chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain and tightness starting 9/24. Exercised 9/25 could not catch breath and Sob. Went to Er on 9/28 with sob and elevated bp. 133/101.  They said could not rule out paricarditis,
24 hours after vaccination, three red spots just under the size of a dime appeared on the patient's right forearm. The spots are still red today and have a dry, scaly patch in the center. They do NOT itch, burn, or otherwise cause the patient any issues. He states they are just there.
Per pt, was in clinic today for booster covid Pfizer vaccine. 1125 pt reported to LVN that her throat felt tight after 10 minutes of waiting in observation area. Vitals obtained BP167/79, P67, O2sat 100%. Informed charge RN, per RN ok to give pt PO Diphenhydramine 25 mg. Administered at 1129.  Lot: 202906 EXP:09/2023 NDC: 0904-5306-61 Pt reported has been told by PCP that she has elevated BP and anxiety. Per pt did not have current symptoms with previous doses. Informed pt to wait an additional 30 minutes to reassess. Pt agreed with plan. Pt was provided water while waiting. Pt vitals obtained 1156 BP 155/99, P 60 O2 sat 100%. Pt reports feeling better, per pt has a ride and is not driving. ER precautions given to pt. Pt verbalized understanding. No further questions at this time.  Pt left in stable condition. LVN
This case was reported by a physician and described the occurrence of cellulitis in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on unknown arm. The patient experienced cellulitis. The patient received another vaccine (details not provided) in the same arm but in different anatomical location. This case is one of the case reported by the same reporter.
Intense Headache (No relief after taking Aleve), Chills, Body Aches, Sinus Pressure.  All symptoms lasted 24 hours followed by weakness for about 6 hours.  After symptoms subsided feeling 100% better.
High fever 101F started around 8:00 p.m. on 08/23/2021 and broke around 6:00 a.m. on 08/24/2021.  When the fever broke I got a splitting headache and took 800 mg of ibuprofen and the headache subsided and never returned.  For the rest of 08/24 and all of 08/25, I was very tired. On 08/26 I felt well enough to return to work.
Pt recvd 3 doses of Engerix-B 19FEB92 & 19MAR92 & 19AUG92 & p/1 & 2nd doses pt exp nausea, body aches, dark urine, light stools, diarrhea & malaise; 20AUG92 p/3rd dose pt exp nausea, body aches, dark urine, light stools, diarrhea & malaise;
This spontaneous report was received from a medical assistant referring to multiple unspecified patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II which had lot # L000458, expiry date: 06-JAN-2017 (route, dose not reported). The vaccine was exposed to temperature of 53 degree Fahrenheit for 50 minutes. No previous temperature excursion and no adverse effects were reported. The vaccine was brought back in range. No further information provided. Additional information has been requested.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/26/2023 Discharge Date: Feb 16, 2023   PRESENTING PROBLEM: Weakness generalized Acute cystitis with hematuria  COVID-19  Failure to thrive in adult    HOSPITAL COURSE: Pt is a 83 yr old F with PMHx of atrial fibrillation, prior stroke, bladder cancer with history of chemotherapy, recurrent urinary retention and bladder spasms with chronic indwelling Foley catheter, legally blind presented to ED on 01/26  with progressive debility and inability of caregiver to care for her anymore.  Hemodynamically stable upon arrival to emergency department.  Tested positive for COVID.  Admitted to Service for further assessment management.  She was treated supportively during her hospital stay.  PT cleared her to return home with assist however family is unable to care for her anymore at home.  Elected to pursue placement to assisted living facility. She was restarted on vagifem due to persistent dysuria.   Care management assisted with placement. Ultimately discharged in stable condition on 02/16/2023  to Long Term Care.
Approximately 24 hours after receiving Varicella injection SQ in left arm, child developed red blotchy erythema around injection area and down to elbow.  Parent reported area was slightly warm to the touch and that the child seemed to be running a low grade fever.  Parent took child to MD to have the site evaluated.  Dr. diagnosed a local reaction to the injection and suggested cold compresses to the site.  Parent stated the problem resolved itself in 24 hours without applying cold compresses.  Parent stated that she had no further concerns.
