chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VOMITING; CHILLS; FEVER; This spontaneous report received from a patient concerned a male 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, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F, 104 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and vomiting was not reported. This report was non-serious.
7mins of shock like-state; pallor, stare in space, dec responsive took 12 hrs to act completely nl;not seen by MD
Patient is 13 and was given a pediatric dose of Pizer for his second dose. So he got the .2 instead of the .3 full dose.
This spontaneous case was initially received on 02-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 35 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 30-OCT-2015 - 30-OCT-2015, Batch no: U56306, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: The AFLURIA vaccine shipment was received at the pharmacy on 26-OCT-2015. The pharmacy thought it may be frozen so segregated it in the refrigerator so it would not be dispensed. On an unknown date, the patient was administered with one vaccine from quarantined syringes (temperature excursion occurred - frozen) (non serious outcome: Unknown), (non serious, outcome: unknown) Action taken: not provided Event treatment: Referred to the PCP (primary care physician) and recommended repeat vaccination per CDC. Rechallenge/Dechallenge information not provided. For relevant tests results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The Health Professional considered the event(s) Administered one vaccine from quarantined syringes, Temperature excursion occurred - frozen as non-serious and causality of unlikely in relation to AFLURIA.
Information has been received from a health professional concerning a 71 yr old female with penicillin and morphine allergies and a history of shingles who on 19Jul06 was vaccinated IM with a 0.65 ml dose of varicella zoster virus vaccine live (lot 65295/0621F). There was no concomitant medication. On 26Jul06 the pt experienced a rash with little tiny blisters. She also had a congested chest and chest pain associated with the rash. The rash would come and go and was worse in the afternoon. The pt was treated with triamcinolone cream and diphenhydramine hydrochloride (Benadryl). The pt reported that she was very sick, but was feeling better. The pt reported that she was seen by another physician who noted that she had a rash inside her esophagus, chest and lung. The week of 14Aug06 the pt was fine, but on 23Aug06 she broke out in blisters. The pt had been taking diphenhydramine hydrochloride (Benadryl) 25mg TID. On 24Aug06 the pt was going to take two 25mg tablets of diphenhydramine hydrochloride (Benadryl) since her rash is always worse in the afternoon. The nurse reported that the pt had a history of cancer and had a tumor in her head a year ago, in 2005. The pt was in remission and was in between her chemotherapy treatments, with the last treatment in May 2006. At the time of the report, the pt had not yet recovered. There was no product quality complaint involved. The pt's chest pain was considered to be an other important medical event (OMIC). Additional information has been requested.
Reporting event due to administration error.  Pt inadvertently received a 3rd dose of the Moderna vaccine.  Vaccinations given 1/4, 2/1 and 3/1
1st dose: Facial Flushing on left side of face, fatigue, covid arm, headache 2nd dose: Facial flushing on right side of face, headache, fatigue, fever, chills at night, joint and muscle aches, extreme covid arm, lymph node swelling near collar bone. 3rd dose: Less severe covid arm, hives and itchiness from shoulder to elbow, lower back pain
Apr. 6 hours after vaccine pt had SOB, racing heart, dizzy, aches and pains, lasted for 2 hours, did not go to ER.
Shivering, nasal congestion, dry cough, fall, fevers, tachycardic.
Nausea; Tiredness, feeling drained; Swollen lymph nodes under right armpit and in neck; Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 05Mar2021 at 12:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol/levonorgestrel (AMETHIA LO) and fexofenadine hydrochloride (ALLEGRA) for unknown indications from unknown dates and unknown if ongoing. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), sulfamethoxazole/trimethoprim (SEPTRA), cefdinir (OMNICEF), vancomycin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and experienced drug allergy. On 05Mar2021 at 13:30, one-hour post vaccination the patient experienced headache and sore arm. The patient experienced tiredness, felt drained and swollen lymph nodes under the right armpit and in the neck which was not sore and did not hurt. These were still present 3 days post-vaccination. On 05Mar2021 at 20:30, the patient experienced nausea after 8 hours of vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was recovered on 05Mar2021, lasted approximately 4 hours. The clinical outcome of the event nausea was recovered 06Mar2021, lasted approximately 6 hours. The clinical outcome of the event sore arm was recovered on 06Mar2021 at 13:30, after the duration of 24 hours. The clinical outcome of the event tiredness, feeling drained, and swollen lymph nodes under right armpit and in neck were not recovered (also reported as recovering) at the time of this report.  No follow-up attempts are needed. No further information is expected.
