chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lost hearing in the left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Lost hearing in the left ear) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030L20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DEAFNESS UNILATERAL (Lost hearing in the left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Lost hearing in the left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) everything done but it is not showing why she death in that ear.         Patient is taking other medication.  Treatment medication was not provided by the reporter.  Company comment: This case concerns a 75 year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Deafness unilateral. The event occurred approximately 4 to 6 weeks after the second dose of Moderna COVID-19 vaccine, exact date not provided. The rechallenge was not applicable since it occurred after the second dose and outcome is unknown. Patient´s advanced age remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-376403 (Patient Link).; Sender's Comments: This case concerns a 75 year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Deafness unilateral. The event occurred approximately 4 to 6 weeks after the second dose of Moderna COVID-19 vaccine, exact date not provided. The rechallenge was not applicable since it occurred after the second dose and outcome is unknown. Patient´s advanced age remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Adverse event information provided in this submission, is per a report received by Health Department from a submitting facility. Health Department does not have any further information on this patient remaining hospital course or outcome. Please contact Hospital for any and all additional follow up.   Covid-19 vaccination information is from Immunization Registry.  MODERNA 3/11/2021 LOT # 001B21A  MODERNA 4/8/2021 LOT # 038B21A  MODERNA 12/22/2021 LOT # 013F21A  MODERNA BvlntBstr 10/3/2022 LOT # AS7148B  Admitted TO HOSPTIAL 11/13/2022 Per note submitted: ?Patient was sent to ED from her nursing home because of shortness of breath, cough and generalized weakness. Patient denies any chest pain, palpitations, lightheadedness etc. She is a poor historian and hence much of the information is obtained from previous notes. Review of systems is negative for any the findings. States to be compliant with her medications. Social history is negative for tobacco, alcohol or any recreational drugs. Upon examination of the bedside patient was lying in the bed in no apparent distress. She appeared weak. Her vitals are notable for T-max of 99.8, heart rate in the 70s, respirate r ate of 22 blood pressure was 125/72. She was saturating 100% on 3 L nasal cannula. Of note is the patient's saturation on admission was 85% on room air. Chemistry was notable for creatinine of 1.01 with BUN of 21 and GFR of 40. Troponin and CK within normal limit. CBC unremarkable. UA was positive for leukocyte esterase, nitrites, WBCs and bacteria. Chest x-ray was unremarkable. Patient was given empiric antibiotics, steroids in the E D and is being admitted to hospital for further management.? Health Department does not have any further information on this patient remaining hospital course or outcome. Contact Hospital for any and all additional follow up.
he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021; he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Fall in January 2021.   On 27-Jan-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021) had resolved.            Concomitant medication and treatment drug were not reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.
I attributed the initial left bicep muscle aches to a common reaction to injections; however deep throbbing and aching in left bicep continued; and eventually my left bicep was hard and rigid; the muscle would spasm uncontrollably and with the least amount of movement of the arm. The spasms felt as if an electrical impulse was being sent through my arm; during the spasms I became extremely nauseous; I often walked as if I had had too much alcohol to drink, only thing, I don't drink alcohol. I was unable to lift my arm which caused doctors to believe I had a rotator cuff tear - tested NEGATIVE. I was told I had frozen shoulder because I couldn't move my arm, but the excruciating pain was not in my shoulder, it was in the bicep muscle. I contacted the health department for the state and was told that the nurse who administered the injection probably used an incorrect size needle and that was most likely causing my problem. When I experienced the muscle spasm, I could not move my arm in any direction, it was as if my arm was locked in the position it was in when the spasm started. I couldn't lie on the left side of my body due to the excruciating pain. In late December 2007, the pain and muscle spasms became bilateral and transferred to the right bicep muscle. I then experienced the same pain, throbbing, and muscle spasms in the right arm, eventually unable to move or lift the right arm. I had a high ANA count which caused doctors to believe I had an autoimmune disease - I have been tested for several - all negative. I experienced the pain from the onset, however I believed others that the nurse stuck a nerve that I waited until 5 months after the symptoms began before bringing it to the attention of the doctor's office that administered the injection, only to be told that I didn't have a a reaction to the injection, that I was most likely ill or getting ill at the time I got the vaccine. Recently within the last month (May 2009) I no longer have the muscle spasms and can now lift my arms, however I do have considerable muscle weakness in both arms, but the right arm is displaying a greater weakness over the left arm. It is difficult lifting many things, even pillows off the bed. In item #8, I checked "required emergency room/doctor visit. I did not go to the emergency room, but have visited 3 MDs (General/Family Practice); 2 neurologists; 2 orthopedic surgeons; 1 Rheumatologist.
