chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Next morning, extreme pain in right arm, redness and swelling. Body aches all over. Felt weak. Took TYLENOL and stayed in bed for most of following 48 hours. Today is 5 days later and still pain/ redness swelling in shoulder.
cough; cold-symptoms; runny nose; ill; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (COMIRNATY), administration date 07Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 2021, outcome "unknown", described as "cough"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "not recovered", described as "cold-symptoms"; RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "runny nose"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "ill".  Additional information: Male patient received primary first shot on 07Oct2021, he is feeling ill as far as cold symptoms, runny nose, cough no fever, now on day 33 past first dose, would Pfizer still recommend giving the shot with cold symptoms?. Is there any efficacy data on the first shot?  The Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Information has been received from a nurse practitioner concerning a healthy 9 year old female patient who on 4/14/04 was vaccinated in the left posterior deltoid with a dose of varicella virus vaccine live (lot # 641787/0758M) during a preventative exam. Concomitant vaccination on 4/14/04 included a dose of hepatitis A virus vaccine inactivated in the other arm. Subsequently in approximately 4/04, the patient's mother reported the patient's arm became very hot, red, and swollen. The area was 10 cm by 8 cm. The mother reported the redness and warmth lasted for four to five days, at which time, the patient was at the beach. When the patient returned, the arm swelling continued. On 5/4/04, the patient was seen with a swollen arm and a mass was noted on her left upper arm. Examination of the left posterior deltoid showed a 1.5 by 2 cm hard, discrete and mobile mass that was non-tender, palpable in muscle mass with no overlying erythema. The reporter stated the mass was at the injection site of the varicella virus vaccine live. It was noted that the patient had developed a skin infection at the injection site. The patient was not treated with any medications and was not complaining of any pain. The nurse referred the patient to a pediatric surgeon. On 5/13/04, the patient was seen by the pediatric surgeon. The surgeon suspected a possible cyst or deep abscess or that an abscess may have healed and the mass was scar tissue. The surgeon wanted a sonogram of the patient's arm and wanted to see her again in one month. The patient was not hospitalized. The sonogram was scheduled for 5/22/04 and the next exam with the surgeon was scheduled for 7/8/04, unless the results warrant something sooner. The reporter felt this case was serious and unresolved.  Upon internal review, the patient's experience was considered to be an other important medical event (OMIC). The reporter also mentioned another patient who developed a skin infection at the injection site post vaccination with varicella virus vaccine live (lot # 641787/0758M). The reporter was very concerned about this lot number and requested a lot check. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. Follow up on 06/08/04 states: "The sonogram showed a 1.6 by 0.7 cm solid hyperechoic mass in the left arm. At the time of the report, the pt was not complaining of pain or discomfort and they were just observing the pt. The next exam with the surgeon was scheduled for 07/08/04.  The reporter felt this case was serious and unresolved.  Additional information has been requested."
Diarrhea; massive loss of weight (15lbs) in less than 2 weeks; after shot not constipated anymore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), WEIGHT DECREASED (massive loss of weight (15lbs) in less than 2 weeks) and VACCINATION COMPLICATION (after shot not constipated anymore) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced WEIGHT DECREASED (massive loss of weight (15lbs) in less than 2 weeks) and VACCINATION COMPLICATION (after shot not constipated anymore). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved and WEIGHT DECREASED (massive loss of weight (15lbs) in less than 2 weeks) and VACCINATION COMPLICATION (after shot not constipated anymore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Follow up received on 19-MAR-2021 Contains new events added, reporter information was added. On 07-May-2021: Addition information document received on 07-MAY-2021 Contains Outcome of the events added, information about second dose added.
