chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea  Narrative: Patient reported feeling dizzy and nauseated at approximately 1345. Vital signs taken, BP146/70 P91 O2sats 96% on room air. Reported feeling better at 1355. Vital signs at 1400 BP142/67 P88 O2 sats 95% on room air, 1415 vitals, BP126/73 P82 O2 sats 95%. Patient reported feeling better and ready to leave facility but starte to feel nauseated again. Patient offered water at 1445, and was able to keep the water down. Reported feeling better at 1455, was able to walk independently with no signs of dizziness with nausea resolved. Condition stable when picked up bye escort at 1500, last vital signs BP143/78 P80 R20 O2 sat 96%.
Any time I move my arm, which is very tender now as opposed to when I initially received the vaccine, my hand will go numb and my whole arm tingles.; Any time I move my arm, which is very tender now as opposed to when I initially received the vaccine, my hand will go numb and my whole arm tingles.; Any time I move my arm, which is very tender now as opposed to when I initially received the vaccine, my hand will go numb and my whole arm tingles.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Aug2021 13:15 (Lot number: EW0176) at the age of 22 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Raynaud's phenomenon" (unspecified if ongoing); "GAD" (unspecified if ongoing); "known allergies: NSAIDs" (unspecified if ongoing), notes: known allergies: NSAIDs; "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: SERTRALINE; JOLESSA. The following information was reported: TENDERNESS (non-serious), HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 11Aug2021 05:15, outcome "unknown" and all described as "Any time I move my arm, which is very tender now as opposed to when I initially received the vaccine, my hand will go numb and my whole arm tingles.". Therapeutic measures were not taken as a result of tenderness, hypoaesthesia, paraesthesia.  Additional information: Facility type vaccine was hospital. Patient had not received other vaccine in four weeks. Patient had not tested covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Woke up around midnight ~14 hours after my vaccine with the worst chills I?ve ever had. Never ran fever during the chills. Fever was around 101 right after chills stopped but that only lasted a few minutes.  During the time with chills I  could not stop shaking. Clenched my teeth so bad. Jaws were sore fur several days afterwards. Chills lasted  about 3 hours. When chills were over I was totally wiped out for about 3 days. Mainly slept during that time.
Swelling on Ulnar side of left hand.; blisters on left hand; hard lumps on left hand and wrist; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via unspecified route of administration in the left arm on 27Mar2021 at 11:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), evolocumab (REPATHA), losartan (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from unspecified dates for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9809) via unspecified route of administration in the left arm on 06Mar2021 at 11:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation and montelukast (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 09:00, the patient experienced swelling on ulnar side of left hand, five hard lumps on left hand and wrist and blisters on left hand. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling, lumps and blisters was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse practitioner concerning an 18 year old female patient who was vaccinated with her first dose of HPV vaccine (yeast) and had no adverse side effects.  Subsequently, she was vaccinated with her 2nd dose of HPV vaccine (yeast) and within 24 hours broke out in hives, which developed into shingles.  Medical attention was sought.  As of the report date, the patient was recovering. Additional information has been requested. Follow up information has been received from a Certified Medical Assistant and medical records concerning a 17 year old female stundent with current tobacco use and a history of rash with CEFZIL and CECLOR, diarrhoea with AUGMENTIN and chickenpox who on 11-DEC-2004 at 2:35 p.m. was vaccinated IM in left arm with her second dose of GARDASIL, lot #653735/068HF. Concomitant therapy included YASMIN 28 and Sulfamethoxazole and trimethoprim. The reporter indicated that the patient developed hives post injection, then on 18-DEC-2006 was seen at an urgent care clinic for shingles, which was not felt to be related to the immunization. The patient recovered on an unspecified date. According to medical notes from 18-DEC-2006. Patient states she's here for compains of a rash on her back and under her right armpit, and she describes the pain as an 8/10. States it started last Wednesday (13-DEC-2006) but it's gotten much worse. States she had the 2nd HPV immunization last Monday, and they wonder if this might be a reaction to it. "It was also reported that the patient did have a burning/pain sensation prior to 13-DEC-2006 and prior to the administration of GARDASIL and blistering. The blisters were in clumps/painful, and were aggravated by touching. The patient stated she was under a lot of stress with school and that she had some low grade fevers. Her assessment was shingles, right T5 dermatone - increase vesicles in patches along the T5 dermatone. She was treated with VALTREX. 1 tablet 3 times daily and Tylenol with Codeine #3). 1 tablet every 4 hours as needed for pain. Additional information is not expected.
