chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site warmth; Itch around the injection site; Injection site immediately turned red; Injection site immediately began to swell; vaccination site pain; Vaccine was given subcutaneously; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subcutaneously) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) from 01-Jan-2016 to an unknown date for Seasonal allergy.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subcutaneously). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subcutaneously) had resolved.            Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: updated new events , vaccination site erythema, vaccination site pruritus, vaccination site pain, vaccination site warmthReporter contact details updated In product tab, second dose details of mRNA 1273 was updated. concomitant drug was updated patient demographics was updated; Sender's Comments: This report refers to a case of Inappropriate route of vaccination for mRNA-1273, lot # 029A21A with no associated AEs.
fatigue; achiness; increase in blood pressure; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-086275), for BNT162B2. An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization; and lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 04Jan2021 to 07Jan2021, at 20 mg, daily, then via an unspecified route of administration from 26Jan2021 at 10 mg, unspecified frequency for uterine cancer. Medical history included: uterine cancer and systolic blood pressure greater than 150. Concomitant medications included: lisinopril and amlodipine besylate taken for systolic blood pressure greater than 150, start and stop date were not reported. The patient previously took pembrolizumab (KEYTRUDA) infusions. Patient stated continues to monitor blood pressure and still sees increase in blood pressure. Patient is now taking lisinopril 20 mg in the morning and 20 mg in the evening. Is also taking amlodipine besylate 5 mg for systolic blood pressure greater than 150. Is scheduled to speak with pharmacist next week, and if blood pressure remains consistently greater than 150, then will increase amlodipine to 7.5 mg. Received second COVID vaccine (Pfizer) two weeks ago. Stated is now feeling better this week. Noted with fatigue and achiness all last week. Patient is also scheduled to see gynecological oncologist next week for follow up appointment. Diagnosis C55 Uterine Cancer, LENVIMA 20 mg once daily, start date 04Jan2021, temporarily stopped medication on 07Jan2021, resumed LENVIMA 10 mg on 26Jan2021. The action taken in response to the events for lenvatinib mesilate was unknown. The outcome of the events was unknown.
According to mother, patient regressed in speech skills abruptly after administration of stated vaccines.  Mother also noted rapid regression of social skills and interaction with environment.  8/29/08 Reviewed child development evaluation of 2/22/2007. FINAL DX: autistic disorder Records reveal patient experienced speech regression, developmental delays, social withdrawal, no eye contact, does not respond to verbal stimuli, plays by self, sterotypical repetitive behaviors.  7/4/08 Reviewed PCP medical records of 12/19/2005-4/04/2008. FINAL DX: Records reveal patient experienced URI w/croupy cough , runny nose x 3-4 days prior to vaccination on 12/19/2005 (behind on vax schedule, no WCC since 6 mo of age).  Exam revealed patient refused whole milk & would accept only 2%.  Was developmentally on track.  Oropharynx was red w/exudate on both tonsils & dx w/acute pharyngitis.  RTC on 2/14/06, 2/24/06, 3/21/06, 4/3/06, 5/12/06, 6/14/06 w/fever, vomiting, cough, reduced oral intake, irritability.  Sibling w/sinusitis.  Tonsils red w/white patchs  Dx w/acute pharyngitis, sinusitis, suppurative OM.  On 8/21/2006 vs expressed concern that doesn't play w/other, unresponsive to verbal directions, temper tantrums, delayed language skills, delayed fine motor skills.  Referred for hearing test & developmental eval.  RTC 10/2006 w/acute pharyngitis, URI x 3 wks, fever & reduced appetite.  Continued w/socialization issues, lack of interaction w/others, sterotypical repetitive behaviors.  Had not had hearing tested.  Dx: suspect PDD & referred for developmental eval.  RTC 1/3/07 w/runny nose, congestion, fever, insomnia, decreased appetite, vomiting x 1 week.  Dx w/viral infection.  Referred for developmental eval.  RTC 3/5/07  Had been dx w/autism 2/22/2007.  Receiving ST/OT & developmental services.
Eye and tongue swelling 45 minutes later. Treated with 25mg Beandryl-1:1000 SQ epinephrine.
