chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bronchitis; Sickness; Cold; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), NASOPHARYNGITIS (Cold) and BRONCHITIS (Bronchitis) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ILLNESS (Sickness) and NASOPHARYNGITIS (Cold). On 16-Mar-2021, the patient experienced BRONCHITIS (Bronchitis). At the time of the report, ILLNESS (Sickness), NASOPHARYNGITIS (Cold) and BRONCHITIS (Bronchitis) outcome was unknown. Not Provided          No concomitant and treatment medication were provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable
pt reports about 1.5 hours after injection she developed hives on her face.  No SOB or other symptoms.  she took 25mg oral Benadryl.  Hives have not progressed as of today---slightly better.  she is taking OTC Benadryl as needed for itching
This is a spontaneous report from a noncontactable nurse (patient). A 46-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot: unknown), at the age of 46, via an unspecified route of administration, on an unknown date in 2021, single dose, for COVID-19 immunisation. No medical history reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient received unspecified medication within two weeks of vaccination. The patient previously received Tamiflu (oseltamivir phosphate) for unknown indication on an unknown date and experienced drug allergy. On Apr 7, 2021, patient experienced headache, body ache and extreme tiredness. Since the vaccination, patient has not been tested for COVID-19. Therapeutic measures taken as a result of reported events included treatment with Tylenol (paracetamol). The outcome of headache, body ache and extreme tiredness: not recovered at the time of this report. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
10-12 days (9-1-2021) after shot Hives occurred and doc issued a Cortisone shot, Methylprednisolone, Hydroxyzine HCL on (9-8-2021) Stomach issues before this but only now has had a chance to get it checked out.
Patient felt his HR increase post injection.  Denied palpitations. HR 82, BP 140/70
Information has been received from a registered nurse concerning a 19 year old female who on unspecified dates was vaccinated with a first and second dose of Gardasil (lot number unknown). In June 2007, the patient received her third dose of Gardasil (Lot # 653650/0702F) IM. The patient was observed for about 15 minutes and she seemed fine, but soon after the patient started complaining of her throat tightening and the patient started trembling. The nurse checked her blood pressure (148/85) and heart rate (97) both of which were elevated. The office did not believe it was an anaphylactic reaction since there was no respiratory distress. The patient was given diphenhydramine hydrochloride 25mg (BENADRYL) and ibuprofen (MOTRIN). The patient recovered from throat tightening, elevated blood pressure and elevated heart rate within 20 minutes and was sent home. Medical attention was sought. The patient called the next day and said she was feeling fine. She felt fine after the first two doses. Additional information has been requested.
Information has been received from a physician via a field employee referring to a 14 year old male patient. Information about medical history, concurrent condition and concomitant medication was not provided. On 24-JAN-2018 the patient was vaccinated with a dose of GARDASIL 9 (intramuscular; lot#, dose and frequency unspecified) for human papillomavirus (HPV) prevention. On an unspecified date in 2018 the patient experienced unspecified fatigue and apathy towards school and sports. No treatment was given for the events. The physician reported that patient was doing much better on 26-FEB-2018. The outcome of the events was reported as recovering. The causality was not provided.
Malignant neoplasm of colon, unspecified part of colon. Admission for surgery - Open resection of transverse colon, abdominal wall, and portion left liver. Managed and recovered in hospital. Admission was within 6 weeks of receiving the COVID vaccine.
slight headache; Nausea; Woke up very dizzy; head was spinning; Could not focus his eyes; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woke up very dizzy), VERTIGO (head was spinning), EYE DISORDER (Could not focus his eyes), HEADACHE (slight headache) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 31-Jan-2021, the patient experienced DIZZINESS (Woke up very dizzy), VERTIGO (head was spinning) and EYE DISORDER (Could not focus his eyes). On 01-Feb-2021, the patient experienced HEADACHE (slight headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Woke up very dizzy), VERTIGO (head was spinning), EYE DISORDER (Could not focus his eyes), HEADACHE (slight headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.    Reporter did not allow further contact
Pt states she immediately became dizzy following administration of vaccine. This was communicated when leaving after monitoring period. She stated she felt anxious, and experienced blurred vision but was not sure if this was related to cataracts. She had slight sweating and stated she felt flushed. She was provided water and fruit snacks. She was provided oral Benadryl 50 mg and thought she had some difficulty swallowing. She states she was a diabetic and her bs was 118 at 0630 and she reported having egg, spinach, cheese, banana, and yogurt for breakfast. Her bp was 138/78, 98% Spo2, pulse 73. She then expressed that she was no longer able to read. An ambulance was called and arrived shortly after. She was transported to local ER.
She has been vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (She has been vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VOMITING (She has been vomiting). At the time of the report, VOMITING (She has been vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
This spontaneous report was received from an office manager referring to a 12-month-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 24-JAN-2019, the patient was vaccinated with a dose of VARIVAX (lot # R020652 and expiration date 18-JUL-2020), subcutaneously for prophylaxis. The administered dose experienced a temperature excursion of -2.3 degree Celsius for 1 hour. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1901USA010788: US-009507513-1901USA010789: US-009507513-1901USA010790.
