chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DTAP- IPV liquid component was administered to the patient but not the HIB component with no reported AE; Initial information received on 18-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had dtap- ipv liquid component was administered to the patient but not the hib component with no reported ae while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE with unknown dose, lot number not reported via unknown route in unknown administration site. for immunization.  On an unknown date the patient had dtap- ipv liquid component was administered to the patient but not the hib component with no reported ae (single component of a two-component product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (DTAP- IPV liquid component was administered to the patient but not the HIB component with no reported AE).  At time of reporting, the outcome was Unknown for the event dtap- ipv liquid component was administered to the patient but not the hib component with no reported ae.  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 the 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.
About 9 days after my first dose, my arm started getting itchy, and after scratching, I developed a large, red, warm, swollen circle around the injection site. My allergist looked at it and reassured me it was a common side affect of the Moderna vaccine. I am just reporting it for statistical purposes. I am now 11 days after the vaccine and the "Covid Arm" has not subsided yet.
16 year old patient administered first dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient administered first dose of Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient administered first dose of Moderna vaccine). On 12-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient administered first dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow-up received and reporter contact details was updated
I received the second dose of Moderna on 2/23/21. On 3/6/21 at approximately 3 pm, I felt a fullness and significant decrease in my hearing in my left ear. I went to Urgent Care the following day (3/7/21), and they prescribed steroids and sent me to an ENT and audiologist for an exam and hearing screening for the following day. I was prescribed more steroids and regained my hearing after about a week. An MRI was ordered to rule out other causes that might have led to the sudden onset hearing loss. The MRI was unremarkable.
Shortness of breath, muscle weakness, fast heartbeat, chest pain, itching, flush, body feeling like sunburned, hoarseness, headaches Treatment - Benadryl every 4 hours - set alarm to take wake and take medication during night time hours.
Received FLUVIRIN shot and 1 to 2 minutes later felt dizzy and felt better after about 5 minutes, 11:55 complained of dizziness BP 148/84, P 64 and reg sitting in a recliner, 12:10 stated her dizziness was gone at about 12:00 and 12:15 BP 122/82, P 72, and no dizziness is present
Dizzyness immediately after taking vaccination  lasted 2-3 days Brain fog within thirty minutes of vaccination - lasted two days Severe headache for three days (took 2 tylenol every 6 hours for 3 days) balance problems the morning after the vaccination cough (only lasted two days)                                                      fatigue  and achiness for about three or 4 days soreness at vaccination site (for several days)
Big Red circle/oval type of rash on around the injection site. In the morning, the spot inside the circle/oval felt warm to the touch. In the evening, the circle/oval has raised and can be felt with rubbing your finger around it and the spot inside the circle/oval felt warm to the touch.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In November 2021, the patient received third 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) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In January 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.  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.  Company Comment: This is a spontaneous case concerning a 65-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 2 months after receiving the third dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 65-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 2 months after receiving the third dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Right cheek swelling (looks like cellulitis) started 1 day after first vaccine dose, submandibular, drainage to ear area, throbbing and aching. Seen in Urgent Care and prescribed Kelfex 500 mg BID, along with Valacyclovir (for Herpes Zoster).
This is a spontaneous report based on the information received by Pfizer from Merck & Co. Inc. (Number: 00454732). A non-contactable Medical Assistant reported that a patient of an unspecified age, gender and race received PREVNAR 13 for Prophylactic vaccination, via an unspecified route at single dose on unknown date. The patient experienced a red, swollen, itchy rash, the medical assistant reported that the rash was warm to the touch and covered "about a quarter" of the patient's arm. The medical assistant did not specify when the rash began or when it resolved. The outcome of the events was unknown.
fatigue Narrative: Pt reported at his 2nd injection appointment the adverse reactions from his 1st dose of fatigue and muscle aches which lasted 3 days after dose #1. Patient did not report any treatment medications taken.
