chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a female patient with diabetes and no allergies  refers to herself. On 10-MAY-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included glimepiride. The patient reported she had been experiencing "flu like symptoms" after receiving the ZOSTAVAX vaccine. Patient stated that her symptoms included fatigue and shortness of breath after receiving the ZOSTAVAX. Patient also stated she had not been able to work because of these adverse events. Laboratory studies performed included routine blood work. Patient sought medical attention by seeing the doctor. At the time of the report, the patient's outcome was reported as not recovered/not resolved. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse concerning a patient of unknown age and gender who on 18-FEB-2014 was vaccinated with 0.5 ml dose of PROQUAD (route and lot # not provided) and a dose of VARIVAX (Merck) (dose, route and lot # not provided). No adverse effect was reported. Additional information has been requested.
Acute on chronic heart failure with preserved ejection fraction. DuoNeb treatments were also ordered for COPD exacerbation.  Patient had a new onset transient approximately 4.5-hour episode of slow atrial fibrillation that spontaneously reverted to sinus rhythm.  Therapeutic anticoagulation with enoxaparin was initiated and cardiology service consulted.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Medium
bivalent vaccine was administered to patient which was beyond the BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered to patient which was beyond the BUD) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered to patient which was beyond the BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered to patient which was beyond the BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered to patient which was beyond the BUD).    Dosage text for suspect product was reported as initial booster.  Concomitant drugs were not reported.  It was reported that unknown bivalent vaccine was administered to patient which was beyond the BUD. No other symptoms were reported.  Treatment medications were not provided.
Information has been received from a registered nurse concerning a 11 year old female with no drug allergies and no medical history, who on 15-AUG-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot# 655620/0171U). Concomitant vaccinations included DTaP and meningococcal vaccine (unspecified). On 15-AUG-2007 the patient experienced pain and burning during administration. The pain lasted for 30 minutes after receiving the vaccination. The patient sought unspecified medical attention. No laboratory diagnostics were performed. On 15-AUG-2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
By 10/23 fever started, took TYLENOL for fever. On 10/24 was in bad shape so took him to ER with 102.3 fever. He was diagnosed with Pneumonia; admitted by the evening. White blood cell count over 20. Will be there for 2 more days. He is in antibiotic treatment.
STIFF IN THE MORNING; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had other concomitant therapy of steroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced stiff in the morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stiff in the morning was not reported. This report was non-serious.
Vaccine administered to special population; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to special population) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to special population). On 06-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to special population) had resolved.      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.   concomitant medications not provided Treatment information was not provided
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 28-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Extreme itching, hives, rash,  swelling of hands and feet began 11 days after the shot suddenly starting with itching.  The hives and swelling began the next day. Before these symptoms I had fatigue 2-3 days after the shot, and then a runny nose and sneezed a lot on days 5-8 after the shot.  Due to the allergic reaction I went to health services and received a shot and prednisone to take over the next 6 days. This somewhat relieved my symptoms. Since
Information has been received from a physician concerning a female who was vaccinated on an unspecified date with her first doe of GARDASIL. Concomitant therapy included VARIVAX, (duration and dose not reported) on the same day. Subsequently the patient became dizzy and very faint. The patient sought unspecified medical attention and her outcome was not reported. Additional information has been requested.
Weakness (particularly after eating a cake today),; Had a lack of appetite; Going to the bathroom frequently; Tenderness at the site where she received her vaccine; Unusually fatigue/feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness (particularly after eating a cake today)), DECREASED APPETITE (Had a lack of appetite), POLLAKIURIA (Going to the bathroom frequently), VACCINATION SITE PAIN (Tenderness at the site where she received her vaccine) and FATIGUE (Unusually fatigue/feeling very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ASTHENIA (Weakness (particularly after eating a cake today)), DECREASED APPETITE (Had a lack of appetite), POLLAKIURIA (Going to the bathroom frequently), VACCINATION SITE PAIN (Tenderness at the site where she received her vaccine) and FATIGUE (Unusually fatigue/feeling very tired). At the time of the report, ASTHENIA (Weakness (particularly after eating a cake today)), DECREASED APPETITE (Had a lack of appetite), POLLAKIURIA (Going to the bathroom frequently), VACCINATION SITE PAIN (Tenderness at the site where she received her vaccine) and FATIGUE (Unusually fatigue/feeling very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
The vaccine leaked out of the vial, it ran down to his elbow; The vaccine leaked out of the vial, it ran down to his elbow; A spontaneous report was received from a consumer, regarding himself, a 53-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), where vaccine leaked out of the vial, it ran down to his elbow.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (MOD-2021-021503) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 02 Feb 2021, the vaccine leaked out of the vial, it ran down to his elbow. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events vaccine leaked out of the vial, it ran down to his elbow was considered as resolved on 02 Feb 2021.; Reporter's Comments: This case concerns a 53-year-old male who experienced nonserious unexpected events of Device leakage and Incorrect dose administered for mRNA-1273 (lot # unknown) without associated adverse events.  He reported that vaccine leaked out of the vial, it ran down to his elbow. The events occurred the same day as the first dose of mRNA-1273.  Event outcome resolved.