Fever (101); chills; aches; a mild cough; started to get itchy red spots in a few places on my body; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 46-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in Left arm on 03May2021 12:30 pm (46-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient's medical history was reported as none. The concomitant medications were reported as none. The patient received ibuprofen (IBUPROFEN) and experienced allergy. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in Left arm on 05Apr2021 at 12:30 pm (46-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient does not have COVID prior to vaccination. The patient was tested positive since vaccination. On 04May2021 (reported as 12:00 am), the day after vaccination, the patient experienced Fever (101), chills, aches and a mild cough. The patient also started to get itchy red spots in a few places on body. Had mild symptoms the day after the second shot and then again on Sunday 09May. The. Starting the night of 14May I started to experience more severe symptoms. Fever (101), chills, aches and a mild cough. Also, started to get itchy red spots in a few places on my body. The symptoms seem to come and go in severity, but usually worst at night. They persist as of today 17May. No treatment was received for the events. The patient underwent lab tests which included Body temperature  101 (fever) on 04May2021 and PCR Abott ID NOW (nasal swab) negative on 17May2021. The outcome of the events were Not recovered as of 17May.  Follow-up attempts completed. No further information expected.
about 30 minutes after shot was given, arm started itching a lot and started feeling sore and heavy. following day, the site where the vaccine was given was red swollen and had a big bump, felt hot to the touch and was still itching, swollen and redness lump lasted about 2 days. to this day it is still itching, bump in almost gone but still red.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 22-OCT-2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), at a healthcare facility as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated (by an unspecified healthcare worker) at a health care facility, for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Rcvd vaccine (PNEUMOVAX) on 1/10/11. Next day severe redness, tenderness. Increasing pain, fever and lethargy. To hospital by ambulance on 1/12/11. Tx'd with IV abx and released on 1/16/11. Will require cont'd IV tx x 3-4 weeks (Pt. statement).
Pain in neck, base of scull, shoulder and back on right side one week later for 2 to three days.
Stomach cramps started early morning March 23. By day break, had sharp pains from head to toe. Also, chills, dizzy, light headed and migraine. All symptoms were gone by Wednesday, March 27.
Patient received extra 4th dose of Hib when it was not needed per manufacturers guidelines, no adverse effect reported, Manufacturer states per CDC, no harm with extra dose and to monitor for side effects per usual.
Extreme fatigue, extreme muscle soreness, extreme joint pain, and as the day wore on, torso on fire, limbs cold and 2 hours of shivers, extreme headache, no sleep for 24 hours, extreme thirst and dryness.
Received Jannsen Covid vaccine.  5 days later her INR (blood thinner test) was at 5.0 which is much higher than the 2-3 normal.  Usually this only happens when she is on an antibiotic, but she has not taken an antibiotic in months.  The ONLY thing that changed was her vaccination.  Not sure if it is related, but thought we would report it.  Was able to get it back to normal after decreasing coumadin for a few days.
Reported large rash 48 hours after initial immunization on upper right arm ( site of shingrix injection). Site was warm, blotchy red, larger than 5 inches
Vomiting, nausea, fever, malice, extreme shivering, feeling very cold, night sweats, headache, body aches, right arm pain at injection site. I started feeling ill that same night as the booster. I vomited while sitting on the toilet and had to struggle to get off the toilet and walk to bed. I spent the following 2 days in bed, was so weak and tired I could hardly move. I had no appetite, did not eat and was so nauseous I didn't want to take any of my medications. It was a very hard struggle to get up to go to the bathroom. Thursday and today I was able to get out of bed and get myself dressed.  At this time I still feel nauseas, no appetite, and very tired. Very slowly recovering. My 2nd dose I was in the hospital for 7 days as I passed out after I vomited. I am not going to get any more boosters.
Fever of 101.7 degrees, rash & allergic reaction (raised red area) at injection site - rash spread to underside of arm & last several weeks.
More than 48 hrs post vax, pt developed generalized macular, patchy rash. She had minimal itching. At date of report, face looks slightly puffy with rough skin. Pt taken to ER on 7/1/01 and given Benadryl. She had appt with MD on 7/2/01.
Pt experienced rash on chest & discomfort starting a few days after Tdap shot (approx 8/12-8/14). Pt. finally went to ER & was diagnosed w/ shingles - pt. says Tdap triggered shingles reaction. (No major pain noted at injection site.)
No adverse event occurred.  Patient was given booster dose of monovalent COVID 19 vaccine instead of bivalent as vaccine history was not on file at our office and was not communicated.  Nurse administering this thought this was patient's first dose of COVID 19 vaccine as wasn't made aware of other doses until after the injection was given.
