chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High pitched ringing on ears; Headache; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), TINNITUS (High pitched ringing on ears) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 038A21A) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM for an unknown indication.   On 19-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (Headache). On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (High pitched ringing on ears). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) and HEADACHE (Headache) had resolved and TINNITUS (High pitched ringing on ears) had not resolved. Ringing  seems to be more on the right side of patient's head/ear.          This case was linked to US-MODERNATX, INC.-MOD-2021-085912 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow up was received on 22-MAY-2021. Patient demographics- height, weight and race were added. Vaccination times for both doses were added. Vaccine facility information and concomitant medication- clonazepam were also added. Additional events- headache and dizziness were added. On 22-May-2021: Follow up received on 22-MAY-2021 contains no new information with respect to the patient; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-085912:Case for Daughter (MOD21-080096)
Seizure lasting 1 minute. Eyes glazed over and rhythmic rocking started, could not be distracted and was not responding to me for the duration of the event. This happened almost once daily for 6 months. This child has allergy now to Gluten, soy, dairy.
Patient received SHINGRIX on left arm. Patient's right arm had a previous injury that she is going to physical therapy for. She states after the shot the pain in the right arm was significantly increased.
With 2 hours of injection began feeling nauseated. N&V for about 24 hours from clinic held 12/5/09.
first dose on 12/19/2021, second on 27-Jan-2022.; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 1-month-old male patient who received HBV (Engerix B) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 27th January 2022, the patient received the 2nd dose of Engerix B. On 27th January 2022, unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The patient received a 2nd dose of Engerix B later than the recommended interval, which led to drug dose administration interval too long. Consent to follow up was granted.
This spontaneous report as received from a patient's mother refers to a 12 month old patient of an unknown gender. On an unknown date, the patient was vaccinated with a dose of VAQTA lot # K005958 (dose and route were not reported). Concomitant therapies included PREVNAR13 and an unspecified HIV vaccine. Shortly after administration, the patient experienced agitation becoming very excitable and psychomotor  hyperactivity described as "hyperactive". At the time of the report the outcome of agitation and psychomotor hyperactivity was unknown.  Additional information is not expected because the reporter did not provide any contact details.
Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization.  The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.
I am not certain if this outcome is related to COVID -19 vaccination, but I can think of no other possibly related event.  I had no illnesses or injuries in winter 2021.  No side effects to first Pfizer shot in Jan,  then I received the second Pfizer shot on the afternoon of Feb 2.  The next morning  I was dizzy, felt feverish, nauseated and very tired.  I stayed in bed the entire day.  The next day I returned to work but felt very tired and had intermittent headaches. The third day after the shot I had headaches that started tapering off.   I did not notice anything else at that time.  No illnesses or injuries from that time until early May, when I gradually became aware that I had mild-moderate tinnitus.  It started to bother me particularly in the middle of the night, and sometimes made it hard to fall asleep.  It is a constant issue, though my awareness of it fluctuates depending on the ambient noise and what I am doing.  I recently had a hearing test, which was perfect, but doctor  I saw recommended an ENT referral and that I file a VAERS since neither of us could think of another precipitating factor. I would add that I do target shooting in an indoor range sometimes, and have spent about 2-3 hour at the range between Feb and May, but I always wear double ear protection (foam earplugs and heavy duty ear muffs).  The doctor did not think this would explain the tinnitus
Due to history of allergic reactions, patient waited a full 30 minutes after receiving vaccine. However, shortly after getting in her car she experienced a feeling that her throat and tongue were swelling. Epinephrine administered and patient transported by EMS to hospital in area. patient states she left hospital at 5 pm on 3/26/21.
Tingling in fingers of arm that received the injection; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW 0169) via an unspecified route of administration in the left arm on 30Aug2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 vaccine. Concomitant medications were not reported. On 31Aug2021, the patient experienced tingling in fingers of arm that received the injection. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken for the event. The clinical outcome of the event tingling in fingers of arm that received the injection was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
22DEC97 pt devel pain, swelling lt deltoid p/vax;pt has persistent pain;
Pt vaccinated with DTP developed 3 episodes of tonic-clonic seizures following DTP on days 1 & 3 following vaccine.