Tested positive for COVID; Tested positive for COVID; first dose was 28Dec2020, wondered when he should get the second dose; This is a spontaneous report from a contactable health professional, the patient. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EH9899), via an unspecified route of administration on 28Dec2020 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. On 13Jan2021, the patient tested positive for COVID. The patient was on his 10th day of quarantine "tomorrow" and wondered when he should get the second dose. The clinical outcome of "Tested positive for COVID" and "first dose was 28Dec2020, wondered when he should get the second dose" was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
My first Vacination I experienced severe arm pain at injection site and dizziness. About 3 or 4 hours later I was racked with full body pain. I mean pain in my entire body that lasted 4 to 5 days. Had no energy. Headache. Felt like I was dieing. After approximately 5 days later I was free from symptoms. Did contact my PCP. After the 2nd dose 04/02, within minutes I was again racked with pain in every spot of my body. Headache. Lack of appetite. No energy at all. Sick to my stomach. Today is 04/11 and I'm still experiencing some of these affects. I don't feel good or like myself. When it comes time again to update this vacine I'm doubting I'll want to get it based on the side effects I experienced.
tested positive for Covid virus; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for Covid virus) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced COVID-19 (tested positive for Covid virus). At the time of the report, COVID-19 (tested positive for Covid virus) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-2 test: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Treatment information included antiviral infusion.
sore throat; congestion; feels like has a mild cold; achiness; throat red; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (158559). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "feels like has a mild cold"; PAIN (non-serious), outcome "unknown", described as "achiness"; PHARYNGEAL ERYTHEMA (non-serious), outcome "unknown", described as "throat red". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Warm transfer from (name). Agent states she has a caller on the line that is scheduled for her 2nd dose today, 9Mar2021 and she had felt a mild sore throat and congestion and wanted to know if it is still safe to take the 2nd dose. Agent states she had not told caller that she is coming to make a report and states from here she can be sent to (name). Stated if she doesn't take the second dose today she couldn't get another for 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching, welps, skin rash, over entire body. Requiring Steroids and antihistimine. Lasted one week.
I was feeling a lil chest congestion and had a stuffy nose. Then I started with a fever and a mild cough. I didn't go to work the next day so I took home COVID test and it was positive so I went to Dr. & it was verified I had COVID-19.
Adacel was administered to an individual when it was expired/no AE; Initial information was received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (unknown demographics) who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] when it was expired (batch number, route, site of administration and expiry date not reported) on an unknown date for prophylactic vaccination (Expired product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case 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 and Module VI of the 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.  There will be no information available on batch number for this case.
Yesterday, on the ninth day following my vaccine, at the vaccine site, my arm became hard, swollen, red, with round welts (not a rash) and intense itching. Today, 24 hours later it is 50% improved. I consider this unusual and wonder if I should now receive my second dose.
High blood pressure; 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 BLOOD PRESSURE INCREASED (High blood pressure) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (High blood pressure) (seriousness criterion hospitalization). At the time of the report, BLOOD PRESSURE INCREASED (High blood pressure) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.         Concomitant medication information not provided.  Treatment information not provided.  Company comment: This case concerns a patient of unknown age and gender, who experienced the unexpected event of high blood pressure with seriousness criteria of hospitalization. The event occurred an unknown time after the second dose of mRNA-1273. The rechallenge was not applicable since the event occurred after the 2nd dose. It is to note that very limited information has been provided for this case report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, who experienced the unexpected event of high blood pressure with seriousness criteria of hospitalization. The event occurred an unknown time after the second dose of mRNA-1273. The rechallenge was not applicable since the event occurred after the 2nd dose. It is to note that very limited information has been provided for this case report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 17-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
On Wed 11/3/2010 received pneumonia vaccination in left arm and flu vaccination in right arm. The flu vaccine was drawn up in front of me.  However, the pneumonia vaccination was not, but already drawn. Assistant came in room and gave injection.  Woke up Thursday morning with 103.2 fever, chills, mild ache in arm, lower back ache, weakness, dizziness. Started ibuprofen.  Was in bed Thursday afternoon through Saturday am. Saturday work up with pain in injection site, redness and hardness in site and patches of red hot skin on my arm with temp of 101.8. Injection site and bicep area became worse, spreading to elbow area.  Called her on call physician called me back at 3:43 pm.    Explained all signs and symptoms.  Advised to use warm compresses/ibuprofen.  If worse on the next day I was to go to walk in clinic or ER.  Sunday am went to Urgent Care who gave me an antibiotic injection (? name) and prescribed Bactrim DS po bid.  Started Bactrim DS Sunday night.  Much worse on Monday evening.  Went to Medical Center, admitted that evening for Advanced cellulitis and infected hematoma at injection site.  Treated with Rocephin IV and then vancomycin IV in emergency room. Received vancomycin IV two times day, with last dose on Friday, 11/12/2010 approx 11am.    Discharged on Friday, 11/12/2010.  Treated by Dr. in hospital.  Now taking Bactrim DS bid for a ten day course.   Still have hematoma, sore site area, fatigue.   Have follow up apt with Dr on 11/24.