Temperature of 101.0F starting 1/30/2021 @ 7:00am (Tylenol administered)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 28Aug2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 27Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "Gluten (celiac dx)" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID; LIOTHYRONINE; LATANOPROST; PROGESTERONE. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet"; Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: indication=Treatment of COVID-19. Therapeutic measures(paxlovid) were taken from 18Sep2022 to 23Sep2022 as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was given a dose of Moderna 6 years - 11 years instead of a bivalent booster
I had like a heart pain/I felt pain in my left side; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I had like a heart pain/I felt pain in my left side) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (I had like a heart pain/I felt pain in my left side). At the time of the report, CHEST PAIN (I had like a heart pain/I felt pain in my left side) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test (700-1600 mg/dl): 192 mg/dl Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-307662 (Patient Link).
Rt. thigh red, warm to the touch, slightly swollen site measuring approx. 4 cm wide x 3 cm length. S/s x 2 days. Recommended BENADRYL, TYLENOL or IBP OTC as directed on the bottle per Dr.
Client reported hives on right arm 10 hours after receiving vaccine. Per client took Benadryl and went to sleep. Next morning hives had disappeared. Per client no current medical history, no medications and no known allergies.
Student received Hep A #1 vaccine, turned to sit with received Hep B #2 in opposite arm (right arm). Injection of Hep B, pt began to stutter, eyes rolled back, he lost consciousness, was assisted to the floor. Regained consciousness. Oxygen mask applied. U/S affected. BP 110/60. Rested, food given, parent called.
pt recv vax 18MAY95 & on 28MAY95 pt devel 5-6 lesions that were varicella-like in appearance;
This spontaneous report as received from a nurse concerning unspecified number of patients of unknown age and gender. Approximately in 2017 (reported as between 30-MAY-2017 and 16-AUG-2017), the patients were vaccinated with improperly stored VARIVAX lot # M031969 for with expiry date: 30-JUN-2018 (dosing details unknown) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# unknown). It was reported that the vaccines were exposed to a temperature range of 15F to 46F for a duration of 1 hour. During the previous temperature excursion the vaccines were exposed to a temperature range of 15F to 46F for a duration of 1 hour. Data logger was involved. No adverse effects were reported. There were no product quality complaints. Sender's Comments: US-009507513-1708USA007720: US-009507513-1708USA008040.
Approximately 3 minutes after injection, our daughter was sitting next to her mother, her head lolled over the back of her chair and she began to have a seizure. The event only lasted about 45 seconds before she came out of seizing. She had a bright orange ring around her mouth, trouble breathing and vision issues. the pharmacist called an ambulance. These symptoms were mostly cleared up before medical arrived, with only dizziness, disorientation and slight vision issues remaining.
Fever 100 last night starting at about 8 pm, severe flu-like aches and pains, Fever down this morning, some aches and pains remain, sore throat.  Suspect just a response to the vaccination.
Vomiting, fever, rash all over body with in 30 minutes to 1 hour.  BENADRYL 12.5mg children's meltaway given and ambulance called to monitor.
Information has been received from a nurse practitioner concerning a 66 year old male patient with diabetes and high blood pressure and familial heart disease and a history of heart bypass who on 16-DEC-2010 was vaccinated with PNEUMOVAX 23 and influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant therapy included NOVOLIN 70/30, metoprolol, CELEBREX, "osteoarthritis" and enalapril maleate (manufacture unknown). On 17-DEC-2010 the patient notice that had redness on his left tricep and bicep. The nurse practitioner described it as "looks like sunburn" in appearance. The injection site itself and the left deltoid muscle did not appear red. The patient reported that he was in minimal discomfort. His laboratory data was significant for a temperature of 98.7 Farenheit on 18-DEC-2010. As of 18-DEC-2010 his right tricep and bicep were still red, and the nurse was considering starting him on BACTRIM. Additional information has been requested.
