chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tumor markers elevated after first dose; burning shoulder and arms; both arms have a burning sensation, was felt in jaw and face; joints popping throughout body; symptoms traveling to different parts of the body; very weak, can't push up off the floor; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (both arms have a burning sensation, was felt in jaw and face), JOINT NOISE (joints popping throughout body), SYMPTOM RECURRENCE (symptoms traveling to different parts of the body), ASTHENIA (very weak, can't push up off the floor) and TUMOUR MARKER INCREASED (tumor markers elevated after first dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer NOS stage IV since an unknown date and White blood cell count low (low while blood count due to stage4 breast cancer.) since an unknown date.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced BURNING SENSATION (both arms have a burning sensation, was felt in jaw and face), JOINT NOISE (joints popping throughout body), SYMPTOM RECURRENCE (symptoms traveling to different parts of the body), ASTHENIA (very weak, can't push up off the floor) and ARTHRALGIA (burning shoulder and arms). On an unknown date, the patient experienced TUMOUR MARKER INCREASED (tumor markers elevated after first dose). At the time of the report, BURNING SENSATION (both arms have a burning sensation, was felt in jaw and face), JOINT NOISE (joints popping throughout body), SYMPTOM RECURRENCE (symptoms traveling to different parts of the body), ASTHENIA (very weak, can't push up off the floor), TUMOUR MARKER INCREASED (tumor markers elevated after first dose) and ARTHRALGIA (burning shoulder and arms) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Thyroxine free: 1.54 her freeT4 was at 1.54. In March 2021, Tumour marker increased: 48.4 (High) Her CA27-29 are at 48.4 range, markers went up after the vaccine and are now outside of normal range, where they had been.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on medications for her breast cancer. No treatment medications were provided
01/12/2021 (8:00 A.M.) Felt dizzy. (8:15 A.M.) Severe fatigue. Went to sleep in recliner. Slept for 13 hrs. (only waking up to go to the bathroom or to eat lunch and dinner). Went to bed at 9:00 P.M. Slept for an additional 8 hrs. Woke up at 5 A.M. and felt fine.   01/19/2021 Began itching at the injection site. Spots all over body appeared shortly thereafter (with exception of neck, face, head and feet). Resembled chicken pox. Severe itching for 4 days. Itching subsided slowly. Got better each day until no itching ~ 01/24/2021. Spots mostly gone by ~ 01/29/2021.
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No medical history was reported.     On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.   This case was linked to MOD-2021-325991 (Patient Link).
Purple bruise at injection site; Pink cheeks; Flushing; Little lump at injection site; Severe rash/ bad rash over her body; Headache; Purple mark at injection site; Felt a heat surge on face/felt a heat surge in her body; Redness facial/ face red; Face blotchy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt a heat surge on face/felt a heat surge in her body), ERYTHEMA (Redness facial/ face red), RASH MACULAR (Face blotchy), VACCINATION SITE BRUISING (Purple bruise at injection site) and VACCINATION SITE DISCOLOURATION (Purple mark at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD. Concurrent medical conditions included Thyroid disorder and IBD. Concomitant products included LEVOTHYROXINE, LANSOPRAZOLE (PREVACID), LORATADINE (CLARITINE), BECLOMETASONE DIPROPIONATE (QNASL) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FEELING HOT (Felt a heat surge on face/felt a heat surge in her body), ERYTHEMA (Redness facial/ face red), RASH MACULAR (Face blotchy), VACCINATION SITE DISCOLOURATION (Purple mark at injection site), RASH (Severe rash/ bad rash over her body) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Purple bruise at injection site), RASH ERYTHEMATOUS (Pink cheeks), FLUSHING (Flushing) and VACCINATION SITE INDURATION (Little lump at injection site). On 31-Mar-2021, FEELING HOT (Felt a heat surge on face/felt a heat surge in her body), ERYTHEMA (Redness facial/ face red), RASH MACULAR (Face blotchy), VACCINATION SITE DISCOLOURATION (Purple mark at injection site), RASH ERYTHEMATOUS (Pink cheeks), RASH (Severe rash/ bad rash over her body) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE BRUISING (Purple bruise at injection site), FLUSHING (Flushing) and VACCINATION SITE INDURATION (Little lump at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant Follow-up received on 08-JUL-2021. The concomitant product and the route of administration was updated. The events were updated.
