chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 12:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 12:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 48.73  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported. .
Possible vasovagal episode / vs vaccine reaction  while having his blood drawn in 4th Floor Lab. Patient found sitting in lab chair pale, diaphoretic - Responsive, without report of loss of consciousness. Patient had also received 6 vaccines earlier today in the office - HPV (1st dose), MENACTRA (1st dose) Tdap (1st dose) MMR and Varicella (2nd doses) and Hep B (2nd dose). He had been monitored x 15 minutes in provider's office after vaccine administration and had displayed no weakness, hives, dizziness after vaccines' administration. In LAB 09:45 AM: Vital Signs BP: 96/68, HR:46, 02 Sat: 98%, BS: 82 (after administration of 4 Oz OJ) - No rash, hives, wheezing -  09:55 AM Blood Sugar 84, BP: 92/62, HR: 67,  patient A+O x 3. crackers, OJ 4 OZ given. Patient stabilized and transferred via W/C  to Family Medicine Dept for further monitoring. Patient monitored x 1 hr: No rash, wheezing, hives, respiratory distress noted VS stable at departure - Mostly likely vasovagal response to blood draw.
pt recv vax devel numbness & pain on the side of face 30OCT96;dx w/Bell's palsy 5NOV96;
arm soreness; fever; chills; felty achy; she felt tired; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 09Apr2021 as single dose for covid-19 immunization. Medical history included covid-19 from 13Jan2021 to an unknown date. The patient's concomitant medications were not reported. The patient waited 90 days before getting the first dose because she got Covid-19 last 13Jan2021. She experienced side effects after the first dose. First, she experienced arm soreness and took Tylenol. She also had fever, chills, felty achy and the following day she felt tired. She was not scheduled for her second dose yet. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
trouble breathing; This is a spontaneous report from a contactable consumer (reported for self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced trouble breathing. The outcome of the event was unknow.  No follow-up attempts are possible. No further information is expected.
BRUISE ON BOTTOM OF RIGHT LEG; TINGLING IN LEGS; SWELLING OF LEGS; UPSET STOMACH; BODY ACHES; CHILLS; EXHAUSTION; HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ADHD, and hay fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. Batch number was not reported and has been requested. On 10-APR-2021, the patient experienced upset stomach. On 10-APR-2021, the patient experienced body aches. On 10-APR-2021, the patient experienced chills. On 10-APR-2021, the patient experienced exhaustion. On 10-APR-2021, the patient experienced headache. On 14-APR-2021, the patient experienced bruise on bottom of right leg. On 14-APR-2021, the patient experienced tingling in legs. On 14-APR-2021, the patient  experienced swelling of legs. Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in legs, and swelling of legs, and upset stomach, body aches, chills, exhaustion, and headache on 11-APR-2021, and had not recovered from bruise on bottom of right leg. This report was non-serious.
ADVERSE EVENTS: INITIALLY PATIENT DEVELOPED  ITCHING, FLUSHING AND FELT FEVERISH INVOLVING HEAD, NECK AND UPPER CHEST.  THE NEXT DAY SHE DEVELOPED ABDOMINAL PAIN AND MORE THAN 3 EPISODES OF DIARRHEA.  TREATMENT: BENADRYL PO AND METHYLPREDNISOLONE IM ADMINISTER AT THE ER; THEN TYLENOL AND PO HYDRATION AT HOME FOR 1 DAY. SYMPTOMS RESOLVED COMPLETELY ON DAY 3. OUTCOMES: SYMPTOMS ONLY LASTED  2 DAYS.
