chrisvoncsefalvay/vaers-outcomes huggingface dataset:
if she should get the second dose because its already been 8 or 9 weeks since her first dose; exposed to person's with COVID-19 virus; she was ill; This is a spontaneous report from a contactable consumer (patient). A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: WS2736, expiry date: not reported) via an unspecified route of administration on 26Jul2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient exposed to person's with COVID-19 virus, she was ill, if she should get the second dose because its already been 8 or 9 weeks since her first dose. Patient stated she received her first dose of the Pfizer Covid-19 Vaccine on 26Jul2021.  Shortly after, she was exposed to person's with COVID-19 virus. She had the first dose on 26Jul2021 and she was ill after that and was exposed to people with possible expose to COVID-19 virus and she was quarantine after, So she is asking is if she should get the second dose because its already been 8 or 9 weeks since her first dose. She was just exposed to people with the virus and was quarantine. She did not mentioned that she was positive. The outcome of events was unknown.  Follow-up (20Sep2021): New follow-up information from a contactable patient via a Pfizer sponsored program included: lot number of dose, event information added.
She took moderna primary series back in 2021 only the first dose; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (She took moderna primary series back in 2021 only the first dose) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (She took moderna primary series back in 2021 only the first dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (She took moderna primary series back in 2021 only the first dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (She took moderna primary series back in 2021 only the first dose).    No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Didn't feel good, soreness on arm.  Monday I had chills Uncomfortable at work Took Antibiotics Chills  Possible UTI  the following Wednesday I discovered a cold sore on lip
Since date of vaccination (12/29/20), the  adverse events, symptoms and side effects patient has experienced are the following: Pain, tenderness and swelling in the same arm of the injection. Fatigue, headache (on the second day only), muscle pain, chills. He is usually a very active person but now he has been sleeping a lot. He is also experiencing lack of appetite.
looks like a balloon on her elbow; She has light muscle pain in the left arm on the same arm that you received the vaccine in; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm on 10Mar2021 scheduled at 11:00 and got it 3 hours later (70-years-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, blood pressure, spine stimulator and cholesterol from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for an unspecified indication, Olmesartan taken for blood pressure, Ezetimibe taken for an unspecified indication start and stop date were not reported. Historical vaccine included bnt162b2 dose 1 via an unspecified route of administration, administered in Arm on 09Feb2021 (Batch/Lot Number: EN6210) as DOSE 1, SINGLE for covid-19 immunisation. Patient reported side effect to # earlier today. She received her first Pfizer Covid vaccine dose on 8Feb2021 and her second dose on 10Mar202. After the first dose she did not experience any side effects but after her second dose she experienced pain in her left arm (injection arm) and 3 hours ago today (12Mar2021) she stated, I suddenly see something on my elbow which looks like a soft tennis ball - reddish/pink - not painful, it looks like it is filled with water. Patient stated that the balloon on her elbow was about two inches in diameter and it looks like a little ball. The patient put ice on it hoping it would go away. The patient noticed it 2.5 hours before calling Pfizer. On 10 Mar2021, she had light muscle pain in the left arm on the same arm that received the vaccine in, wanted to know if this was normal. She was worried about this side effect and wants to know what to do. She was scheduled for a hip replacement on 15Mar2021 and was worried she would not be able to get the surgery if they see she had this bump on her elbow. She stated she had her thyroid removed in 2014 and takes levothyroxine. She mentioned that her husband had cold like symptoms after getting the vaccine. The clinical outcome of the event She has light muscle pain in the left arm on the same arm that you received the vaccine in was recovering and looks like a balloon on her elbow was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected
28hr p/vax fever, chills, h/a;72 hr p/vax rt arm sore w/hot, red inj site lasting several days;12 days p/vax devel tightening of mid back to scalp vertebrae, pain radiating up neck to both shoulders & severe nausea lasting 1wk
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/23/2022 BACTEREMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/23/2022 HX OF ISCHEMIC STROKE W UNSPECIFIED RESIDUAL DEFICITS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/23/2022 HYPERCALCEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/23/2022 SEPTIC SHOCK
Pt was initially "injected" with a syringe that contained no vaccine.  Following this, a syringe with vaccine was given.
