chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doctor thinks its continuous migraines but theyre not 100% sure; unable to work; Continuous nausea; Light headedness; Weak; This is a spontaneous report from a Pfizer sponsored program from patient and patient's mother. A contactable 35-year-old female consumer (patient) reported herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 06May2021, as 2nd dose, single for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as 1st dose, single for COVID-19 immunization and had no reaction. On an unknown date the patient's mother reported that her daughter was unable to work. On 16May2021 the patient experienced side effects, she was really weak and had continuous nausea and lightheadedness. The doctors thought it was continuous migraines, but they were not sure. The patient had spoken to 4 different clinicians around the area and the clinicians stated that people had weird immunological things. The patient was calling to see how long this reaction would last and to report the symptoms.   Information on the lot/batch number had been requested.
flu; Initial information received on 14-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine influenza vaccine.  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 influenza vaccine produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for influenza immunization.  On an unknown date, the patient developed a non-serious event of flu (influenza) (latency: 2 days) following the administration of influenza vaccine.  It was reported, Guess I got my shot late. 2 days after spent over week in bed with flu.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
At 3:15PM vaccine was administered Intramuscularly into Left Deltoid and advised to remain seated in post vaccination observation  waiting area for 15 minutes.  At 3:20PM patient reported feeling faint, upon observation patient appeared Pallor (pale skin and lips) and to be sweating. Patient reported no loss of speech, no dizziness, no vertigo and no trouble breathing. Blood Pressure was taken and was within normal limits.  Ice Pack was given. Around 3:30pm Patient reported feeling neck /jaw pain, Blood Pressure was taken and was within normal limits, Ibuprofen 200mg was administered.  Roughly 3:45pm Patient's spouse requested EMS, while EMS was being Activated Patient DENIED EMS.  Roughly 4pm Patient requested to Leave observation area and to return home. One final Blood Pressure reading was taken and within normal limits.
2 weeks of green frothy bubbly stools with up to 20 times per day.  Was not fussy.  Fed well the whole time.  Was Breastfed.
Redness and hard bump at the site of injection (started as approximately 1 inch in diameter and is now approximately 3 inches in diameter)
When I got home after getting the vaccine, I was tired. When I woke up the next day, I was achy. I had a fever that kept getting higher and higher. I was nauseous and had a headache. I was advised by the nurse to take Tylenol and to rest.
On the 3rd day of receiving my vaccine, I was putting some plants on my yard when I started to get really agitated. I could not breath, had trouble taking in deep breaths. I also could not walk fast, my muscles in my whole body ached, my ears closed up and I could not eat. On 05-11-2021, I went to a hospital where I saw a doctor in the ER who gave me a steroid injection, also gave me medication for my cough an phlegm. They also did heart exam which was normal, and also did test to check my thyroid because I could not eat which this test came back as my thyroid levels were out of control. I've lost weight since the second vaccine as well. To this day, I still feel agitated and still have some trouble breathing. I still get tired when performing my yard work and feel out of breath. I never had any health problems before receiving the vaccine.
PATIENT PASSED AWAY ON 3/14/2021 @ 6:10 PM
Staff member complained of backache, hot sweats and cold chills.  Took Ibuprofen, she did work today 1/13 and states she feels better.
Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches; Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches; Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches; Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches), INJECTION SITE SWELLING (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches), INJECTION SITE ERYTHEMA (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches) and INJECTION SITE INDURATION (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061e2a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aleve), Allergy to topical drugs (Estrogen cream) and Drug allergy (Birth control pills).    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 19-Aug-2021, the patient experienced INJECTION SITE WARMTH (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches), INJECTION SITE SWELLING (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches), INJECTION SITE ERYTHEMA (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches) and INJECTION SITE INDURATION (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches). At the time of the report, INJECTION SITE WARMTH (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches), INJECTION SITE SWELLING (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches), INJECTION SITE ERYTHEMA (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches) and INJECTION SITE INDURATION (Large swollen area where recd injection red hard and hot to touch went from two inches to 4 inches) was resolving.            Relevant concomitant medications were not reported.  The treatment information was  not provided.
I95.9 HYPOTENSION 7/29/2023 CELLULITIS
Became sick after the flu shot, 2 years in a row. Post vax, the pt developed sinus infection, ear infection, throat infection, eye infection and headaches. Not all at the same time but continuing for about 3 months. Did no get a flu shot in 2001. Did not get sick again. The doctors did not believe the flu shots caused it.