When I woke up in the morning of 5/5, six days after taking my 1st shot of the vaccine, I felt pain under my right armpit . Looking at myself in the mirror I could see that the area was swollen. It is still very painful and doesn't seem better as today (7/5).
fever, cough, SOB, loss of taste and smell, poor appetite, nausea, diarrhea, headache, fatigue, muscle aches and chills
Nerve pain and tingling on lower face along mandibular branch of trigeminal nerve. Developed into mouth sores and blisters on left lower mouth and along all mucus membranes in lower jaw area. Nerve pain associated through region, scalp and ear pain. Sharp shooting ear and temple headaches. Diagnosed with shingles on 5/12. On Valtrex.
** Do not know which flu vaccine was given, so selected one.  Was not the high-dose version.    Because I'm immunocompromised from Enbrel, I had initial series of 3 COVID vaccines plus 2 boosters before getting the bivalent booster.    No unusual symptoms, just headache, malaise, and arthralgia post-dose.  Missed only 1 hour work on day 1 (vaccination = day 0).  Bloodwork shows leukopenia on day 2.
Cellulitis, redness all around vaccination site, very painful, she went to doctors on 10/17/18 and received Doxycycline monohydrate 100mg every 12 hours for 10 days.
Face swelling; Itchiness all over her body; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Face swelling) and PRURITUS (Itchiness all over her body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced SWELLING FACE (Face swelling) and PRURITUS (Itchiness all over her body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Face swelling) and PRURITUS (Itchiness all over her body) outcome was unknown.        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.
Mom states 2-3 day post vax pt devel runny nose, body rash, lethargy, irritability & fever; Seen by MD given Amoxcil x 10 days; 2-3 days p/med pt improved; Mom states MD felt illness may have been vax related;
she had a low grade fever after the first dose of Pfizer vaccine; This is a spontaneous report from a contactable consumer and pharmacist reported that. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced she had a low-grade fever after the first dose of pfizer vaccine on an unspecified date. The event outcome was Unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
The first 3 vaccines prior was Pfizer. I started getting symptoms of sore throat, headache, fatigue, fever, and diarrhea. I also had somewhat of congestion and chest pains. I did an at home COVID-19 test that was positive. I contacted my doctor and was prescribed PAXLOVID. I took that for 5 days. I had a rebound effect and COVID-19 came back. I am starting to feel more normal now after 10 days.
Localized reaction to vaccine given 07/01/2003 PM.  Reaction seen 07/03/2003 @ 08:45.  Area at 6inches round, red, swollen, warm and tender to touch.
1st dose- chills, rash, body aches, tense arm, fatigue. I was also hungover from beer all night when I got this dose. 2nd dose- I drank a bunch of Gatorade, took 2 airborne chewables, and had ibuprofen 1 hour later after the 2nd dose. I got a bit dizzy, light headed, had a start of headache 3 hours after. Felt fatigued. Next day felt fatigued but was able to contact trace for my local health department
Patient reported redness and soreness in arm. Reported redness from her shoulder to her elbow
Patient called in on 5/6/22. Patient having redness as big as a "softball," with pain and swelling.
Redness at site of injection, swelling, warm to the touch. Patient saw doctor on 2/7/14 and was prescribed 10 day course Cephalexin.
I had leg pain, lymph nodes were swollen on the left side, pain down the right arm and tingling in my fingers, dizzy spells, back and head pain.
