chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt had large (approx 4cm in diameter) hives on both cheeks & elbow of vaccinated arm; later in day on other arm & legs; very itchy pt feeling OK on 9MAR95; tx Cortisone cream & DPH;
Extreme chills, fever and  heavy sweating for 10 hours. Fever was in shot area, back of neck, upper back and face. Lower body was cool.
3-4 days later I broke out into hives and red patches on my body. They seem to come and go, it's been almost 3 weeks. It goes from arm to arm, my body, my eye, finger, hands and feet. I have been taken Reactine, but not all the time. I'm using cream to help with the itching.
Moderna vaccine given to underage patient.  She is 16.  Informed her mother  today (5/20/21) via phone call.  Mom says she is feeling fine, other than her arm is sore.  She verbalizes understanding regarding the error.
On 10/25, I felt very fatigued. I went to work, but I was feeling hot and cold and having headaches. The back of my right ear started hurting, but it never went into my ear. On 10/28, I was going to go to Urgent Care to have it checked, but I didn't. On 10/29, I woke up and noticed that my face felt swollen. I asked my mom what my face looked like, and she told me it was drooping. She took me to the ER in case I was having a stroke. My one eye was not blinking, and they diagnosed me with Bell's Palsy. I was given prednisone and an antiviral (the generic of Valtrex). Now, I am medicating with Dual Action Advil. I just had my eyes checked today and my vision is still 20/20. My eye is starting to blink now, and I was using eye drops to help with moisture. I am currently using them still. I am able to smile again now too. Last night I felt better and slept better than I have since this started. My doctor told me that my eye is back to normal tracking. It was mildly lagging on 11/09. I have had major improvement between 11/09-11/17 to my eye. My face feels like I've had an extreme workout, but it is noticeable better. There is overall improvement with my face since 10/29.
chills, teeth chattering uncontrollably, cold extremities (hands/feet), fever, flu-like feeling
COVID19 Pfizer Bivalent vaccine given as dose #1 of the primary series.
8 mins after vaccine reported feeling dizzy, chest tightness and difficulty swallowing tight throat, VSS 151/84,HR 83, O2sat 95%, Epinephrine administered 1000:1 @ 9:52 0.3ml, repeated at 10:27 due to no improvement of symptoms.Stablized  at 11:11 with BP 128/88- HR 85,
Information has been received from representative via a nurse practitioner concerning a 15 year old (also reported as 16 year old) female with a penicillin allergy who on an unspecified date was vaccinated with GARDASIL (lot# unknown). The patient's date of last menstrual period was 25-APR-2007. Subsequently, the patient developed blood clots and was hospitalized. Medical attention was sought. The representative reported that the number of doses administered were unknown, the number of days the patient was hospitalized was unknown and the details for the patient's pregnancy was unknown. Follow-up information was received from the nurse practitioner. The patient was administered GARDASIL on 18-MAY-2007. The patient was scheduled to be induced on 09-FEB-2008 since she was past her due date which was 30-JAN-2008. The details regarding the intervention for the blood clot in the hospital was unknown. Further information was not available. Additional information has been requested.  This is in follow-up to report (s) previously submitted oon 2/14/2008; 2/25/2008. Follow-up information was received from a physician's office via phone. The patient's name was updated. On 8-FEB-2008, the patient went into the hospital with contractions. The patient failled to progression and then the patient was induced. The patient delivered "as far as they know a healthy boy". The baby weighed 7 pounds 10 ounces. Follow-up information was received via pregnancy forms. On 27-JUN-2007 and 31-AUG-2007 ultrasounds were performed for dating of the pregnancy. During the pregnancy the patient had deep vein thrombosis in the left leg and a urinary tract infection. On 30-JUN-2007 the patient was given MACROBID 100 mg BID for 7 days for UTI, LOVENOX 1.5 mg on 30-NOV-2007 and heparin was given subcutaneously on 15-JAN-2008. The patient gave birth on 08-FEB-2008 41 weeks from LMP. Additional information is not expected.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 3:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Based on the additional information received on 03 September 2015, this case is medically confirmed. Initial unsolicited report received from a non-healthcare professional on 4 August 2015. Case is linked to case 2015SA088110, 2015SA117518, 2015SA117519 and 2015SA117520 (same reporter). A two-month-old female patient, had received a 0.5 ml dose of PENTACEL (batch number C4767AD, expiry date, dose number and site of administration were not reported) intramuscularly on 08 June 2015 (1:40 PM). Pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination was reported as none. Patient had no other vaccine within four weeks of vaccinations. Patient had no other medications. On 08 June 2015 (07:30 PM), i.e. five hour fifty minutes after vaccination patient had experienced swollen thigh not whole limb, painful to touch and irritable. Laboratory investigations was not performed Corrective treatments was not reported. On an unspecified date, patient had recovered. Follow-up information received from a Physician on 03 September 2015. The patient had received a first dose of 0.5 ml of PENTACEL in right thigh on 08 June 2015 and received a dose of HEPATITIS B VACCINE (Manufacture: unknown), a dose of PREVENAR, (Manufacture: Other) and a dose of ROTAVIRUS VACCINE (Manufacture: Other) batch number, expiry date, dose, dose in series, route and site of administration were not reported on an unspecified date. Patient has no illness at the time of vaccination. No vaccine was given four weeks before vaccination. The patient had no reaction after receiving Hepatitis B, PREVENAR and Rotavirus. Documents held by sender: none.
