chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; This case was reported by a consumer via media and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the allergic reaction was fatal. The reported cause of death was allergic reaction.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's sister in laws mother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient passed due to allergic reaction complications to the Shingles vaccine about a month ago from the date of reporting. This case had been linked with case US2021AMR188219, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188219:same reporter; Reported Cause(s) of Death: Allergic reaction
Labor and delivery on 11/11/2021. This visit was within 6 weeks of receiving the COVID vaccine.
Covid third dose clinic for pfizer vaccine was held 10/4/2021 at Nursing Home for residents. Facility Director of Nursing took Public Health Nursing staff room to room to administer vaccine. Director of Nursing already had paper forms made out ahead of time. This resident had already had three doses of the covid vaccine and was inadvertently given a fourth dose today. This was not caught until entering the vaccines in the registry later in the day. No adverse effects reported at this time. Primary Care physician notified of incident.
When I got up Saturday morning I had a red bump on my arm approximately size of a penny.  By 6pm it was the size of a dollar coin bright red hot hard.  I started to feel bad that night.  Chills, achy, swollen glands, tired, felt like I was getting sick.  The next morning I felt better however the area of redness had increases in size and was getting brighter.  We marked the outer edge each morning and night to monitor the growth.  I called the dr Monday morning and had an appt that afternoon.  I was told it was cellulitis and was given Keflex 4 times a day for 10 days.  I went in today 10/9 for a follow up as I still have a reddish/purplish tone to the area and a small bump.  I was told that he didn't think it was cellulitis but a reaction to the Prevnar13.  At this point there was no way to know for sure and he gave me another round of Keflex to take at least for 4 more days if not the whole 10 days.  He felt my arm should return to its normal color soon.
According to patient's verbal history during his office visit he ended up in the hospital in August after vaccination where he was diagnosed with Guillain-Barre syndrome.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.87.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient came in and got his shingles shot on 01/30/2021. When patient came in, techncian put in shingles shot, and gave patient consent form to fill out. Patient answered no to every question on the consent form and did not have a fever. The vaccine was administered. After the vaccine was given the patient asked what he could get over the counter for shingles, indicating after the shot was givenf that he had an active shingles rash. However, the vaccine was not a live vaccine, the pharamcist verified the dose was still valid and patient had doctors appointment next day for shingles rash the next day.   The next day he received treatment for his singles and let the doctor know he received the vaccine while he had the rash. Patient called pharmacy several months later in early April indicating that his shingles had still not gone away, and that he had a very severe case. He was admitted to the ER on March 27th, due to severe rash on his chest that was cauing chest pain. They did ECG, first came back abnormal, but second came back normal.  Patient is now at home stating that he is starting to feel better, but feels as though this reaction was due to getting Shingrix shot with the shingles.  I called the CDC and the CDC verifed that "The adverse reactions form the Shingrix shot and symptoms of the disease can occur at the same time, but we would not expect a combined effect" The shot would not exacerbate the shingles disease or make it worse".  The patient just wanted this reaction documented as to provide information and further research.
This spontaneous report as received from a registered nurse refers to a 55 years old female patient with current condition included hepatitis c, hypertension, hyperthyroidism, vitamin d deficiency and diabetes mellitus and with no known "allergies". On 16-JAN-2013, the patient was vaccinated with PNEUMOVAX23(lot# and expiration date unspecified by the reported) (0.2ml single dose vaccination, intramuscular injection, site was unspecified). No other co-suspects were reported. Concomitant medications included insulin. The registered nurse reported that the patient reports that one day following the vaccination with PNEUMOVAX23, on 17-JAN-2013, her arm was sore, two days following the vaccination on18-JAN-2013 her arm additionally became red and swollen, it was mentioned that symptoms have improved since 18-JAN-2013. The patient sought medical attention at office visit and treatment was given with Nonsteroidal anti-inflammatory drugs (NSAIDS) and compressions. The patient's arm remains stiff and sore at the time of the report. Additional information has been requested.
