnosis of pneumonia and empyema. On 2/11/03, a blood culture was positive for Streptococcus pneumoniae serotype 19. She recovered. Follow up received on 08/20/2003: "CASE CANCELED: This case has been determined to be a duplicate of case #HQWYE828304MAR03.  Therefore all information from this case has been combined with HQWYE828304MAR03 which remains the official case of record."
developed large lump under left armpit the day after shot  had an ultrasound done  and  results was enlarged lymph nodes; received second  dose on march 15-- swelling still present--after 3 weeks  lymph node swelling increased--- had another ultrasound and biopsy performed on  May 3rd-- diagnosed with b-cell lymphoma-- awaiting visit to doctor for further results and treatment
generalized pruritis, left arm swelling, redness, tenderness. significant redness and warmth surrounding site of injection.
pt recv vax; same day, pt's theophylline level was 16.1; adm to hosp because theophylline level was 25.6; had n & v beginning on the day prior to adm to hosp;EEG suggested sinus tachycardia;
Itching all over arms, legs, and trunk.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via unspecified route in the right arm on 11Mar2021 at 13:15 (at the age of 56-year-old) for COVID-19 immunisation. Medical history included GERD (gastroesophageal reflux disease). The patient was allergic to sulfas (sulfonamide drug) and gluten (might be as reported) allergy. Concomitant medications included naltrexone hydrochloride, bupropion hydrochloride (CONTRAVE), omeprazole (MANUFACTURER UNKNOWN), valacyclovir (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient experienced itching all over arms, legs, and trunk. It was reported that the patient was not experienced rash. Therapeutic measures were taken as a result of event itching included treatment with over the counter (OTC) skin calming cream and OTC BENADRYL gel. The adverse event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event itching all over arms, legs, and trunk was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recvd vax 8SEP92 on 16SEP92 mom states had a fever of 102-103 & a rash; pt was seen by MD believed to be reaction to MMR per mom;
Okay after the vaccination shot I had a serious allergic reaction which it swelled for like a week red around the injection point excruciating pain for like a month continuous ongoing pain I've complained numerous times I got the documents to show and it was noted every time I went and for treatment they just gave me exercises stretching to do and that's about it send me on my way it got so bad that I couldn't perform my daily activities like make the bed and whatnot shower sleep Etc
tested positive for Covid-19; felt like she caught a really bad cold; was very congested; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt like she caught a really bad cold), NASAL CONGESTION (was very congested) and SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Cholesterol, Blood pressure and Asthma.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced NASOPHARYNGITIS (felt like she caught a really bad cold) and NASAL CONGESTION (was very congested). On 21-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (felt like she caught a really bad cold), NASAL CONGESTION (was very congested) and SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication includes unspecified treatment for Asthma, thyroid, cholesterol and blood pressure.
Immediately following the booster, i woke up with constant noise and pressure in the back of my head. Along with occasional strong headaches that lasted for about 3 days. Excedrin relieved the condition at that time. While the headaches disappeared there was continuing sound and pressure. In addition to that, in December I noticed that if I shook my head I heard a bong like sound. Into January and February I have had at least 4 or 5 in stances of the strong headache returning and lasting a few hours. They were relieved by taking Excedrin, The headaches usually started in the morning. I went to doctor in Mid February and he sent me to a radiology place for a ct scan which nothing showed up on, I followed up with the doctor and he referred me to a neurologist. I had the initial examination a few days ago on March 02. I went to have an MRI this morning. I have a follow up appointment in 4 weeks.  The neurologist did placed me on gabapentin as well.
case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. On 6th April 2018, the patient received the 1st dose of Shingrix. On 29th June 2018, the patient received the 2nd dose of Shingrix. On 3rd August 2018, 119 days after receiving Shingrix and 35 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, less than year after receiving Shingrix, the patient experienced rash, scratch, skin discoloration and pain. The patient was treated with triamcinolone acetonide. On an unknown date, the outcome of the vaccination failure, shingles, rash, scratch, skin discoloration and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles, rash, scratch, skin discoloration and pain to be related to Shingrix and Shingrix. Additional details were provided as follows: The age at vaccination was not reported. In 2018, less than a year after vaccination, the patient had big rashes. She was black and blue from scratching them. The patient stated that, Shingrix did not worked and she was diagnosed with shingles on 3rd August 2018. The patient was in treatment. The physician prescribed her triamcinolone acetonide cream. The patient stated she was used to quality medicine. The patient had a college degree. This experience had cost her 500 dollars (including pain and suffering, writing the letter along with cost of pen, paper, envelope and stamp). This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.