React badly; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an attorney and describes the occurrence of ADVERSE DRUG REACTION (React badly) in a not specific patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (React badly). At the time of the report, ADVERSE DRUG REACTION (React badly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Two weeks to the day after receiving the vaccine I expereinced sever tinnitus that has not gone away yet
A cluster of 2 female patient who received FLUZONE (lot number UT3172BA) and developed injection site redness, lump, and burning one day after vaccination. Initial report received on 24 September 2009 from a healthcare professional. A 28+ year old female patient, whose medical history was not reported, received a left deltoid intramuscular injection of FLUZONE (lot number UT3172BA) on 23 September 2009. Concomitant medications and illness at the time of vaccination were not reported. She had received no other vaccinations within the four previous weeks. She had received previous flu shots and had no adverse event following prior vaccination. One day after vaccination, 24 September 2009, the patient developed redness, a lump, and burning at the injection site. Corrective treatment was not reported. At the time of the report, the patient had not recovered. Follow-up information was received from a health care professional on 13 October 2009. Patient identifying information was provided. It was indicated that the patient did not require an emergency room or doctor visit and that the patient recovered. No further details were provided. Case 2009-04079, with the same reporter and same FLUZONE lot number, describes the events for the second patient.
Fever, chills, arm pain, numbness from shoulder to elbow in left arm, fatigue,  headache, dizziness, nausea for 8 days Headache, dizziness and fatigue still 19 days after vaccine
tinnitus and tingling of the ears; tinnitus and tingling of the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus and tingling of the ears) and PARAESTHESIA (tinnitus and tingling of the ears) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus and tingling of the ears) and PARAESTHESIA (tinnitus and tingling of the ears). At the time of the report, TINNITUS (tinnitus and tingling of the ears) and PARAESTHESIA (tinnitus and tingling of the ears) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Non significant Follow up received on 20-May-2021. Email address was updated On 08-Jul-2021: non significant followup On 09-Jul-2021: Non significant Follow up  received on 09 Jul 2021 - phone number was updated.
On April 25 about 2 hours after receiving the meningitis vaccination, in the area of the shot, she developed a localized reaction that was red, hot and painful. The patient also reports having myalgias and a bad headache following the shot. The patients symptoms continued to worsen so she came in to urgent care on April 27. She was started on Benadryl and triamcinolone cream at that time. The following day the symptoms worsened significantly so she was given a steroid burst and hydroxyzine. For the next 2 days the symptoms became slightly worse after which they began to abate. The patient was seen in follow-up on May 2 and at that time the patient had some bruising in the area but very minor erythema and warmth with a 2 cm slightly tender lump at the center.
Activities of daily living impaired, difficult time with typing; Difficulty in walking, struggling to walk; Grip strength decreased, struggling to open things; Fatigued; COVID-19; Fatigued; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired, difficult time with typing), GAIT DISTURBANCE (Difficulty in walking, struggling to walk), GRIP STRENGTH DECREASED (Grip strength decreased, struggling to open things), the second episode of FATIGUE (Fatigued) and the first episode of FATIGUE (Fatigued) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.    No Medical History information was reported.   In April 2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) Citrate free and second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (Intramuscular) 1 dosage form. In April 2021, the patient experienced the first episode of FATIGUE (Fatigued). In November 2021, the patient experienced COVID-19 (COVID-19). In January 2022, the patient experienced the second episode of FATIGUE (Fatigued). On 26-Apr-2022, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired, difficult time with typing), GAIT DISTURBANCE (Difficulty in walking, struggling to walk) and GRIP STRENGTH DECREASED (Grip strength decreased, struggling to open things). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired, difficult time with typing) outcome was unknown, GAIT DISTURBANCE (Difficulty in walking, struggling to walk), GRIP STRENGTH DECREASED (Grip strength decreased, struggling to open things) and COVID-19 (COVID-19) was resolving and last episode of FATIGUE (Fatigued) had resolved.            No concomitant medications were provided. No treatment medications were provided.  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.