LETHARGIC; DIZZY, LIGHTHEADEDNESS; SLEPT THE WHOLE DAY; FLUTTERY HEART  PALPITATIONS; SUPER BAD ACHES; HEADACHE; LOST CONSCIOUSNESS; This spontaneous report received from a patient concerned a female 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, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 in right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the patient experienced lost consciousness (for couple of minutes) immediately after vaccination, she stayed around at vaccination site for 30 minutes. On 09-MAR-2021, the patient experienced super bad aches and headache. On unspecified date, the patient was lethargic, slept the whole day, fluttery heart palpitations, dizzy and lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness on 08-MAR-2021, and the outcome of headache, super bad aches, lethargic, fluttery heart palpitations, dizzy, lightheadedness and slept the whole day was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked. Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-Lost consciousness. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pt had flu vac immediately followed by covid vac. Immediately following the above two injections, Depo was given  and within 30 seconds, pt had syncopal episode falling from exam  table to floor. There were no apparent injuries. Pt  aroused and sat up within 3 seconds of syncope and c/o  dizziness. Pt transferred to exam table and placed in rescue  position. A+O x 3, BP 102/62, HR 60, O2 Sat 95%. Doctor notifed. Cool compress placed behind pt's neck. After 5 mins, pt  sat up and c/o lightheadedness, which resolved within several  seconds. Sips of H2O given. BP 113/76; HR 66, O2 Sat 94%. Pt remained in  observation x 30 mins following covid vaccine and left w/o  complications.
1st dose of Shingrix around 19Dec2019 / is late for the 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Twinrix (received Twinrix about 6-8 years ago, refer case US2021086439) and Shingrix (1st dose received on 19th December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by pharmacist on behalf of patient. The patient received 1st dose of Shingrix and was late for 2nd dose. Till the time of reporting, the patient did not received 2nd dose which led to incomplete course of vaccination. No symptoms were reported.  The reporter consented to follow up. The case was linked with case US2021086439 for same patient and reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086439:same patient (Twinrix case)
Baseline: 72 yo male social worker retired with asthma, CAD, some memory loss doing well quarantining and masking. January 22:  First dose Pfizer// January 30 repeated chills and malaise/February 1 wife called saying she was worried about vomiting, diarrhea, lack of intake//February 2 no vomiting, able to keep down clear liquids and bland food, canceled primary care appt//Febrary 3: Patient examined:  Afebrile, BP 140100 not orthostatic, HR 80 T 98.6.  Negative exam. Was oriented but wife mostly spoke for him.  "I've never been this afraid in my life"  February 6 exhausted, unable to do activities of daily living.  Fluids being pushed and eating bland food ok/ February 12:  Feels ok.  Covid PCR rtn'd negative.   February 13:  Second dose of Pfizer//February 17 malaise returns, poor oral intake/February 19 early AM found walking on street about 1/2 mile from his house disoriented. When he was return home by person who turned out to be his psychiatrist thought he was in DC.
Thyroiditis; ear pain; trouble in swallowing; chills; nausea; fever; terrible aches; feeling unwell; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of THYROIDITIS (Thyroiditis), PAIN (terrible aches), MALAISE (feeling unwell), DIARRHEA (diarrhea) and EAR PAIN (ear pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM and VITAMIN D3 for Supplementation therapy, BUPROPION and ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 12-Feb-2021, the patient experienced PAIN (terrible aches), MALAISE (feeling unwell), DIARRHEA (diarrhea), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever). On an unknown date, the patient experienced THYROIDITIS (Thyroiditis), EAR PAIN (ear pain) and DYSPHAGIA (trouble in swallowing). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, THYROIDITIS (Thyroiditis), PAIN (terrible aches), MALAISE (feeling unwell), DIARRHEA (diarrhea), EAR PAIN (ear pain), DYSPHAGIA (trouble in swallowing), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Computerised tomogram: (Inconclusive) results are not provided.. On 22-Mar-2021, Ultrasound thyroid: (High) thyroiditis..         patient visited ENT on 26 march 2021, Otolaryngologist on 22 April 2021, Endocrinologist on  03/22/2021, 05/04/2021, 05/27/2021.   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: follow up was received on 30 may 2021 contains vaccination facility details updated.concomitant medications updated.laboratory test details updated.
