chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Lot number: EN6206, Expiration Date: 30Jun2021) at the age of 71 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN CITRATE taken for neoplasm malignant. The following information was reported: TASTE DISORDER (non-serious), outcome "unknown", described as "mouth taste really strange"; PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "lips kind of like salty all the time"; TOOTHACHE (non-serious), outcome "unknown", described as "teeth are aching"; DYSGEUSIA (non-serious), outcome "unknown", described as "odd taste in my mouth". Therapeutic measures were taken as a result of taste disorder, paraesthesia oral, toothache, and dysgeusia. Additional information: The retired nurse stated she had both of her doses of Pfizer, first one was on 10Mar2021 and second dose was 31Mar2021, on the news, it was said that people were experiencing like a mouth full of metal or mouth full of Nickle have you heard anything about that. No follow-up attempts are possible. No further information is expected.
5 month old male afebrile (97.8), mild URI, immunized with DTaP, IPV, HIB, and PCV about 14-20 hours prior to sudden death. Found lifeless in crib. Autopsy Report received on 1/25/2005 states bronchial pneumonia, tracheitis, and pulmonary edema.
A 22 month old female patient experienced fever and vomiting after receiving RabAvert for post exposure treatment. The patient received RabAvert ( dose and route unspecified ) on 08/20/2004 and 08/23/2004. The patient was also concomitantly treated with rabies immunoglobulin on 08/20/2004. She had no known drug allergies. Her past medical history and other concomitant medications were unspecified. The patient was scratched by a rabies infected stray rabbit and received rabbies immunoglobulin along with two doses of RabAvert as mentioned above. Approximately 10 hours post the second vaccination with RabAvert on 08/23/2004, she developed a fever of 101.5 degrees F (axillary) and vomited. She was given tylenol. On 08/24/2004, she continue to spike fevers ( temperature up to 102.4 degrees F ) and vomited. She was evaluated by a physician and a red throat was noted. Throat cultures were obtained and showed negative growth for Streptococcus. The patient was instructed to take Motrin every 4 hours. At the time of this report, the adverse events continued to persist. Follow up information received on 10/18/2004: The patient received additional doses of RabAvert on 08/24/2004, 09/02/2004 and 09/16/2004: The RabAvert lot number was provided. The fever reportedly persisted through 08/24/2004 and became low grade. Throat culture for streptococcus (group A ) was negitive on 08/24/2004. The fever completely resolved before the thrid dose of RabAvert on the 08/28/2004.
Information has been received from a registered nurse concerning an 84 year old Caucasian female patient who on 10/8/02 at approximately 2:30PM was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot # 643503/0541M), in the left deltoid. There was no illness at the time of the vaccination. On 10/10/02 the patient presented to the doctor's office with 1-2 days history of a skin lesion. The patient had a body temperature of 97.0 degrees F. The location of the lesion was reported to be the left upper arm extending from the elbow up into the axilla and down to her upper lateral chest wall. It was also noted that the patient experienced chills the night of vaccination. The patient initially felt bad and experienced pain and itching in the area. On 10/10/02 it was reported that the patient now feels better but the area of redness became larger. It caused the patient pain to raise her arm. There was redness in the entire left deltoid region with a red streak extending into the axilla and down into the left chest. Edema was noted in the elbow area with erythema. Warmth was also noted in the left deltoid region. There was no induration. The area was tender to palpatation. There was regional lymphadenopathy in the anterior axillary node, one node palpated which was tender. The patient was diagnosed with cellulitis. The patient was treated with cephalexin (Keflex) for 10 days and desloratadine (Clarinex). There were no relevant diagnostic tests or laboratory data. It was reported that the patient recovered. The reporter considered the patient's experience to be an other important medical event OMIC). It was also reported that another patient (WAES0210USA01927) had been vaccinated from the same lot and had localized reactions at the injection site. The reporter requested a lot check. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected.
Moderna COVID-19 Vaccine EUA  Symptoms: Muscle tenderness at vaccination site, general achiness, fatigue, occasional difficulty breathing (felt like someone squeezing on my diaphragm and made it uncomfortable breathing for short periods of time. Started in the evening time, lasted a minute max each time, and occurred around 5 times before ceasing). Symptoms ended around 9 pm the same day they began
decreased appetite; dizziness; disorientation; felt out of it; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (decreased appetite), DIZZINESS (dizziness), DISORIENTATION (disorientation), FEELING ABNORMAL (felt out of it) and NAUSEA (nausea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030120A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (decreased appetite), DIZZINESS (dizziness), DISORIENTATION (disorientation), FEELING ABNORMAL (felt out of it), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, DECREASED APPETITE (decreased appetite), DIZZINESS (dizziness), DISORIENTATION (disorientation), FEELING ABNORMAL (felt out of it), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.            No concomitant medicines were included.  treatment drugs were not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-049844 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: TCR attached. Patient said she is fine now; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049844:First dose case
Patient called to report that the right arm she received her Varivax vaccine on 11/2/23  is Itchy, has a red bump, she has body aches, headache and has become short of breath.  Since she reported shortness of breath, I encouraged her to go to the Emergency Room.  She verbalized agreement and understanding.