Burning in arm during shot process. Followed by burning down your arm right after shot. That evening, itching down arm and palm of hand along with start of blister on underside of upper arm. While itching arm there was a burning sensation. Next morning start of blisters at shot side, under upper arm and on palm of hand between thumb and 1st first. Small blisters started to appear over full arm. Started BENADRYL the 1st morning after shot at recommendation of pharmacist. Symptoms worsened by the 2nd day and went to ER. Treated for allergic reaction to shot....shot of BENADRYL, prednisone pills.
Patient was 17 y/o at the time of the vaccine. The state went into next phase following week.
Fever up to 104-105 F for 2 days.  9/17/07 Case closed with hospital D/C summary that accompanied report.  Summary reveals patient experienced fever, vomiting, diarrhea, decreased oral intake, dehydration, anemia, irritability, increased sleepiness, & bulging fontanelle.  Admitted 8/30-9/10/2007.  Extensive w/u done & tx w/IV antibiotics.  Improved & D/C to home w/PICC line for continued IV antibiotics & additional renal w/u. FINAL DX: E.coli  UTI, pyelonephritis, bacteremia; presumed meningitis secondary to clinical diagnosis.
Fatigue; I became ill; I had pain in the injection site; Fever at the injection site; Vomited; Diarrhea; Body fever; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Mar2023 at 07:45 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; LIPITOR; ACTOS. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious) all with onset Mar2023, outcome "not recovered" and all described as "I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit"; PYREXIA (non-serious) with onset 24Mar2023, outcome "unknown", described as "Body fever"; DIARRHOEA (non-serious) with onset 24Mar2023, outcome "unknown", described as "Diarrhea"; VACCINATION SITE WARMTH (non-serious) with onset 24Mar2023, outcome "unknown", described as "Fever at the injection site"; VACCINATION SITE PAIN (non-serious) with onset 24Mar2023, outcome "unknown", described as "I had pain in the injection site"; VOMITING (non-serious) with onset 24Mar2023, outcome "unknown", described as "Vomited"; MALAISE (non-serious) with onset 24Mar2023 at 15:00, outcome "unknown", described as "I became ill"; FATIGUE (non-serious) with onset 25Mar2023, outcome "recovering".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
10/20/23 extreme fatigue 10/21/23 woke with pounding heartbeat that subsided after an hour, then fatigue. When resting in bed at 3pm, Fitness Watch vibrated with alarm about heart rate over 120 Taken by ambulance to Hospital emergency, and hospitalized until next night Treated for dehydration and tachycardia
Information regarding Prevnar was received from a Physician regarding a female patient who experienced pneumococcal disease. The patient received a dose on an unspecified date. The patient's concurrent illness includes cochlea implant (had not received Pneumovax). Concomitant medications were not reported. On an unspecified date, the patient experienced pneumococcal disease and died. The cause of death was reported as pneumococcal infection. CSF culture (results: Streptococcal pneumoniae serotype 19A) was done on an unspecified date. No additional information was available at the time of this report.
The employee came into the flu clinic today to receive her annual influenza vaccination. The employee reviewed the screening questions and answered no to all of the above. The employee stated that she has had her annual flu vaccines every year for the last 7 years. RN administered the flu vaccine to the employees left arm at 0947. The employee tolerated the shot well. The RN was speaking with the employee when the employee was started to clear her throat. The employee stated that it was hard to breathe and that her throat felt itchy at 0950. The employee also stated that she felt light headed. The RN asked the writer if there was any orange juice or snacks for the employee. The writer ran to grab the employee some orange juice and gave her one Benadryl 25mg at 0955. The employees face was red and her throat was splotchy. The employee sat with the writer for about 10 minutes after taking the Benadryl and stated that she was feeling better. The writer let the employee complete her stations and checked in with her afterwards. The writer notified the employee that she should no longer receive the flu vaccine unless she goes to her primary care provider and should not have her COVID booster either. The employee agrees with this plan. Will plan to follow up later. Signed on 9/26/2023 at 10:29am
unspecified route of administration on an unknown date (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer 10 years ago. The patient did not have any known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and venlafaxine hydrochloride (EFFEXOR) 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 15Mar2021 at 16:00, the patient experienced shaky, nausea, diarrhea, couldn't walk, headache  and fever. Therapeutic measures were taken as a result of  the events included treatment with TYLENOL ,ADVIL, ZOFRON and IMODIUM. The clinical outcomes of the events shaky, nausea, diarrhea, couldn't walk, headache, fever were not recovered at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
12/06/2001 4:40 PM Benadryl 125 mg PO given at 4:55 PM.
On 08/16/2021 at 04:00AM, I wear a living smart watch that detects A-fib. That is how I know that I went into A-fib at that point and time. I spoke with my doctor, he had me wear a heart monitor for 2 weeks. I had a follow up appointment, then they performed a cardio aversion.