itching at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). At the time of the report, INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
extreme fatigue; blisters on my hands, nose, feet, elbows, between my fingers, underneath and between my toes; This spontaneous case was reported by a dental hygienist (subsequently medically confirmed) and describes the occurrence of RASH VESICULAR (blisters on my hands, nose, feet, elbows, between my fingers, underneath and between my toes) and FATIGUE (extreme fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included IgA decreased.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced RASH VESICULAR (blisters on my hands, nose, feet, elbows, between my fingers, underneath and between my toes). On an unknown date, the patient experienced FATIGUE (extreme fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic rash, at a dose of unknown; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, at a dose of unknown; DOXYCYCLINE for Antibacterial prophylaxis, at a dose of unknown; VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Antiviral prophylaxis, at a dose of unknown and PREDNISONE ACETATE for Antiinflammatory therapy, at an unspecified dose and frequency. At the time of the report, RASH VESICULAR (blisters on my hands, nose, feet, elbows, between my fingers, underneath and between my toes) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Tingling sensation in the left leg; Felt very cold / random cold sensation and sometimes in her arm and left side of face; Swollen lymph nodes in her armpit; Felt like it went into my leg, something float to my left leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling sensation in the left leg), FEELING ABNORMAL (Felt like it went into my leg, something float to my left leg), FEELING COLD (Felt very cold / random cold sensation and sometimes in her arm and left side of face) and LYMPHADENOPATHY (Swollen lymph nodes in her armpit) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like it went into my leg, something float to my left leg). On 08-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in her armpit). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation in the left leg) and FEELING COLD (Felt very cold / random cold sensation and sometimes in her arm and left side of face). At the time of the report, PARAESTHESIA (Tingling sensation in the left leg), FEELING ABNORMAL (Felt like it went into my leg, something float to my left leg), FEELING COLD (Felt very cold / random cold sensation and sometimes in her arm and left side of face) and LYMPHADENOPATHY (Swollen lymph nodes in her armpit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Specialist consultation: nerve inflammation (abnormal) The patient stated that she has been seen by her health care provider and who thinks it was nerve inflammation..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included aurovela. Treatment details was not provided.
Blood clot resulting in stroke on 12/15/2021 that was treated by TPA (tissue plasminogen activator) following an MRI scan. At the hospital no cause for the clot was found. Later, through a TEE (Echocardiogram Tranesophageal) a (PFO) Patent Foramen Ovale was located between two chambers of the heart that allowed the clot to go to the brain. Today my hematologist confirmed that all of my blood tests were negative for clotting factors and that she has seen many clots form from ALL of the COVID vaccinations with her patients including Moderna, which is why I am reporting this today. She plans to report this as well since all of my other tests including with cardiologists, neurologists, primary care physician, and the hospital tests were negative for other reasons for the clot to form.
Painful knot in left arm that moved locations: from site of injection to inside/ under arm then back to middle of arm and now on the outside of arm.; Painful knot in left arm that moved locations: from site of injection to inside/ under arm then back to middle of arm and now on the outside of arm.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm right on 19Mar2021 at 12:00(at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously took PERCOCET on an unknown date for unknown indication and experienced drug allergy. On 20Mar2021, the patient experienced painful knot in left arm that moved locations from site of injection to inside/ under arm then back to middle of arm and now on the outside of arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful knot in left arm that moved locations, from site of injection to inside/ under arm then back to middle of arm and now on the outside of arm was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ which had lot # L046320 with expiry: 29-SEP-2017, (dosing details not reported). No adverse effects reported. The vaccine with above lot number was exposed to a temperature excursion of 72.1 degree Fahrenheit for 1 hour 42 minutes, and it had no previous temperature excursion. It was detected by data logger. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
prednisone in june sick .1st vaccine in january2021 and 2nd dose 22 Feb20212021. March saw the doctor and I had xray of my hand and osteoarthritis was diagnosed. In may , I was still sick. May2021, 3 way course of prednisone.   fibromyalgia and anti bodies checked and no antibodies, 20 Aug2021 3rd dose and no change. IGG and IZA level has not improved. 1.2 percent. After 3rd dose, I got sick in the middle of the night. Had a low grade fever and entire body ached and fibromylya and osteoaritis flared up and been doing tele doctor. I am bedridden, cant drive and going to do PT rehab   My doctor wanted to wait 3 weeks to get my antibodies tested on 13 sep2021
Following vaccination, the parents noticed flu like symptoms. A slow and progressive loss of weight, drop in weight percentile. We brought this to his physicians attention along with his tooth decay and it was dismissed as being overly concerned parents and the tooth decay was staining. Hospital Diagnoses:  New onset IDDM and dehydration
About a week after second dose I started getting a feeling of blocking in my ears. Six weeks later the ringing in my ears started along with the blocking feeling. Still having this problem, doctors can't explain.
Pt had reaction to PNEUMOVAX 23 after receiving vaccine in office. Pt "could not move" arm that injection was given in. There was no redness, swelling or warmth. Pt reports severe pain.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-OCT-2012 10:24, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
VAERS is being reported as this account needs to be merged with another account of the same name with different spelling.