chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; DIZZINESS; CHILLS; JOINT PAIN; MUSCLE PAIN; NAUSEA; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced muscle pain. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, and muscle pain on 12-APR-2021, and fatigue, and headache on 13-APR-2021, and was recovering from nausea, and dizziness. This report was non-serious.
Next day after receiving vaccine, Patient had Itching a few inches below injection site. No redness, No swelling, No rash, No hives, No effect on breathing. Two days after receiving vaccine, itching improved but not fully resolved.
Systemic: Exhaustion-Medium, Systemic: Fainting-Medium, Systemic: muscle tightness and weakness-Medium
when it woke up saw the bleeding from the nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (when I woke up saw the bleeding from the nose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HRSTE372A1B) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced EPISTAXIS (when I woke up saw the bleeding from the nose). At the time of the report, EPISTAXIS (when I woke up saw the bleeding from the nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
9-29-21 injection (L) Deltoid 9-30-21 seems sl red over site 10-1-21 Red, warm, swollen, + enlarging ro systemic symptoms
Headache, Arthralgia, FATIGUE, PAIN/SWELLING INJ SITE Narrative:
Physician/patient reporting having generalize urticaria rash after getting the vaccine; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Physician/patient reporting having generalize urticaria rash after getting the vaccine) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient did not report having allergy or diseases.     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 URTICARIA (Physician/patient reporting having generalize urticaria rash after getting the vaccine). At the time of the report, URTICARIA (Physician/patient reporting having generalize urticaria rash after getting the vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Patient received series of Pfizer COVID vaccine. 1st dose was given on 1/12/22 (FL3197) and 2nd dose was given on 2/8/22 (FL6369). On 3/2/22 at 20:51 he goes to emergency room complaining of fast heart rate since earlier that evening around the time he had dinner. He has never had fast heart rate or palpitations before. He was very anxious upon arrival. CBC, CMP and chest x-ray were performed and all was normal. He was given a liter of fluids and heart rate decreased. He was discharged a few hours later in stable condition with instructions to follow up with PCP. Patient believes palpitation may have been result of COVID vaccine a few weeks prior.
No side effects until 12 hours after with fever, chills, soreness, nausea, and fast heartbeat throughout the following day.
Patient was given covid moderna vaccine, dose number 2, at 21 days instead of 28 days.
Mother is the caller, child with immunizations yesterday - mother describing swelling of the Rt thigh and pain with walking child is limping.  Unsure of any fever, feels warm. Denied any emergent symptoms.  Stated that the swelling is noticeable - Rt is about 1/4 of a size larger than the Lt thigh.  Recommended clinic appt today for exam. Hive like reaction noted in clinc localized to injection site.
Asthma attack which is not a normal experience; Wheezing continues; chest still feels tight; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to sulfonamide (sulfa) and latex. Concomitant medications included fluticasone propionate and salmeterol xinafoate (ADVAIR) 250/50, cetirizine hydrochloride (ZYRTEC) and vitamin B12  (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 03:00, the patient experienced asthmatic attack, tightness in chest and wheezing. Its reported that, early morning, 3 a.m., of 07Apr2021, patient woke up to an asthma attack which was not a normal experience. Her chest still feels tight and wheezing continues. Her controller meds had kept from having any sort of attack since 2003. Therapeutic measures were taken as a result of reported events and included treatment with controller/rescue inhaler. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or  urgent care. The clinical outcome of the event of asthmatic attack  was recovering at the time of this report. The clinical outcome of the events of  wheezing and tightness in chest was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reports. No product quality complaint was involved. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursions of 48 hours. The highest recorded temperature was 52 F (11.11111111 Celsius). The vaccine status was reported as "in excursion". The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.
Chills; arm pain; fever 100.5; diarrhea; This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 04:30 (Batch/Lot Number: EW0179) as DOSE 1,SINGLE, dose 2 via an unspecified route of administration, administered in Arm Right on 15May2021 (Batch/Lot Number: EW0172) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing Allergic to green beans and nuts. Concomitant medication(s) included beclometasone dipropionate (QVAR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced chills on 05Jun2021 17:45 with outcome of not recovered, arm pain causing pain in extremity on 05Jun2021 17:45 with outcome of not recovered, fever 100.5 causing pyrexia on 05Jun2021 17:45 with outcome of not recovered, diarrhoea on 05Jun2021 17:45 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature:at 100.5 on 05Jun2021. Therapeutic measures were taken as a result of these events.  Follow-up(27Jul2021):This is a Follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non HCP letter sent that included: No information can be released on this person.  Follow-up attempts are completed. No further information is expected.
