chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad reaction; Hard to breathe; Pain in the middle of her chest; Ached all over the body; Fever; Chills; Head exploded with a headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction), DYSPNOEA (Hard to breathe), CHEST PAIN (Pain in the middle of her chest), PAIN (Ached all over the body) and PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Kidney disorder and Allergy NOS (Allergies). Concomitant products included LOSARTAN, AMLODIPINE, EZETIMIBE (ZETIA), ASPIRIN [ACETYLSALICYLIC ACID] and PATIROMER SORBITEX CALCIUM (VELTASSA) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION COMPLICATION (Bad reaction), PAIN (Ached all over the body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Head exploded with a headache). 26-Feb-2021, the patient experienced DYSPNOEA (Hard to breathe) and CHEST PAIN (Pain in the middle of her chest). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 27-Feb-2021, VACCINATION COMPLICATION (Bad reaction), DYSPNOEA (Hard to breathe), CHEST PAIN (Pain in the middle of her chest), PAIN (Ached all over the body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Head exploded with a headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101-102 degree fahrenheit (High) 101-102 degree Fahrenheit : fever.         Concomitant medication also included Lovaxacine 100 micrograms once daily and Pression vision for unknown indication. The patient had no history of pericarditis/myocarditis and COVID-19 infection. The treatment with Tylenol did not work for the patient. Going to the second day after the second dose vaccination, the patient felt normal. The patient asked whether it was safe for the patient to get the third or booster dose or not, even after having a bad reaction to the vaccine and having some allergies. The patient felt like vomiting but did not vomit.
Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as well as headache for 24 hours.  One week later, severe joint pain for 48 hours.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 02-AUG-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # H015630 and expiry date: 21-FEB-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Swollen Injection Site  8cm X 1/2 cm; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE SWELLING (Swollen Injection Site  8cm X 1/2 cm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 032L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced INJECTION SITE SWELLING (Swollen Injection Site  8cm X 1/2 cm). At the time of the report, INJECTION SITE SWELLING (Swollen Injection Site  8cm X 1/2 cm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
About 2-3 weeks later he began complaining of swelling of both of his hands associated with erythema and pain. The pain is described as burning and aching. At rest the pain is 1-2/10, but with any movement of the upper extremities the pain intensity goes up and at times can reach 5-6/10. As a result, the patient tends to hold the hands in a suspended posture while minimizing upper extremities movements. Shortly after developing hand swelling and pain,the patient was noted to have a fine tremor in both hands. The tremors temporarily attenuated by activities requiring use of hands. There is no associated paresis or paresthesia. MRI of the brain was unremarkable. Symptoms: tenderness, diaphoresis, pallor.
Genital swelling; hand swelling; Feet swelling; Chills; Headache; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7533 and expiration date was not reported), via an unspecified route of administration on 30Mar2021 14:50, as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration on 09Mar2021, as single dose for COVID-19 immunization and experienced same event (chills, headache, swollen hands, feet and genital). It reported that on 31Mar2021 patient experienced chills and headaches that went away after a day. And next day on 01Apr2021 experienced Feet swelling and on 05Apr2021, hand and genital swelling. Patient mentioned that the swelling on her hands and feet went away but her genitals are still a little swollen. She mentioned that genital swelling gets a little less day by day. She will be seeing her doctor and would like to know what to tell him before getting treatment. Caller stated the first day she took Tylenol for her headache just one Tylenol and it went away. Caller stated she had all these symptoms after the first dose as well. Adverse events does not require a visit to emergency room and no physician office. No prior vaccinations within 4 weeks and no adverse event following prior vaccinations. The outcome of the event chills and headache were recovered on 01Apr2021, feet swelling was recovered on 02Apr2021 and hand swelling was recovered on 06Apr2021 and the outcome of the event genital swelling was recovering.  Follow-up (15Apr2021): This is a spontaneous report from a contactable consumer. Patient demographic, event details, corrective treatment information's were updated and Caller stated she had all these symptoms after the first dose as well.   No follow-up attempts are needed. No further information is expected.