Experienced pain and swelling at the injection site; Experienced pain and swelling at the injection site; Muscle aches; Headache; fatigue; A swollen lymph node in my left armpit; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 17:00 (Lot number: FJ1620) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D; FISH OIL; VITAMIN B COMPLEX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 17:00, outcome "unknown", described as "Booster dose"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 28Nov2021, outcome "recovering" and all described as "Experienced pain and swelling at the injection site"; MYALGIA (non-serious) with onset 28Nov2021, outcome "recovering", described as "Muscle aches"; HEADACHE (non-serious) with onset 28Nov2021, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 28Nov2021, outcome "recovering", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 28Nov2021, outcome "recovering", described as "A swollen lymph node in my left armpit". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, myalgia, headache, fatigue, lymphadenopathy. No other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer who reported for her daughter. A 21 year-old female patient of an unspecified ethnicity received the first single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced fuzziness, dizziness, fatigue, bad headache, weakness, shivering/cold, she slept for very long time, she had rash, red rash of about 2 by 2 on her arm and it was itchy, she could not think straight, all on an unspecified date. The outcome of the events was unknown. The reporter inquired if the patient should see her doctor and if the reported symptoms could be allergic reactions. He also asked if it would be ok if the patient would miss the second and the third vaccination, and just got the first one. Follow-up (06Mar2015): New information reported from the same contactable consumer includes: patient age, vaccine dose number, reaction data (new events weakness, could not think straight, shivering/cold were added), reporter questions. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Within a few minutes after receiving injections pts both legs started to turn red and warm at injection site. Pt didn't experience any difficulty breathing or any other problems. Pt did receive 1st MMR and varicella and Prevnar 13. Pt has had previous doses of Prevnar 7. Mom stated no known allergies. Pt stayed in office and was treated in office same day. BENADRYL 9mg given (R) IM thigh lot D19077 exp 1/11-given ORAPRED O DT 15 mg. Mom was instructed by Dr to make f/u in 24 hours.
Patient has developed a shingles rash along lower back, groin, and buttock areas. Rash appeared one day after receiving first dose of the vaccine.
Since 09/2021 I have been having breathing issues. It is hard to get a full breath in. I went to my doctor in September and was prescribed an inhaler and steroids that have not helped so now I have to go see a pulmonary specialist 12/13/2021. I also went to Urgent car in the beginning of November because I was struggling to get more than 4 words out at a time and I was wheezing. This lasted for a couple of days.
onset Nausea and vomiting at 3 am the following morning of vaccine.  Had about 5 hours of this then fevers, body aches and fatigue. Noted the following day this his eyes looked yellow, more that usual, and came to the clinic on 3/1/21 for evaluation.  was feeling better but due to acute jaundice had blood work that indicated markedly elevated bilirubin and low platelets.  Further testing for hepatitis was negative.  Was sent to the ER the following day as we were unable to get blood drawn and GI consult was desired.  There he had a normal abdominal US and bilirubin had dropped and he has since been followed by GI and is currently being evaluated by Hematology for any underlying conditions that may be contributing.
Administered vaccine from a punctured vial kept in refrigerator more than 6 hours; A spontaneous report was received from a physician's assistant concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered vaccine from a punctured vial kept in the refrigerator more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020, a nurse administered a vaccine from a previously punctured vial that was kept in the refrigerator for more than 6 hours. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.   The event, administered vaccine from a punctured vial kept in the refrigerator more than 6 hours, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of s patient administered a vaccine from a previously punctured vial that was kept in the refrigerator for more than 6 hours (Expired product administered)  for mRNA-1273, lot # 026L20A. There were no reported adverse events associated with this case of administered a vaccine from a previously punctured vial that was kept in the refrigerator for more than 6 hours.
Within hours of receiving the second Moderna vaccine, the patient began experiencing excruciating pain in his lower back and sciatica. Consensus among the health professionals he saw is that the second vaccine triggered an inflammatory response. The pain did not respond to medication physical therapies.