Fatigue. Body aches.  Confusion or "brain fog".    Basically just felt sick, not really nauseous, but definitely not right.   Lasted almost 3 full days.  Some pain in the arm with the shot location, but not bad.  My history is that I very rarely get sick.   I have not had a shot of any sort in 30 years.  I have never had a flu shot.  I have not had a tetanus shot since high school.  I don't go to the hospital.  I just don't get sick.  I did not take many precautions in the 15 months of the pandemic.  I did not stay home.  I did not limit my travel. I occasionally wore a mask in public (when required).  And I did not get sick until I got this shot.
received the first dose of Pfizer COVID-19 (Lot#: EN6207) in the left deltoid in the early afternoon of March 24, 2021.  He immediately felt left hand tingling/numbness at his left thumb and first finger that has intermittently worsened with flexing his arm.  There was no local reaction.  The next morning, he experienced severe fatigue, headache, muscle aches/soreness, fever and mild chest congestion that resolved after 5 days.  He also developed itching and hives that occurred from his chin downward on his neck, bilateral shoulders, back, chest and abdomen with no hives below his waist. He had photo showing erythematous blotchy rash scattered over this neck, anterior shoulders, chest and upper abdomen.  The hives continued daily despite Claritin 10 mg daily and have gradually subsided.  There was no nausea, vomiting, diarrhea, abdominal pain, dysphagia, swelling, cough, wheeze or shortness of breath.  HIs last hives was 2 days ago and no hives today.  Prior to the vaccine he was well without colds or flu-like symptoms in his usual state of health.  He had not taken NSAIDs or other medications or supplements.
Information has been received from a pharmacist via a company representative referring to a less than 55 years old adult female patient (the patient is 60 years old at the reporting time). Information regarding relevant medical history and concurrent condition were not reported. On an unknown date, when ZOSTAVAX first came out, the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). At that time, the patient was less than 55 years old. No adverse symptoms reported. Additional information has been requested.
I had my first Shingrix 0.5ML shot on 02/19/2019. 24 hours later I experienced a fever of 102.8, chills, headache,and body aches. 4 days later I was seen in the emergency room for a severe headache and moderate to severe vertigo. I had my 2nd Shingrix 0.5ML shot on 05/11/2019.Within 12 hrs, I had a fever of 102.5 and the chills. My arm hurt at the sight of the injection. There was a 9cm diameter hot, hard, raised, painful circle. Went to the nearest urgent care 48hrs later and was told I had Cellulitis. I don't know if I was administered the shot with a dirty needle.
I got the flu vaccine and not sure on brand or any other particulars.  Within 2 hours Ulnar nerve pain/discomfort and tingling and numbness in ring finger and pinky finger and outside of palm - still have this today and have been referred to a hand specialist Ortho and also need to schedule EMG
Copious bloody stool with clots produced approximately 30 hours after receiving Comvax vaccine #2. Same response seen after 2 month shots, on 12/20/04, his first set of immunizations. Decision to split up shots made to see if any correlation existed between shots and bloody stool.
After receiving the first Gardasil vaccine on Jan 11th, I have not gotten my period. My last one was around Christmas time. I have always been regular and never missed a period.
Severe Headache, took Tylenol every 4 hours. Did not help. Went to bed early and woke up feeling fine.
Information has been received from a licensed physical therapist assistant concerning herself, a 28 year old female with a history of blood pressure high who was vaccinated with MMR II (lot number, route an site of administration not reported) as a child. There were no history of drug reactions and allergies. Concomitant therapy included NORVASC. The reporter stated that her titer for mumps was low now, she did not know how many doses of MMR II she has received in the past. the patient did not seek medical attention. At the time of reporting, the patient's mumps titer was still low. Additional information has been requested.
Fever to 104 onset 8 hrs p/vax pesist 12 hrs & as of 10AUG92 conts 99-101; blood (red from rectum, brown fr vagina & urine) noted 25AUG92 on 30JUL found to be anemic, Pred started; bleeding stopped in 3 days-continues to bruise easily;
NERVOUS PRIOR TO VACCINATE. PT TURNED PALE AND LOST CONSCIOUSNESS X 10 SEC. CODE GREEN CALLED, PT WOKE UP, BP: 107/73, HR 84. BS+ 77. PT DID EAT ALL DAY, LIGHT HEADED, SX IMPROVED, REFUSED TRANSPORT.
