chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SLEPT  MORE THAN USUAL; SLIGHT FEVER 99F; INCREASED TIREDNESS/FEELING  DRAINED; This spontaneous report received from a consumer concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced slept more than usual, slight fever 99f, and increased tiredness/feeling drained. Laboratory data (dates unspecified) included: Fever (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever 99f, increased tiredness/feeling drained and slept more than usual was not reported. This report was non-serious. This case, from the same reporter is linked to 20210818227, 20210817805, 20210818021, 20210818107 and 20210818401..
Reportedly at 6:20pm the patient complained of feeling of fullness in her chest. There was no wheezing. The patient was treated with Benadryl and given instructions to follow-up. There was no induration at the injection site. Reportedly the patient recovered from this experience.
Post vax, the normal pain that feels like a bee sting lasted for about 15 minutes. Physician said this was a subcutaneous nodule. The following day she noticed a general pain and heat at the injection site. After the 3rd day a bump, noticeable heat and pain at the injection site lasted for a week. After the 7th day all symptoms except the bump went away.
Within a few weeks my son had developed a severe ear infection, putting him into a febrile seizure and he had to be taken to the ER in order to receive higher doses of fever reducing medication to stop the spike in body temp. At time of arrival to the emergency room, my son's eyes were rolling to the back of his head and his core temp was over 105 degrees.  He had motrin and tyelnol in his system, but it still was not bringing his fever down.
injection site began to itch; injection site began to itch and the coloring of the rash turned to a purplish hue; the coloring of the rash turned to a purplish hue with smaller somewhat raised bumped within the rash area; rash area itches and feels warm; rash area itches and feels warm; Injection site feels hard; Injection site was red; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authtoirty. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Feb2021 at 11:30 AM (Batch/Lot number was unknown) (at the age of 29 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine; bisacodyl (DULCOLAX); iron; unspecified prenatal vitamin, all taken for an unspecified indication, start and stop date were not reported. The patient was also taking unspecified medication reported as "b". The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Feb2021 at 11:30 AM, the patient reported that injection site was red, following injection within 24 hours. Injection site remained red and began to fade by day 7. On 08Mar2021 at 12:00 AM (also reported as day 9), the injection site began to itch and the coloring of the rash turned to a purplish hue with smaller somewhat raised bumped within the rash area. Area itched and felt warm to the touch. Injection site felt hard. The patient has not taken any treatment for the events. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
In addition to the commonly reported milder temporary reactions I started having chest pains, shortness of breath (difficulty getting a full breath) and extreme fatigue the day following the vaccine.  Two weeks later still had the chest pains, fatigue, and difficulty getting a full breath.  Almost a year later I am STILL suffering from the chest pains which seem to be getting worse.  For a period they were intermittent and now the last two months it's all the time.  Still extremely fatigued and difficult to get a full breath to the point I am now becoming claustrophobic.
liquid leakage; there is a little blood coming out on the injection part; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Mar2021 at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced liquid leakage, there is a little blood coming out on the injection part on 22Mar2021. Patient got her first dose (22Mar2021) and apparently while she in the process of the injection of the first dose there is a liquid leakage of the vaccine while she is taking it. Patient noticed there is a little blood coming out on the injection part and the liquid leakage is like 5 inches long on her arm and the administrator/nurse wiped it out. And also, her concern was if she will be going to take another shot of covid vaccine since there is a liquid leakage happened. This question referred or forwarded to Medical Information. Outcome of the events was unknown.
COVID-19 symptoms Per report, employee "got COVID-19 symptoms,  started 01/05/2021." COVID-19 positive test result on 01/007/2021. No other family members exhibiting signs or symptoms of COVID-19 as of date of report (01/14/21).
