chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 days after the Moderna booster, I woke up in the middle of the night, itching and covered in hives. The hives were huge, puffy, very red, very itchy. The only thing that helped was ice compress. From the start I had dermatographia, rush of heat to my ears, "stuck pill" feeling, and wheezing.  I took Benadryl, but it didn't reduce their intensity at all. I didn't know what I was dealing with - I had only had hives once before (in 2014) when I was stung by multiple bees and nearly had anaphylaxis. When benadryl didn't work, and hives continued for longer than 2 weeks, I tried Allegra and Zyrtec. Both relieved the itching, but Allegra wore out sooner. As of today, hives have been going on 2.5 months and I take a Zyrtec every day. It takes away the itching but the redness and dermatographia is there.  The hives are not puffy anymore, more like a skin rash.
Within 5 minutes: skin sensation of burning, throat sensation of burning  Within 10 minutes: shortness of breath, coughing, throat tightness/ anaphylaxis
The patient states that immediately after receiving the vaccine she experienced significant pain in her arm. She states that it felt like the needle was left in her arm. She states that she made mention of her discomfort to the immunizing healthcare professional at that time. Soreness in her arm continued for the remainder of the day she received the vaccine. She states that starting on 9-28-19, she noticed an area of what appears to be bruising surrounded by a yellow border. She denies any use of routine or scheduled blood thinning medications. When she presented to the pharmacy on  10-5-19 to report her adverse event, she still had an area bruising with a yellow border. She denies any pain in the area beyond the day of vaccination and has full range of motion in this area with no reported discomfort. A fax has been sent to her PCP today and we will be calling her PCP  to inform her of the adverse event as well. The patient was advised to continue to monitor the area and to contact her PCP on Monday to report the issue.
No additional AE reported; Temperature excursion; This spontaneous report has been received from a non-health professional and refers to an 17-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot number W017343 verified as valid, expiration date reported and upon internal review established as 13-DEC-2023, administered intramuscularly in the right thigh for prophylaxis (strength was not provided) after a temperature excursion that happened on 01-DEC-2022 at a temperature of 47.9 degree Fahrenheit for 47 minutes (product storage error). No additional adverse event reported.  This is one of several reports from the same reporter.
Pt tested positive for COVID-19 on 6/8/2021, received both Moderna vaccines in January
feeling tired; had a sore arm at the injection site; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date in 2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported.  Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization and patient received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. On 2021, the patient reported that he received a third COVID vaccination yesterday and was feeling tired and had a sore arm at the injection site. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
late for the second dose of Shingrix / first dose was administrated on January 20 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th January 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 follow: The age at the vaccination was not applicable. The patient did not receive 2nd dose yet which lead to incomplete course of vaccination. No adverse events were reported. No lot number nor expiration date and date of birth was provided.
Initial case received from a health care professional on 01 October 2014. A 38-year-old female patient had received an intramuscular dose of FLUZONE on 26 September 2014 at 10: 30AM (batch number UI189AA, site of administration not reported). She had a medical history of hypothyroidism, Von Willebrand's disease, endocrine disease; as well as food allergies (not specified) and "opioids (anaphylaxis)". No illness was reported at time of vaccination. She had received "many" previous doses of Flu vaccine. She had received no other vaccinations within the 4 weeks prior 26 September 2014. It was not reported whether she was taking concomitant medications. On 26 September 2014, at 12:00PM, i.e. 1.5 hours post vaccination, she experienced rash in the area of injection site. The patient discovered the rash while she was eating her lunch. While waiting to be evaluated at the ER, she also developed difficulty breathing. She was diagnosed with anaphylaxis and was admitted overnight to the ICU. As relevant diagnostic tests, the following was reported: "EKG, Chem, CDC, MRSA cultures for admission". No results were provided. It was unknown whether the patient had received corrective treatment. The patient's outcome was recovered. This case is linked to the case 2014SA137013 which was reported by the same reporter on the same day (01 October 2014). Follow-up information received on 27 October 2014 from a health care professional. FLUZONE was administered in the left deltoid. Lot number was corrected from U1189AA to UI189AA. Patient medical history was clarified: the patient had an history of drug allergy: opiates - anaphylaxis. It was precised that before she started to experience the symptoms, she had lunch: soft-shelled tacos with carne asada. It was also mentioned that, in fact, she had no food allergies. No allergy test was done on admission. Laboratory results were provided. On 26 September 2014, the patient was found with: calcium 8.0 mg/dl (L), glucose 154 mg/dl (H), creatinine 1.1 mg/dl (H), MCV 79.9 fl (L), MCH 26.3 pG (L), neutrophil percentage 93.0% (H), lymphocyte percentage 5.8% (L), monocyte percentage 1.0% (L). On 27 September 2014, she was had: potassium 3.5 mmol/L (L), calcium 8.3 mg/dl (L), glucose 139 mg/dl (H), white blood cells 11.3 10^3/ul (H), MCV 79.7 fl (L), MCH 26.1 pG (L), neutrophil percentage 87.3% (H), lymphocyte percentage 9.7% (L), monocyte percentage 2.8% (L). On 26 September 2014, culture VRE screen (rectal swab) showed no vancomycin resistant enterococcus isolated, and culture MSRA screen (nares) showed no methicillin resistant staphylococcus aureus until 03 October 2014; as well as BENADRYL (25mg PO, TID) on unspecified date. She was hospitalized from 26 September 2014 to 27 September 2014 (reported as 1 day). Documents held by sender: none.