Suffering from a continuous cycle of fever blisters, aka cold sores on "my" lower lip.; Fatigued; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 13Mar2021(at the age of 40-years-old) as a single dose for COVID-19 immunisation. The medical history included asthma and penicillin allergy. 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 COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the arm left on an unknown date in Feb2021 at 11:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, since the second vaccine dose the patient had been suffering from a continuous cycle of fever blisters, aka cold sores on lower lip and also had been fatigued. The patient also reported that prior to vaccine she never had a single fever blister. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events fever blisters, aka cold sores on lower lip and included treatment with acyclovir (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever blisters, aka cold sores on lower lip and fatigued was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
This case was reported by a healthcare professional and described a 60 year old male subject who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). On 12/15/, 01/21 2005, 06/15/2005, the subject received the first three dosed of Engerix B (lot AHBVB005AA, expiration date 01/23/2006. Approximately one month later, on 8/10/2005, a hepatitis B surface antibody titer was negative.
Information has been received on 04-OCT-2007 from a registered nurse concerning two "elementary school age" children who were vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, the two children developed "confirmed cases of measles, asymptomatic, mild rashes." It was also reported that there were "6 suspected asymptomatic cases who have also completed the series of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been received from an epidemiologist on 11-OCT-2007. It was reported that there was only one confirmed case of a child diagnosed with measles. This child had been previously vaccinated with two doses of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). She also reported ten probable cases of measles in children that have not been confirmed by lab results. The ten children were also vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). No outcomes were reported. Follow-up information was received on 18-OCT-2007 via a telephone call with the R.N. She reported that she did not know anything about the measles cases. Also on 18-OCT-2007, information was received from the County Public Health Department's Disease Control confirming that there was one confirmed case of measles and one suspected case. A contact was given from the State Health Department. Follow-up information was received on 19-OCT-2007, via a telephone call with a male from the State Health Department. He reported that there were no confirmed cases of measles in the state. He reported that there were two IgM positive cases that were identified. They are still trying to figure the suspected cases out, however the symptoms are not strong. He felt that he would have more information "in about a week." No further information was available at the time of this report. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Vision became  blurred.  Not able to read for about45 minutes.  Took 50mg of Benadryl and after 15 minutes the blurriness went away.  Informed my doctor and they advised to continue taking 50mg of benadryl ever 4 hours for the next 24 hours.
pt recvd vax; noticed small area of swelling 19aug94 lt arm area;inc to 8cm;area reddened,tender,warm to touch;no broken areas of skin noted today although pt states did have a few "bumps" on area but did not drain any fluid;
Fever and localized reaction/pain (edema, redness, warmth) started at injection site today at school. Parents and school nurse were concerned with size of reaction (size of grapefruit). Will follow-up tomorrow.
This is a spontaneous report from a contactable physician via Pfizer sales representative. This Physician reported similar events for four patients. This is 3rd of 4 reports. An adolescent (Age: 16-17) patient of an unspecified ethnicity and gender received TRUMENBA , via an unspecified route of administration on an unspecified date, at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced arm pain, swelling and fever, all on an unspecified date with outcome unknown.
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were unknown. It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms and soreness at injection site. The reporter did not agree to follow up from GlaxoSmithKline (GSK).
myocarditis; fluttering in her heart; fever; headache; chills; chest pain; cough; This is a spontaneous report from a contactable consumer (patient) or other non hcp via Medical Information Team.   A 52-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FF8839; Expire Date: unknown) via an unspecified route of administration, administered in Arm Left on 26Sep2021, (at the age of 52-years-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 (she had COVID before and had that same feeling as when she had COVID in her chest that became cloudy and had that same feeling and had a little cough because of the discomfort in her chest; states she has the little pain in her chest and the fluttering; states she was diagnosed with COVID the end of Mar on 18Mar2021 or 20Mar2021 Caller states the cough, pain in her chest and fluttering are the same as when they began), little cough on March2021 to unknown date, discomfort in her chest on March2021 to unknown date, little pain in her chest on March2021 to unknown date, pain in her chest and fluttering on March2021 to unknown date, and cholesterol from unknown date unknown if ongoing. Concomitant medications included simvastatin taken for blood cholesterol, start and stop date were not reported and bisoprolol fumarate (EMCONCOR) taken for palpitations start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FC3183) via an unspecified route of administration, on 05Sep2021 (at the age of 52-years-old) as dose 1, single for COVID-19 immunization. No investigation assessment was performed. No additional vaccines were administered. On unspecified date, the patient experienced fever, myocarditis, headache, chills, chest pain and fluttering in her heart, cough. she asked and was wondering if these are symptoms of myocarditis. At the time of this report, she did not have a fever and did not feel weak or have a headache but had a little discomfort in her chest and had that because she had COVID before. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (she was diagnosed with covid the end of March on 18Mar2021 or 20Mar2021) on 18Mar2021 and 20Mar2021. The patient did not require emergency room and physician office visit. She did not have treatment or do anything about the reported events. The outcome of the events fever, headache and chills was recovered on unspecified date. The outcome of the events fluttering in her heart, chest pain, myocarditis, cough was not recovered.  No follow-up attempts are possible. No further information is expected.