face, eyes, and one side lips started dropping; numbness on her left face, head, inside mouth, and left hand; numbness on her left face, head, inside mouth, and left hand; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization.  Medical history included allergies to sulfa drugs. There were no concomitant medications.  The patient also received first dose of BNT162B2 on unspecified date for COVID-19 immunization.  After a week of the second dose on unspecified date, the patient had to go to the ER. There was numbness on her left face, head, inside mouth, and left hand. Her face, eyes, and one side lips started dropping. The patient received antiviral and steroid as treatment for the events.  The patient has no COVID prior to vaccination and was tested for COVID via nasal swab post vaccination with negative result on unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Patient spent an hour being monitored.  At first she complained of an itchy site and being sweaty.  About 15 minutes later she said that her fingers on that hand were numb and her pulse was racing.  I gave her ice water (she took it with her numb hand)  and offered to walk her to the emergency room (we are situated in Hospital just by the ER).  Patient declined and stated she didn't want to be around sick people.  She then asked me if it could be related to the heart problems she has been having lately and stated she is between various cardio tests.  She continued to rest in a seated position and I continued to monitor her every 5 minutes.  I offered her a benadryl unit dose 25mg.  She accepted, opened the blister pack with both hands, and swallowed capsule and told me that she had a general unwell feeling.  She swallowed benadryl at 5:04 pm.  At 5:15 pm she said she was better and that benadryl had cured the numbness.   I cam to check on her at 5:20 and she had left the premises.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013537: US-009507513-1708USA013538: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Developed left side facial numbness - presented to ER and was diagnosed with Bells Palsy
Patient received a dose of MCV4, as well as Varicella on 10/13/2022 and again on 10/19/2022. No symptoms, signs, etc reported
This spontaneous report was received from a registered nurse regarding a 8 week old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 19-MAR-2018, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # N021308 and expiration date: 05-MAR-2019), (strength and dose were not reported) orally for prophylaxis (product storage error). It was reported that the vaccine was stored between 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous cold temperature excursion (09-FEB-2018) was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1809USA008678: US-009507513-1803USA009994: US-009507513-1809USA008676: US-009507513-1809USA008677:
non-necrotizing skin granuloma; diffuse neutrophil inflammation (DNI-type) gastrointestinal tract granuloma; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 12 year old patient of unknown gender with hemophagocytic lymphohistiocytosis (HLH). On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, the patient experienced non-necrotizing (M-type) skin granuloma. On an unknown date, the patient also experienced diffuse neutrophil inflammation (DNI-type) gastrointestinal tract granuloma. The patient had sustained small jejunal perforations; disseminated cytomegalovirus (CMV) and Histoplasma spp. infections were identified in addition to RuV. Predominant RVC+ cells were neutrophils and well-formed granulomas with clearly defined macrophage or neutrophil cores as present in skin biopsies were not observed. Nasopharyngeal swab was positive for iVDRV and gastrointestinal biopsies were positive for rubella virus capside (RVC). The patient was treated with antibiotics, antifungals, and oral steroids with no effect. The patient was also treated with intravenous immunoglobulins and received hematopoietic cell transplantation. At the time of the report, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (2201USA004372, 2202USA004885, 2202USA004887, 2202USA004888 and 2202USA004889).; Sender's Comments:  US-009507513-2201USA004372:
Altered menstrual cycle (by weeks), very heavy, painful, continued changes persist for 2 months so far
every time I get the flu shot I get 10 times sicker; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received via consumer.  This case involves an unknown age and unknown gender patient who stated every time i get the flu shot i get 10 times sicker after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had an event of every time i get the flu shot i get 10 times sicker (illness) (unknown latency) following the administration of influenza vaccine.  It was unknown if any lab data/test results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event.
Itchy throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itchy throat) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A218A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (seasonal allergies to dust), Food allergy (allergic to food like apples) and Food allergy (sensitivity to raw food). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced THROAT IRRITATION (Itchy throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of UNK, as needed. At the time of the report, THROAT IRRITATION (Itchy throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 12-JAN-2012, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided), administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-APR-2016, the patient was treated by a physician assistant certified, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Little swelling in her tounge. Admintestered diphenhydramine 12.5/5mls, qty 10mls 12:50pm, patient stated that she is feeling better and decided to leave at 1:00pm
Subsequent to receiving first and second dose of varicella virus vaccine live the pts laboratory values indicated a negative varicella antibody level.
Initially started out with a headache, by the next morning (11/5) I had a cough, runny nose and congestion. All the respiratory symptoms lasted for about 3 1/2 days. On 11/8, I had stomach cramping, nausea and diarrhea that contained frank blood. I continue to have a headache.
I woke up the night after I got the shot and I had a fever, chills, headache, and trouble falling back asleep. It continued into that day. The first day and second day were the same. I had a metallic taste in my mouth. I did not want to eat anything. The third day I started feeling a little bit better but I was very tired. I had a cough. The day after that I started feeling better but the cough, headache and exhaustion stayed around. On 12/8/2021 I went to a local medical Clinic to make sure I did not have Covid and it was negative. They also tested me for Strep and Flu, which were negative too. They told me to keep taking Tylenol and Dayquil. I was feeling better by the weekend. I did not have a fever anymore. I still had a bad cough and I was exhausted. That continued for a couple of weeks. The cough has mostly stopped by now. On 12/21/2021 I was exposed to Covid and tested negative. A couple of days after that I started feeling worse again. On 12/24 my cough got worse. On 12/25 I was feeling very tired, I had a headache and cough. On 12/27/2021 I went to the pharmacy and they tested me for Covid again and it was negative. They could not find anything wrong with me so they thought it was from the vaccine. They gave me an antibiotic and cough medicine. The cough has gotten better since 2 days ago. I am not as tired as I was before. Yesterday was the first day that I have not had to take Tylenol or Dayquil to feel better.
