chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JAN-2022 after the 9 months of vaccination, the patient experienced covid-19 infection (coded to suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority.  .; Sender's Comments: V0; 20220145028-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
PATIENT STATES INJECTION SITE GOT HARD, SWOLLEN AND HOT RIGHT AWAY, AND THEN PAIN IN ARM GOT PROGRESSIVELY WORSE. SHE HAS DIFFICULTY LIFTING HER ARM AND STILL FEELS A HARD SPOT AT SITE OF INJECTION.  ADVISED PATIENT TO SEE HER DOCTOR.
My younger Brother Received the PFIZER Injections in Jan and Feb of 2021. I Had visited with him the beginning of June 2021 for several hours and everything seemed okay at that time. on the morning of the 23rd I received a call from the assisted living facility that patient was Found on the floor near his room. The staff administered CPR until the emergency services arrived. That stated that patient was blue. At the ER at Hospital in town they were keeping his heart going. They (DR. in the ER) conducted a head xray to see if any head trauma which was none. However it was noted that there was severe fluid around his heart! He was pronounced dead that afternoon. When I called his primary care doctor and informed him of patient passing, he was shocked! He was even concerned because he had received the Pfizer injections as well. Brother (Private). Patient was heading back downstairs after his breakfast that morning when he collapsed on the floor and was blue.  In fact patient was receiving messages that day from one of his doctors about him missing his morning doctor appointments. In my opinion this is an Vaccine Adverse Event. One can not explain the massive amount of fluid around his heart. In the beginning of June he did not complain about any health issues. Patient was two years younger than me and we both graduated from school and had the same job. We both received multiple injections at our job and as children. Nothing like this.
Slight Headache (After first v accine); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight Headache (After first v accine)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (Slight Headache (After first v accine)). At the time of the report, HEADACHE (Slight Headache (After first v accine)) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I was in A Fib; feel strange; felt like my heart was racing; I felt shaky; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL963), via an unspecified route of administration on 26Jan2021 12:00 at single dose in the left arm for COVID-19 immunization. The patient medical history included borderline high blood pressure, high cholesterol, Hashimoto's, hypothyroid. The patient's concomitant medications included rosuvastatin, levothyroxine sodium (LEVOXYL), hydrochlorothiazide and lisinpro received within 2 weeks of vaccination. The patient previously took ezetimibe (ZETIA) and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. After sitting in recovery room for about 10 minutes following injection patient began to feel strange. Patient called the nurse on duty and said she felt like her heart was racing. The nurse took her BP and pulseox and administered a mini EKG. Then the nurse called the EMT on duty who gave patient a six leader EKG and said patient was in A Fib. Asked if patient had ever had A fib before, patient said no. Then asked if patient wanted to go to the hospital, patient said no. After sitting with the EMT for five minutes or so another EKG showed patient was no longer in A Fib. Patient felt shaky for the rest of the day, but is normal now. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Outcome of the events was recovering.
A few hours after receiving the J & J vaccine, instead of feeling the noted expected possible symptoms I began to feel very different from my daily medical norm of pain, pins, and needles and tingling. I started to feel unusually well and my daily medical norm started to subside substantially. This continued for approximately three days before everything returned to what has been my normal for many years.   Since I am under continuous doctor care, I notified my doctor of the vaccination effect, asking about the possibility of another shot for the same relief. The doctor said no to my request and stated that since the effect of the vaccination was advantageous and not adverse, interested parties may wish to be informed. I am not sure how many people have had the same advantageous effect with the Johnson & Johnson vaccine but, it would be nice to know. Thank you.
Raspy voice, losing voice, chest congestion, cough (like whooping-dry), elevated temp (no taken), pale, weak, dizzy, & light-headed; MD did not see pt but ordered Amoxicillin & decongestant;
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.
This spontaneous report has been received from a Nurse, concerning a 70 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On an unknown date in 2016 (reported as "last year", the patient was vaccinated with a dose of PREVNAR 13 (dose, strength, route of administration were not provided) for prophylaxis. Then approximately in April 2017 (reported as within the last month), the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular, lot # reported as N0039997 and expiration date of 20-OCT-2018 (dose and frequency were not provided) for prophylaxis. In April 2017, the patient experienced blood red areas around the arm (erythema), swollen, warm to touch, nothing at the injection site. The patient was treated with MEDROL dose pack and ATARAX as also experienced itching. It was unknown by the reporter if laboratories studies were performed. The patient was recovering from these events on an unknown date in April 2017. However, in April 2017, the patient died. It was unknown whether an autopsy was performed. The patient's cause of death was not provided. The causal relationship between the therapy with PNEUMOVAX23 and the events of blood red areas around the arm, swollen, warm to touch, itching and death was not reported. Upon internal review the patient's death was considered medically significant. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1705USA004706: US-009507513-1705USA004705.