My asthma has been flaring more then it should be (have to use my rescue inhaler depending upon the activity for the day) since I took the 2nd dosage of the Moderna vaccine. My doctor asked me to take the vaccine because I had it and it would be worst if I had COVID again since I had it last year in May. I didn't go to the hospital because I didn't want to be put on a respirator just because I have asthma. Since taking the vaccine I went to urgent care to make sure that I'm fine since I've had COVID.
Vaccine error, patient had Pfizer 1st dose December 2020 and 2nd dose January 2021.  Patient had asked for her 2nd shingles shot that was due.  Patient isn't immunocompromised so she just got 3rd dose early and it was Moderna instead of Pfizer.   Patient did not have any adverse event with the immunization.
Two weeks post vax, the pt experienced hives. He continued to experience outbreaks of 12-24 hours of hives several times a week since that time. He was treated with hydroxyzine dihydrochloride. The pts hives persisted.
A father reported that his 5 month old son received an injection of Prevnar on 10/5/00 and on 10/7/00, the infant's eye "became extremely swollen and red". The reporter stated that the physician treated him with Benadryl and an unspecified antibiotic.
patient passed out for about 10-15 secs 5-10min after administration of the vaccine
No adverse effect; Improperly stored vaccine administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUL-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, lot # S003326, expiration date: 02-AUG-2020 (exact dose, site and route of administration were not reported) for prophylaxis. No adverse event was reported. The vaccine experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius (-0.4 degrees Celsius) for 20 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA010133: US-009507513-1907USA010132:
The patient became nauseous and stood up.  She then had a syncope episode and sustained an injury to right lateral upper side of forehead.  10x10mm closed wound with erythema and edema.  She continued to be unconscious and unresponsive for approximately two minutes.  Two ammonia inhalants were used and patient did not respond.  Emergency responders were called.  Ice pack to forehead placed and vitals within normal limits.  Orientated x 3 after she was responsive (approximately 2 minutes) but stated lack of memory of event.  Also, she denied HA, nausea, SOB, and dizziness.  EMS responded and transferred patient to hospital via ambulance.  On 8/21 2015 spoke with patient's guardian. She stated patient continued with decreased blood pressure yesterday afternoon.  She had an emesis episode and "after vomiting began to feel much better".  She was kept at the hospital overnight for observation and was discharged today.  CT scan and X-ray of head and neck normal but did have a "slight neck sprain".
within 30 minutes, patient had violent diarrhea, and a 3" diameter swollen red spot at the injection site. She became very irritable and fussy. Diarrhea continued for 14 days with no successful treatment to stop the diarrhea. She was pulled from her ISR lessons (ISR Self-Rescue® Survival Swimming Lessons) due to the reaction of the vaccine.
Onset of tongue numbness a few hours after vaccination, which was gone the next day. Vaccinated on 12/16 - 10 days later on 12/26/20  tongue numbness recurred & he developed (R) facial droop - seen in ER on 12/17 had normal head CT, negative work up for stroke. Seen in clinic on 12/28 - diagnosed with Bells palsy, started on Valacyclovir. Patient will hold PrEP x7 days (precautionary), no sexual activity during that time.
Positive effect  chronic lower back pain for 50 years, it is now gone; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Feb2021 at 11:00 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included lower pack pain from an accident and surgery in 1971. The patient had no known allergies. Concomitant medications included acetaminophen; codeine phosphate (TYLENOL NO. 3) and levothyroxine (MANUFACTURER UNKNOWN) of dose 125 (units unspecified), both for unknown indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Feb2021, the patient experienced positive effect. The patient had chronic lower back pain for 50 years, which was now gone. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event unexpected therapeutic benefit was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
?COVID arm? 2/20/21 I noticed a 2.5? (diameter) hard mass below injection site. Mass became  deep red, painful and itchy. 2/20-2/22/21 I ran a low grade fever, burning eyes, malaise, and significant generalized muscle aches. On 2/21 the mass and redness had become larger 3.5?, remained tender and very red. 2/23, I was no longer febrile and had no extraneous symptoms other than my arm.  The area became softer, still tender, redness was a lighter red but more diffuse. 2/24 much better but still noticeable.
Sore gums after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Sore gums after the 2nd dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GINGIVAL PAIN (Sore gums after the 2nd dose). At the time of the report, GINGIVAL PAIN (Sore gums after the 2nd dose) outcome was unknown.
PATIENT CAME IN FOR FLU VACCINE AND COVID BOOSTER. PATIENT IS 64 YEARS OLD BUT SHE WAS GIVEN THE FLU VACCINE FOR 65 AND OLDER (FLUAD). SHE WILL NOT BE 65 UNTIL FEBRUARY. NO ADVERSE EVENTS TO REPORT.