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 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 11:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 11:01 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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.   Age of patient was reported as 28.90 for dose administered on 28-Apr-2021.   No concomitant medications were reported.  Batch number 007C21A underwent temperature excursion on 27-Apr-2021 with temperature 35 degrees Fahrenheit from 09:00 AM and underwent temperature excursion on 28-Apr-2021 with temperature 33 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 27-Apr-2021.  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 for 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician assistant concerning a "7 or 8 years old" male who in September 2007, was vaccinated with a second 0.5 mL dose of VARIVAX (Merck). Subsequently the patient experienced breakthrough varicella, less then 50 lesions after receiving the vaccine. No further information was provided. Unspecified medical attention was sought, patient saw the physician assistant. There was no product quality complaint. Additional information has been requested.
Client has tested positive on 9/15/2021 for COVID 19. She started to have symptoms on 9/14/2021.
This spontaneous case, reported by a consumer, describes the occurrence of pain (a little sore spot on body, near private area) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 21, 2021, patient had pain (a little sore spot on body, near private area). At the time of the report,  pain (a little sore spot on body, near private area) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported/provided. She denied providing any further information for safety reporting. Consent for safety follow-up could not be obtained.
fainted in parking lot lips blue, shallow breathing taken to ER by ambulance; pt exp nausea & sinus arrhythemia; became lightheaded;
11/25/22 I started feeling pretty down. I left work early and went to a medical clinic and I was diagnosed with pneumonia. I was given doxycycline for the rest of that week. I was also prescribed an albuterol inhaler. The following Monday, my appetite returned. I had edema in my feet after eating egg drop soup. I followed up with my PCP and she prescribed LASIX. I had no resolution. My feet were still swollen. I returned to the clinic that diagnosed me with pneumonia and was referred to the ER. I was admitted to a room to rule out CHF. I had an exploratory cath and was diagnosed with a diffuse blockage around the heart. 12/9/22 I had a 4-bypass surgery. Around 12/29/23 I had a stroke. I was admitted to the hospital. I have been having home health for rehab. I have not recovered.
I was very tired, had a bad headache, achy body, my arm swelled huge, sore and blood red over the left arm.  It was all I could do to get out of bed. It took 1 week for the arm to start healing.  My chest also on Sunday felt like it had 100 pounds on it.  I waited daily for it to get better and it did somewhat.  Later by the end of the week I called my lung Doctor and explained the situation.  They call me an antibiotic and prednisone in and I am healing nicely now.  With the 2nd shot I ran a fever for one day of 103 with the shot it was only one day and was only 99.3.
Vomiting, clear fluid, before breakfast, 30 minutes after taking  Doxycline casule (4th day of 7 treatment after oral surgery 4 days previously) -- I believe the Doxycline was the prime cause of vomiting.
Within 5 minutes of vaccine administration patient started to feel muscle tension and tightness. Involuntary muscle contractions that occur constantly since the day of the vaccination. Some shaking felt.  Pt reported BP was elevated post vaccine administration
Patient stated that she woke up the next morning following her vaccine administration feeling flu-like symptoms. She was achy/sore over her entire body and felt cold. The symptoms lasted for a day or two. She received the second dose in the series on 6/14/18, which was when she reported the side effects she experienced from the initial dose in the series.
