chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, chills and significant body aches (back, neck, arms, legs) starting about 4 hours after administration.
Pt recvd vax & exp h/a, chills, frequent sneezing, nasal congestion, muscle aches, copious watery rhinitis, chest congestion, cough & anorexia; allerg react, upper resp tract, infect, bronchitis;
Bright red and hot arm at injection site, rash from shoulder to elbow of injection arm, fever 101 degrees for 4 days. Febrile; needed to stay in bed for multiple days and was very fatigued. Dizziness, feeling like she was going to faint a couple days after the fever.
Patient is  64 yo  with past medical history of HTN, reactive airway disease, GERD, clear cell carcinoma of l ovary with peritoneal carcinomatosis s/p TAH-BSO on 3/30/22 and chemoport on 5/19/22 presents with complain of     Reports left lower extremity swelling and tenderness for 1 day Denies shortness of breath Denies chest pain Send by Dr, her oncologist, to ED for follow-up valuation to rule out DVT No fever, chills, nausea, vomiting     Tolerated well for last cycle of carboplatin/paclitaxel on 5/25/2022 Admitted for saddle pulmonary embolism on anticoagulation, concerning for HIT - pending results   Clear call carcinoma of the left ovary with peritoneal carcinomatosis. on chemo, s/p cycle 1 of carboplatin/paclitaxel on 5/25/2022.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication was provided.  Date the vial was initially stored in the refrigerator was 24-Sep-2021. Date of administration of vaccine was 24-Oct-2021 - 27-Oct-2021.
extreme pain at the injection site; extreme tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Mar2021, outcome "recovered", described as "extreme pain at the injection site"; FATIGUE (non-serious) with onset 09Mar2021, outcome "recovered", described as "extreme tiredness". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient had extreme pain at the injection site and extreme tiredness the following day after first COVID vaccine dose. Events did not result to physician office visit and emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist concerning a 70 year old male patient with high cholesterol and no drug reactions/allergies. On 03-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX, (vial 19400 PFU) (lot # H012576, expiration date: 28-SEP-2013), 0.65 ml, subcutaneous. Concomitant therapies included LIPTIOR (generic). The pharmacist reported that the patient developed a rash which may have contained pustules at an unspecified site on his body on an unspecified date. Patient sought medical attention at his physician's office on 26-AUG-2013. The patient was treated with VALTREX. VZVIP packet was declined. The outcome of event was reported as recovered/resolved. This is one of several reports from the same source. Additional information has been requested.
really sore arm; low grade fever; feeling flu-ish; body aches; headaches; eyes hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really sore arm), PYREXIA (low grade fever), INFLUENZA (feeling flu-ish), PAIN (body aches) and HEADACHE (headaches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TIZANIDINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), DULOXETINE HYDROCHLORIDE (CYMBALTA), METFORMIN, FLUOXETINE, FENTANYL, LOSARTAN, HYDROCHLOROTHIAZIDE, METOPROLOL, ATORVASTATIN, Terasozin and OTC supplements for an unknown indication.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (really sore arm), PYREXIA (low grade fever), INFLUENZA (feeling flu-ish), PAIN (body aches), HEADACHE (headaches) and EYE PAIN (eyes hurt). At the time of the report, PAIN IN EXTREMITY (really sore arm), PYREXIA (low grade fever), INFLUENZA (feeling flu-ish), PAIN (body aches), HEADACHE (headaches) and EYE PAIN (eyes hurt) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
I work as a CNA for a hospital. I had my first Covid vaccine dose on 8/30/21. I didn't notice anything unusual after this first dose. My second dose was on 10/4/ 21. About a couple weeks after I started to notice a faint tickle or flutter deep in my chest that would come and go. This went on for a couple more weeks eventually getting worse and evolved into to pressure feeling in chest that would get worse upon exertion. I also started to get heart arrhythmias and have episodes of my heart racing. This gradually kept getting worse over then next few weeks including chest pain  and shortness of breath. My health insurance recently expired so I put off going to the doctor. On 12/8/21 I went to a walk in clinic and got a checkup and EKG and the doctor was concerned about possible myocarditis  from the covid vaccine and referred me to a cardiologist. I was not able to get an appointment until 12/28/21, about 3 weeks later. During this time these symptoms got to the point at times I felt I would need to go to the Emergency Room. When I saw my cardiologist he checked me out and I got and echocardiogram. He felt these symptoms stemmed from the vaccine.
patient started with irritability, vomiting, diarrhea and sweating in the 2 hours after vaccine administration
Around 2/13/21: Right Hand second finger with rash, swelling, mottled color with redness on knuckle and dorsal side of skin from knuckle to nail. Same day I developed a growth on right hand middle finger similar to a cyst or nodule.  2-3 days later I developed a reddened raised lesion on my left hand 4rth finger dorsal side near the joint. Doctor looked at it over zoom but not in person and thought it was contact dermatitis or allergic dermatitis from hand sanitizer or glove use.  Steroid cream triamcinolone and cloberasol have been tried for 1.5 weeks but not working.  After second dose of vaccine I developed pain and redness to left hand 4th finger knuckle near where the previous lesion had been.  And the cyst on my right hand middle finger is growing and taki bf on a weird shape, its surface area has increased and these creams are not helping.
