chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEAD; This spontaneous report received from a consumer via a company representative via Social media concerned 14 patients of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the reporter stated that, " thanks to the poison vaccines I have 14 dead relatives and friends ". On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case is a duplicate of 20220527210. This case, from the same reporter is linked to 20220126450, 20220126177, 20220126174, 20220126211, 20220126582, 20220126614 and 20220126701.  Additional information was received from consumer on 12-MAY-2022. It was determined that Manufacturer Case Number was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number. The following information was updated and incorporated into the case narrative: social media added as source, reporter added, patients number updated from 12 to 14 in narrative.; Sender's Comments: V1: Additional information received is regarding Manufacturer Case Number was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number and social media added as source, reporter added, patients number updated from 12 to 14 in narrative. This follow up information received does not alter the assessment of prior company causality of previously reported event.  20220126708-COVID-19 VACCINE AD26.COV2.S-Dead. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pain during the night.  Worse pain, nausea, aches, headache, diarrhea, lethargy.
Tinnitus/Sudden onset on ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 22Mar2021 09:00 (Batch/Lot number: unknown) at the age of 54 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 22Mar2021 10:00, outcome "unknown", described as "Tinnitus/Sudden onset on ringing in ears". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since having the vaccine. It was reported that the patient never had sudden onset of ringing in ears before.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient verbalized fever, nausea, sore arm, trouble mobilizing arm, chills, vomiting, decreased range of motion, weak arm, and pain in her arm.  Patient treated with Tylenol, heat, and ice.   X-ray of right shoulder, CBC, CRP, and sed rate were ordered at visit on 3/29/2023.
Vaccine was administer too high on the arm and infiltrated the bursa sack around the shoulder joint of the left arm.  The patient alternated ice and heat on the shoulder joint, self administered ibuprofen, and exercised the arm for 48 hours.  The patient was unable to lift the arm more than 20 degrees, in front or to the side.  The pain resolved in about 60 hours. She has no residual affects.
Very swollen painful lymph nodes under jaw on left side. First noticed 3/11. Remained swollen to date (3/17)
Fever and chills began at  3 am. Fatigue and headache started at 4 am.
11-03-05 moist mouth breathing no verbal response. Flaccid rt arm. Bilateral rhonchi yellow phlegm. 11-04-05 Verbally responding in the am Drank water. Expired 11-05-05 at 11pm. Death certificate states respiratory failure and pneumonia as cause of death.
Psoriasis flare up/break out on left butttocks; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220607090(0.0) (Janssen Research & Development, LLC).  A male patient in his 50's received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 20Oct2017 (ongoing) (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history included: "Psoriatic Arthritis" (ongoing), notes: continue yes; "Moderate to severe  Chronic Plaque Psoriasis" (ongoing), notes: continue yes; "Interchange of vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare up/break out on left butttocks"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "sore arm". The action taken for adalimumab was unknown.  Additional information: The patient received covid-19 vaccine (dose number 1) (suspension for Injection), intramuscular, on 10Apr2021 for prophylactic vaccination. Age at time vaccination 53 years old. The batch number was not reported. On an unspecified date, the patient experienced psoriasis flare up/ breakout on left but tocks and sore arm (dose number 1). The patient received non-company suspect drug Humira (adalimumab) solution for injection in pre filled pen on 27Oct2017 for Psoriatic  arthritis and moderate  to severe chronic plaque psoriasis. The patient had not recovered from psoriasis flare up/ break our on left but tocks, and the outcome of sore arm was not reported. Action taken with Tozinameran was not reported and dose of Adalimumab was not changed. The reporter and the manufacturer assessed the causality of events as possibly related to Janssen coviD-19 vaccine; however the causality between the events and other vaccines was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness Narrative:  Employee was given the Moderna Covid vaccine at approximately 1106 am. Patient was placed on a 30 minute monitor due to her hx of having a severe allergic reaction to Penicillin. At the end of the 30 minutes (at approximately 1136), patient reported having dizziness. When questioned if this was a new symptom for her she reported that she has had vertigo in the past when she had a sinus infection but has not experienced vertigo recently. Patient's VS were immediately taken. Results 98.2-60-20-150/83 (Sitting-LA 156/87 (Sitting-RA) SAO2 98%-RA Pain=0. Patient denied chest pain, SOB, or itching/rash/hives, and was in no apparent distress. This nurse informed patient that 911 would have to be notified in order for her to be further assessed, and she agreed. 1142-911 was notified. Patient remained seated with no changes in condition. Leadership notified, and was on site at 1154, when EMT's arrived. Patient was transported off site at 1156.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-SEP-2015, the patient was vaccinated with the third dose of PNEUMOVAX 23 (lot # H021941, expiration date 11-APR-2014 (dose and route were not reported). No concomitant medications were reported. No adverse reactions were reported. No product quality complaint was involved. Additional information has been requested.