It started with a scratchy throat and nasal congestion. He took cough drops and nasal spray. We took a COVID test and it was negative. He got sicker and sicker so I gave him a second COVID-19 test and it was positive. He had tremendous coughing, low oxygen saturation, and dehydration. His fever remained between 101 and 103 consistently. His doctor advised him to the hospital to have an IV which we did. He was placed on a little oxygen and Paxlovid. He was also taking Flonase, Zyrtec, Tylenol alternating with ibuprofen. He was also given Symbicort. He was coughing up some crappy looking stuff. They sent us to the hospital for the monoclonal antibody infusion and was prescribed amoxicillin. He is off the oxygen and his saturation but he has not fully recovered
Two weeks after vaccination, started getting blisters on my tongue, looks kind of like thrush, looked like a cold sore on my tongue. Next day looked like a white film on my tongue.; Two weeks after vaccination, started getting blisters on my tongue, looks kind of like thrush, looked like a cold sore on my tongue. Next day looked like a white film on my tongue.; Lips drying up; Two weeks after vaccination, started getting blisters on my tongue; Mild rash on stomach (pale in color) and breast; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TONGUE COATED (Two weeks after vaccination, started getting blisters on my tongue, looks kind of like thrush, looked like a cold sore on my tongue. Next day looked like a white film on my tongue.), ORAL CANDIDIASIS (Two weeks after vaccination, started getting blisters on my tongue, looks kind of like thrush, looked like a cold sore on my tongue. Next day looked like a white film on my tongue.), LIP DRY (Lips drying up), TONGUE BLISTERING (Two weeks after vaccination, started getting blisters on my tongue) and RASH (Mild rash on stomach (pale in color) and breast) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ROSUVASTATIN, LISINOPRIL, AMLODIPINE and OMEPRAZOLE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TONGUE COATED (Two weeks after vaccination, started getting blisters on my tongue, looks kind of like thrush, looked like a cold sore on my tongue. Next day looked like a white film on my tongue.), ORAL CANDIDIASIS (Two weeks after vaccination, started getting blisters on my tongue, looks kind of like thrush, looked like a cold sore on my tongue. Next day looked like a white film on my tongue.), LIP DRY (Lips drying up), TONGUE BLISTERING (Two weeks after vaccination, started getting blisters on my tongue) and RASH (Mild rash on stomach (pale in color) and breast). The patient was treated with CLOTRIMAZOLE at an unspecified dose and frequency. At the time of the report, TONGUE COATED (Two weeks after vaccination, started getting blisters on my tongue, looks kind of like thrush, looked like a cold sore on my tongue. Next day looked like a white film on my tongue.), LIP DRY (Lips drying up) and TONGUE BLISTERING (Two weeks after vaccination, started getting blisters on my tongue) outcome was unknown, ORAL CANDIDIASIS (Two weeks after vaccination, started getting blisters on my tongue, looks kind of like thrush, looked like a cold sore on my tongue. Next day looked like a white film on my tongue.) had not resolved and RASH (Mild rash on stomach (pale in color) and breast) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
pt had 2nd shot of pediactric Pfizer felt dizzy pt mom stated pt took prescribed meds in the AM brought pt in medical gave fluids and snack (hungry) pt stated he felt better, but mom stated pt is not himself after observing for 30 min, offered pt to go to ER. EMS called will follow up with pt and mom.
11 year old patient was given pentacel instead of adacel, with no reported adverse event; Initial information was received on 11-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional (under Medical Information (MI) Inquiry Number:00807251).  This case involves a 11- years old male patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]with no adverse event (wrong product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 08-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number: UJ542AA and expiry date: 10-Jul-2022 via intramuscular route in the left deltoid for prophylactic vaccination.  It was of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  It was reported "Do they still need ADACEL. When should they receive it."  At the time of reporting, no adverse event 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.
patient got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient got Covid) in an 8-decade-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (patient got Covid). At the time of the report, COVID-19 (patient got Covid) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment drugs were reported.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning an elderly (8th decade of life) patient of an unknown gender with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an elderly (8th decade of life) patient of an unknown gender with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient administered moderna covid vaccine while temperature excursion assessment was ongoing; Patient administered moderna covid vaccine while temperature excursion assessment  was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion assessment  was ongoing) in a 23-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion assessment  was ongoing). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion assessment  was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.
Painful vaginal sores for over 1 week.  Swabbed by clinic for all viral and bacterial infections - all negative.