Narrative: 73y.o. MALE with a h/o: HFpEF (EF 51% on 11/2020) ,  COPD (no home 02), , mechanical aortic valve (On AC), valvular afib, SSS (s/p  ppm), Hypothyroid, HLD, Iron Deficiency Anemia, GERD, Osteoporosis,  Ischemic colitis (s/p colostomy) was admitted to inpt on 11/29 21 Ct SCAN WAS  done that revealed Small bowel obstruction with proximal air-fluid levels, largely  dilated stomach, intussuseption. Of note patient recently underwent right  hemicolectomy with end ileostomy withinthe past month, affial and miff-al valvular  disease leading to CHF, and hospitalization for the past 2 months make him an  exceptionally poor candidate for abdominal operative intervention. Patient has  since decided he does not want any further intervention. He discussed with  palliative care team and stated he wants to go home with hospice.Terminal care  note/lF designation to be done.C home with home hospice was arranged. Pt was  discharged from inpatient to hospice care on 12/23/2021. pt then died on  12/30/2021. Pt had received covid vaccines on 3/16/2021 & 4/14/2021. Death not  related to covid vaccines.
Child kicked left leg as RN administered Hep A, and needle became dislodged with only half of the vaccine having been administered. RN replaced needle on syringe, recleaned site of left leg and administered the rest of the vaccine without incident. Mother aware of the small surface scratch caused by needle on child's left thigh. RN cleaned and bandaged sites.
After 4 months immunizations (see below) 3 hours of incontrollable crying, not high pitched.
Fever 102.1, chills, body aches, swollen lymph nodes under left arm, swollen lymph nodes on left clavical, headache up the back of the neck and right side of the face, tiredness, mouth sores
I noticed nerve pain(left side back to front), pain on my back right below scapula. On 3/17 I was diagnosed with Shingles prescribed Antiviral, Lidocaine patches and Ibuprofen.
Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 08-Apr-2022; Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 08-Apr-2022) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported The vial was initially put in the refrigerator on 04-Apr-2022.The vial did not undergo any temperature excursions. The pharmacist thought that vaccine will expired on Jun-2022, however vaccine was expired on 01-Apr-2022. No Treatment medication was reported
ARM TURNED RED, WAS HOT, AND SWOLLEN.  URGENT CARE DR PRESCRIBED PREDNISONE. ARM STILL LOOKS SPLOTCHY. NOT AS SWOLLEN OR RED AS YESTERDAY.
Patient had 3 vaccines, felt fine after this, went out to lunch, then felt nauseated, dizzy, headache 2 hours later. Called EMS. They came and found her shaky and nauseated. Gave her TYLENOL and GATORADE, then she took a nap and woke up feeling better. Did not transport her.
I got shingles from the shingles vaccine.  Started as soreness and itching.  A rash appeared and lasted until late March.  I continue to have itching and pain, altho diminishing.
This is a spontaneous case, initially received from other non-health professional (consumer) on 29-Dec-2017, concerning a 61-year-old, adult, female patient. The patient's history included the procedure hysterectomy, nodule in the back and current condition included asthma. No concomitant medications were taken. On 29-Sep-2016, the patient was administered with FLUVIRIN (anatomical location: right arm, batch number: 1619101, expiry date: 30-Apr-2017, dose and route of administration: not reported). On an unspecified date in 2016, 1st week after receiving the vaccination (as reported), she had burnt feeling during vaccination and felt that she has had a bee sting in her arm, she was able to touch the sting area and the spot. It was reported that the patient has visited the doctor for every 3 months and no treatment was received for her symptom. She was not improved, stated that has no problems with the flu vaccine in the past. So, she needs to treat with a medical doctor or else she would contact a lawyer. At the time of this report the patient had not recovered from the event. The reporter assessed the event as non-serious and causality of the event as related to the suspect vaccine.