Moderna Covid vaccine #1 administered at 9:17am. Patient's arms, legs, abdomen, and head begin to itch at 9:30am. No breathing difficulty. Benadryl was provided to pt in the clinic. Patients condition improved and no additional action was needed. Pt was examined by Dr.  in the clinic.
Began feeling heart pounding and what felt like mild shock waves  traveling down neck. Persisted for about 5 or 10 minutes, subsided temporarily, but has reoccurred approximately twice each day since then (about 1 week). Usually occurs around 9:00 am and around 5:00 pm, and while resting or light physical activity. I also feel my heart begin to pound heavily at other times throughout the day (frequently, usually lasting for 5 or 10 minutes). These more frequent occurrences are not accompanied by the sensation of electric shock waves. I can still breathe normally.  I have not had this experience prior to the Covid vaccine.
Little illness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Little illness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included ANTICOAGULANT CITRATE DEXTROSE and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Little illness). At the time of the report, ILLNESS (Little illness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-259124 (Patient Link).
Onset of rhinorrhea & hives on neck & bilat shoulders, w/in 5 min of vaccine administration.
3rd COVID vaccine dose given on 2/4/22. Severe headache, onset 4 hours following vaccine administration, initially relived by Compazine, Benadryl and Toradol. Headache recurred 48 hours later and did not improve with Compazine, Benadryl and Toradol, which was repeated, followed by Prednisone. The patient was seen in the ER on 2/7/22 and given a third round of Compazine, Benadryl and Toradol. She was admitted to hospital and received 4 doses of DHE after which her headache improved. She was discharged from hospital on 2/9/22. She had similar symptoms following doses 1 and 2 and Pfizer vaccine in May and June 2021, VAERS report completed July 2021. CDC CISA consult performed prior to administration of dose 3, recommendations for Neurology consult and mitigation plan followed.
After both shots, have had adverse reactions. Head to toe blisters, enlarged lips, oral blisters, headaches, itchy all over. Have been on steroids 3 times. 6 to 7 days after steroid treatment ends the rash continues to return. I am currently in the beginnings of another outbreak. 1st shot on 01/05/2021. 2nd shot 02/02/2021. Today is 03/11/2021.
Nerve was hit in arm.  Unable to raise arm without shooting pain that goes from injection site to elbow to thumb.  Same thing happens if I try to pick up something with that hand.  More weight of item being picked up worse it is.
29MAY underarm red & peeling underarm & down side & back-under lt arm-devel white bumps; 26MAY very warm, no temp ck; c/o itchy given neosporin ointment;
After the first dose I had a large blood clot during menstruation; now I'm 6 days late with negative pregnancy tests; and with the next 2 cycles in May and June had no LH peak/ May and June periods were lighter than usual.; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: TW0158, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Apr2021 at 11:30 hours as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. The patient also received other vaccine (Lot Number: EW0179, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Apr2021 as dose 2 for immunization. Patient had no relevant medical history. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. Patient always had a consistent and predictable period. On 12May2021, after the first dose, patient had a large blood clot during menstruation, size of a walnut, patient also had blood clot test, for which results were unknown and with the next 2 cycles in May and June had no luteinizing hormone (LH) peak; although patient always had one for all prior cycles, patient had tested. Patient had gone to a fertility specialist and had been deemed more than ok to convince prior to vaccine. Nothing in her life had changed much and now, patient was 6 days late with negative pregnancy tests. Also, May and June periods were lighter than usual. Patient received no treatment for all the events. The outcome of all the events was unknown.   Follow-up attempts are needed. Further information is expected.