devel petechiae 22MAY96-8AM & later in evening had gross hematuria & bruising adm to hosp w/ITP evening of 22MAY96;give IV immune globulin to reverse the rxn today;platelet count to be repeated if still low-transfuse again;nose bleeds also
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 18-MAR-2021, the patient was vaccinated with one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number T007035, which has been verified to be valid, the expiration date was reported and validated as 01-MAY-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
pt stated she had a cough the night after getting the vax.  She developed some hardness, redness and itching around the injection site and down towards her elbow the next day after the vax.  Pt has been using Benadryl skin cream and says the redness is better but it still very itchy.  Pt will contact her PCP for medical advice.
After the first injection I had excruciating Left Arm pain at the injection site that started about 8 hours after the vaccination and lasted about 20 hours.I have psoriasis and I have had it for abou; psoriasis appeared to be getting better; This is a spontaneous report from a contactable other HCP (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE formulation: Solution for injection, lot number: EL1283, Expiration date; unknown), via intramuscular in Left Arm on 19-JAN-2021 14:15 at single dose for COVID-19 immunization. Patient medical history included hypertension, lymphocytic colitis, psoriasis. Concomitant medication included LISINOPRIL (lisinopril), LASIX (furosemide), AMLODIPINE (amlodipine), LIPITOR (atorvastatin), METOPROLOL SUCCINATE (metoprolol succinate). The patient experienced after first dose she had excruciating Left Arm pain at the injection site that started about 8 hours after the vaccination and lasted about 20 hours. She had psoriasis and she had it for about 45 years. After the first injection, psoriasis appeared to be getting better. The outcome of event was not recovered. A contactable Physician stated that she/ he was no informed bythe patient regarding the reported adverse event with the use of the product.  Follow-up (19Apr2021 and 10May2021): New information from a contactable Physician included statement about communication by the patient regarding the reported adverse event with the use of the product. Follow-up attempts are completed. No further information is expected
Pt received Td vaccine 7/1/08, presented to clinic 7/16/08 with pain and a lump to left deltoid muscle.
FluBlok given to 12 yo child.  Intended for 18 and up only.
Hospitalization: 5/3/2023 - 5/5/2023 (2 days) Presentation to the ED: chest pain.  COVID + date: 5/3/2023  Treatment: none. patient was asx.  Discharge to: home.   EW0175 6/2/2021 EW0175 6/24/2021 Lot numbers were recorded as the same lot number.
Intense arm pain/Pain in arm was really bad really intense; Earlier I was so cold then hot then cold/body temperature fluctuations; I can't sleep; Tendons are tightening up hands are clawing up; Talking takes up all energy; Feel like laying down; Hands forming claws; extreme fatigue/I am so tired talking is a lot of work, sitting up is hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up) and ASTHENIA (Talking takes up all energy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up), ASTHENIA (Talking takes up all energy), FEELING ABNORMAL (Feel like laying down), HAND DEFORMITY (Hands forming claws) and FATIGUE (extreme fatigue/I am so tired talking is a lot of work, sitting up is hard). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up), ASTHENIA (Talking takes up all energy), FEELING ABNORMAL (Feel like laying down), HAND DEFORMITY (Hands forming claws) and FATIGUE (extreme fatigue/I am so tired talking is a lot of work, sitting up is hard) outcome was unknown.            This case was linked to MOD-2021-316009.
Called to room by patients father approximately 22 minutes after vaccine was given dad reported patient may be having an allergic reaction, he's c/o itching on neck and arms.
Less than 12 hrs after receiving the vaccine I shed my uterine wall. Discharging large clumps of tissue at a time.
pt complained of chest burning, nausea, diaphoresis, symptoms resolved in supine position and when given water. Pt declined providing DOB for form
Patient complained of headaches, muscle weakness and  teeth hurting. Patient advised to follow up with PCP