chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inflammation; redness; bruising; itching; warm and it hurts to the touch; warm and it hurts to the touch; This is a spontaneous report from a contactable consumer (patient). A 29 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in Left Arm on 03Mar2021 at 16:45 (29-year-old at vaccination) as Dose 1, single for Covid-19 immunization. Facility type vaccination was reported as Pharmacy. The patient had not received any other vaccine with in four weeks prior vaccination. The patient was non-pregnant at time of vaccination. The patient's medical history included Herniated discs, POCS (Polycystic ovaries). No allergies. The patient's concomitant medication(s) included JUNEL FE in two weeks of vaccination. The patient was not diagnosed for Covid prior vaccination. The patient was not tested for Covid post vaccination. On 04Mar2021 at 07:00 the patient at site of the injection had developed inflammation, redness, bruising, itching. It was warm and it hurts to the touch. No treatment received for resulted events. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient experienced widespread redness of the skin from the injection site extending down toward the elbow region. Denies any fever. Area is not warm to the touch. Area of redness is not painful. These symptoms appeared approximately 24 to 48 hours following vaccination .
Patient lost conscience ten minutes after receiving  j&j vaccine. Patient felt dizzy/lightheaded, lost pulse, required CPR and epinephrine. Paramedics were called to the scene, requiring hospitalization.
Severe nausea; Upper abdominal pain; Headache; Fever; Chill; Pain all over body; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8735) via an unspecified route of administration in the left arm on 17Apr2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included colecalciferol (VITAMIN D3) for an unknown indication from an unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 23:00, the patient experienced severe nausea, upper abdominal pain, headache, fever, chill and pain all over body. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events severe nausea, upper abdominal pain, headache, fever, chill and pain all over body were recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Patient received Pfizer COVID vaccine on 1/25/21 and 2/16/21. On 1/22/22, patient admitted to our inpatient med/surg unit with acute hypoxic respiratory failure due to COVID19 infection. As of today (1/25/22), patient is still admitted in the med/surg unit wth hypoxia.
Continued skin burning sensation/ she felt like she was on fire/ she felt like she has the worse sunburn but can't see it; This is a spontaneous report from a contactable consumer. A 71-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL9269; expiration date: 31May2021), via an unspecified route of administration on 17Feb2021 at 13:45 in left arm as single dose for covid-19 immunization. The patient's medical history included hypertension, elevated cholesterol and allergies to medications, food, or other products like sulfa, cipro and macrodantin. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. 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's historical drug included ciprofloxacin from Mar2018 to Mar2018 for which she had a similar experience (she had a fever and checked her temperature several times. She feels like she has the worse sunburn but can't see it. She does not have a rash). After she stopped taking it, the symptoms disappeared. Unless she takes Benadryl, she feels this way. Her doctor didn't want her to stay on Benadryl. In Mar2018, she took Cipro for 3 days straight before she noticed it. She called her doctor and was told to stop taking it immediately. The patient's concomitant medications included losartan, amlodipine and atorvastatin: all has been taking for several years and was ongoing. As per the context, it was reported that all was well until she woke Friday night. On 19Feb2021 at 02:00 AM the patient experienced continued skin burning sensation with no fever or rash for one week, only temporary relief with benadryl, she felt like she was on fire. She felt like she has the worse sunburn but can't see it. She thought she had a fever and checked her temperature several times. Her temperature was normal. She felt like she had the worse sunburn but can't see it. She does not have a rash. There was no emergency room or physician office visit. She was concerned about taking the second dose on of the Covid-19 vaccine which was due on 10Mar2021. She found in her research from a Dr with the Coronavirus Task Force where he talked about allergic reactions. This was listed as an allergic reaction versus a side effect. It mentioned that there was a higher risk for the same thing happening with the second dose. They don't think that it is related to the vaccine but instead to an additive to help stabilize the vaccine. The outcome for all the events was not recovered/not resolved.  Follow-up attempts are needed. Further information is expected.
