chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INNER EAR ISSUE FLUIDS WERE UNBALANCED; COVID; This spontaneous case was reported by a physician and describes the occurrence of INNER EAR DISORDER (INNER EAR ISSUE FLUIDS WERE UNBALANCED) and COVID-19 (COVID) in a 50-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INNER EAR DISORDER (INNER EAR ISSUE FLUIDS WERE UNBALANCED) and COVID-19 (COVID). At the time of the report, INNER EAR DISORDER (INNER EAR ISSUE FLUIDS WERE UNBALANCED) and COVID-19 (COVID) 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 Concomitant medications were Provided By the Reporter. No Treatment history was provided by the reporter.   Reporter did not allow further contact
Pain at the injection site; This is a spontaneous report from a contactable Nurse via Pfizer sales representative.   A patient of unknown age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) at single dose for immunization on unknown date. Relevant medical history and concomitant medications were not reported. The patient experienced pain at the injection site. The outcome of the event was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
In 24 hrs had very large melon size indurated lesion that was purpuric in nature warm but not tender to the touch at the site of the injection. Looked like an arthus reaction seen in immune complex disorders involved only the skin at the injection site Not uricarial.
Severe Shivering; Sweating Profusely; patient woke up in the middle of the night with severe shaking; This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 1st dose of Shingrix. On 12th December 2019, less than a day after receiving Shingrix, the patient experienced shivering, excess sweating and tremor. On 13th December 2019, the outcome of the shivering and excess sweating were recovered/resolved and the outcome of the tremor was recovering/resolving.   It was unknown if the reporter considered the shivering, excess sweating and tremor to be related to Shingrix.  Additional information was provided as follows: The patient after receiving 1st dose, woke up in the middle of the night, experienced severe shaking, severe shivering and sweating profusely. The patient was so incapacitated that she couldn't reach the phone. On 13th December, the patient was fine. The reporter wanted to knowhow to proceed with 2nd dsoe of Shingrix. The reporter did not consent to follow up.
at 11:30 PM noticed increasing labored breathing with wheezing ; felt like a band was across chest;. Sat up in chair, concentrated on NOT gasping , as exhale was most difficult. Started to ease up around 5:30 AM and had totally cleared up by10:00 AM
Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 029A21) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, 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 experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown.            No concomitant medication were reported.   No treatment information was provided by the reporter.  Company comment: This case concerns a 62 year old male with no reported medical history, who experienced Serious ( Medically significant ,)  , unexpected event of Pneumonia , which occurred on an unknown date  with an unknown dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The age of the patient  can be considered as a confounder for this case ( since elderly are vulnerable to infection ) . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 62 year old male with no reported medical history, who experienced Serious ( Medically significant ,)  , unexpected event of Pneumonia , which occurred on an unknown date  with an unknown dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The age of the patient  can be considered as a confounder for this case ( since elderly are vulnerable to infection ) . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Urge to urinate while in bed, fever, chills, shaking, all muscles tensed up, pain in head, neck, back, and legs, followed by urination roughly every hour for nine hours.  Feeling of being very hot while in bed, but no sweating.  Low-grade fever, headache, and muscle aches through 10 AM (present time).
pt reports 6DEC92 noted pink area on inner arm w/itching; 7DEC92 t98.3 pink area 4-4 1/2 inchs side x 3-3 1/2 in, warm to touch, inner arm about 1 1/2in below inject site; MD ? foreign protein reaction vs cellulitis;
Swollen, red and warm to touch area at injection site, 6 inches long and 2 inches wide (onset approximately 2 hours after injection).
My son had a seizure the day after (11/11/08) he had the yellow fever vaccine (11/10/08).  It was during nap time at school.  He was rushed to the emergency room.  He also had another seizure in his sleep on 12/14/08.  He was then referred to a pediatric neurologist who has scheduled him for a sleep deprived EEG on 2/5/09.  2/3/09 Received ER medical records & peds neuro consult records. ER records of 11/11/2008: FINAL DX: seizure Records reveal patient had seizure while in school when he cried out & then started shaking all over followed by sleepiness & confusion.  Peds Neuro consult of 1/22/2009: FINAL DX: partial seizure Records reveal patient traveled out of county x 1 mo.  Had witnessed nocturnal convulsive seizure lasting approx 2 min on 12/12/08.  Referred for EEG.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Moderna vaccine on 1/28/21, 3/4/21, 11/1/21, and 6/24/22. Admitted to hospital x9 days w/covid pna for a myasthenia gravis crisis.  Initially req'd BiPAP. Prior to transfer she became progressively weak and unable to move extremities or swallow. Intubated, status c/b progressive shock and hypoxemia. Pt expired on 9/26/22. Pt treated with remdesivir, decadron, rocephin, azithromycin, cefepime, and solumedrol
Redness and swelling at site of DTaP injection with a fever of 100 the day after receiving shots. She worsened the following day with a fever of 103; headache, and swelling up to 10 cm. Child was taken to Dr. whose plan was to monitor. She began to feel better the next day, July 19th, with less redness and a temp of 102. It was on this day that she returned to the clinic and the reaction was noted. The father was phoned the following day, July 20th, and he stated she was continuing to improve.