Itchy skin rash; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included thyroid, high blood pressure and cholesterol from an unknown date and unknown if ongoing. The patient has no known allergies to medications, food, or other products. Concomitant medication included levothyroxine, lisinopril and atorvastatin. The facility where the most recent COVID-19 vaccine was administered was not specified. The patient did not receive 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 has not been tested for COVID-19. The patient experienced itchy skin rash on 29Jan2021. The outcome of the event was not recovered. No treatment was given to the patient for the events. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and was not a congenital anomaly/birth defect.
Pt received vaccine on 8-26-09 on 8-27-09 onset redness, edema L upper arm, site of vaccine.
No symptoms presented but after dose 1 and booster 1 I had a mammogram and was then diagnosed with breast cancer after my second booster. J/J 3/31/21, Moderna 11/3/21, Pfizer 4/12/22. I had surgery on 6/30/2022 and they successfully removed the lump. As of today I am doing good now but am undergoing radiation. It will start in a few weeks and will continue for 4-6 weeks.
pt states the following day after getting booster shot she developed brain fog.   She felt like she was drunk and disoriented.  She seemed to be having altered perceptions when writing.  She had gone a couple of days of not taking her BP medicine because she was out of them so she refilled her meds and took them which seemed to help with these symptoms.  These symptoms subsided within a few hours.
Patient's arm was very swollen, red, and sore. Called the pharmacy to alert the pharmacist regarding the reaction. Patient was advised to go seek medical care in case of infection. Patient followed up with medical doctor and was diagnosed with dermatitis from post-injection. Patient was prescribed cephalexin 500mg every 12 hours for 10 days for treatment.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a series of RECOMBIVAX HB (Lot number, expiry date, route and dose were not reported) as a child. On an unspecified date, the patient had the titers drawn that had resulted negative. The outcome of the reported event was unknown. This is one of the two reports received from the same reporter Link(MARRS#1308USA011228). Additional information has been requested.
Tested positive for COVID on 20Jun22; Tested positive for COVID on 20Jun22; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "unknown" and all described as "Tested positive for COVID on 20Jun22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive.  Clinical course: Received three doses of the COVID 19 vaccine - the most recent being on 05Nov. Symptoms are mild and allergy-like. No fever reported.  The information on the batch/lot number for [COMIRNATY] has been requested and will be submitted if and when received.
Pt with hx of pancreatic cancer, on chemotherapy via port for about 1 yr Presented to hospital with fever an nausea and vomiting. Brain Mri showed hemorrhagic foci now presumed to be metastatic foci
On Friday 1/29/2021 my wife tested negative for COVID19, and received thePfizer vaccine. Then over the weekend she developed  petit mal seizures and went by ambulance to the hospital unable to walk on Monday morning, and also on Monday 2/1/2021 she was diagnosed with having had a stroke and also was tested positive for COVID19.
This case was reported in a literature article and described the occurrence of neurological symptom in a adult male patient who received Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine. On an unknown date, less than a week after receiving Hepatitis B vaccine, the patient experienced neurological symptom (serious criteria disability). On an unknown date, the outcome of the neurological symptom was unknown. The reporter considered the neurological symptom to be related to Hepatitis B vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of unspecified neurological symptoms in a male patient of unspecified age who had received an unspecified Hepatitis B vaccine (manufacturer unknown). The patient had a Doctorate of Philosophy and worked in a medical school laboratory at the time of the event. He and his sister received the vaccine on the same day, but the author commented that she was fine. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received the first dose of an unspecified Hepatitis B vaccine. Dosage was unknown; administration route and site were not unspecified; batch number was not provided. On an unspecified date, within a week of the administration of the vaccine, the patient was experiencing unspecified neurological symptoms and required a wheelchair. No further clinical details or diagnosis were provided by the author. The event was considered as disabling as it required the use of a wheelchair. Treatment was unknown. Outcome was unspecified at the time of reporting. The author believed that the vaccine could have caused the event. The author concluded that "the controversy regarding vaccines will continue, with no resolution in the foreseeable future due to the divergence of views. Are vaccines a success story? Yes, they are as can be attested to with polio, smallpox, rubella diphtheria, measles and tetanus. How do we address the concerns mentioned earlier? One answer is to give one vaccine at a time, which would help identify which vaccine gives an adverse reaction. Added to this, waiting 90 days between live virus vaccines is prudent. Last, never give a vaccine to a child who has been ill in the last 2 weeks, or if there are signs of inflammation, such as active allergies, wheezing, or eczema". The article corresponding to this case is not available for submission due to copyright restrictions.