SWOLLEN FACE ON LEFT SIDE, DIZZINESS, WEAKNESS, HIVES, CHEST PAINS SHORT OF BREATH.
Patient reported joint pain and muscular aches, fever 3-4 days post vaccination. ED visit on 05/1152013 and released with diagnosis of cellulitis at the vaccination site, pt was given antibiotics and released. Second visit to ED on 05/13/2013 with dyspnea with exertion, chest palpitations, mild rash on neck, generalized weakness, papules on neck area, redness at vaccine site. Evaluated at hospital and released.
A sore vaccinated left arm for 2 days, fatigue 6 hours after the shot and lasted for 2 days, calves ache and joints pain for 2 days, fever 99.5-99.9 second night for one night, after day 2  I had swollen lymph node under the vaccinated left arm for  4 days.   I am very much back to 95% normal after 6 days from the first vaccinated day.
painful outbreak of skin rash; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 24-JUN-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) being administered, the pt developed a painful outbreak of skin rash. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of zoster vaccine live (ZOSTAVAX) that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the pt. The outcome of the event was not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event of rash to be disabling.
eyes were dilatated; issue with the vision; His vision was blurry; very sanative to light; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (issue with the vision), VISION BLURRED (His vision was blurry), PHOTOPHOBIA (very sanative to light) and MYDRIASIS (eyes were dilatated) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VISUAL IMPAIRMENT (issue with the vision), VISION BLURRED (His vision was blurry) and PHOTOPHOBIA (very sanative to light). On 15-Apr-2021, the patient experienced MYDRIASIS (eyes were dilatated). At the time of the report, VISUAL IMPAIRMENT (issue with the vision) and VISION BLURRED (His vision was blurry) was resolving and PHOTOPHOBIA (very sanative to light) and MYDRIASIS (eyes were dilatated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ophthalmological examination: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  Reporter stated that the patient never had eye issues before.   Reporter did not allow further contact
Mouth, tongue numbness and odd taste in mouth within 20 minutes of vaccine. Also occurred with 1st vaccine and a headache the next day.
Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest and neck
Pt states her left arm is swollen & red. She called her MD & MD stated it should drain soon. She also stated her shoulder was painful for 5 day after her flu shot.
Headache (0930 AM 8/13/14) Ibuprofen, TYLENOL. Temperature elevation (102 degrees) (1200 8/13/14 - 8/16/14). "Flu" like symptoms, malaise, body aches (8/13 - 8/18/14). Right hand numbness 8/15/14 (prednisone). Injection site (left deltoid) red, hot, swollen (8/15/14). Resolved symptoms 8/23/14.
Information has been received from a physician concerning an approximately 73 year old female who on 23-SEP-2010 was vaccinated with PNEUMOVAX 23 (lot # 667134/0738Z, route not reported). After administration of the vaccine, the patient experienced redness, pain and swelling at the injection site. The patient also experienced swelling of the arm. Outcome of the events were not reported. This is one of several reports received from a same source. Additional information has been requested.
Erythema with swelling approx 7 x5.5cm around injection site---LEFT DELTOID, no treatment necessary at this time other than symptomatic management.
Patient arrived to local Healthcare via EMS from home with difficulty breathing. Room air sat was 65% with productive cough. Patient was given steroid and placed on nasal cannula. Patient had a history of Covid 19 in January 2022. CTA of chest revealed large bilateral pleural effusion, right greater than left with compression atelectasis of bilateral lower, upper and middle lobes. Patient was admitted to hospital services and transitioned to comfort measures. Patient expired on 03/07/2022.