13:10--Patient complained of feeling warm, lips feeling tingly. Ice pack and water given. Breathing appeared to increase. Patient then appeared diaphoretic and complained of feeling light-headed. She lied down on the floor. She then complained of difficulty breathing, and tightness in throat. Emergency services were called at 13:25. Epinephrine administered at 13:26. Patient still complained of feeling warm, tingly lips, and difficulty breathing. Rash began to develop around neck. Epinephrine administered again at 13:31. First responders and paramedics arrived two minutes later. She was transported to hospital via ambulance.
Movable 1/4" nodule on left shoulder blade at end of old, healed break in center of bone. Slightly tender; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 04May2021 at 10:00 (at the age of 60-year-old) at single dose for COVID-19 immunisation. Medical history included old, healed break in center of bone (shoulder blade, not ongoing), it also reported as lifetime typical for age, nothing chronic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medication included curcumin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration in left arm on 13Apr2021 at 16:00 (at the age of 60-year-old) at single dose for COVID-19 immunisation. On 06May2021 at 12:00, the patient experienced a movable 1/4" nodule on left shoulder blade at the end of old, healed break in center of bone. Slightly tender. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event painful nodule was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 'old, healed break in center of bone (shoulder blade)' added as medical history, patient received bnt162b2 in US.
Pain at site of PCV-13 immunization left deltoid. Pain currently, has persisted since admin of Iz.
Hives started on hands and spread to palm. by 9 pm started scratching legs and noticed big hives. Site of injection swollen, red, hoarse voice called nurse help line. Advised to go to ER arrived at ER at 10:45 pm given Benadryl which helped. Released by 1 am. On Monday some what better itching subsided. Today voice still hoarse, hives disappearing.
She has got high TSH; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. This consumer (patient's mother) reported for a female patient (daughter) that:  A 17 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), outcome "unknown", described as "She has got high TSH". Relevant laboratory tests and procedures are available in the appropriate section, which included TSH, results: increase (She has got high TSH).   Additional information: Reported tried to find out information on, her daughter got the Covid vaccine and months later now, has a thyroid disorder. She was only 16 when she got it and 17 now (not clarified further), and she didn't have any problems. Now, she has got high TSH and all sort of stuff. So, she was just checking to see if there is any kind of studies or any information I can get on whether or not the vaccine, not having Covid but the vaccine may contribute to that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax & 3-4 minutes p/vax pt felt dizzy, then clammy, nauseated & became very dizzy went to ER; became lethargic & uncoordinated; inc BP noted; sx took 10 hrs to resolve; pt is under observation;
Shortness of breath  Rapid heart rate   Pulmonary embolisms (bilateral)
pt recvd vax & devel fever of 105 during 48 hrs following vax; tx w/ meds;
Vial expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and vaccine was administered on 8-Jun-2022; Dose administered post the expiration or beyond use date (vaccine expired on 13-may-2022 were administered on 08-june-2022); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date (vaccine expired on 13-may-2022 were administered on 08-june-2022)) and PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and vaccine was administered on 8-Jun-2022) in an 83-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 034F21A, 031B21A and 036A21A) for COVID-19 prophylaxis.     It was unknown if the patient had any allergies to medications, food or other products. It was unknown if patient was diagnosed with/ tested positive for COVID-19.  It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before and if patient had chronic or long-standing health conditions.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 11-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 8:48 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 08-Jun-2022 at 8:48 AM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date (vaccine expired on 13-may-2022 were administered on 08-june-2022)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and vaccine was administered on 8-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date (vaccine expired on 13-may-2022 were administered on 08-june-2022)) and PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and vaccine was administered on 8-Jun-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date (vaccine expired on 13-may-2022 were administered on 08-june-2022)) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and vaccine was administered on 8-Jun-2022).    No concomitant medication was reported by reporter. Event did not cause the patient to seek medical care. There was no other potential cause for the event.  No treatment medication was reported by reporter.