Extremely high fever for 24 hours 102 - 103.5 - only reduced to 101 with Advil. Severe chills and ?flu-like? symptoms for 4 days following booster phizer shot. Several days later I am still very fatigued and will start running a fever with any activity. I tested as a precaution and was negative for flu and COVID.   Similar symptoms with Moderna  for my 1st two vaccines - 1st shot symptoms lasted 2 days; 2nd shot lasted 4 days but not as high fever a fever as booster - typically 102.5.
Client waited 20 minutes after administration of the vaccines due to "previous reactions" to medications. Left office feeling fine, but short time later started to have an "itchy nose and throat." Pulled over on the side of the road for an unknown amount of time and administered Histaminum 30C (natural antihistamine) to herself. Client states that she then developed a hive-like rash on her face and neck. She had severe abdominal cramps and "they have lessened but are still present." She also states that she had a metallic taste. Client did not seek medical attention and is doing "better."
Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer doses (The patient received first two doses of Pfizer vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer doses.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. The vial was stored in refrigerator and the date vial(s) moved from freezer to refrigerator on 03-Mar-2022. Maximum or minimum temperatures reached, as applicable (specify temp is in C or F) was Maximum Temperature was 49 degrees Fahrenheit and Minimum Temperature is 37.7 degrees Fahrenheit. The temperature excursions occurred on 04-Mar-2022, 05-Mar-2022, 07-Mar-2022, 08-Mar-2022, 08-Mar-2022, 09-Mar-2022, and 10-Mar-2022. Vials were not visualized and proposed desired Use by Date is given as 16-Mar-2022 No treatment details were provided.
Patient has history of vasovagal syncope. Patient became pale, was perspiring and experienced syncope. Patient was given ice packs and recovered fully  in about 10 minutes.
was diagnosed with disease hyperthyroidism; Feeling symptoms but I just thought it was a side effect of the shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (was diagnosed with disease hyperthyroidism) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTHYROIDISM (was diagnosed with disease hyperthyroidism) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Feeling symptoms but I just thought it was a side effect of the shot). At the time of the report, HYPERTHYROIDISM (was diagnosed with disease hyperthyroidism) and VACCINATION COMPLICATION (Feeling symptoms but I just thought it was a side effect of the shot) outcome was unknown.           Concomitant medications were not reported. Treatment information was not provided.  Very limited information regarding these events has been provided at this time. No further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
Splitting headache that started three hours after vaccine and has lasted over 7 days, to the point of making her sick.
Pt had been toilet trained, refused to use toilet, couldn't tolerate noises, had stiffening when approached, fists clenched all at 1 month, post vax. First symptoms were fever of up to 105F X 24 hours (axillary), vomiting and diarrhea. Also, at about 1 month, post vax, child would not leave the house, had screaming tantrums. Lost her words, had ringworms and fungal infection at 21 months. Was evaluated in Atlanta by developmental pediatricians in 8/98 and dx'd with autism/PDD.
Pt received DTP and developed fever, unconsolable screaing x 2hrs high pitched cry.
Patient began to feel weak and nauseous. I had patient lay down while I measured blood pressure and heart rate and 911 was called. Patients feet were elevated to increase blood pressure after no improvement in blood pressure and heartrate 62/38, 48bpm, patient was administered  epinephrine 0.3mg dose in the thigh. Patient was monitored until emergency services arrived and took over.
A little more than 24 hours after receiving the vaccine developed severe chills, mild fever (99.4), headaches, neck and shoulder discomfort.  Fever and chills persisted for about 24 hours.  Neck and shoulder discomfort persisted about 72 hours.  These resolved.  There was still soreness at the injection site a week later.
small scaly plaque developed on her body (possibly chest per HCP); This spontaneous case was reported by a nurse and describes the occurrence of SKIN PLAQUE (small scaly plaque developed on her body (possibly chest per HCP)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced SKIN PLAQUE (small scaly plaque developed on her body (possibly chest per HCP)). At the time of the report, SKIN PLAQUE (small scaly plaque developed on her body (possibly chest per HCP)) 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.   Concomitant medication not provided.  Treatment information not provided.   This case was linked to MOD-2021-230017 (Patient Link).