Reaction around the injection site (R) arm erythema 24 hr later, with area swelling. Erythema extending to mid arm 48 hr later. No lymphadenopathy
1.  swelling, redness, heat, itching at injection site. Lasting 10 days.  Peak discomfort at day 8.  Hard lump, hot to touch, red,  strong itch.  Was 3 inches by two inches. The arm is now back to normal.  .2. Day 8.  Woke at roughly midnight with extreme heat and burning in all toes.  Quite painful.  Very unusual, as I have never experienced anything like this before.  When pain and burning became overwhelming I took Tylenol.  It helped and I was able to sleep.   The next morning the pain and burning were gone but my toes were, and continue to be quite numb, as is the area of my feet that surrounds my toes.  I can't fully feel my socks, shoes, sheets, etc.  It feel like I have cotton stuffed in my shoes.  It is hard for me to related the level of heat, burning and pain that happened.  I felt like I could melt a block of ice with my feet.  It was severe. I marked "disability or permanent damage" below because I don't know if the nerves in my feet will return to normal.
Rapid heart rate, throat swelled, jaw locked, stomach pain, headache, vomiting.
This spontaneous report as received from a pharmacist refers to a 30-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 17-FEB-2017, the patient was vaccinated with a 1st dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis and on 07-AUG-2017, with a 2nd dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. It was stated, that at the reporting time, the patient was in the pharmacy to receive the 3rd dose of GARDASIL 9 but had not received it yet. No adverse effects were reported.
sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) and ATORVASTATIN for an unknown indication.    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 PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.
SHINGRIX vaccine administered at approximately 09:45 am on 7/30/2018. Patient reports having fever of 103 degrees with chills around 9pm that same day. Patients reports feeling better by 10 am the next day 7/31/2018.
Pfizer-BioNTech COVID- 19 Vaccine EUA: Wife of patient called Primary Care Physician to inform that patient had received dose #2 of Pfizer COVID vaccine, and later that evening experienced a seizure and expired.
I'd had knee replacement surgery on my left knee on September 25th and had problems with it not completely healing for a week.  Therapy helped me overcome all but the pain in the knee.  On December 12th, I woke up feeling fatigued, as if I had just come home from the hospital. I slept fitfully all day with much pain in my knee.  It subsided about December 13th, then resurfaced again on Monday, December 17th about 5pm with a constriction of my rib cage as if the shingles had come back.  I had to lay in bed most of the evening  to get the pain to subside. Fatigue is still a problem.
uncontrolled shaking muscel weakness delurium-not being able to sleep--lack of strength- fatigue
Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Vomiting-Medium, Additional Details: Customer sitting next to the patient came to the pharmacist and reported a man had passed out. Rph went over to examine the patient. Patient was unresponsive apon arrival. Pulse 54, shallow breathing. Patient started to regain consciousness. Patient was shaking, sweating, cold, and vomiting. Pt stated "very nauseous, blurred vision, no trouble breathing." Pt symptoms were not resolving after a few minutes pass. Rph instrcuted tech to call 911. Rph waited with the patient until EMS arrived.
I started to feel ill on 5/24, and I took an at home test which was positive. I had nasal drip and sore throat. 5/25 I took an antigen test at at testing facility. Added sinus pressure, headache and chills on 5/25 as well. Consulted Doctor's Office on 5/25, Doctor's office recommended vitamins C, D, Zinc, and rest.
PATIENT REPORTED MUSCLE STIFFNESS AND WEAKNESS STARTING 2-3 DAYS AFTER IMMUNIZATION. NOT SURE IF PATIENT WAS GOING TO SEE DOCTOR.  SHE BELIEVED THAT WAS SUBSIDING AFTER 2-3 WEEKS.