Episode of extreme sleepiness 3-4 hrs after vaccines, very hard to arouse, even wih stimulation.
As per mom the night of shots child staring/blank episode lasting hours & the screaming & crying the entire night & fussy for a wk. No ER visit or med care sought.
Felt like dartboard when shot administered. Felt as though shot was given too high on arm. The pain got worse as time went on. Got to where she could not lift arm over head to remove top. Could not sleep lying on Left side. Too Painful. The pain was worse several days after the shot. At it's worst pain rate was 8. Today pain rate is a 4. Still painful when lifting arm above head to remove clothing. Used Tylenol for the pain and it helped some.
Swollen lymph node on left neck. migraine, nausea, and vomiting
Immediately felt faint, and passed out within 10 minutes of getting second dose. Appeared to have 30 second seizure. Paramedics intervened and fainted a second time, and appeared to have another 30 second seizure. Blood pressure and heart rate dropped dramatically. Systolic number was around 40. Transported by ambulance to Emergency Department. Vital signs returned to normal. EKG performed and was normal. Diagnosed as Vasovagal syncope.
This spontaneous retrospective pregnancy report was received from female patient (nurse) of an unknown age regarding herself. The patient's drug allergies and pertinent medical history was unspecified. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency and route were not reported) when she was approximately 12 weeks pregnant. Concomitant medications were not reported. The LMP and EDD were not known. Initial exposure to GARDASIL was at 12 week(s). The patient delivered a female infant on an unknown date. The pregnancy outcome was live birth. The patient and her daughter did not had any adverse effects due to the GARDASIL. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Pt.'s sister states after receiving the J&J 06/01/2021, started experiencing nervousness, nauseous, vomiting, anxiety, memory loss, and constant shaking. Weight lost (estimated 15lbs), loss of sleep. Physician visit (07/15/2021) Blood test ran still awaiting results. Cognitive Test 07/15/2021, recommendation for MRI.
4/22:  First Vaccine; 5/07:  Second Vaccine 06/04:  Hives/itching 06/07:  Hives/Itchy bumps/ increased itching all over body 07/29:  RA Doctor visit:  shared symptoms - told result of the vaccine caused my IgE antibody level to increased; should see relief in about 6 months; post visit called re worsening symptoms  as described below - advised to see dermatologist. August to Nov 2021:  symptoms worsened:  rashes, itching on legs, arms, torso, neck; bleeding pustules on legs, arms, neck abdomen; extreme, incessant itching; pictures available of all.  - Have pictures of above.  - Visited primary care; dermatologist and allergist for further evaluation on worsened symptoms to determine further and relief.  Details and dates available along w/pictures.
I don't know if it is connected to the shot at all, but my blood pressure was higher than normal. I never had high blood pressure before.
This spontaneous report was received from a physician via a company representative, referring a 12 year old female patient. The patient's medical history, concomitant medications were not reported. The reporting physician stated that the patient was "often seen for various unspecified illnesses".  On an unknown date, the patient was vaccinated with GARDASIL 9 dose 1, intramuscular (strength, frequency, lot number and expiration date were not provided) for prophylaxis. The physician stated that when it was time to receive the second dose of GARDASIL 9, the patient's mother refused to allow the patient to receive the injection because her daughter did not experience a "normal menstrual cycle" (abnormal menstrual cycle) which lasted for 6 months. On an unspecified date, the abnormal menstrual cycle became normal again. Also it was reported that the patient experienced severe cramping (abdominal pain) and discomfort. At the reporting time, the outcome of abdominal pain and discomfort was not mentioned. The patient's mother, believes that all of her daughter's issues were a result of vaccination with GARDASIL 9, however the physician considered menstrual disorder, discomfort and abdominal pain to be not related to GARDASIL 9.