AS PER PT: 11 DAYS AFTER RECEIVING CHICKEN POX VACCINE, INJECTION SITE WAS VERY SORE. AFTER ANOTHER 2 DAYS, HAD SEVERE HEADACHES. 17 DAYS AFTER VACCCINE, NOTED 3 BLISTERS ON FACE: HAD CHILLS AND LOW GRADE FEVER. 18 DAYS AFTER VACCINE, ON MY WAY BACK TO THE U.S. FROM THE PHILIPPINES, NOTED MORE BLISTERS/VESICLES ALL OVER THE FACE, NECK, CHEST, AND UPPER ARMS. SUSPECTED CHICKEN POX. CONFIRMED AS CHICKEN POX BY PHYSICIAN ON  SEPT. 8, 2009, 22 DAYS AFTER RECEIVING THE VACCINE. PHYSICIAN PRESCRIBED VALTREX.
Information has been received from a pharmacist referring to a patient of unknown age. The pertinent medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (lot # L046897, expiration date: 23-FEB-2017(dose and frequency unspecified). On an unknown date, the patient had a rash on an unspecified arm after receiving ZOSTAVAX and the patient also developed bruising at the injection site. The outcome of the events was unknown. Additional information has been requested.
Information has been received from a physician concerning a 15 year old patient who on 21-MAY-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (656692/0457U) subcutaneously in the left arm. On 23-MAY-2007 the patient experienced red area where the vaccine was given, the size of a silver dollar. No pain was reported. Outcome of the patient was unknown. No further information is available.
October 2 - Around midnight, he was making a slow cooked beef braised in wine (tomatoes and wine) - it took hours - he went to check it and I didn't want to eat it that late at night because I can be sensitive. He brings a small plate - I had a few bites. I start to feel, shortly after, severe pain in my upper stomach that went through right through to my back. I had some water. The pain gets worse. And it starts to spread to one side of my body. I started walking around to help it feel better; it got worse. I start to feel heartrate went up and I start to feel out of breath and agitated. I was fine before I ate something. It kept getting worse no matter what I tried to do. I could feel it in my back and in my jaw and in my arm. I had my husband to call the Medical center. - Ambulance (he had to stay with our son at home). My pulse is through the roof and my heart rate was higher than 140 (on our oximeter). My blood pressure was 200. They took me to the hospital - they did heart tests.
feeling sick today; This is a spontaneous report from a female contactable consumer or other non hcp (parent) (patient's mother) reported for a male patient (in his 40s). A 4-decade-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 for covid-19 immunisation. On an unspecified date the patient experienced feeling sick today. Reporter stated that she was speaking with another agent and got disconnected from the call. She is a 76-year-old female calling to report side effects after receiving her second dose of the Pfizer COVID-19 vaccine yesterday. She states she did not receive any paperwork including the recipient fact sheet so she did not know what to expect. Since yesterday she has been experiencing: having pain at injection site it was very bad and could not raise my arm until today, fatigue, muscle pain, chills, lymph nodes in my neck are swollen, last night it was pretty bad, it took me until midday to feel a little bit better. Reporter also states that her son is in his 30's almost 40 and is feeling sick today, he has received his second dose as well. Reporter wanted to know if these symptoms were common after receiving the second dose of the Pfizer COVID-19 vaccine and how long these symptoms would last. Reporter also mentioned that when she was speaking to the agent prior to disconnection she was told that more people have reported side effects after the second dose than the first dose and would like to know if that information is true. Reporter wants to know how long she should wait before contacting her doctor about her side effects or what red flags she should be looking for after experiencing her side effects with the second dose of the Pfizer COVID-19 vaccine. Reporter wants to know if there are any contraindications regarding what she can or cannot eat after receiving the Pfizer COVID-19 vaccine. Outcome of the event was unknown.  Information of the Lot/Batch number has been requested  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Redness, swelling, inflammation at site of injection. Shot was 8 days ago and I?ve had no other symptoms in the last week.