had mild covid; had mild covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had mild covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She reported that she took the Paxlovid medication in August because she had mild covid. Began taking Paxlovid on 12Aug2022 and stopped taking it 5 days. The patient administered covid vaccines way back and had two. She declined to provide dates of her Pfizer Covid vaccines or lots. She had covid on 09Aug was her first symptom till now so it is 4 months since she had covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1-2 days he got really sick like he got the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (1-2 days he got really sick like he got the flu) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (1-2 days he got really sick like he got the flu). At the time of the report, INFLUENZA LIKE ILLNESS (1-2 days he got really sick like he got the flu) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-072301 (E2B Linked Report).; Sender's Comments:  MOD21-072301:
soreness at site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose in April 2019 and experienced soreness at site of injection, refer case US2020025196).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain. The patient was treated with ibuprofen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient after vaccination experienced soreness at site of injection. The patient stated that it was a dull, sore like pain that he notices from time to time when using his left arm and also sometimes bothers him when trying to sleep on it. The patient did not consent to follow up.
Received flu vaccine on 8/22/15. 2 weeks later, I got the flu, last year. Last year, I got the flu vaccine around the same time, and got the flu in Dec, 14. so that's twice now. I received flu vaccines for the past several years because my child has asthma, so I get one with him. I never got the flu for the past 5 years. Now I move here and got the flu both time. There's something wrong here. I think I got a placebo.
Blood in urine starting a week later. Put on antibiotic for 12day but still having same issue.
Fatigue, irritability night shot given 27MAR91; nausea, excessive fatigue, joint soreness 28MAR91; low grade fever(100) q day since 27MAR91; emotional labile
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose pfizer,Lot#EK5730, 12/17/20 2nd dose: 01/06/21,Pfizer,Lot# EL3246 Diagnosed covid positive:07/21/21 symptoms Began:07/19/21 Exposure:Travel Symptoms:Cough, fatigue.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient medical history and the concomitant medications were not reported. The patient had an allergic reaction to Pfizer covid 19 vaccine. She had jaw, mouth and throat tightening, nausea and dizziness from the first shot which got cleared by Benadryl.  She would like to know if she should take the second shot or not. The outcome was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
His arm was red/swollen; Red arm; red with white welts; This non-serious case was reported by a consumer and described the occurrence of welts in a 8-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2023-2024 season) (batch number FC22G) for prophylaxis.   On 06-SEP-2023, the patient received the 1st dose of FluLaval Tetra 2023-2024 season (right arm). On 07-SEP-2023, 1 days after receiving FluLaval Tetra 2023-2024 season, the patient experienced welts (Verbatim: red with white welts). On 07-SEP-2023 06:00, the patient experienced swelling arm (Verbatim: His arm was red/swollen) and erythema of extremities (Verbatim: Red arm).The outcome of the welts, swelling arm and erythema of extremities were not resolved.   The reporter considered the welts, swelling arm and erythema of extremities to be related to FluLaval Tetra 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.   The company considered the welts, swelling arm and erythema of extremities to be related to FluLaval Tetra 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-SEP-2023 This report was submitted via the online direct entry reporting system.  The patient had FluLaval tetra 2023-2024 approximately noon. No previous injection site reactions had been experienced. The patient's arm was red/swollen at 6am and had gotten worse as of 4pm on the same day (7th September 2023). The patient was not having any primary disease. The patient was not having any no complicating disease. This was not related to existing case.