1st dose of Shingrix 18 months ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 18 months ago from reporting).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient asked did he/she need to start the series again. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Dizziness; Injection site pain; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 37-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN] via an unspecified route of administration in left arm on 08Mar2021, at 14:30(at the age of 37-year-old) as a single dose, for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included buspirone (MANUFACTURER UNKNOWN), SYNTHROID and WELLBUTRIN. The patient experienced dizziness, vaccination site pain and fatigue on 08Mar2021, at 16:00. No therapeutic measures were taken for the reported events. The clinical outcome of events vaccination site pain, fatigue and dizziness was recovered on unknown date in Mar2021.  Information about lot number cannot be obtained. No further information expected.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Inflammation after months in my arm  Miss diagnoses with autoimmune conditions  High white cell blood count  High antibodies  High hsv 2 reaction
presenting to the ED via EMS from an assisted living facility for chest pain, shortness breath, abdominal pain and a fulminant yeast infection in her groin. She was diagnosed with COVID last thursday. She is difficult to ascertain an accurate history from. She states that she has had intermittent diarrhea for the last few weeks as well as a new cough and increased fatigue. She denies nausea, vomiting, fevers or chills.
Vaccine administered on 10/05/14, on 10/06/2014 hives started to appear on face only. Progressed to 10/07/2014 now covering whole face, hives with pustules. Patient reports itchy, hot sensation, and pain.
Patient with history of Bechet's Disease - feel that vaccine is causing an exacerbation of symptoms including Stomach Pain and Upper Right Quadrant Pain
Information has been received from a nurse concerning a 27 year old female who on 07-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot# 659055/1522U) and on 07-FEB-2008 was vaccinated IM in the deltoid with the second dose of GARDASIL (Lot# 658556/1060U).  There was no concomitant medication.  On 07-FEB-2008 the patient experienced pain when 2nd dose of GARDASIL was injected into arm.  A week after the vaccination she was still experiencing pain radiating from her deltoid to her fingers.  Patient told the nurse that her arm felt like lead.  She had pain with routine tasks.  The patient did not report pain with her first dose of GARDASIL.  At the time of reporting the patient had not recovered from the pain radiating from her deltoid to her fingers.  Unknown medical attention was sought via phone.  No product quality complaint was involved.  Additional information has been requested.
Approx in 1991 a pt recvd Engerix-B & exp high fever & sore arm;
This spontaneous report was received from a physician via company representative, referring to an 18 year old female patient. The patient's medical history included Helicobacter pylori (H. pylori) that was cleared. The patient's concurrent conditions, concomitant medications, and historical drugs were not reported. In approximately 2014 (reported as "about 4 years ago"), the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The physician reported that on an unknown date, the patient had been experiencing daily vomiting and also recently a significant weight loss. Also the patient saw an unspecified specialist in the psychiatric field on an unspecified date, and for an unknown reason. At the time of the report, the outcome of vomiting and weight decreased was reported as not resolved. The physician did not mention the causality assessment between the events and GARDASIL 9 vaccination, but the physician reported that the patient's mother saw information from an unspecified online source that said her daughter's symptoms could be related to her daughter receiving a dose of GARDASIL 9. The physician considered that the events of daily vomiting and the significant weight loss were disabling.
client complained of tongue muscle contracting after receiving 1st Pfizer Covid Vaccine . At 1400 client was walking out of waiting area when he approached EMT to ask if muscle contracting was normal and if he could leave. EMT informed PHN . Client asked to stay longer for further assessment. Per client noticed feeling 10 mins after sitting at post vaccine area. Feeling had not worsened during this time. Client alert and oriented. Declined shortness of breath, tingling or numbness in mouth area, no swelling or redness noted. Per client no complaints besides occasional feeling of lower left side of tongue contracting on its own. Per client did not have this prior to receiving vaccine. Past allergy to sushi but does not know exactly what. No other history of allergies. History of hypertension and takes one medication for it. Vitals at 1404: blood pressure 120/80, pulse 76, oxygen 99%. Client stayed with EMT to complete 30 min observation. Vitals 1415: blood pressure 120/82, pulse 75, oxygen 99%. Client stated cramping was improving. It was happening less frequent. Last vitals at 1425: blood pressure 120/80, pulse 79, oxygen 99. Prior complaint had resolved. Client stated driving himself today. Felt well to leave.
Patient is a 78 years Old  female patient of DO with history of CKD 3, HTN, prediabetes, thyroid disease, DDD, and back pain presented to a local Hospital with generalized weakness with nausea and vomiting.Initial CXR revealed  Opacity in the R lung base WBCs 20k. Lactate 1.8.  CRP 176.  PCT 3.15.  COVID +  Blood cultures w/ NGTD.   Urine antigen + pneumococcus ,responded to antibiotic.Hospital course complicated with NSTEMI,A-fib,initially managed with Cardizem drip,subsequent TEE/cardioversion with restoration of NSR . Patient is now stable cleared for discharge.   Discharge Diagnoses: Community acquired pneumonia  Covid-19 pneumonia  Severe sepsis, POA. AF w/ RVR   NSTEMI, suspected type 2 Acute kidney injury Hypokalemia. Chronic normocytic anemia  Hypertension Essential  Obesity; BMI 34.13
I am on birth control with regular periods. After the vaccine I had heavy bleeding with clotting and spotting. I also had severe cramping. It lasted about 3 months.