Post vaccination  patient stated he felt like his heart was beating fast.  B/P137/92, P68.  Stated B/P was a bit high for him.   Within 10 min post vaccination, stated his upper left chest was aching, then stated that his mouth was feeling like it was getting smaller.  Rapid response was called and patient transported to Emergency Department at 1125 for further assessment and intervention.
Case number PHEH2016US026564, is an initial spontaneous report received from a consumer on 11 Oct 2016. This report refers to a 75 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 166001) at a dose of 0.5 ml intramuscularly in left arm on 06 Sep 2016. On the same day of vaccination, patient experienced sore in upper left arm. It was reported that, patient received FLUAD about 3 weeks ago and her arm still bothered her where the injection was given. Symptoms began since day of administration and continued till the day of report. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Patient received 1st dose of Pfizer at our store when she already received 1 dose of J&J earlier this year. Patient did not disclose this information at time of administration. We found out when we billed her insurance.
I noticed I was getting red sores with whitish flaky skin and it was increasing throughout the week. On Friday December 03, 2021, I ended up going to the doctor who took a skin biopsy and determined it was Psoriasis and he gave me 2.5 Hydrocortisone Ointment to apply twice daily. It calmed down the symptoms some but they are still ongoing. I am scheduled to see a Dermatologist on February 09, 2022.
History and Physical   Date of Admission: 1/17/2022   Chief Complaint:  Chief Complaint Patient presents with ? Corona Virus Concern     Per EMS pt sent to hospital because they were unable to obtain a pulse ox reading and pt is covid +. Pt pulse ox 100% on RA upon arrival.      Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 79y.o. male with a past medical history of dementia, Afib, and hypertension who presents to the ED on 1/17/22 from nursing home after mottling/reddish discoloration was found in the toes and unable to obtain a pulse ox at the facility. He tested COVID positive on Friday. EMS obtained a pulse ox in the high 80s with a poor waveform. In the ED he was placed on a pulse oximeter and satting at 98%. He is laying on the side of the bed. Patient is Aox1 at baseline and today he is minimally responsive to questions. He is able to answer his first name but unable to appropriately answer other questions. When asked why he is here he responds with uncomprehendingly. According to the daughter at baseline he often only gives short responses, often inappropriately, and only rarely follows commands or is able to be directed.
On my way home from getting the vaccination, the Left side of my face (cheekbone around left eye and above eyebrow) felt like it was on fire, felt swollen but was not visually, and was painful to the touch.  After about 3 hours the burning sensation was reduced to an ache but to the touch it felt numb.   Almost like I had had novacaine and it was wearing off without the tingling sensation.   I called my PCP and left a message.   The next day, Saturday, it felt like I had been punched in the face.  It was very sore and ached.  Sunday was better, with just a slight ache, but not 100%.  As I write this, it feels a little off (best way to describe it) but no pain or ache.  My PCP has not called me back.
I was suffering from paralysis and numbness on the left side of my face.  I went to the ER and was diagnosed with Bell's Palsy; This is a spontaneous report from a non-contactable consumer (the patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration in left arm on 21Feb2021 11:30 a.m. at age of 31-year-old, at single dose for COVID-19 immunisation. The patient had history of frequent ear infections. Concomitant medication included fluticasone which was taken within 2 weeks of vaccination for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient reported when he woke up the next day after receiving the vaccine (22Feb2021), he found that he was suffering from paralysis and numbness on the left side of his face. He went to the emergency room (ER) and was diagnosed with Bell's Palsy. He had been experiencing some minor pain in his left ear beginning two days before he received the vaccine (i.e., three days before onset of facial paralysis), and this ear pain had continued as he continue to experience the palsy. Since visiting the ER, he had also seen a neurologist. The doctors he had seen do not necessarily think that the palsy resulted from receiving the vaccine. The onset date of the event "I was suffering from paralysis and numbness on the left side of my face. I went to the ER and was diagnosed with bell's palsy" was reported as 22Feb2021 09:00 a.m. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The event was non-serious (the event did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect). Oral steroid and antiviral drugs, eye ointment was received to treat the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot # M019691, expiration date: 02-NOV-2017 and lot# L048854, expiration date: 31-AUG-2017). There was no adverse effects reported. Administered doses of ROTATEQ experienced the temperature excursion of 38 degrees Fahrenheit for 16 hours. The outcome of the event was not reported. This is 1 of 2 reports from the same reporter. Additional information has been requested.