Felt very hot, no perspiration, felt like he was burning up. Fast respiration, shivering, felt he was hallucinating. Felt weak the next day but otherwise normal. It was very scary. had felt chilled 10/22 in the evening.
Starting around 1AM this morning, intermittent jolting pain in elbow- along path of ulnar nerve- feels like nerve pain.
Arm pain and dizziness starting day of vaccination. Dizziness has continued since time of vaccination.
Oval warm and raised red patch of two inches wide and one and half inches long on the arm; Oval warm and raised red patch of two inches wide and one and half inches long on the arm; Oval warm and raised red patch of two inches wide and one and half inches long on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Oval warm and raised red patch of two inches wide and one and half inches long on the arm), VACCINATION SITE ERYTHEMA (Oval warm and raised red patch of two inches wide and one and half inches long on the arm) and VACCINATION SITE SWELLING (Oval warm and raised red patch of two inches wide and one and half inches long on the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Oval warm and raised red patch of two inches wide and one and half inches long on the arm), VACCINATION SITE ERYTHEMA (Oval warm and raised red patch of two inches wide and one and half inches long on the arm) and VACCINATION SITE SWELLING (Oval warm and raised red patch of two inches wide and one and half inches long on the arm). At the time of the report, VACCINATION SITE WARMTH (Oval warm and raised red patch of two inches wide and one and half inches long on the arm), VACCINATION SITE ERYTHEMA (Oval warm and raised red patch of two inches wide and one and half inches long on the arm) and VACCINATION SITE SWELLING (Oval warm and raised red patch of two inches wide and one and half inches long on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. None pertinent medical history, drug reactions or allergies were reported. On 18-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K009199, expiration date 27-SEP-2015, 0.65 ml, subcutaneous (dose number and anatomical location were not reported). None concomitant therapies were reported. On 19-OCT-2014, 24 hours after vaccination, the patient experienced intense itching "all over the entire arm". No treatment was given. No rash reported. The outcome of the event was unspecified. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
08/24/22 presents to EC ED for "abnormal imaging and rapid heart rate". PMHx of "Ischemic stroke L parietal lobe with small superimposed hemorrhage 07/22, Afib, IDDM s/p RBKA and L toe amputation, HTN, HLD, PVD "
Initial redness,pain and itching at site of injection. Next morning redness radiated down back of arm approx. halfway to elbow and around to front of arm as a band in the middle of arm.  2-3 days later all the redness turned into a bruise which lasted approx. 3 weeks.  Initial pain severe enough to require Ibuprofen for 48 hours.
Dizziness 30 minutes after leaving facility 5 days after vaccine - heavy period with clots
pt recv vax APR97 & approx 2wk post vax pt devel polyarthritis involving the shoulders, wrists, hips, knees & ankles;pt hosp 5 days;diagnostic testing was unrevealing although 2 SED rate determinations were 40 & 80;tx w/med;
and seemed to have severe abdominal pain,crying, seemed to be gassy, pulling legs up; and seemed to have severe abdominal pain,crying, seemed to be gassy, pulling legs up; and seemed to have severe abdominal pain,crying, seemed to be gassy, pulling legs up; pulling legs up; This spontaneous report was received via a company representative from a medical assistant referring to a 4 months old female patient. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was unknown.  On 15-APR-2019, the patient received a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # R027272; strength, dose detail and expiration date were unknown) orally for prophylaxis (reported as prevention of rotavirus). On the same day,  the patient seemed to have severe abdominal pain, crying, seemed to be gassy, pulling legs up. On the same day, the parents brought the patient back to the office, and they were told to take the patient to the Emergency Room. It was unknown if the patient was given treatment for the events. It was unknown if the patient performed any lab diagnostics/studies. The outcome of all events was unknown. The causality between all events and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was not provided.
Well over 6 weeks since patient received first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Well over 6 weeks since patient received first dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Well over 6 weeks since patient received first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Well over 6 weeks since patient received first dose) 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.   No relevant concomitant medications were reported. No treatment information was provided. .