This case was reported by a nurse practitioner and described the occurrence of hair growth at the injection site in a 2 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). On 25May04 the pt received the first dose of Pediarix (lot 21924A2) at .5ml. Approx 2 weeks later, in June 2004, the pt developed a patch of hair at the injection site. It was reported that the pt received other vaccines were not reported. The pt received her second dose of Pediarix on 15Sep04. The outcome of the event is unk.
After first shot, 2 days after, started causing him severe neck pain and shoulder pain; After first shot, 2 days after, started causing him severe neck pain and shoulder pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "After first shot, 2 days after, started causing him severe neck pain and shoulder pain".  Additional information: Last shot he has taken, was last year, second shot, didn't remember what month. After first shot, 2 days after, started causing him severe neck pain and shoulder pain. Can not do any exercising at all because of this pain. It has injured his lifestyle. Looking for monetary compensation.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Chills,  fever 101.3 onset about 28 hours after vaccine. Resolved with Tylenol.
After receiving shot, pt reports she was itchy and had a stomach ache. The following morning she noticed her right hand, foot, and butt cheek were numb.
After taking the vaccination, about 2 weeks later, I begin to develop lesions on my legs that look like Erythema Nodosum. I have these spots on the chins of my legs and a few on the back part of my calfs. I have never ever had this happen before in previous years or from any other vaccinations taken.
Information has been received from a nurse practitioner concerning an 11 year old female with diabetes and no drug allergies, who on 20-AUG-2007 was vaccinated intramuscularly in the left arm with a first dose of GARDASIL vaccine (yeast) (Lot# 0530U). Concomitant suspect vaccination included varicella virus vaccine live. Other concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). On 21-AUG-2007 the patient felt "under the weather and could not get out of bed." The patient did not seek medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Employee described severe diaphoresis, dizziness, shortness of breath, nausea and vomiting, chills and rigors.
About 5 minutes after the vaccine, pt develop left arm weakness and left facial numbness.  States she has no pain in her arm.  Denies chest pain, dizziness, swelling, itching, rash or sob.
4.5 cm indurated tender swelling at site began 2 days after shot, 2 cm redness persists at site as well.
c/o l122/67, c/o lighted, itchy eyes, warm.  She took Benadryl 50 mg at 0700 - 2 hours prior to event. 0900 - bp 126/70, hr 107, rr 20, sats 100 0905 - bp 122/67, hr 90, rr, 18, sats 100 0910 - bp 113/66, hr 81, rr 20, sats 100 - lightedness no longer present, she c/o of being cold, 0915 - dry throat that water helped.  denied throat itching, states breathing wnl. 0915 - bp 120/80, hr 88, rr 20, sats 100  Pt reports that she feels better.  She is off work today, but she will stay in the rt office with staff for 30 minutes before going home.
Information has been received from a company representative who reported that a physician informed him about a 16 year old female with no known drug allergies and no past medical history who on 29-JUN-2007 was vaccinated with her first dose of GARDASIL (lot# unspecified, site and route not reported). The patient received the second dose of GARDASIL (lot# unspecified, site and route not reported) and the third of GARDASIL (lot # unspecified, site and route not reported) was given on 15-MAR-2008. There was no concomitant medication. Subsequently the patient experienced a very low white blood cell count. The white blood cell count is so low that she may be neutropenic. The patient has no known underlying causes for neutropenia. The patient sought medical attention at the doctors' office. A blood test was performed on 24-MAR-2008. The patient's outcome was reported as not recovered. No further information is available. Additional information has been requested.
This spontaneous report was received from a registered nurse (other health professional) and refers to a female patient of unknown age. The patient's medical history, concomitant medications, concurrent conditions and drug allergies/reactions were not reported. On 21-AUG-2017, the patient was vaccinated with unspecified doses of RECOMBIVAX HB immunization series with (lot # N002202, expiry date:04-NOV-2019) which were improperly stored (Incorrect product storage). No adverse effects were reported. The vaccine was stored at 3.7F at worst for 7 hours. There was previous temperature excursion at 48F for 1 hour. Data logger was involved. The outcome was unknown. No product quality complaint was involved. No further information was provided. This case is cross-referenced with MARRS# 1708USA010454 and  MARRS#1708USA010841 (same reporter).; Sender's Comments:  US-009507513-1708USA010841:US-009507513-1708USA010454:
Acute appendicitis with rupture.  Was in hospital receiving IV antibiotics for 5 days.  Woke wife at 3am and dressed and went to hospital with acute pain. Surgery at 6pm.
Incorrect vaccine given for this age of patient. Received 6mo-4yr covid monovalent dose instead of 5-11yrs covid monovalent dose. No adverse reaction.