Patient claims she developed an infection in her eye and cold symptoms a few days after her flu shot - also a rash both on her scalp and below her eyes, and little bumps on the side of her head.
This case was reported by a pharmacist via call center representative and described the occurrence of arm infection in a elderly female patient who received dTpa vaccine for prophylaxis. The patient's past medical history included lymph node excision and breast cancer. On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced arm infection. On an unknown date, the outcome of the arm infection was unknown. It was unknown if the reporter considered the arm infection to be related to dTpa vaccine. Additional details were provided as follows: This case was reported by the pharmacy intern. The age at vaccination was not reported. The patient received Tdap (unspecified brand) in the deltoid. The patient developed infection in her arm. The reporter did not have any additional information.
acute myopericarditis with severe chest pain, diffuse st elevations, significantly elevated troponin levels indicating significant heart muscle injusry,  and reduced ejection fraction of the heart to 42% as well as severe chest pain. Required treatment with high dose steroids and milrinone. patient currently admitted to the pediatric ICU for care. Condition currently improving ejection fraction increasing towards baseline,  however overall prognosis unknown at this time.
pt recv vax 12APR94 & 16APR94 devel swollen eyes & a rash on neck, chest & extremities which disappeared 2 days later; also exp pruritus & acted a little crabby; 22APR94 pt devel an erythematous, macular, papular rash & was examined by MD;
Nausea, vomiting, migraine, mensuration disturbances, ovulation disturbances, transient Paresthesia
Patient probably will be receiving 2nd dose on 48 days interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient probably will be receiving 2nd dose on 48 days interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient probably will be receiving 2nd dose on 48 days interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient probably will be receiving 2nd dose on 48 days interval) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Cough  Shortness of Breath  Sore throat NAUSEA HEADACHE WHEEZING
Pt. given PEDIARIX combination vaccine and also given Hepatitis B and Polio vaccines.  (These are components of PEDIARIX).  No reaction reported/deserved.
Hot, red and very hard lump in injection site. Painful too. And itchy. No signs of it getting smaller or going away after 10 days
Received Hep B on 12/4/07 at 8:30 AM. She experienced a lot of pain in upper arm almost immediately. By 12 noon the pain progressed to left side of face and to fingertips, and left half of trunk area. She noted redness on right clavicle and breast area.  She felt very shaky and her head was pounding.  The pain persisted until the next morning. The redness continued.  She saw her MD who ordered Benadryl 50 mg q4hrs for one dayand labwork.
potential bowel obstruction; gastric distress; low-grade fever spiking up to 104F; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (potential bowel obstruction), GASTRIC DISORDER (gastric distress) and PYREXIA (low-grade fever spiking up to 104F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 024M20A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease (has Crohn's disease and Colitis for 4 years.) and Colitis.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced INTESTINAL OBSTRUCTION (potential bowel obstruction) (seriousness criteria hospitalization and medically significant), GASTRIC DISORDER (gastric distress) (seriousness criterion hospitalization) and PYREXIA (low-grade fever spiking up to 104F) (seriousness criterion hospitalization). The patient was hospitalized on 17-Aug-2021 due to GASTRIC DISORDER, INTESTINAL OBSTRUCTION and PYREXIA. At the time of the report, INTESTINAL OBSTRUCTION (potential bowel obstruction), GASTRIC DISORDER (gastric distress) and PYREXIA (low-grade fever spiking up to 104F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 104 (High) low-grade fever spiking up to 104F..         No concomitant information was provided. Patient was hospitalized, and went to the ER, had CT Scan for potential bowel obstruction and gastric distress results were unknown. Then patient  was discharged along with heavy maintenance medication.  Company comment: This case concerns a  male of unknown age with relevant medical history of Crohn's disease and colitis who experienced serious unexpected event of intestinal obstruction, gastric disorder and pyrexia one day after the third dose of the Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a  male of unknown age with relevant medical history of Crohn's disease and colitis who experienced serious unexpected event of intestinal obstruction, gastric disorder and pyrexia one day after the third dose of the Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.