Patient was admitted to the hospital on 10/9/2021 for upper respiratory symptoms which began on Tuesday, generalized weakness, shortness of breath at rest, headache and dyspnea on exertion.  Nasal congestion, runny nose, and wet nonproductive cough began on Tuesday.  Patient developed generalized weakness, shortness of breath at rest, and shortness of breath on exertion.  Patient was previously tested twice for COVID and the results came back negative.  Patient tested positive for COVID-19 on 10/9/2021.
REDNESS, SWELLING, INTENSE ITCH, 3x3 cm ROUND LOCAL RXN AROUND CHICKEN POX VACCINATION SITE (LEFT ARM)
Headache for the past day started around 2 hours after vaccination; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 08Mar2021 at 16:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included Retinoblastoma 1 (RB1) mutation diagnosed at birth, Retinoblastoma (RB) history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pseudoephedrine hydrochloride (MANUFACTURER UNKNOWN) 120mg taken for an unknown indication from an unknown date and unknown if ongoing.  On 08Mar2021 at 18:30, around 2 hours after vaccination, the patient experienced headache for the same day and sore left arm; nothing major besides headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and sore left arm were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient experienced a warm red band form below the site of injection as well the normal side effects of fatigue, fever, swelling, pain and redness
patient appeared to have fainted. She then said she could not see. Her father was present at the time and said she appeared to be turning  blue as I was calling 911 for EMS. He insisted that we administer Epinephrine 0.3mg via Auto-injector. EMS arrived and transported patient to the hospital.
Developed stomach pain and didn't feel well starting Monday March 15th, (12 days after vaccine) by Tuesday night developed severe stomach pain that eventually let to ER visit and appendectomy on March 17th, 2021 For the record - my brother also developed appendicitis 8 days after his second MRNA vaccine, and also required appendectomy and 3 days in hospital. Seems too coincidental for 2 people in the same family (with in a month of each other)  to have this happen in the second week after the vaccine.
redness, warmth, swelling, hard area extending from shoulder to above elbow on left arm
Arm got real sore; Body aches really bad like she has the Flu; Sore underneath the armpit; Body aches really bad like she has the Flu/aches really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "With the first shot, she had a little sore arm and that was it".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm got real sore"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Body aches really bad like she has the Flu"; AXILLARY PAIN (non-serious), outcome "unknown", described as "Sore underneath the armpit"; PAIN (non-serious), outcome "unknown", described as "Body aches really bad like she has the Flu/aches really bad".  Additional information: It was stated that after receiving second dose of vaccine, the patient was fine until the middle of the night. The patient didn't know if she could take Aspirin or Ibuprofen. The patient didn't know if that was a 24 hour thing. The patient stated that she was unemployed. The patient informed that her husband has not been doing well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever; soreness/aches; fatigue; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sensitive to vaccines" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "soreness/aches"; FATIGUE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown". Additional information: Respondent received the Comiranty booster and within 15 minutes began to feel sick including: fever, soreness, fatigue, aches. Respondent became ill after getting the Comiranty booster including fever, fatigue, soreness, nausea. Reporter consider event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
23Mar2021 at 09:15 (at the age of 55-year-old) as single dose for COVID 19 immunisation. Medical history and concomitant medication have not been provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in left arm on 02Mar2021 at 09:15 AM (at the age of 55-year-old) as single dose for COVID 19 immunisation. On 23Mar2021 at 09:15, the patient experienced (reported as only for second dose) chills with shivering, shaking and feeling cold for lasted four hours. Chills came back on next day and milder without shivering and shaking. Tiredness, headache continued the next day and also experienced mild pain at side of injection for first 24 hours. Treatment received for the adverse events was reported as no. The clinical outcome of the event chills with shivering, shaking, feeling cold, tiredness, headache and mild pain at side of injection was resolved on an unknown date in Mar2021. No follow up attempts are needed. No further information is expected.
Felt a pain in his shoulder. Found the lump at the time. Had small headache all day. This morning has grown to 2" length x 1.75" wide. Hurts to move arm. Lump in armpit now as well.