He presented to ER with sx 8-23-22 altered mental status and hypoglyemia and tested + for covid.  He was admitted 8-25-22 and discharged 10-5-22 , complicated course requiring multiple consults including: pulmonology for pneumonia and resp failure, cardiology for afib, neurology for altered mental status, psychiatry for delirium, surgery (had peg tube) , nephrology for Acute kidney injury and CKD,  Infectious diseaase for COVID.    He developed encephalopathy due to covid, pneumonia, had acute resp failure, required icu and intubation  He was given remdesivir, dexamethasone, lovenox. lopressor.   Had to have bronchoscopy 9-13.   DC to a residential facility.  Readmitted  peg tube problem 11-2-22  and was to be discharged 11-3-22 home with hospice .  He  passed 11-12-22 at his home.
LOSS OF COLOR IN FACE, NAUSEA, VOMITING, DIZZINESS, DIAPHORESIS
Tdap administered on 10/20/2017 (last dose of Td 7/21/2003). That evening, she described aches and chills. Her temperature at approximately 7:00 pm 103.6. She then went to the ER and was admitted 10/20-10/23/17; discharge diagnosis was no known etiology sepsis. Upon follow-up with her primary care provider on 10/27/2017, she was diagnosed with allergy to Tdap.
Patient received ZOSTAVAX inj. on Friday 4/28/2017. Returned to pharmacy on Tuesday 5/2/2017 with red half circle rash and tingling sensation.
Patient was to receive her flu vaccination and was incorrectly given a 4th dose of Pfizer covid-19 vaccine instead. As of noon on 10/26/21 she was experiencing expected side effects of vaccination, feeling tired, body aches, headache, and arm soreness. She reported that her arm was sore enough that it hurt to lift it. We notified primary provider and continue to follow up with patient.
At 7:10am yesterday 1/7/21 I received the covid vaccine. Immediately my lips went numb, and my left arm and hand went numb. I waited at the hospital for 15 minutes and then attempted to drive home. I got about 2 blocks away and noticed my face was numb all the way from my chin to my nose. I went back into work into employee health and let them know. They called the pharmacist who instructed me to go to the ER. While walking to the ER I began to have difficulty breathing, and throat tightness. They called a rapid response alert and I was taken on a stretcher to the ER. I felt dizzy, nauseous and the numbness to my face was from my mid neck up to the top of my hairline at the top of my face. My left hand and arm were still numb. When they took my vitals I was hypertensive BP approximately 155/86, I was also tachycardia HR 104-110. EKG was abnormal-sinus tachycardia HR 104, and probable left atrial enlargement. I began to have severe chills/shaking for approximately 1 hour. I was given 1 liter of normal saline IV, Benadryl 25mg IV, and Zofran 4mg IV. After inspection by the doctor my throat was not swollen, or closing so an epi pen was not administered. My oxygen saturation remained above 91%. After 3 hours of being monitored in the ER my numbness to my face started to improve so I was discharged home. Labs were taken in the ER and my potassium was 3.1, calcium was 8.1. The day prior at my primary care doctors office labs were taken and all my labs were normal including my potassium and calcium. My primary care physician believes the low electrolytes the day of the reaction were due to the reaction to the vaccine. I also had a repeat EKG today (1/8/21) the day after the reaction at my primary cares office and it was normal sinus rhythm with no abnormalities. Vitals were all within normal limits. Today (1/8/21) approximately 36 hours after the vaccine administration I have mild numbness to my face as well as moderate body aches. My primary care physician believes I should not have the second dose of the covid vaccine as she fears I would have a anaphalactic reaction.
PATIENT PRESENTED TO HOSPITAL EMERGENCY DEPARTMENT 10/20 @ 0927 IN CARDIAC ARREST AND EXPIRED.