No symtoms reported; One patient received GARDASIL 9 that was stored improperly; This spontaneous report was received from a office Manager referring to a 11-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication were not reported.     On 26-DEC-2019, the patient was inadvertently vaccinated with an improperly stored dose (product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular in the left deltoid by prophylaxis (strength, dose, frequency were not provided) (lot # S008154 has been verified to be a valid number; expiration date 20-NOV-2021). The  temperature  excursion was at (36 degrees Fahrenheit (F) to 46 F) 46.2 F, for a time frame of 15 minutes, and (below 36 F) 30.9 F for a time frame of 4 hours and 37 minutes, the previous temperature excursion was (above 46 F) 52.7 F for a timeframe of 30 hours and 37 minutes. It was reported that the call was due to data logger. No symptoms were reported.
Patient received COVID booster however vaccine appears to be administered at a 30 degree angle or less on the skin resulting in the needle entering the skin at one point and exiting the skin at another point. Patient concerned vaccine administered incorrectly resulting in both harm as well as vaccine not being administered into the shoulder. The patient reported no expected side effects to the vaccine, which worried the patient that the dose was not effective. Repeat dose administered on 11/12/21.
After I received the vaccine. I started experiencing a weird feeling in my body. I started experiencing pain in the soles of my feet. Pain in the sole of my feet traveling nerve pain in my thighs, legs and in my head. May June and July I was unable to work. I went to see several doctors but they have not diagnosed my condition. I was referred to a Rheumatologist and was prescribed Tylenol, gabapentin, tramadol, prednisone and ibuprofen for nerve pain. I have also had to see my therapist for depression due to my condition.
approx 1 wk p/vax pt broke out in a rash; sent home from school as school concerned pt was contagious; itching has accompanied rash; 2 1/2 wks later rash w/itching cont although DPH given;
PT REPORTS- FEVER, RASH ON BODY TRUNK, BACK AND FACE TWO ON BOTTOM LIMBS. FATIGUE, HEADACHE, RETRO ORBITAL PAIN AND LOOSE STOOLS.
she had a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest; Chest tightness; like she was going to faint or go to sleep; like she was going to faint or go to sleep; she barely had a little pain at the COVID-19 Vaccine injection site that went away quickly; This is a spontaneous report from a contactable consumer, the patient. This 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249),  dose 1 , single dose via an unspecified route of administration in the left upper arm on 08Jan2021 at 09:15 AM (at the age of 78 years-old) for COVID-19 vaccination. Relevant medical history included ongoing high blood pressure in Dec2020. Concomitant medications included valsartan (DIOVAN) 160mg tablet, once a day from 10Dec2020 and ongoing for high blood pressure and clobazem (CALM) from Jan2021, lot: 1115941, expiration: Mar2022. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 09:15 AM, the patient  barely had a little pain at the COVID-19 vaccine injection site that went away quickly. On 18Jan2021, the patient had chest tightness and a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest. She said it was like she was going to faint or go to sleep. She said the wave went down to her chest area and stayed for a big portion of the day. She said she had a heaviness in her chest, clarified as a chest tightness. She said she has no heart issues. The patient still had some tightness in her chest and it may be just from worry. She said she was normally calm, so she was not sure about what was causing her current chest tightness. The patient did not think what she experienced on 18Jan2021 was serious enough to contact her primary care doctor. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of event, barely had a little pain at the COVID-19 vaccine injection site was recovered on an unknown date in Jan2021. The clinical outcome of event, wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head was recovered on 18Jan2021 after treatment was given. The clinical outcome of chest tightness was recovering after treatment was given. The clinical outcome of like she was going to faint or go to sleep was unknown.
Immediately after injection, arm very sore, actually painful to lift.  Redness at site. On morning of 09/30/10, woke up with sore, scratchy throat, muscle soreness, and head congestion. Progressively worsening as the days go by.  Unable to concentrate, which was never the case previously.  Loss of appetite.
Patient received Moderna COVID vaccine on 4/8/21 and 5/6/21. On 1/10/22, patient presented with awake L side hemiparesthesia and hemiparesis and admitted to our inpatient CCU with embolic stroke potentially related to Depo-Provera (if paradoxical) +/- COVID infection. Patient was found to be COVID positive upon admission with cough, sore throat, fever, and chills. Patient underwent mechanical thrombectomy on 1/10/22. As of today (1/11/22), patient was transferred to our med/surg unit and still admitted.
No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-MAR-2020, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number: S028920, expiration date: 16-SEP-2021 (strength and frequency were not provided) subcutaneously for prophylaxis. Sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. The suspect vaccine was exposed to temperature from 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.69 degrees Fahrenheit) for a time frame of 1 second. There was a previous temperature excursion reported, at a temperature from 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes. Data logger was involved. No additional adverse effect was reported.