Muscle aches; malaise beginning approximately 24 hrs after the 2nd dose; This is a spontaneous report from contactable consumer or other non-HCP via Pfizer Colleague. A 42-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EM9809) via an unspecified route of administration on 17Feb2021 as dose 2, single (at the age of 42-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EL9263) via an unspecified route of administration on 27Jan2021 as dose 1, single for COVID-19 immunization. Event took place after use of product. The patient experienced muscle aches, malaise beginning approximately 24 hours after the second dose of the COVID-19 vaccine on an unspecified date in Feb2021. The outcome of the event was unknown.     Follow-up attempts are completed. No further information is expected.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 27 years old female patient who was vaccinated with 0.5 ml second dose of vaccine IMOVAX RABIES (lot number: N18051M and expiry date: 26-Feb-2019) in the left deltoid (route of administration not reported). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to exposure via skin contact because the vaccine dripped on the patients arm during administration and under dose because patient got only third fourth of the dose. Caller said it was leaking from where the needle attaches. Unknown to the caller if it was cracked because it had already been discarded. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: None.
Information has been received from a healthcare professional concerning to an unknown number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of ROTATEQ. Lots and expiration dates were unknown by the reporter. No adverse effects reported. The call was made due to a data logger. Excursion information was: Temperature and time frame:  0°C to 1°C for 2.5 hours 9°C to 25°C (9.36C) for 8.75 hours No previous temperature excursion. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA008767: US-009507513-1706USA008768:
Patient reported pain in her arm beginning immediately when she received the vaccine. Pain has been constant since then at rest and while moving her arm.
positive covid patients after first dose administration; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive covid patients after first dose administration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive covid patients after first dose administration). At the time of the report, COVID-19 (positive covid patients after first dose administration) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
This case was reported by a physician via call center representative and described the occurrence of swelling arm in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional information was reported as follows: During the escalated call from the physician, he stated that he didn't want to have another swollen arm from an extra shot of SHINGRIX  since the SHINGRIX vaccine was not available at the time of reporting, which led to product availability issue. No additional details were available. The patient has denied permission to contact their physician.
2 days p/vax became febrile, emesis, red throat, yellow nasal drainage;placed on ventolin & cephalexin;has otitis/pharyngitis;
Date of refrigeration was 10/29/2021 and expired date was 10/13/2021 and administration date was 11/8/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Date of refrigeration was 10/29/2021 and expired date was 10/13/2021 and administration date was 11/8/2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date of refrigeration was 10/29/2021 and expired date was 10/13/2021 and administration date was 11/8/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Date of refrigeration was 10/29/2021 and expired date was 10/13/2021 and administration date was 11/8/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter It was mentioned that the vial was initially refrigerated on 29-Oct-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events. No treatment medication was provided by the reporter.
Within 2 minutes of receiving the vaccine, the patient complained on dizziness, bright lights in vision, and tingling in both hands. His color was pale. He was responsive, he recited his name and location. I gave him a bottle of water to sip on and a chair to sit. Within 2 minutes, the patient passed out. His head slumped forward, did not fall out of chair. I immediately took his pulse, it was strong. I shook his shoulder and spoke loudly calling his name. He perked up, looked at me but with no recollection, and was starting to sweat. I had a nearby technician call 911. He then passed out again, same presentation (slumped over, didn't fall). I grabbed an EPI pen quickly, came back to check pulse (still strong), and shook him. He woke again without use of epi pen. EMS arrived at 2:55pm to further evaluate. They ruled out anaphylaxis and deemed this to be a hypotensive reaction to getting a shot.  Patient started feeling better, and declined to go to the hospital for further evaluation. He waited in the pharmacy for 20 more minutes then drove himself home (he did say his mother was coming to sit at home with him just in case). I called him at 5pm to check on him and he reported no issues and doing ok. He will not be getting second shot.
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 57 or 58 years old. The patient reported a sore arm after the SHINGRIX injection. This case was linked with US2019035161, reported by the same reporter.
Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: I accidentally hit a vein and blood squired out, applied pressure to stop bleeding and applied cold pack to reduce swelling, pt felt very faint, profusely sweating, pale in color, pt has high anxiety when getting a shot, talked to pt and kept him alert, supported him so he wouldn't fall and called ambulance asap and by time ambulance arrived, pt had started to stop sweating, color returned to his face and he was feeling better but they still checked all his vital signs and all were good