1503 Patient received PFIZER COVID19 booster. 1510 Patient complained of feeling dizzy and lightheaded.  BP 152/92 HR 97 1510 Provided crackers, water and juice, as patient denied having eaten at all today. Continued to monitor and encouraged to deep breath. 1528 Patient complained of feeling nauseous and had visible tremors and difficulty speaking.   BP 155/89 HR 79 1530 EMS contacted 1535 Mother notified of patient condition and status, advised EMS contacted to transport patient to hospital for further evaluation and monitoring 1540 EMS arrived and transported patient via stretcher to hospital
pt recvd vax in DEC93 & 4 wks later pt was hospitalized for 4 days for severe abdo cramps; pt was jaundiced & lab eval revealed neg hepatitis antigen & anti-Hbs of 26;
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild
Swelling of the legs began on the 28th of February, Patient went to ER on March7th and diagnosed with DVT. Patient was discharged about 12 hours after arrival and put on rivaroxaban. Patient returned to the ER on March 13th and was diagnosed with bilateral Pulmonary Embolism patient was kept overnight put on heparin drip and then transitioned to rivaroxaban. Patient does not know if the vaccine was the cause as patient has had 2 previous DVT's (no previous PE's). DVT's both occurred after transcontinental flights. This recent DVT and PE occurred with no know reason. Patient is positive for Leiden5
pt recv vax had a sl fever; Wed noc was warm temp not taken; APAP given; 3PM mom recv call fr daycare stating pt eyes had rolled back;
Donor reports that when he awoke at approx. 0500 on 3/9/21 he was feeling feverish with chills and too tired and weak to get out of bed.  Reports remained bedridden throughout the day and into the early am of 3/10/2021.  Reports decreased appetite and that he continued to feel feverish with alternating periods of cold and hot with sweating.  Unable to take his own temperature.  Denies N/V, diarrhea, headache, dizziness, LOC; also denies any rashes to body or dyspnea.  Denies any swelling, redness, pain/numbness/tingling to right arm/hand.  At approx. 0930 on 3/10/2021 donor reported feeling much better and believed the fever had broken.  Was tolerating fluids well and able to get up and about independently.
Site: Swelling at Injection Site-Medium, Additional Details: swelling of arm for 3 days
Information has been received from a physician via a company representative concerning a 4 year old male patient, with no medical history reported, who on 22APR2003 at 03:15 pm (previously reported as 22APR2003) was vaccinated into the right lateralis with a second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Concomitant therapy on 22APR2003 at 3:15 pm included a fifth dose of alum, potassium + diphtheria toxoid + pertussis vaccine + tetanus toxoid (TRIPEDIA) into the left lateralis and a fourth dose of polio virus vaccine IPOL into the left anterior lateralis. It was noted that there was not ill the time of vaccination. Subsequently,the patient developed a " reaction." In follow up information, it was noted that on 22APR2003 at 3:15pm, the patient developed localized swelling and redness to the site. The pt was treated with diphenhydramine hydrochloride (Benadryl) 12.5mg (1.5 tsp.). The patient recovered on 22APR2003.
Information has been received from a nurse practitioner concerning a patient, (demographics unknown), with a history of hepatitis C and treatment with interferon who, "within the last 12 months", was vaccinated with Vaqta (manufacturer unknown). Within the past 12 months, the patient experienced arm hurting more with the second shot than with the first shot. There was bleeding from injection site and dizziness. Unspecified medical attention was sought. Subsequently, the patient recovered from the arm hurting, bleeding from injection site and dizziness. Additional information has been requested.
Pins and Needles in the left hand for about 30 hours starting at 10PM day of vaccine Chills starting day after vaccine given for about 26 hours
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; OFF LABEL USE; RECEIVED 2 DOSES BEFORE THE BOOSTER WAS AUTHORIZED; This spontaneous report received from a patient concerned a 6 decade old male. Initial information was processed along with additional information received on 23-DEC-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: cannabis consumer. The patient received with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that patient received 2 doses before the booster was authorized (off label use and Inappropriate schedule of vaccine administered), and that it was like patient was part of a study without being in a study.  On an unspecified date, the patient experienced three to five days of flu like symptoms with yellow phlegm which indicates suspected covid-19 infection and suspected clinical vaccination failure (dose number in series 2). The patient stated that it was unsure if this was a break through case as he has not been tested for Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of off label use, suspected clinical vaccination failure and received 2 doses before the booster was authorized was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208210. The suspected product quality complaint has been confirmed to be voided (did not meet regulatory authority criteria as reported complaints were adverse events) based on the regulatory authority evaluation/investigation performed.; Sender's Comments: V0: 20211250896-covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Chills, High fever 103, headache, body aches and pain at injection site.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced AXILLARY PAIN (sore arm). At the time of the report, AXILLARY PAIN (sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.