I contracted COVID-19 on 12/23/22 with symptoms of sore throat, congestion, runny nose, cough, fever, headache, and chest tightness. I was prescribed PAXLOVID on 12/23/22. The fever, sore throat, and fever resolved on 12/24/22. The congestion worsened beginning 12/24/22. I am still experiencing lingering cough and congestion. I am recovering, but not fully recovered yet.
MENACTRA place in Rt arm on 7/20/11. On 7/22/11 pt return to clinic PPD reading & c/o redness of right arm with circumferential with minimal raised.
Information has been received via a company representative, from a health professional (HCP) concerning her daughter (age unspecified), who was vaccinated on an unspecified date, with the second dose, 0.5ml, of Gardasil (Lot # not provided). The HCP reported that her daughter developed pain and swelling at the injection site, that lasted for '3-4 days" and then resolved. No further information is expected.
she could feel her throat swelling up; she felt very sick her arm swelled up; her arm was red and spread out to her upper arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine, for IMMUNISATION, reaction(s): "allergic to the flu vaccine". The following information was reported: ERYTHEMA (non-serious) with onset 12Nov2023, outcome "not recovered", described as "her arm was red and spread out to her upper arm"; PHARYNGEAL SWELLING (non-serious) with onset 12Nov2023, outcome "unknown", described as "she could feel her throat swelling up"; PERIPHERAL SWELLING (non-serious) with onset 12Nov2023, outcome "not recovered", described as "she felt very sick her arm swelled up". The events "she could feel her throat swelling up", "she felt very sick her arm swelled up" and "her arm was red and spread out to her upper arm" required physician office visit. Therapeutic measures were taken as a result of pharyngeal swelling, peripheral swelling, erythema.  Additional information: Caller stated she was allergic to the flu vaccine and was advised to take Benadryl after each dose of the Pfizer Biontech COVID 19 vaccine which she has always done. After she got the Pfizer COVID-19 booster her arm was red and spread out to her upper arm. The last dose of Pfizer Covid-19 vaccine she could feel her throat swelling up even after taking Benadryl immediately after. She had the dose on Friday (10Nov2023) and on Sunday (12Nov2023) she felt very sick her arm swelled up and was really red, however she felt better after eating something. Today (13Nov2023) she does not feel great but not bad either. Saw her doctor today (13Nov2023) briefly. Her arm was red. It is spread out very big on her whole upper arm where she had the shot. All on the left side. It is maybe the size of a small dollar pancake. Outcome reported as worsened. Treatment: Doctor advised her to take Benadryl right after the shot.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pain with arthritis; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), ARTHRALGIA (Pain with arthritis) and PAIN IN EXTREMITY (Sore arm) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis. No Medical History information was reported.  On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue), ARTHRALGIA (Pain with arthritis) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) had resolved and ARTHRALGIA (Pain with arthritis) had not resolved. No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Woke up the day after shot, went for a long walk and noticed very slight ache/soreness in bilateral buttocks and hamstrings.  1/10, didn?t limit activities at all.
Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 4 / Pfizer / BioNTech Dose Number: 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Oct2022, outcome "not recovered", described as "Moderna Dose Number: 4 / Pfizer / BioNTech Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive; (27Nov2022) Negative; (05Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: tested positive for Covid on 23Nov2022 and started Paxlovid. On 27Nov2023 tested negative and all symptoms were gone. On 04Dec2022 covid symptoms returned (head congestion) and tested positive on 05Dec2022. Event COVID 19 treatment included Paxlovid, treatment started on 23Nov2022 and treatment stop date was 27Nov2022.  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.
This spontaneous report was received from a pharmacy technician regarding a patient of unknown age and gender. On 11-NOV-2013 the patient was vaccinated with first dose of ZOSTAVAX lot # J004311; expiry: 12-JUL-2014, 0.65 ml, subcutaneous. On 22-OCT-2015 the patient was vaccinated with second dose of ZOSTAVAX lot # L003217; expiry: 30-APR-2016, 0.65 ml, subcutaneous (extra dose administered). No concomitant medications were reported. No adverse effects were reported. No further information was provided. The outcome of extra dose administered was unknown. Additional information has been requested.