First vaccine given on 03/05/21 were listed side effects ,  achy joints and fatigue and very very sore arm lasting over 1 week.  The sore joints and fatigue only lasted 48 hrs. The second vaccine as listed in this report, given on 4/2/21 cause fever up to 102, achy joints, nausea and extreme fatigue.  I also had swollen lymph nodes under arm injected and swollen glads under my chin on side of injection and the unexpected side effect of extreme tooth pain on upper and lower teeth only on side of injection.  (Left). The tooth pain was almost all teeth on the left upper and lower mouth . Nerve like pain. I thought maybe it was a coincidence, but it started resolving at same time and rate as other symptoms and now my teeth seem fine. It was probably the worst of the side affects cause I could not eat or drink anything hot or cold without pain.  It took 3.5 days for all symptoms to subside but they all went away including the tooth pain.
A 35 month old male received an injection of Prevnar on 12/5/00 and 2 hours, post vax, he experienced a seizure. The pt was seen in the ER and then admitted to the hospital. As of 12/6/00, the pt was still hospitalized.
She has had a sore arm after the dose yesterday as usual; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She has had a sore arm after the dose yesterday as usual) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for an unknown indication.    No Medical History information was reported.   On 05-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (She has had a sore arm after the dose yesterday as usual). At the time of the report, PAIN IN EXTREMITY (She has had a sore arm after the dose yesterday as usual) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. She has received 7 doses of the Moderna COVID-19 vaccines, on 3MAR2021 with lot number 027A21A, on 31MAR2021 with lot number 039A21A, on18AUG2021 with lot number unknown, on 24FEB2022 with lot number 022521A, on 29SEP2022 with lot number A57146B, on 25APR2023 with lot number unknown, on 5OCT2023 with lot number unknown. Patient had a sore arm after the dose that day as usual. She was concerned for reduced efficacy because of the medication interaction. Nurse noted that with this medication the vaccine may have a diminished effect reducing the efficacy of the Moderna vaccine. At her 7th dose, nurse told that because she was taking the medication Jakafi she would have a diminished efficacy from the vaccine. Treatment information was not reported.
Nursing noticed R sided facial droop.  Resident sent to ED on 10/25/2021, CT head which was negative and resident passed swallow screen.  Family opted to have her come back rather than admission for CVA w/u.  MD reported because she is unable to raise R eyebrow and close R eye, meaning both hemispheres affected, more likely Bells Palsy
Information has been received from a physician concerning a 7 year old female who on approximately 14-MAR-2008 was vaccinated with a second dose of VARIVAX (Merck).  Subsequently the patient fainted in the office about 10-15 minutes after receiving her second dose of the vaccine.  No other information was available at the time.  Unspecified medical attention was sought, in the physician's office.  The outcome was reported as recovered.  There was no product quality complaint.  Additional information has been requested.
No adverse event observed.  Adult dose of Hepatitis B vaccine was mistakenly administered instead of pediatric dosage. Dept of health contacted and patient's family notified.
SHINGRIX VACCINE INJECTION #1: WENT TO LOCAL ED DUE TO FAST HR, FEVER, WEAKNESS - WAS DC'D IN A COUPLE HOURS AND SYMPTOMS LASTED ONLY 3 DAYS.  SHINGRIX VACCINE INJECTION #2 (THIS EPISODE): PATIENT REPORTS RAPID HR, WEAKNESS, DIZZINESS, FEVER, WHICH HAVE LASTED 13 DAYS. TODAY WAS THE FIRST DAY SHE WOKE UP AND DID NOT HAVE A RAPID HEART RATE.
Injection site very swollen, both breasts and lymph nodes were very swollen, joint, Body pain and extreme fatigue. This started the next day after my injection and Lasted 2 days
Mild soreness at the site of the injection beginning about two hours after the injection. Took Tylenol about four hours after the injection.  Soreness went away fairly quickly after taking the Tylenol.  Had only a fairly slight soreness during day two.  No soreness from day three onward.
Had sore arm; Abdominal cramp; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (Solution for Injection, Lot/Batch number and expiration date: unknown), via an unspecified route on an unknown date, as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot/Batch number and expiration date: unknown) for covid-19 immunization and experienced I had was a sore arm. On an unknown date, the patient experienced had sore arm and abdominal cramp. The patient reported that, received second dose last night and my arm got a little sore few hours later and now experiencing a little bit of abdominal cramp I didn't experience that last time and I was looking on the list of side effects and I didn't necessarily see that and I just wanted to make sure is that a normal reaction. The clinical outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Serious Tinnitus  Also had tiredness fever, sore arm, headache that pass after three days. Tinnitus has not gotten better.