Patient up to date on Moderna COVID vaccinations who admitted to hospital with positive COVID test.  Provider d/c note below:  "Acute Pharyngitis -required intubation in the ER and remained on the vent until 1/10/22 -acute respiratory failure resolved, did not require supplemental oxygen upon dc -could be related to covid though cant exclude bacterial etiology, sputum cx with klebsiella, dc with 5 days of augmentin   History of Methamphetamine Use -pt denies any recent use in the past month -counseled ongoing cessation   Covid Positive -received remdesivir and regeneron   Hypertension -on hctz   Brief Admission History/Reason for Admission: Per H&P: This is a 67 yo male, with PMH significant for HTN, HLD, who presented to ED early this morning with complaints of a sore throat that started last evening prior to going to bed. Per ER notes, he awoke around 0030 today noting significantly worsened sore throat. He also reported a muffled voice and difficulty swallowing and managing secretions. He did not complain of any difficulty breathing. ED staff noted posterior oral edema, so decision was made to give decadron and racemic epi. CT of the neck was obtained, which revealed mucosal thickening and enhancement involving hypopharynx and larynx; no abscess. He was intubated in the ED without difficulty and subsequently OG was passed without difficulty. She was started on Unasyn and Vanco in ED and transferred to hospital for further care. Will continue decadron and Unasyn on admission.  Discussed case with ENT, who is in agreement with above plan. Will re-evaluate tomorrow afternoon for possible readiness for extubation.    He was incidentally noted to be COVID positive. He was started on Remdesivir and Regeneron. "
Narrative: Patient reported reaction to second dose of Moderna vaccine, BP dropped to 92/58, and I had vosovagal sycope, wasn't able get up for half an hour. Moderna COVID-19 Vaccine given previously Patient received a prior dose of the Moderna COVID-19 Vaccine. Date: April 11, 2021 Location: health center Patient received a prior dose of the Moderna COVID-19 Vaccine. Date: May 10, 2021 Location: health center
This is a spontaneous report from a contactable consumer (Patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731 ), dose 2 via an unspecified route of administration, administered in Arm Right on 10Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Left arm on 20Mar2021 as single dose for covid-19 immunisation, time the Vaccination Was Given (24 hour clock): 1626 (first dose). Patient her first dose, she had a swollen arm. She knew this was normal. She had no rash, but the swelling lasted quite a few days. That evening, she had night chills. She was feeling cold day and night. No matter how much or what she was wearing she was constantly cold. Eventually her arm swelling went down after 5 days. She iced, massaged and used the arm as advised, but it was the chills that were unbelievable. She had her 2nd dose on 10Apr2021. That one wiped her out. She never gets headaches, and she got a headache. She never has had a headache to compare. The headache started on Sunday in the middle of the night, it woke her up and has lasted until today. It is dissipating and she is taking Tylenol for it. She has joint pain everywhere, all over, her hands, feet, and everything. Caller added if this is a side effect, she hopes it goes away, she feels crippling. She has nausea all the time. She's forcing fluids. She ate toast to keep her stomach acids down so she wouldn't vomit. She knows it will go away. Caller asking how soon her symptoms will go away and how may persons have reported the same symptoms she is having. She has low blood pressure and knows what that feels like. With her chills she couldn't sleep or stop feeling cold or function. Her chills stopped on the 8th or 9th, caller confirmed 9Apr2021. Second dose, 10Apr2021, LOT number ER8731, right arm injection. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient did not have any Medical History (including any illness at time of vaccination). The outcome of the event Headache was recovering, for joint pain and Nausea was not recovered and for low blood pressure it was unknown.     No follow-up attempts are needed. No further information is expected.