Pt developed numbness in left arm (site of vaccine) almost immediately. The burning sensation in both hands with ezcema like rash the next day lasting less than 48 hours. Then numbness (pins and needles sensation) left side of face left arm and left leg that is intermittent
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter asked if her husband could have the 2nd dose since he had been tested positive for Covid-19. The patient experienced fever, chills, malaise. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021191296 same reporter and drug, similar event, different patient.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 94-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for almost 48 hours and it reached 11.6 degree Celsius. On 12-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2020 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805488 was crossed linked to original case 201804863 due to same reporter.
Thyroid cancer; This spontaneous case was reported by a consumer and describes the occurrence of THYROID CANCER (Thyroid cancer) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20 and 028l20a) for COVID-19 vaccination.     The patient's past medical history included Kidney stone. Concurrent medical conditions included Sarcoidosis and Diabetes. Concomitant products included AMLODIPINE, ATORVASTATIN, FOLIC ACID, GLIPIZIDE, LOSARTAN, METHOTREXATE, METHYLPHENIDATE, OMEPRAZOLE, PREDNISONE, LEVOTHYROXINE SODIUM (SYNTHROID), BROMAZEPAM (TENSONIL), TRAZODONE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced THYROID CANCER (Thyroid cancer) (seriousness criterion medically significant). The patient was treated with ZOLEDRONIC ACID (intravenous) on 20-Aug-2021 for Thyroid cancer, at an unspecified dose and frequency. At the time of the report, THYROID CANCER (Thyroid cancer) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The patient was diagnosed with thyroid cancer in the middle of April, and on 11-May-2021, it was removed.  Company Comment: Very limited information regarding this event has been provided at this time. However, patient's past medical history/underlying medical conditions (Kidney stone, Thyroid cancer, Sarcoidosis and Diabetes) remains a confounder. Further information is not expected.   This case was linked to MOD-2021-299900 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. However, patient's past medical history/underlying medical conditions (Kidney stone, Thyroid cancer, Sarcoidosis and Diabetes) remains a confounder. Further information is not expected.
Patient is DECEASED (2.1.22);  Hospitalized 1.22.22 - 2.1.22;  COVID-19 positive (1.19.22); fully vaccinated (no booster) Admission Date: 1/27/2022 (to higher level of care; moved from HCF to another Hospital ICU) Date of Death: 2/1/22 Time of Death:  1:11 PM Preliminary Cause of Death: Pneumonia due to COVID-19 virus DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory distress syndrome (ARDS) due to COVID-19 virus (HCC)  HOSPITAL COURSE: 53yo with history of asthma, HTN, and morbid obesity (BMI 55). Single dose of J+J COVID vaccine received in May 2021.  He was found to be COVID+ 1/19 and was admitted 1/22 to HCF on HFNC. He continued to decompensate and was intubated 1/23. NMB and proning started.  Proning was stopped 1/26 due to severe facial edema. He developed progressive AKI and was transferred to ICU for nephrology consultation and potential need for RRT. PIRRT was started on 1/28. 1/31 developed anisocria, CT head showed severe cerebral edema with diffuse sulcal and basilar cistern effacement, transtentorial herniation, and cerebellar tonsillar herniation.  Neuro ICU consulted. Mild hyperammonemia and low-normal sodium. Multifactorial causation for cerebral edema. Patient was not responsive to any stimuli.  Patient was DNR status, after discussion with family on 2/1, transitioned to comfort care on 2/1. Interventions withdrawn with death shortly afterward at 1:11pm 2/1/2022.
Intractable headache, body aches, stuffy nose, puffy eyes (mild), photophobia, nausea, tachycardia, dizziness, fatigue.
tired, nausea, fever of 101 degrees Fahrenheit, facial redness/flushing