Patient symptoms "on the chin, lips, left side of face near the eye and right cheek bone underneath the right eye."; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Juvederm voluma ® xc. The following information was reported: FACIAL DISCOMFORT (non-serious), outcome "not recovered", described as "Patient symptoms "on the chin, lips, left side of face near the eye and right cheek bone underneath the right eye."".  Additional information: Patient reported that they were injected in the cheeks with one syringe of JUVEDERM VOLUMA ® XC. About a year and a half later patient was injected in the lips with one syringe of JUVEDERM VOLBELLA ® XC. About five months later patient reported experiencing "delayed on set nodules." About a month later patient received the first Pfizer COVID Vaccine dose and the second dose the following month. Patient symptoms "on the chin, lips, left side of face near the eye and right cheek bone underneath the right eye." Symptoms are ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hemoglobin level was 10 (low); black stools; lymphoma/ spot on his right kidney and his duodenum; drug dose; This case was reported by a consumer via call center representative and described the occurrence of lymphoma in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS TOXOID (TETANUS VACCINE) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blood calcium increased (received 1st dose on 26th July 2019, refer case US2019188932). Concomitant products included apixaban (Eliquis).   On 26th August 2019, the patient received the 2nd dose of Shingrix and TETANUS VACCINE. On 26th August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 11th September 2019, the patient experienced hemoglobin decreased (serious criteria hospitalization) and black stools (serious criteria hospitalization). In September 2019, the patient experienced lymphoma (serious criteria hospitalization and GSK medically significant). The patient was treated with blood transfusion, auxiliary products (Blood Transfusion). On an unknown date, the outcome of the lymphoma was not recovered/not resolved and the outcome of the hemoglobin decreased was recovered/resolved and the outcome of the black stools and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the lymphoma, hemoglobin decreased and black stools to be related to Shingrix.  Additional details were provided as follows: The patient received a 2nd dose of Shingrix on 26th August 2019, which led to shortening of vaccination schedule. The patient went in to have some blood tests and discovered that his hemoglobin level was 10 (low) and patient had black stools.  The patient's hemoglobin then decreased to 7.5. The patient was hospitalized and received a blood transfusion which increased his hemoglobin. After the blood transfusion, the patient's hemoglobin increased to 9.5 then eventually to 10.2.  The patient stated that around this time he was diagnosed with lymphoma and has a spot on his right kidney and his duodenum.  The patient will start receiving aggressive chemotherapy in 3 weeks. The reporter consented to follow up. It was unknown if the reporter considered the lymphoma, hemoglobin decreased and black stools to be related to tetanus toxoid (tetanus vaccine).
48 hours after injection neck stiffness and pain moving in any direction which has persisted for 3 days; 48 hours after injection neck stiffness and pain moving in any direction which has persisted for 3 days; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 30-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 09:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and hemangioma cavernous. The patient had no known allergies to food, medicine or other products. Concomitant medications taken within two weeks prior to the vaccination included bupropion (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN) both from unknown date for unknown indication. 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 06Apr2021 at 15:00, 30 hours after injection, the patient experienced severe stomach pain, vomiting, diarrhea, fatigue. On 07Apr2021 at 09:00, 48 hours after injection, the patient experienced neck stiffness and pain moving in any direction which had persisted for three days. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue and 48 hours after injection neck stiffness and pain moving in any direction which had persisted for 3 days was not  resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Started noticing that my glands in my neck on left side were swollen. At the same time, I started becoming overwhelmed with fatigue. Not my normal energetic self. I had a headache on left side of my head. I really did not feel like myself. I saw my doctor two days after that, a PA in my doctor's office, and she surmised by palpitating the glands that I had a virus. She told me to come back in three weeks to see if anything had changed.  The symptoms - the glands - three of those were quite swollen along left side of neck - after 7 days they went down; except one by my ear is still swollen at times - the swelling comes and goes. Was hospitalized for three days. I went to ER and was hospitalized - July 30th -Headache - felt like left eyeball was being pushed out my head; No treatment to go home with. I went to Dr. - he did blood tests and MRA on the Wednesday after getting out of the hospital on Monday. The MRA was normal and everything was normal on the blood tests. I still have occasional headaches above my left eyebrow. That is unusual for me as I am not a headache sufferer. I don't get them all the time; just get them randomly and can't pinpoint anything that is triggering them.
On 08/23/01 this patient had elevated pink area on the back of left at the site of MMR, diameter 1 1/2 inch.
2 days after shot (4/4/3021) experienced severe stomach pain and diarrhea that lasted 2 days. Had to go to hospital and get pain med to handle pain.
Headache, Myalgia, soreness, muscle aches, tiredness, headache- after 2nd dose Narrative:
Patient developed a half dollar sized welt that was red and painful. He was taken to the Emergency Room and was told it was just a reaction to the vaccination.
1/6- had congestion, shortness of breath and headache; 1/8 and 1/9- low grade fever (also reports recent potential exposure to COVID-19)
Symptoms started on 6/13 with nausea, body aches, severe neck pain / stiffness, inflamed lymph nodes, fatigue, and a slight sore throat.  The main complaint would be the stiff neck and associated pain.  Ibuprofen 800-1600mg daily controlled the symptoms.  On 6/21 I developed full blown covid with fatigue, loss of smell/taste, body aches, fever, severe sort throat, cough, headache, and nausea.
Immediately developed swelling at site of injection; twenty minutes later developed lightheadedness, scratchy throat, emesis, and coughing.  Received IM epinephrine, prednisone, diphenhydramine, ranitidine, prednisone.  Symptoms resolved within minutes of receiving epinephrine.
Injection painless. Within 30 seconds tingling in left arm. Within an hour confusion/brain fog, tingling and swelling in arm and at injection site, body aches, fever, chills, feeling unwell, racing heartbeat, feeling panicky, felt unwell in my brain for a period of two weeks.   After day 12 still having side effects, numbness, tingling in my arm shoulder and across my back. I have canceled my second vaccine and do not intend I?m getting another until I get a call from you. I would like to speak with someone about the symptoms and why they occurred.