Hives for3months straight non stop....then 5 strokes at end of hives
12 hour flu symptoms starting ~8 hours after vaccine; headache and canker-sores appeared 1-2 days later and have lasted 1 week (as of now)
Warm to touch; Redness 2 and 1/2 inch around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) outcome was unknown.        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.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up information received on 3-jun -2021 does not contain any new information. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) outcome was unknown.        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.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up information received on 3-jun -2021 does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient - received the Johnson & Johnson vaccination (Lot # 1808609) on 05/22/2021 at 1131 in the left arm. Upon walking to observation patient fell, it was observed that he hit the back of his head by nurse at nursing station #4, nurse immediately cradled patient?s head and turned patient on his side for safety.  Patient was assessed for open wounds, hematoma and bleeding.  Negative findings.   EMS called by RN Patient assessed RN.  Patient is a 21-year-old with no past medical history per patient?s grandfather.  Patient is laying on the floor, with eyes wide open, not verbally responsive, and unable to follow commands.  Patient was pale and diaphoretic.  Patient is awake, but not oriented to time and place.  Patient also does not recall having breakfast, but his grandfather stated that he did have eggs earlier this morning. Vital signs as follow: Time 1134: BP 147/78, pulse 43, 98% room air, temp 97.1 Time 1138: BP 147/82, pulse 47, 98% room air, patient started to become response asking questions.  Patient denies any lightheadedness or dizziness, he only felt a burning sensation on the back of his head.  Patient?s grandfather at his side.  Patient?s wallet, vaccination card and glasses given to patient?s grandfather. Time 1142: BP 125/79, pulse 64, 98% room air Privacy screen in place for confidentiality from other patients.  Awaiting EMS. Incident aware 1144 EMS arrived. 1146 Patient placed in wheelchair and left the building with EMS. Patient was awake and alert upon leaving the building.
The pt experienced severe pain in his right shoulder with swelling. 2 days later it had improved. No treatment needed.
Received Influenza vaccine 10/02/2012; developed swelling, itching, pain within 24 hrs. Signs and symptoms disappeared eventually but now has persistent (R) arm pain and discomfort. Has been seen and treated by physician and chiropractor. Symptoms persist.
Fever 101.1, severe headache, malaise, myalgias, severe pain at injection site, moderate redness and induration and warmth at injection site extending.
High Fever, body aches, fatigue, headache.  extreme hair loss, mental fog, anxiety
Immediate flushing of the face, elevated heart-rate, dizziness, burning of the lungs and throat and shortness of breath. Recovered quickly (<1hr, and I saw no need to tell a doctor)
Patient developed an urticarial rash of the upper and lower extremities one day following vaccination. Family denies new medications or new topical agents at that time. Patient treated himself with a dose of Benadryl for which rash resolved initially, but the next day patient had a similar eruption (this time including the back) on the skin with lip swelling requiring a second dose of Benadryl. Family reports that patient had a waxing and awaiting urticarial rash over the next 5 days following administration of meningitis B vaccine. Symptoms were treated with 25-50 mg of Benadryl each time.
Information was received 13-JUL-2017 via a phone call from a female consumer who reported that her son experienced an adverse event after receiving an MMR vaccine a couple of years ago (Lot # and expiration date not provided). Description and outcome of the event and age of her son were not provided. The reporter opted not to provide any further information. Additional information is not expected.
Patient is allergic to AVELOX.  Developed sinus infection 2 days after vaccine administration, started 2 - pack.  The next day she noticed her arm was red and warm to the touch at administration site.
DAY AFTER INJECTION-FEVER ACHES WHICH RESOLVED IN 24 HRS BUT DEVELOPED LARGE RED WHEEL AND INDURATION AT INJECTION SITE AND PAIN AT SITE.
Patient is a 55 y.o. male  2017 renal transplant CABG 2018, type 1 diabetes on insulin pump, peripheral arterial disease who presents today with fever, cough, diarrhea.   Patient was vaccinated for COVID in March and April.  Had been in his general state of health and had attended a wedding recently.  He developed symptoms on 08/03 with with fever, worsening fatigue, nausea with poor oral intake and developed diarrhea several episodes per day. Also headaches, he had then developed a cough as well.  Several other members of the wedding had also developed COVID like symptoms including his sister.  With feeling worse he had then presented emergency department.