Patient observed in observation complaining of small rash around his vaccinated arm. Patient declines shortness of breathe, and difficulty breathing.  No major distress noted. Patient give Benadryl 50 mg oral. Patient was monitored for five minutes for any changes of condition. Patient rash decreased. Patient was moved to passenger seat. Patient was released .
numbness; tingling on left side, left leg and foot; This is a spontaneous report from a contactable non-health care professional. A 33-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 on an unknown date in Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included zinc (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for unknown indication on an unknown date and unknown if ongoing. 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 vaccination. On 01Apr2021, three days after first vaccine, the patient experienced numbness, tingling on left side, left leg and foot, it had moved to fingers and right side now. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with unspecified medication. It was reported that the patient had MRI of neck and brain. The clinical outcome of the events numbness and tingling on left side, left leg and foot was not recovered at the time of this report.   No follow up attempts needed. Information about lot/batch number cannot be obtained.
High fever, extreme body aches and chills, headache and weakness. All lasting 24 hours. Headache and very mild body ache still lingers after 24 hours.
Pt experienced lightheadedness & a rapid heart rate.  1:27pm BP 146/94 AR 120; 1:35pm BP 130/80 AR 110; 2:10pm BP 120/82 AR 78; 2:35pm BP 128/78 AR 82
Patient's spouse stated that her whole left arm (down to her wrist) was swollen for a week after both immunizations were administered. Patient contacted her primary care doctor, but they never responded.
Several minutes after receiving the vaccine (between 10- 20 minutes), the child passed out standing up. She fell to the floor and convulsed for several seconds. She "came to" shortly thereafter and was fine.
Breakthrough case admission after 3 vaccines  Pfizer 3/23/21 Lot# EP6955;  Pfizer 4/14/21 Lot# Ew0164;  Pfizer 4/11/22  Lot# FK9893
On 3/16/23 at approximately 1040 a nurse alarm was called. At approximately 1041, RN arrive to find  PHN manager on scene with pt. 14 year old male, was found conscious, pale, and laying on floor of lobby accompanied by his mother. Per pt.'s mother shortly after receiving vaccines patient fainted and hit head on lobby floor prior to nurse arrival. Patient was alert to name, time, location, and situation. Patient reported feeling dizziness, numbness on hands and arms, and body feeling "heavy" prior to fall. Patient denied any current medications and history of syncope. Patient denied eating prior to vaccination. Patient's first set of vital signs were O2 99%, heart rate 70 bpm, blood pressure was 120/70. PHN assessed neuro status. Pt. could move all extremities and pupils were equal round reactive to light and accommodation. Per pt.'s mother pt.'s affect and demeanor were normal. Pt.'s color returned and pt. reported feeling shaky with symptoms improving. Pt.'s second set of vital signs were O2 99%, heart rate 83 bpm, blood pressure 115/70. Pt. reported feeling better. RNs assisted pt. to sitting position on floor. Pt. denied any dizziness and reported numbness localized to area where he bumped his head. RNs observed pt.'s head with redness on scalp and bump present where pt. reported numbness. RNs assisted pt. to wheelchair and provided client with icepack to place on head. PHN provided snack to pt. and pt. ate it. Pt. reported pain 1/10 at area where he bumped his head after placing icepack on area. Pt.'s third set of vital signs were O2 99%, 73 bpm, blood pressure 130/65. EMS offered to be called, pt.'s mother declined services. Pt.'s mother educated to monitor pt. closely for signs and symptoms of concussion and follow up with PCP. Pt.'s mother instructed to report to ED/UC if any changes in pt.'s behavior/level of consciousness. Pt.'s mother verbalized understanding and had no further questions. At approximately 1112 RNs assisted pt. via wheelchair to exit the building to their car accompanied by pt.'s mother. Pt. received Hep B, Flu, IPV, MMR, TDAP, and varicella vaccines.
I formed a very large mass just outside my buttocks hole. The doctor told me it formed because of a blood clot. It was very painful. I had no problem before. I was provided topical medication.