PT RECEIVED 1ST DOSE OF PFIZER COVID VACCINE. SHE SAT ON A CHAIR FOR 15 MINUTES AND WAS FINE WHILE SEATED. AFTER 15 MINUTES SHE STOOD UP TO LEAVE AND WALKED ABOUT 25 YARDS WHERE SHE SUDDENLY FELT DIZZY AND PASSED OUT. SHE FELL TO THE GROUND, HER FACE SLAMMING THE FLOOR. AFTER A FEW SECONDS SHE WAS CONSCIOUS AND BREATHING. WE KEPT HER LAYING ON THE GROUND AND TOLD HER TO KEEP BREATHING. SHE WAS CONSCIOUS AND RESPONDING TO OUR QUESTIONS. WE CALLED 911 AND EMT ARRIVED AND TOOK OVER HER TREATMENT
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 24 year old female patient. Medical history and concurrent conditions were not reported. The patient had received 2 doses of MMR II on unspecified dates, when she was a child. On 07-APR-2015, the patient was vaccinated with a booster dose of MMR II. Concomitant medications were not provided. The patient was seen by her healthcare provider on 22-MAY-2015 and had titers drawn which showed negative immunity for measles, mumps and rubella. The patient sought medical attention (was seen by an unspecified healthcare provider). The nurse also stated the patient was currently pregnant; she was in her early pregnancy because she had her menstrual period last month approximately on an unknown date in April 2015. The pregnancy outcome was outcome pending. No treatment was provided for the events. Action taken with the vaccine was not applicable. The outcome of antibody test negative and exposure during pregnancy was unknown. The causality was not provided for the event antibody test negative. Additional information has been requested.
Redness and swelling at injection site. 5x5.5 area redness/swelling. Left arm 9in in diameter. Right arm 7.5in in diameter for comparison. Kinrix was given at that site. No other vaccines given in that arm.
Became very fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Became very fatigue) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Became very fatigue). At the time of the report, FATIGUE (Became very fatigue) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  The concomitant medications and treatment details were not provided.
Info has been received from an RN concerning a 8 month old female twin, with a healthy pertinent medical history born prematurely at 28 weeks and no known drug reactions/allergies, who in June, 2004, was vaccinated in another country with a dose of varicella virus vaccine live. A varicella lab diagnostic studies was performed on 4/1/05, which came back negative. Outcome unknown. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info was received from an RN indicating that the pt was vaccinated again on 4/19/05. The reporter also noted that the pt's twin sister was vaccinated with a dose of varicella virus vaccine live and had a negative titer. Additional info has been requested.
Noted enlarged lymph node about right clavicle on anterior chest wall of a few days duration following hep vaccine #2 and again after hep vaccine #3.
After injection, site started to swell. No redness, rashing, or trouble breathing occurred. Referred patient to urgent care. She returned in 1.5 hr, stating they released her telling her to ice the area. Swelling almost gone at that time. Also after injection, muscle twitched 1-2 times.
BlurredVision, Confusion, Dizziness, Headache, Myalgia, Arthralgia, Fever, body aches, chills, nerve pain, unsteady gate, edema of hands & feet, jumbled speech, jumbled speech & difficulty recognizing objects, knot on right arm and arm pit Narrative:  On 11/27- Headache, body ache and chills, and nerve pain. 11/28- Headache , body aches and chills, night sweats, unable to pronunciation words, object recognition, jumbled speech, hand and feet swelling, knot on right arm, knot under right arm pit, fatigued, poor concentration, confused, forgetful, unsteady gait.. 11/29- headache, body aches, knot on right arm and arm pit, fatigued, forgetful, unsteady gait. 11/30- headache, fatigued, poor concentration, 12/1-(headache, body aches, fatigued). Mental clarity improving, no confusion, no chills, speech clear.
Six patients received expired Moderna vaccine booster shots after 30-day Use By Date /after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date /after manufacturer date of expiry) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date /after manufacturer date of expiry). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date /after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication was not provided.   This case was linked to MOD-2021-429306 (Patient Link).