Patient started to have chest pain, SOB, dizziness, and feeling as if tongue were swelling 5 minutes after receiving 1st Moderna dose.
This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 05-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609.
Lymph nodes in left armpit hurt; Bruise where vaccine was injected; Hot and cold; Arm was a little sore; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 06Apr2021 at 10:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to food, medications, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 01:00 on day 3 of vaccination, the patient experienced that lymph nodes in her left arm pit hurt, plus she got a bruise where the vaccine was injected. On 07Apr2021, (last night as of report), the patient felt hot and cold and her arm was a little sore. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events lymph node in left armpit hurt, bruise, felt hot and cold and arm sore were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Seen yesterday for MENACTRA vaccine. Arm was a little sore. Today arm was swollen and tender.
Significant shortness of breath (even with mild activity), racing heart, could not get deep breath and elevated heartrate (with mild activity).
She still has headache that comes and goes; She ended up being in hospital for few hours dehydration; She had nausea  next day; Pain in shoulder; Within 1/2 hour, she started with migraine that lasted for 3 weeks.; She had pain in neck; She had pain in her left eye that started within few hours; Her injected(left) arm was sore and achy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Within 1/2 hour, she started with migraine that lasted for 3 weeks.), NECK PAIN (She had pain in neck), EYE PAIN (She had pain in her left eye that started within few hours), PAIN IN EXTREMITY (Her injected(left) arm was sore and achy) and DEHYDRATION (She ended up being in hospital for few hours dehydration) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Asthma. Concomitant products included RIZATRIPTAN, ONDANSETRON (ZOFRAN [ONDANSETRON]), VITAMIN B NOS and VITAMIN D NOS for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 20-Apr-2021, the patient experienced MIGRAINE (Within 1/2 hour, she started with migraine that lasted for 3 weeks.), NECK PAIN (She had pain in neck), EYE PAIN (She had pain in her left eye that started within few hours), PAIN IN EXTREMITY (Her injected(left) arm was sore and achy) and ARTHRALGIA (Pain in shoulder). On 21-Apr-2021, the patient experienced NAUSEA (She had nausea  next day). On 27-Apr-2021, the patient experienced DEHYDRATION (She ended up being in hospital for few hours dehydration). On an unknown date, the patient experienced HEADACHE (She still has headache that comes and goes). On 11-May-2021, MIGRAINE (Within 1/2 hour, she started with migraine that lasted for 3 weeks.) had resolved. At the time of the report, NECK PAIN (She had pain in neck), EYE PAIN (She had pain in her left eye that started within few hours), PAIN IN EXTREMITY (Her injected(left) arm was sore and achy), DEHYDRATION (She ended up being in hospital for few hours dehydration), NAUSEA (She had nausea  next day), ARTHRALGIA (Pain in shoulder) and HEADACHE (She still has headache that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use also included anti-depressant and asthma medicine.  Treatment information also included muscle relaxer and anti-nausea medicine.  Patient ended up being in hospital for dehydration and migraine management one week after receiving the first dose. She was in hospital for few hours.
Redness, pain, lump and itchiness at injection site.  This went away after 3-4  days.  On day 8 after  injection all symptoms returned specifically at the injection site.
Systemic: Moderate pain radiating from neck down to wrist.-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Pt State she had moderate pain radiating from neck down to wrist after administration of flucelevax. Pain disrupted sleep.
Patient reports loss of taste and smell 2 days after vaccination 8/18/21  and it has not come back as of 8/23/21.
12:50 Symptoms: itching lips, heat/itchy arms  Signs: Hives, redness 12:55 Vitals: HR-88, O2 Sat-97.2, BP-138/72, RR-18, Treatment provided/observation: Benadryl 50mg 1 tab po 13:05-swollen tongue, lips, throat clearing 13:10-Admin of epipen R thigh, 911 call 13:15-HR:93 O2 sat 98, BP140/70, R-24 13:20-ice pack given 13:23-HR 110 O2:98, less itching, lip swelling going down, 0 throat clearing 13:30-paramedics arrived
2cm X 3cm redness with warmth present on left upper arm at injection site with pruritus. (Got shot at 11:00 on 10/10/00 and by 20:00 on 10/10/00, had 1cm of redness and itching and the irritation has increased to the above size by 10/12/00 at 14:00. Advised to apply cool compress to site and take Benadryl and Advil for itching.)
17OCT97 pt report a large site specific rxn 6-7" diameter swelling, erythema to rt arm;noted enlarged nodes (axillary) Tuesday evening, fever 102.5 on Wednesday relieved by APAP;low grade fever on Thursday;has had joint pain, achiness x 2d;