dizziness; Hot flashes; Didn't sleep well last night; Pain in arm at vaccination site; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HOT FLUSH (Hot flashes), INSOMNIA (Didn't sleep well last night), VACCINATION SITE PAIN (Pain in arm at vaccination site) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concomitant products included ATENOLOL, LISINOPRIL, GLIPIZIDE, OMEPRAZOLE, CALCIUM and UBIDECARENONE (COQ-10) for an unknown indication.   On 09-Mar-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) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced HOT FLUSH (Hot flashes), INSOMNIA (Didn't sleep well last night), VACCINATION SITE PAIN (Pain in arm at vaccination site), CHILLS (Chills) and NAUSEA (Nausea). On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness), HOT FLUSH (Hot flashes), INSOMNIA (Didn't sleep well last night), VACCINATION SITE PAIN (Pain in arm at vaccination site), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-123 is not applicable.   This case was linked to MOD21-049743 (E2B Linked Report).; Sender's Comments:  MOD21-049743:Crosslinked Case
Broke out severe rash and patches all over my body on buttock, legs, back, breast and neck; itching so bad that I can't stand up; took Benadryl and used Cortisone but it does not seem to be working; I haven't slept since I have this shot; Broke out severe rash and patches all over my body on buttock, legs, back, breast and neck; itching so bad that I can't stand up; took Benadryl and used Cortisone but it does not seem to be working; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 64-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0181), 1 via an unspecified route of administration, administered in Arm Left on 28Jun2021 (at the age of 64-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: High blood Pressure. The patient's concomitant medications were not reported. When probed for event start date, consumer stated, I started itching that day 28Jun2021 but rash did not start until the 29Jun2021 and then it coming out getting worse. The patient experienced broke out severe rash and patches all over my body on buttock, legs, back, breast and neck, itching so bad that I cannot stand up, took Benadryl and used Cortisone but it does not seem to be working was reported as worsened and I have not slept since I have this shot, On 29Jun2021. The events itching, rash all over assessed as serious (medically significant) and while other event was non-serious. When probed for the concern, patient stated, I got my first round shot on 28Jun2021 at (withheld) and I am calling because I broke out severe rash all over my body and I am itching so bad that I cannot stand up. I want to know that what I can do because I took Benadryl and used Cortisone but it does not seem to be working. Patient second dose vaccination due date: 19Jul2021. Treatment was received for the events as Benadryl and Cortisone. Consumer stated, I just went to Emergency Room and they just cannot helped me. I think if they cannot help me, what is the shot if it cannot help. I called CDC and I do not know what to do about it. Consumer stated, nobody can help me today. What should I do. I broke out the rash on my body. I have patches all over my body. Pfizer do not give an information in weekends. I gave information and you gave me nothing. I wish I never got this. This is stupid there should be somebody, hell with the Pfizer. The outcome of the events was reported as not recovered and while for other was unknown.  Follow-Up (06Jul2021): Follow-up attempts are completed. No further information is expected.
Patient is a 70 YOF with PMH of DM2, CKD4, cardiorenal syndrome, anemia of CKD, HTN, mitral regurgitation, STEMI in 2020, and CHF who presents with 3 days of generalized weakness and pain in her feet, knees and wrists as well as a left-sided facial droop.  Arthrocentesis of right knee shows monosodium urate crystals consistent with diagnosis of acute gout flare. Covid PCR positive.  Admitted on 12/06/21
patient received a expired dose of menactra vaccine with no reported adverse event; Initial information received on 19-Aug-2021 regarding an unsolicited valid non-serious case from a consumer via Medical Information (Reference number- 00732275) in the United States.  This case involves a patient (unknown demographics) who was vaccinated with the expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number not reported and expiry date: 30-Jul-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "caller wanted to know if there was any information if this is harmful and when is the soonest they can receive a non-expired Menactra vaccine and to report an AE (adverse event)".  At time of reporting, 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 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.  There will be no information available on the batch number for this case.
Myalgia, Arthralgia, Fever, Injection site and arm soreness Narrative:
Small, itchy bumps have begun to appear around the injection site.  They are flat-topped, but look like they might develop into blisters.  The injection site is also warm to the touch.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This pharmacist reported for a female patient receive PREVNAR 13, (lot number and expiration date were not reported) and FLU VACCINE VII; both via an unspecified routes of administration on unspecified dates at single doses for immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient complained of muscle soreness in both arms on an unspecified date, which resolved in 2-3 days. Information on lot number, batch number and expiration date has been requested.
autoimmune disease; other injuries; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 08-JAN-2018, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, dose, route of administration, lot # and expiration date were not reported) as prophylaxis.  As a proximate result of wrongful acts and omission and it's negligent and fraudulent testing, labeling manufacturing, marketing and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), plaintiff had suffered and continues to suffer severe and permanent physical injuries and associated symptomatology and had suffered severe and permanent emotional injuries, including pain and suffering. Plaintiff also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at increased risk of cancer and future symptoms and harms associated with his autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). As a direct and proximate result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) induced injuries, plaintiff had suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and he would continue to incur these losses and expenses in the future. The outcome of the events was unknown.   The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  Upon internal review, autoimmune disease was determined to be medically significant.
raised rash on complete trunk of body; had no fever; 11AM 5FEB94 above rash devel went to ER; c/o not feeling good; DPH given;
Dizziness, Myalgia, Fever, chills Narrative:  Other Relevant History:
5 year old male received a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 07-OCT-2024) for prophylaxis.   On 31-MAY-2023, the patient received Boostrix. On 31-MAY-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 5 year old male received a dose of Boostrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023. A medical assistant reported that a 5 year old male received a dose of Boostrix on 31 May 2023. No symptoms reported. The reporter consented to follow up. Healthcare professional consented to follow-up via email. A dose of Boostrix was administered to a 5 year old patient, which led to inappropriate age at vaccine administration.
Baby was found dead in parents bed (she sleeps in parents bed). She was on the side with face down in the memory foam mattress. This happened on 8-28-12. Day after she received her 2 months vaccines on 8-27-12. Most probably a case of SIDS.