She got really sick; Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose.), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She got really sick"; HEADACHE (non-serious), outcome "unknown", described as "Severe headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via other company manufacturer (Pfizer) concerned a 67 year old female. Initial information was processed along with the additional information received on 24-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, morphine allergy and wool allergy. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 total administered to right arm on 13-MAR-2021 16:00 for prophylactic vaccination. Age at time of vaccination 66 years old. Concomitant medications included calcium/cholecalciferol, Vitamin C and lisinopril. The patient additionally received non-company suspect vaccine of Moderna, elasomeran (Spikevax) (dose number in series 2) (form of admin, route of admin not reported, batch number: 050C21A, expiry: unknown) dose was not reported, administered to right arm on 28-OCT-2021 11:00 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Moderna vaccine, elasomeran (Spikevax) (dose number in series 2). The patient received second dose of non-company suspect vaccine of Moderna, elasomeran (Spikevax) (dose number in series 3) (form of admin, route of admin not reported, batch number: 007J21-2A, expiry: unknown) dose was not reported, administered to right arm on 06-APR-2022 13:00 for prophylactic vaccination. On an unspecified date, the patient felt sick (confirmed covid-19 infection, dose number in series 3) and tested positive for Covid-19 on 20-MAY-2022 (confirmed clinical vaccination failure, dose number in series 1). The patient received Paxlovid as prescribed by doctor from 20-MAY-2022 to 25-MAY-2022 for treatment of Covid-19. On 26-MAY-2022, after completion of the 5 day anti-viral treatment, the patient tested negative. Laboratory data included: COVID-19 virus test Negative. On 02-JUN-2022 at 09:00, a week later, the patient had Covid symptoms again and tested positive for another full week until 09-JUN-2022. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (dose number in series 2) and elasomeran (dose number in series 3) was not applicable. The patient recovered from confirmed covid-19 infection on 09-JUN-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000237576.; Sender's Comments: V0-20220650460 -COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive 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. Therefore, this event(s) is considered not related.
Rash all over body, very itchy; Rash all over body, very itchy; This is a spontaneous report from a contactable nurse reporting for herself.  A 62-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EJ1685) at single dose at left deltoid on 20Dec2020 in the afternoon around 13:30-13:45 for covid-19 immunisation, administered by a nurse at a tent outside of the hospital.  The patient medical history was not reported. There were no concomitant medications. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. The patient got Flu shot a long time ago for immunisation. No events occurred following prior vaccinations. The patient experienced bad rash all over body, very itchy on 20Dec2020 in the evening. The rash was driving her crazy.The reporter assessed the events were not really life threatening, not requiring hospitalization. Therapeutic measures were taken as a result of events: patient just bought Benadryl cream. No invesitgations. The outcome of events was unknown. She wanted to know if she has to get the second dose.
I went surfing after vaccine, it was not until 8:00 that night  that  I experienced  a racing heart beat. The following night, I had a rash on left side of my face with raised area and had heart palpitations. The rash went away soon there after and I took some benedryl  just incase
Admitted with COVID Pneumonia and AKI on CKD. Completed vaccine in Jan 2021. Treated w/ steroids, O2,eliquis, Rocephin, doxy, remdesivir, tocilizumab. She had difficulty breathing and was found to test positive for COVID-19. Patient remained on nasal canula throughout her hospital stay, completed remdesivir course, 5 dya course of rocephin/doxy, but was given solumedrol 60 mg IV. She was on prednisone 40 mg daily when she discharged and will continue to be tapered off it at the skilled nursing facility (due to her positive covid status and need to continue to isolate).
All PCOS symptoms went crazy and hormones off the charts. Acne came back from 1 active breakout per week to about 5-7 per day. Anxiety came back in full force.
stomach ache; itchy; chills; tired; head ache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), PRURITUS (itchy), CHILLS (chills), FATIGUE (tired) and HEADACHE (head ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), PRURITUS (itchy), CHILLS (chills), FATIGUE (tired) and HEADACHE (head ache). The patient was treated with NAPROXEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), PRURITUS (itchy), CHILLS (chills), FATIGUE (tired) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
5x macular papular rash over trunk, extremities started 8/1/08. Pruritic; Fever. 99deg oral. Tx: Benadryl, Tylenol for sx. Patient finished course of prednisone 7/22/08. Did not inform staff here.