6/30/08: 8:30 a.m.-given shots. That evening: fussy,low grade temp.   7/1/08: 3:00a.m.- high pitched crying, 102 temp, grunting noises-alternately gave tylenol and motrin.    7/1/08: 3:00p.m.- Dr.'s office visit, sent to hospital- still has 101.5 temp, grunting noises and lethargic 9/8/08-records received for DOS 7/1-7/2/08-DC DX: Otitis Medial. Possible shot reaction. Medical observation for sepsis. Presented with fever and grunting respirations. Treated with IV antibiotics. Follow-up: I feel very strongly that this was indeed a vaccine reaction. My reasons behind this are as follows: I have two other children, one who had multiple ear infections before the age of two. I know what a ear infection entails. Pt's ears were checked at the doctor's office and that was it. They were never checked in the hospital or before she was released to see if her "ear infection" was doing better. Once admitted she was hooked up to an IV and her vitals checked every hour or two. She was hooked up to an apnea monitor to observe her breathing and heart rate. She was also hooked up to a continual pulse OX machine to observe that. He ordered blood tests and a urinalysis. All of this for an ear infection?! The day before her shots she was not running a temperature (I checked just in case), she was not pulling at her ears or favoring them, she was eating fine, and was not fussy at all. She also slept fine the night before. As I said previously, I feel very strongly that this was a vaccine reaction and would like this put on the record if possible.
Patient reports having a 1 inch to 1 1/4 in round, red, "blister-like" area approximately 1/2 inch below the area of injection on her left arm. It is not painful or itchy. She claims that this area first appeared Saturday (9/8).
This spontaneous report was received medical assistant refers to unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On 16-JUN-2016, an unspecified patients were vaccinated with six improperly stored doses of VAQTA, with lot # M009377, expiry date: 17-JUN-2017 (dose and route not reported), which were exposed to temperature excursion of 47 F for 9 hours . Then, on 23-JUN-2016, an unspecified patient was vaccinated with an improperly stored dose of VAQTA, lot # L015460, expiry date: 20-JUL-2017 (dose and route not reported), which was exposed to temperature excursion of 47 F for 9 hours on 13-JUN-2016, 47 F for 8 hours on 17-JUN-2016 and 47 F for unknown number of hours on 23-JUN-2016. No adverse effects were reported. The nurse stated that the refrigerator back in range. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
tiredness; Limited range of motion of arm without pain; Pain at injection site; fever of 99.4 usually 97.5; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, osteoarthritis, blood pressure high and COVID-19 from an unknown date and unknown if ongoing. The patient previously had wheat and sulfa and experienced allergy. Concomitant medications included Fluticasone Propionate/Salmeterol and salbutamol sulfate (ALBUTEROL SULFA), both from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 11Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation and experienced severe headache, pain at injection site, limited range of motion of arm without pain. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 17:00, the patient experienced fever of 99.4 (units unspecified) usually 97.5 (units unspecified), pain at injection site, limited range of motion of arm without pain, tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of fever of 99.4 (units unspecified) usually 97.5 (units unspecified), pain at injection site, limited range of motion of arm without pain, tiredness and included treatment with acetaminophen, Biofreeze spray. The patient underwent lab tests and procedures which included body temperature 99.4 (units unspecified) on 09Apr2021. The clinical outcome of the events fever of 99.4 (units unspecified) usually 97.5 (units unspecified), pain at injection site, limited range of motion of arm without pain, tiredness was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Presented with cough, congestion, fever x 4 days; + covid 2 days PTA; admit 9/17 with Covid PNA;  tx with 9/17 remdesivir, zinc, eliquis, maxipime, steroids, singulair, 9/18 Vit D3,  9/22 actemra, 9/23  lovenox; O2; Initially 4L NC; would increase to 15 L and then improve back to low O2 several times throughout stay; eventually maintained on 3 LPM at time of d/c
Received Hep A #1 and Prevenar #11 at same site, left thigh-site very red, swollen and warm, size of half dollar.