On 08/30/98, the patient developed a fever of 103 degrees F and a slight rash on his legs. The event required a doctor visit. the patient recovered. Additional information has been requested.
patient complained that she had a rash for 4 days.  She also stated that she had pain on the top right of her chest with some swelling.  She went to urgent care and they are to be scheduling her for a CT scan.  Finally urgent care stated that she was given blood pressure medication and she had no other history of hypertension.
treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Aug2023) negative; (29Aug2023) positive; (04Sep2023) negative.  Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 20Aug2023 to 24Aug2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
sore arm, arm was hurting; fever; chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, arm was hurting), PYREXIA (fever), CHILLS (chills) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm, arm was hurting), PYREXIA (fever), CHILLS (chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm, arm was hurting), PYREXIA (fever), CHILLS (chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medications were not provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 09:00 as dose 1, single (Lot number: HH7595) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypogammaglobulenmia" (unspecified if ongoing); "severe scoliosis kyphosis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ciprofloxazosin, reaction(s): "known allergies: Ciprofloxazosin", notes: known allergies: Ciprofloxazosin all osteoporosis meds. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 5, Batch/Lot No: 6j2524, Location of injection: Arm Left), administration date: 13Sep2022, when the patient was 54-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 4, Batch/Lot No: FR9894, Location of injection: Arm Left), administration date: 29Mar2022, when the patient was 53-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: FL3181, Location of injection: Arm Left), administration date: 17Aug2021, when the patient was 53-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 06Mar2021, when the patient was 52-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 05Feb2021, when the patient was 52-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Pt's aunt called back 2 days after ER visit to notify us that patient was very weak + had drowsiness, a "knot on the left arm". The was patient last dose of HPV that she received in Texas.
See copy of progress sheet dated 8/25/05 and 8/26/05. Emergency room reports with discharge. 8/25/05 allergic reaction to vaccine 14:30 pt coughing, red swelling eyes, no wheeze with increased cough, administered 2 tsp Benadryl PO 14:40, 14:50 called ambulance, administered albuterol neb. Pt alert, oriented, stable, transported to hosp (with mother) by ambulance.
My daughter got the shot at 1 pm on the 8th of April, 2021. (My daughter & I both got the shot at the same shot at the same time). By 11:00 pm my daughter started complaining with feeling dizzy. She kept saying she felt like she was going to throw up, meaning she was nauseated. She was complaining with her bones hurting. We both got these symptoms at the same time. We both stayed in and out of the shower letting the shower water just run on us. I had to give her ibuprofen because she complained of a mild headache & the pain all over her body. She couldn?t sleep at all. She cried. It had her scared. I fully believe she?s having an allergic reaction to the Janssen shot. I have fully read the Janssen ?fact sheet?. My daughter was having hot flashes & cold sweats. She has ongoing symptoms & it?s been 2 days since receiving shot including fever. She was having what I thought heart palpitations. We both swelled up causing our bodies to feel tight. We both were healthy before receiving the shot. We?ve never had covid nor tested positive. We are currently going to receive a check up by a doctor. The side effects of this medication is dangerous & doesn?t compare to flu like symptoms.
I was 13 week and 4 days along when I received the vaccine I am due May 2nd, 2021. Adverse event was itching on joints such as feet, hands, elbows, knees  and a random spot on my right arm.
Satellite lesions, approx 10 surrounding primary lesion due to auto-innoculation. No Tx needed. Pt's primary innoc.
severe pain at injection site (controlled with 1 extra-strength Tylenol); fatigue; chills & fever (101.5 at highest); mild nausea fever lasted until midday the following day, but chills lasted only several hours
Patient started having frank bleeding 4/22/2022 with clots. W/u showed endometrial cancer. Needing a total hysterectomy
Swollen lymph node left armpit; Itchy back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 12:00 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 11Feb2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 11Jan2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Dec2021 23:00, outcome "not recovered", described as "Swollen lymph node left armpit"; PRURITUS (non-serious) with onset 02Dec2021 23:00, outcome "not recovered", described as "Itchy back". Therapeutic measures were not taken as a result of lymphadenopathy, pruritus.  Additional information: No other vaccine in fourweeks. Not tested covid post vaccination. No known allergies.  Follow-up attempts completed. No further information is expected.
vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED   CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/2/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE
This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with GARDASIL that were stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
1.  Severe pain starting at the underarm lymph gland and radiating around the scapula and up the neck.  Started on 11/23/2021 and ended in June 2022.  Treated with physical therapy, acupuncture and lymphatic massage.   2.  On September 3, 2021 I received a great report from eye cancer specialist doctor, there was no sign of cancer.  On January 13, 2022 a lymphoma recurrence in the right eye was identified by another doctor and was confirmed by the specialist via eye biopsy on April 7, 2022.  Radiation treatment was performed May 23-June 8, 2022.  On August 9. 2022, the specialist confirmed that the cancer was gone.