Pt received vaccination shots 2 days ago; now complaining of redness and swelling around site of shots. Reddened area about 7" in diameter. No fevers or difficulty breathing.
Localized reaction: Bruise 1.5 inches by 1.5 in circular. Erythema: Reddened, swelling and increased warmth in area 2.5 inches by 3.5 inches. Treatment: Ice to area, TYLENOL.
Injection site reaction: skin discoloration, redness, tenderness, and indentation that has been present for 4 months and is still present.
Evening following the immunization patient states she experienced 100 degree fever, felt like she had the flu and she experienced a racing heart. She experienced a racing heart that evening, the following day and the morning after it subsided.
following the receipt of the first dose of the COVID-19 vaccine; testing positive to COVID; This is a spontaneous report from a non-contactable other Healthcare Professional reported for herself. A female patient of an unspecified age (Age: 47, Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient explained testing positive to COVID on the 29Dec2020, following the receipt of the first dose of the COVID-19 vaccine on the 20Dec2020. She stated that minor symptoms remain, and asked if she could receive the second dose of the vaccine due on the 10Jan2021. The outcome of the events was not reported.  No follow-up attempts are possible; information about lot/ batch number cannot be obtained.; Sender's Comments: The reported testing positive to COVID  after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
pt vaccinated with 2 doses of COVID vaccine; pt had a prior hosp admission due to hypoxia (70% O2 sat on RA), COVID test was negative at that time, given O2 3-4 L via NC, treated and released with supplemental O2 2 L via NC to home; brought to ED with worsening dyspnea and hypoxia; placed on NRB; COVID test was positive; given remdesivir and steroids; pt died in the hospital.
Started feeling achy and feeling extremely cold, shaking like chills. Some nausea and abdominal pain (crampy type pain). She did not take her temperature. Had problems most of the night, but felt fine the next AM.
URINARY TRACT INFECTION SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-APR-2021, the subject experienced urinary tract infection symptoms. Laboratory data included: Urinalysis (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of urinary tract infection symptoms was not reported. This report was non-serious.
Myalgia & Fever DOSE 2- fever, all over body pain, worsening of sciatic pain
about an hour after receiving the vaccination, the patient came back to the pharmacy and showed me both of her lower arms. both arms were red and the patient said they were also itchy. She said besides that, she felt fine and no other part of her body seemed affected.
This 14 year old female patient presented with her mother for the first dose of her COVID vaccine. She opted to receive Pfizer. Her mother and her both expressed fear of needles. Administration of the vaccine was uneventful, but during 15 minute follow up, the patient fainted in front of the pharmacy. Her eyes appeared to be moving a lot left and right. There was no shortness of breath. Her mother stated at this time that her daughter did not eat anything that morning prior to administration. Patient's state stabilized very quickly, within a few minutes, after elevating feet and lying down. Mother stated she had history of seizures.
About 20 seconds after Flu admin. pt. felt dizzy and had to be laid out on floor. Pt. was responsive and 911 was called.
MCH on CBC - low at 26 neutrophils - low at 42 Symptoms - presyncopal episodes which began after 2nd shot
I had the typical sore arm after the short for approximately 72 hours.  The worst of it, the first 24.  I did get some intense diarrhea as well for a few days but as I'm near my period, I haven't any idea if it's due to that.  On the 27th of May in the evening, I noticed my lymph nodes visibly swollen out of nowhere by my clavicle and they were incredibly painful to palpate.  Upon going to the ER they noted that my lymph nodes in my throat were also swollen but not painful.  This being a new thing to me, I called the nurse line who advised me to go to the ER.  The ER said I didn't have cancer (not helpful) and would not talk about any side effects.  I got a Covid test (negative). They sent me home and told me if I have issues breathing or anything, to return.  5/28 I started developing some nausea, congestion, headache, and fatigue, and I have lacked appetite all day.  Around 6 pm I developed, so far, one hive on my abdomen.