Mental fog; Extreme body ache; Fever; Chills; Fatigue; Swollen Lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 11:45 (Lot number: ff8841) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPRINTEC. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: en6199, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 32 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en5318, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 32 years old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Mental fog"; PAIN (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Extreme body ache"; PYREXIA (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Fatigue"; LYMPHADENOPATHY (non-serious) with onset 03Nov2021 15:00, outcome "recovering", described as "Swollen Lymph nodes". Therapeutic measures were taken as a result of feeling abnormal, pain, pyrexia, chills, fatigue, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient took Sprintec within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Patient received treatment of Acetaminophen for the events. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
A couple of pox noted by school nurse 11-21-06. Sibling diagnosed with chicken pox 11-16-06.
1 of 2 pts immunized from the same pnu-immune lot# who exp an adverse event;pt vaxed 2FEB95 & devel redness,tenderness & swelling (3cm) @ inj site;nausea,chills & fever;tx w/APAP;5 days later 7FEB devel sore throat,congestion,laryngitis
Muscle pain and stiffness, more on the left side where I received vaccine. Fever 1/18/21@2100hrs-101.4/1/19-20/21@ throughout evening Headache
Large area of redness and pain to the injection site. Not improving. No tx administered d/t no s/s of fever, vomiting, or rash.
Pt pregnant at time of vaccinations 7/08 unknown to PCP. 7/16 mom came to tell PCP of pregnancy.
Covid breakthrough case. Pt presented to ER on 6/23/22 with c/o chills, runny nose, congestion, headache, cough and body aches x 1 day. Hx of moderna vaccine x 2 doses. DC home.
Experienced minor fatigue; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer, the patient. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 08Mar2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced minor fatigue on an unspecified date. Clinical outcome of minor fatigue was unknown.   Follow-up (04Apr2021): No follow-up attempts are possible; information about lot number cannot be obtained.
Pt received vaccine on 7/10/12. On 7/11/12 pt noticed that her arm was a little red and swollen; localized to the site vaccine was given. On 7/13/12 she came to the pharmacy to get a second opinion and report it to us. Pt mentions that it has gotten better every day. She was recommended to put cold compresses and see a doctor if it gets worse.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium
This spontaneous report was received from a nurse concerning a patient unknown gender and age. The patient's pertinent medical history and drug reactions or allergies were not reported. On 08-JUL-2015, the patient was inadvertently administered a dose of VARIVAX (Merck) (dose and lot# not provided) subcutaneous, instead of the intended dose of ZOSTAVAX. The ZOSTAVAX was not administered. No adverse effect was reported. No product confusion was reported. Additional information has been requested.
Swollen lymph nodes, fever, headache, body aches, stomach upset for 3 days
Arm turned and stayed real red for about 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm turned and stayed real red for about 2 weeks) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Arm turned and stayed real red for about 2 weeks). At the time of the report, ERYTHEMA (Arm turned and stayed real red for about 2 weeks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-390656 (Patient Link).
13 days after the vaccine, there is a red streak on my left arm  and my arm feels hot. These were the same symptoms that I had initially and on the second day. This went away after 48 hours.   Sometimes my body has a week delay to severe problems like pain, that is a normal cycle for me.
No further AE information available.; HCP called to report that 2 doses of VAXNEUVANCE were given after a TE.; This spontaneous report was received from a nurse referring to two patients of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On an unknown date, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) experienced temperature excursion with 46.67 Fahrenheit degrees for 3 Hours 0 Minutes 0 Seconds. There was no previous temperature excursion.    On an unknown date in 2023 (reported as at some point during the last 20 days), the patients were vaccinated with 2 doses of improperly stored r pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) (lot # W036242, expiration date 01-OCT-2024; strength was not reported) for prophylaxis (product storage error). HCP reported no symptoms. No product quality complaint (PQC) was reported.  This case was considered non-valid due to lack of patients identifiers.
cold sweats  after the first or the second dose of vaccine; got chills  after the first or the second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats  after the first or the second dose of vaccine) and CHILLS (got chills  after the first or the second dose of vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026521A, 021C21A and 032F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLD SWEAT (cold sweats  after the first or the second dose of vaccine) and CHILLS (got chills  after the first or the second dose of vaccine). At the time of the report, COLD SWEAT (cold sweats  after the first or the second dose of vaccine) and CHILLS (got chills  after the first or the second dose of vaccine) outcome was unknown.            No concomitant medication information provided.  It was reported that patient was having trouble reading the writing on the card. The patient did not remember after which vaccine that she had these reactions.  The patient did not remember which arm she had received the first, second and booster dose.   The patient reported no adverse reactions or side effects after booster dose.  Expiration date was not available for first, second and booster dose.  No treatment information provided.