8/26/2022- Presents to Ed, EMS  found him, had fallen. confusion. o2 sat was in 80's  put on NRB.  CRP-140  covid + test. CXR: bibasilar opacities which may represent atelectasis. Admit sepsis s/t to aspiration pna, covid pna. Acute hypoxic resp failure s/t COPD. Given Vanco and clindamycin. Ordered remdesivir, dexamethasone, doxy, Afebrile. cefepime, Flagyl and vanco.  G Supplemental 02 HFC, 30L 90%.  8/28/2022-BC negative, taper antibiotics to ceftriaxone, Flagyl and doxy.  02 requirements down to 6L.  8/30/2022- improving, downgraded to 4L NC. Completed remdesivir. Continue ceftriaxone and doxy. VSS 9/2/2022-Tolerating room air. IV doxy and decadron continued.  9/7/2022- Tolerating 2L NC, cannot wean will need 02 at d/c. Completed remdesivir, Rocephin d/c. Continue doxy. VSS. D/C to Snf.
Macular, papular, erythematous, pruritic rash on arms, legs and chest starting on day #16 post vaccination. No fever or other symptoms.
Fever more than 100.5F; severe headache; body aches/joint pain; body aches/joint pain; chills; left arm soreness; administration date=06Jan2021 dose number=2/administration date=18Dec2020 dose number=1; administration date=06Jan2021 dose number=2/administration date=18Dec2020 dose number=1; This is a spontaneous report from a contactable pharmacist (patient). A 31-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EK9231) via an unspecified route of administration in left arm on 06Jan2021 16:30 at single dose for COVID-19 immunisation. The patient received the first dose of BNT162B2 (Lot: EH9899) on 18Dec2020 16:30 at 31 years old at single dose for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 07Jan2021 06:00 AM, the patient experienced fever more than 100.5F, severe headache, body aches/joint pain, chills, and left arm soreness all lasting 12 hours. Dose received on 06Jan2021 4:30PM and side effects mostly subsided by 07Jan2021 430PM. No treatment was received for the adverse events. Events outcome of fever more than 100.5F, severe headache, body aches/joint pain, chills, and left arm soreness was recovering.
Mom states "his arms were flexed for 2-3, he had a high fever but didn't take it just gave Tylenol and he reamianed warmer than normal but I didn't ? or take him to hospital . He was very fussy and irritable. He was  back to normal within 3 days.
Patient felt a sense of fullness and tingling in throat shortly after vaccination (10 minutes), and was transferred to urgent care for closer monitoring.  She did not experience any dyspnea, and vital signs remained stable until she was cleared to discharge.  No other complications noted during the 2 hours patient was observed in urgent care.
Night of vaccination October 26th, 2004 high fever 102.9 tympanic (by hospital ER) shakes, increased heart rate, dizzyness and a head ache. Family had flu like symptoms later that week. Sister had vaccinations as well though delayed reaction.   Three days post vaccination taken to clinic with jaundice and (no shaking) above symptoms. Tests were done at that time.
fussiness & low garde temp for almost 1 wk approx 1 wk later spiked temp of approx 103.5 x 2 nights & was fussy, whining & crying;
hard and red spot on her arm around the site of injection; only achy the first night after receiving the injection but not anymore.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (hard and red spot on her arm around the site of injection) and VACCINATION SITE PAIN (only achy the first night after receiving the injection but not anymore.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (only achy the first night after receiving the injection but not anymore.). On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (hard and red spot on her arm around the site of injection). On 12-Mar-2021, VACCINATION SITE PAIN (only achy the first night after receiving the injection but not anymore.) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (hard and red spot on her arm around the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.
herpes zoster; loss of balance; Information was received from a lawyer regarding a case in litigation concerning a male (age and medical history not provided).  In or around 02-JUN-2018 the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Approximately three weeks after receiving the vaccine the patient suffered a severe headache, rash, blisters and loss of balance and was diagnosed with herpes zoster and loss of balance.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) the patient symptoms have resulted in physical imitations not present prior to using the vaccine.  The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition.    Additional information has been requested.
PATIENT PHONED 4/23/08 TO REPORT A WELT OVER VARICELLA IMMUNIZATION SITE APPROXIMATELY 1 INCH WIDE AND TWO INCHES LONG.
Onset of redness and swelling that extended from below the injection site to almost the elbow.  Was 4 in x 6 in size, visible edema on lower edges and appearance of hives on arm and chest the next two days.  No fever.  Warm to touch, not particularly painful. Treated with ibuprofen and ice without success.  Then with Benadryl, no change.  Referred to medical care provider.
Patient received the three above immunizations and about 15 min later she had a syncope episode that caused her to fall and hit the hard floor.
Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; Expired Vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-474599 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow Up received on 10-FEB-2022 Contains Significant information: Updated Outcome of the events