Narrative: Fever, Diarrhea, BODY ACHES, FATIGUE, NAUSEA, INJECTION SITE PAIN
This spontaneous report was received from a Doctor of Pharmacy concerning a patient who on 11-JUN-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 670542/0619AA, expiration date on 26-JUL-2012) that had been stored at an average temperature of 6 degrees Fahrenheit since an unspecified date in April 2012. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
1/20/2021: Around 20:00, I started to feel a little achy. Checked my temperature, it was 99 degrees F. 1/21/2021: Around midnight, I woke up in a cold sweat, shaking.  My entire body hurt and I had a headache. I checked temp again. It was at 102 degrees. I went back to sleep. I woke up again around 2:00, temp was 103. I took 1000 mg of Tylenol and drank water. Around 4:00, I checked temp again. I was back down to 101. I called into work. I kept sleeping all day and took 1000 mg of Tylenol every four hours. Symptoms slowly subsided throughout the day. By 22:00, I was down to 98.8 degrees before bed. 1/22/2021: I woke up at 4:00 and checked temp. It was still at 98.0. I go to work. My hands are tingling and I am hot with no increased temperature. It is now 9:00 and my hands are still tingling.
Myalgia, fatigue, chills, pain and numbness in the arm Narrative: Within 24 hours of the vaccine reported chills and fatigue. Also experienced pain and numbness in the arm that the injection was administered.
pt recv vax 26APR96 & w/in 30min pt began to exp nausea, tremors, & intermittent dilation of pupils;
It's a really minor thing, but my primary care physician said she never heard of this and I should report it as a side effect. I can taste something for a few minutes every time I get a shot or have any medication introduced through an IV. It's not really a metallic taste and it's difficult to describe. I guess the best word would be "medicine-y". It's not life threatening or even inconvenient. It only came up as a matter of fact comment I made at the time. It doesn't matter what type of shot or medicine, as it happens every time. It's probably nothing, since we already know my body is weird and doesn't work the way it's supposed to.
chills; Lymph node swelling; pain under left arm; fatigue; low grade fever (100.3 F) for 2 days; muscle aches; dose_number=3; dose_number=3; headache; This is a spontaneous report from a contactable consumer or other non hcp.   A 55-years-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in Arm Left on 04Oct2021 09:30 (Batch/Lot Number: 301558A) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing, drug hypersensitivity known allergy: SULFA from an unknown date and unknown if ongoing, the patient was allergic to Cephalexin. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 19Feb2021, (at the age of 55 years) (Batch/Lot No: EL9264; Location of injection: Arm Left; Vaccine Administration Time: 09:30 AM) for covid-19 immunization, and the second dose of bnt162b2 on 12Mar2021 (Batch/Lot No: EN6203; Location of injection: Arm Left; Vaccine Administration Time: 08:30 AM) for covid-19 immunization. On 04Oct2021, at 09:30, the patient experienced dose number=3 (off label use), dose number=3 (immunization). On 04Oct2021, at 13:00 the patient developed chills (chills), lymph node swelling (lymphadenopathy), pain under left arm (pain), fatigue (fatigue), low grade fever (100.3 f) for 2 days (pyrexia), muscle aches (myalgia), headache (headache). The patient underwent lab tests and procedures which included body temperature: 100.3 fahrenheit 100.3 F on 04Oct2021. Therapeutic measures were taken as a result of chills (chills), lymph node swelling (lymphadenopathy), pain under left arm (pain) , fatigue (fatigue), low grade fever (100.3 f) for 2 days (pyrexia), muscle aches (myalgia), headache (headache). The clinical outcome for the events chills, Lymph node swelling, pain under left arm, fatigue, low grade fever (100.3 F) for 2 days and muscle aches was recovering. The outcome for the other events was unknown.  Follow-Up (25Oct2021): Follow-up attempts are completed. No further information is expected.