Patient states she had a syncopal episode getting out of the shower 01/25/2022.  Had a mild prodrome.  Fell striking her right eye.  Was seen at an outside facility where imaging showed zygomatic fractures.  Ocular pressure stable.  Also incidentally found COVID positive the same date.  Asymptomatic.  Is fully vaccinated.  Has been following with Ophthalmology.  As of this morning had increasing right eye swelling and pain so presented for cares.  Imaging here showed retro-orbital hematoma.  Warfarin reversed with Kcentra and 10 mg of vitamin K.  Seen by Ophthalmology who performed Right lateral canthotomy/cantholysis.  Eyedrops prescribed.  Patient was also found to be hyponatremic at 123. She has run slightly hypo
refractory ITP; hemorrhagic stroke; This is a literature report from the 2021, Patient died after receiving COVID-19 vaccine under investigation. Full Publication has been requested.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced refractory ITP and hemorrhagic stroke, on an unspecified date. The patient died several weeks after receiving the Pfizer-BioNTech vaccine due to refractory ITP and hemorrhagic stroke. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Immune thrombocytopenia, hemorrhagic stroke and the suspect drug BNT162B2  cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: refractory ITP; hemorrhagic stroke
This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via unspecified route of administration in left arm on 25Jan2021 at 16:45 (at 35-year-old age) as single dose for COVID-19 immunization. Patient had no allergies to medications, food, or other products or any other medical history. No concomitant medications were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has been tested for COVID-19. On an unspecified date in Jan2021, patient experienced strong neck pain in the area-on the left side (vaccine was injected in left arm). Two days after experiencing strong neck pain, on 30Jan2021, at 12:00PM, on day 5 after vaccination with 1st dose, patient developed swelling of the left supraclavicular lymph node (3-4 cm in diameter). Possibly also swelling of groin lymph nodes but more minor. On an unspecified date in 2021, swelling in supraclavicular lymph node was not subsiding by day 8-9 after vaccination and was significantly painful. Reporter considered events as non-serious. Due to the events, patient visited doctor or other healthcare professional office/clinic visit. On 25Jan2021, 27Jan2021 and 29Jan2021, patient underwent lab test of COVID-PCR via nasal swab and tested negative. It was unknown if the patient received treatment for the adverse event. Outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.
adverse reaction to the COVID-19 vaccine.  She states that she got the motor in a vaccine approximately 1.5 hours prior to arriving to clinic.  As she was driving home, she felt that her bottom lip on the right side was becoming mildly swollen as well as having the sensation that her throat was closing up.  She has been able to breathe comfortably and swallow without difficulty.  She states that currently her throat feels ?thick.?  She also states that she has a ?flushed? sensation.  Has had adverse reaction in the past to the the 2nd shingles vaccine.  Denies any adverse reaction at the injection site.  No recent dietary/medication changes.  Denies fever/chills, syncopal episode, severe shortness of breath, numbness/tingling in the extremities or muscular weakness.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unspecified dates, the patients were vaccinated with improperly stored, ROTATEQ, oral (unknown strength). Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports from the same reporter. Additional information has been requested.
Chest pain/Dyspnea, improved. Possible acute heart failure with normal LV function rule out sleep disorder. Lasix changed to Demadex and potassium with BMP blood test in one week and follow up with CHF clinic 10/1/21. Out patient sleep study ordered. Hospital admission within 6 weeks of receiving the COVID vaccine.
01/20/2022 Covid symptoms started with headache. Saturday I had shortness of breath and cough, and by Sunday I was fatigued and had fever. I have a baseball size lump on my arm where injection site was and the Doctor said it might be cellulitis and it's golf ball size now. I tested positive today.
Developed Covid symptoms of headache, fatigue, and sinus congestion on 4/4/2021. Tested positive 4/12/2021.
Initial and follow up information has been received from a nurse concerning a 73 year old white female with Penicillin allergy and sulfonamide allergy and a history of high cholesterol who on 08-SEP-2005 was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (Lot number 649977/0706P) (first dose received October 1997).  Concomitant therapy included pravastatin Na (PRAVACHOL) and lisinopril (ZESTRIL).  In September 2005, "within a couple of days of vaccination", the patient experienced local swelling and redness (severe) from her shoulder to elbow.  Unspecified medical attention was sought.  Subsequently, on an unspecified date, the patient recovered from the local swelling and redness (treatment unknown).  No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 69-year-old patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced muscle pain, tiredness and upset stomach. On an unknown date, the outcome of the muscle pain, tiredness and upset stomach were unknown. It was unknown if the reporter considered the muscle pain, tiredness and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine a few days before the day of reporting on Monday. The patient was asking if upset stomach could be a side effect of SHINGRIX.
This spontaneous repot as received from a healthcare professional refers to a patient of unknown age and gender,. Information concerning the patient's concurrent conditions, medical history or concomitant medication was not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # L013067with expiration date on 14-APR-2017. The vaccine was exposed to a temperature of -7.9C for 46 hours and 4 minutes and this excursion was discovered due to a digital data logger. Additional information has been requested.