A report was received from a health care professional on 10/24/01 regarding a 71 year old female patient who experienced rash on arms and chest few days after receiving Fluvirin vaccine on 10/16/01. The event was reported to be resolved. There was insufficient information to determine the reporter's causality assessment.
Child was out of school for 4 days due to high fever.  Day 1 fever was 104.2.  She also developed a rash to the right upper arm with 3-4 blisters around the site.  On days 2-3 the child's fever was 103.  The blisters lasted 3-4 days total.  The child also had some associtated vomiting.  On the 5th day post vaccination the child developed a rash on the right side of her neck with a few small blisters at that site as well.  The rash and blisters are now resolving.  The child's mother gave her Tylenol every 4 hours while the child had a fever.
My son died, while taking his math class on Zoom. We are waiting for the autopsy because the doctors did not find anything. He was a healthy boy, he had a good academic index, he wanted to be a civil engineer. He was the best thing in my life.
Pt. received vaccination & immediately after reported increased anxiety. dizziness, nausea. Patient reports this is his "normal" and occurs with "shots". Patient attempted to stand , and fell to buttocks. Patient did not head head, no LOC, remained A&Ox4. V/S - 140/85. HR 60. O2 100% Patient reports symptoms subsided, patient left clinic.
was vaccinated for H.flu but acquired the illness systemically several months later and passed away; Initial information received on 28-Oct-2022 regarding an unsolicited valid serious case received from a other health professional.  This case involves Infant and unknown gender patient who after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB] acquired the illness systemically several months later and passed away.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (dose, strength, and lot number: unknown) via intramuscular route in unknown administration site for Haemophilus influenzae.  On an unknown date the patient developed a serious "was vaccinated for H.flu but acquired the illness systemically several months later and passed away" (Haemophilus infection) several months later and passed away (unknown latency) following the administration of HIB (PRP/T) VACCINE.  Final diagnosis was (fatal) for vaccinated for H.flu but acquired the illness systemically several months later and passed away. Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Fatal for the event. No autopsy was done. The cause of death was reported as Haemophilus influenza infection.  Seriousness criteria:  Medically significant for the event and was leading to death.; Sender's Comments: Sanofi Company Comment dated 02-Nov-2022: This case involves Infant and unknown gender patient who after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB] acquired the illness systemically several months later and passed away. The cause of death was reported as Haemophilus influenza. However, the patient's previous vaccine tolerance, concomitant medications and medical conditions, immunological status, allergy history, laboratory investigations and autopsy results  would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be excluded.; Reported Cause(s) of Death: Haemophilus influenzae
Patient Received first dose of COVID-19 vaccine Pfizer on 1/10/22 after first dose Pfizer patient stated that three days after her first dose she experienced chest pain 8/10 on the pain scale, tachycardia, difficulty walking and body aches. Patient states all symptoms came and went for about a week. After a week symptoms completely subsided. RN submitted a medical consult via text message requesting to proceed with the COVID second dose Pfizer. Per Dr., approval to proceed with COVID second dose Pfizer vaccine was obtained from medical consult team via text message, RN, Clinical Project Coordinators. Client received COVID vaccine second dose Pfizer (LOT#: FK9729) at 1338. The patient did not report any symptoms during the 30 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. Patient left vaccination site with her children unassisted and with a steady gait.
The pt experienced a varicella like rash. The pt also experienced fatigue for 1 day. the pt evaluated. No known exposure. The pt experienced papular, early vesicular lesions on torso, face, which were mildly itchy.
8 weeks since she received her first dose; Muscle weakness; Dizziness; Burning in throat; Fatigue; Pain on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), DIZZINESS (Dizziness), THROAT IRRITATION (Burning in throat), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain on the Injection Site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy and Mononucleosis (diagnosed with mono). Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), DIZZINESS (Dizziness), THROAT IRRITATION (Burning in throat), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain on the Injection Site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (8 weeks since she received her first dose). On 13-Jun-2021, MUSCULAR WEAKNESS (Muscle weakness), DIZZINESS (Dizziness), THROAT IRRITATION (Burning in throat), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain on the Injection Site) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (8 weeks since she received her first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Liver function test: increased (High) increased. On 08-Jul-2021, White blood cell count: increased (High) increased.         The treatment information was not provided. Patient was not sure about  Autoimmune disease as the patient never diagnosed. She also reported that In London they recommend and administer the second Moderna COVID-19 vaccine beyond 42 days, they believe the body produces more antibody this way.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 23-july-21 with second  dose information On 04-Aug-2021: Date of birth, concomitant medication and additional event were added.