Patient tested positive for COVID-19; A cold; Cough; Watery eyes; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for COVID-19), NASOPHARYNGITIS (A cold), COUGH (Cough) and LACRIMATION INCREASED (Watery eyes) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included OXYGEN for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced COVID-19 (Patient tested positive for COVID-19), NASOPHARYNGITIS (A cold), COUGH (Cough) and LACRIMATION INCREASED (Watery eyes). At the time of the report, COVID-19 (Patient tested positive for COVID-19), NASOPHARYNGITIS (A cold), COUGH (Cough) and LACRIMATION INCREASED (Watery eyes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, SARS-CoV-2 test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant drug included sugar pill, blood pressure medications and COPD medications. Treatment medication was not reported.  it was reported that cold lasted for 3-4 days.   This case was linked to MOD-2021-299886 (Patient Link).
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    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 and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that covid vaccine first dose caused dizziness.  No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-631087, MOD-2022-631095 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Live follow up contains no new information.
Arm where shot administered became red and swollen, and painful to touch. Did not notify employee health at that time, because it seems like a normal local reaction, however didn't feel well at about 12:30 PM and left work.
Information has been received from a registered nurse referring to an adult patient of unknown gender. On 19-FEB-2016, the patient was mistakenly administered a pediatric dose of VAQTA (lot # L015460, expiration date 20-JUL-2017, dose, route not provided) (inappropriate schedule of vaccine administered and underdose). No adverse effects were reported. There was no product quality issue (PQC) involved. Additional information has been requested.
Woke up morning after receiving vaccine injection and my tongue felt scalded, as if I had burned it drinking a too-hot beverage. My sense of taste was seriously diminished - everything I ate tasted bland.  The scalded sensation lasted about 12-14 days before it began to abate. Gradually improved sense of taste after 12-14 days. Sensation nearly gone completely by about day 19 or 20.
on 1/1/2021,  right arm sore, hard, swollen,warm and red just above the elbow.  ~4" x 5".   Thought it was a bug bite.  Took Benadryl each day (for 2 days) to relieve itching.  Swelling, redness, etc went totally away after about a week.
Information has been received from a health professional concerning a father whose infant was vaccinated with a dose of ROTATEQ (lot # 652964/0145F) on 28-JUL-2006. There was no concomitant medication. It was reported that the patient was severely ill with diarrhea, possibly from shedding. Follow-up information from a health professional indicated that the vaccinated child was perfectly fine and had no symptoms of diarrhea. The reporter thought that it would be strange for the patient to have developed diarrhea in such a short period of time of 24 hours after the infant receiving the vaccine and that most adults would be immune to ROTATEQ. The reporter noted that no family members were immunocompromised. The reporter also noted that the diarrhea could have been due to a viral illness that the family had acquired just coincidentally at the same time that the child was vaccinated with ROTATEQ. Additional information has been requested.
Pt is a resident of County Jail where he states several people have been positive for COVID-19.  Pt is being admitted due to syncope.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 31-MAY-2011, the patient was inoculated with ZOSTAVAX at a medical facility as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 24-JUL-2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Around 12:05pm on 5/5/21, Five minutes after receiving the vaccine, the patient fainted while in the waiting room.  We came out to assist and at that point the patient was already sitting up, but on the floor.  We were able to speak to him and gave him some water to drink.  We called 911, when we were aware he had fainted.  I was the pharmacist on duty, but not the one that vaccinated him.  So I stayed with him.  There was a moment when he took his sweater off saying he was hot, and I saw sweat bullets on his forehead.  So I got some paper towels for him and took his temperature, which read around 98 degrees.  A few seconds later he turned pale and fell over, hitting his head on one of the shelves.  I quickly got him off the shelf and held his head in my arms .  He opened his eyes and started talking and wanting to sit up, but we kept him laying down and continued to ask him questions to keep him alert.  He was able to answer the questions, knew where he was, who he was, who he was with .  The paramedics then arrived and he was taken out of the store on a stretcher.  We provided a copy of the report he filled out to the paramedics .
No additional AE reported; dose of V AQT A that was inadvertently administered after its labeled expiry date; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-JAN-2021, the patient was inadvertently vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) 1 dose, lot # S032359, expiration date 11-JAN-2021 (route of administration and anatomical location were not provided). There was no additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a pharmacist concerning a patient who was vaccinated with ZOSTAVAX. The day after vaccination, the patient came back to the office and said the vaccination gave him/her shingles. Additional information has been requested.