Extreme fever, chills, body-aches, headache for almost 3  days after Booster dose. Body aches was like each bone of my body was paining. It was extreme for me.  1st and 2nd dose of vaccine I had fever and chills but not that bad.
Patient administered vaccine from the freezer without appropriate thaw time. Patient has not reported any adverse reactions to the administration of the vaccine.
Next day after the vaccine I have fever, abdominal pain diarrhea and hole body hurt like flu symptoms.
One year ago I had a total hip replacement (left side, Stryker hardware).   All was well, no problems, got thumbs up from surgeon at year's checkup three weeks before second Moderna covid injection.  About 6 hrs after second injection, my left hip began to ache at exactly the surgical spot.  Aching lasted through the night, and next morning.  Tylenol didn't help.  But by afternoon of next day (approx 24 hrs after injection), aching stopped, and hasn't returned  (12 days now).  If not related to the injection, then this was quite an unlikely coincidence!
dizziness; was sick for three days/sick sick/she was more sick/though up and all of the above; having the flu for a couple of days; diarrhea; felt rush and a fatigue very fast, tired; Nausea; fever/ really bad fever and went away after 3 days; vomiting; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ILLNESS (was sick for three days/sick sick/she was more sick/though up and all of the above), INFLUENZA (having the flu for a couple of days), DIARRHOEA (diarrhea) and FATIGUE (felt rush and a fatigue very fast, tired) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20a and 027L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizziness), ILLNESS (was sick for three days/sick sick/she was more sick/though up and all of the above), INFLUENZA (having the flu for a couple of days), DIARRHOEA (diarrhea), FATIGUE (felt rush and a fatigue very fast, tired), NAUSEA (Nausea), PYREXIA (fever/ really bad fever and went away after 3 days), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills). On 06-Mar-2021, DIZZINESS (dizziness), ILLNESS (was sick for three days/sick sick/she was more sick/though up and all of the above), INFLUENZA (having the flu for a couple of days), DIARRHOEA (diarrhea), FATIGUE (felt rush and a fatigue very fast, tired), NAUSEA (Nausea), PYREXIA (fever/ really bad fever and went away after 3 days), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) had resolved.            Treatment medications were not provided.  It was reported that patient did not had swollen glandes and throat didn't hurt so bad.   This case was linked to MOD-2021-397570, MOD-2021-397419 (Patient Link).
Information has been received from a certified medical assistant concerning a patient (age and gender unknown) who was vaccinated on an unspecified date with a dose of Pneumovax 23 (655289/0958F).  Subsequently, on an unspecified date, the patient developed injection site redness and swelling and experienced a decreased range of motion of the arm.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  No product quality complaint involved.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
extremely sore arm,; had fatigue; muscle ache; headache; Immediately after receiving the shot she felt her throat was closing for a couple of seconds; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Immediately after receiving the shot she felt her throat was closing for a couple of seconds), PAIN IN EXTREMITY (extremely sore arm,), FATIGUE (had fatigue), MYALGIA (muscle ache) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LISINOPRIL, LORAZEPAM, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and MINERALS for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced THROAT TIGHTNESS (Immediately after receiving the shot she felt her throat was closing for a couple of seconds). On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (extremely sore arm,), FATIGUE (had fatigue), MYALGIA (muscle ache) and HEADACHE (headache). On 05-Feb-2021, THROAT TIGHTNESS (Immediately after receiving the shot she felt her throat was closing for a couple of seconds) had resolved. At the time of the report, PAIN IN EXTREMITY (extremely sore arm,), FATIGUE (had fatigue), MYALGIA (muscle ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included ibuprofen
Information has been received from a licensed nurse concerning a pt who in approximately 2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, in approximately 2003, the pt developed redness and edema at the injection site. Unspecified medical attention was sought, but prescription drug treatment was not required. A product quality complaint was not involved. The reporter also mentioned a second pt who had a similar experience post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
t99-100 morning & evening p/vax, 3-4 days duration; diarrhea 1 day post vax, 1 day duration; 3 days post inject 1 episode of palpitations & SOB; Petechiae like rash-especially on lower extremities distal to knees;