Sciatic pain radiating from buttocks down back of legs. Started 2 weeks after 1st vaccine.  2nd vaccine given 4/1/21. PT started in April 2021. 1st epidural 4/22/21. 2nd epidural 6/17/21. 3rd epidural 7/30/21.  By end of August 2021 unable to walk any distance, unable to walk up and down isles of grocery stores, unable to stand to shower.  Before vaccine was walking 3 miles/day, was ballroom dancing.  Now life has changed totally. To be scheduled for radiofrequency nerve ablation.
I woke up in the early morning with a headache, diarheaa, dizzines, chills and vomitting
Swollen arm, warm to touch. Called PCP she had pt come in and she gave her XYZAL samples to decrease swelling.
Swelling, redness, had pain/tender 4 x 7cm area for 4 days.
Information has been received from a physician concerning a female who on 06-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Subsequently the patient experienced a 3 cm triangular wheal with induration at the site of injection. The physician did not have the patient's information available. Medical attention was sought via office visit. No product quality complaint was involved. Additional information has been requested.
Discharge Provider: DO Primary Care Provider at Discharge: NP  Admission Date: 12/19/2022 Discharge Date: 12/30/2022 COVID positive date: 12/19/2022  HOSPITAL COURSE: Patient is a 75-year-old female with a past medical history of a CVA with residual left-sided weakness, hypertension, hyperlipidemia who presented with weakness and falls.  Patient's family stated that she had been falling quite frequently and that her knees would give out.  She did have chronic left-sided weakness which was greater in the upper extremity and prior to this admission was able to ambulate.   In the Emergency Department, she was found to be positive for COVID-19.  She was afebrile and not hypoxic.  Labs were within normal limits. She had pelvic x-ray done 12/18 which showed degenerative changes without any acute pathology.  Lumbar spine x-ray done 12/19 that showed osteopenia, grade 1 anterolisthesis of L4, no compression fracture.  X-ray of the left tib-fib and left foot did not reveal any acute fracture.   CT cervical spine did not reveal any acute fracture or dislocation.  CT thoracic spine also did not reveal any acute pathology. Neurology was consulted and their recommendation was for MRI of the cervical, lumbar spine and brain.  MRI lumbar spine and cervical spine showed degenerative changes without any acute significant findings.  MRI of the brain was completed and did not reveal any acute intracranial abnormality and showed findings of chronic small-vessel ischemic disease, generalized pain atrophy, encephalomalacia and multiple foci of old appearing lacunar infarcts. Neurology did not recommend any further workup and signed off.  She was continued on Plavix and statin for her prior CVA.   Patient was not hypoxic and therefore was not placed on any treatments for COVID-19.  Her blood pressures were found to be elevated and she her doses of Cozaar and Coreg were increased to 12.5 mg and 50 mg, respectively.  She was seen by PT and OT and recommendation was for acute inpatient rehabilitation. However PM&R evaluated patient and felt she was a candidate for subacute rehab and not acute rehab.   She was ultimately discharged for rehab on 12/30/2022.  She should follow-up with her PCP in 1 week.
For approx. 2 weeks, patient had recurring herpes simplex (fever blisters). At one point patient had 4 fever blisters at the same time. Treatment was OTC topical agents with eventual resolution of the herpes simplex .
Within a few hours of getting the vaccine started with Flu symptoms of severe body aches, chills, headache, fever. Day 2 a bit better but still low grade fever of 101 degrees, nausea, weak, body aches but not as bad. In the evening around 5pm noticed ears starting to enlarge but didn't think much of it, by morning today at 7:30am I felt my face was swollen and numb on the right side. Now both ears were swollen and the area in my face was red. When I took my temperature on my forehead I was normal however the swollen cheek was 102 degrees. At that point I went to urgent care to get it looked out.  Currently at 6:30pm on 4/3/2021 the redness in my cheek has turn back to normal however the face is still swollen but not as bad.
Severe swelling, redness & pain around the injection site of immunization area; muscle pain & body soreness; fever & general discomfort; tiredness and general overall need for sleep lasting next several days
2 pts did not respond to Engerix-B; both pts were approx 300 pounds;