chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWELLING, REDNESS, PAIN, AND ITCHING OF INJECTION SITE. SWELLING AND REDNESS WERE APPROXIMATELY THE SIZE OF A SILVER DOLLAR
This spontaneous report as received from a nurse practitioner refers to a male patient (her son). The patient's concomitant medications and pertinent medical history were not reported. The patient's drug allergies included "possible sulfa allergy". It was reported that the patient, when he was 11 year old, was vaccinated with the first unspecified dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (on an unspecified date). The patient developed hives on his whole body and around his mouth one week after receiving hepatitis b vaccine (recombinant)(manufacturer unknown) and he was treated with BENADRYL. There was no diagnostics studies performed. The nurse practitioner also mentioned that the patient sought medical attention and was hospitalized in July 2014 (day unspecified) due to severe case of pneumonia that required surgery. The patient recovered from both the hives (on an unknown date) and pneumonia (on unspecified dates estimated as 2014). The relatedness between the events: "severe case of pneumonia that required surgery" and hives was not reported. Additional information has been requested.
Pain in arm shot was given, extremely tired, fever, decreased appetite, muscle aches pain, nausea, dizzy, high heart rate, headache,
Information has been received from a registered nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (lot # M033904, expiration date: 20-JUL-2018; lot # M025867, expiration date: 24-MAY-2018; lot # M023382, expiration date: 11-MAY-2018; lot # M017292, expiration date: 07-APR-2018; lot # L046887, expiration date: 23-NOV-2017; lot # L010148, expiration date: 24-MAR-2017;dose and route were unknown) for prophylaxis. The nurse reported no adverse effects noted. The temperature for the vaccine stored was 12.9 Fahrenheit degree with 2 hours 10 minutes time frame. Previous temperature excursion was reported as exposure to 13.8 Fahrenheit for 3 hours. Data logger was involved.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA001204: US-009507513-1701USA001205:
Sore arm; Fatigue; This is a spontaneous report from a contactable consumer (patient). An 83-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264), via an unspecified route of administration in the left arm on 08Feb2021 at 08:00 (at the age of 83-years-old) as a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included pulmonary fibrosis and shellfish allergy from an unknown date and unknown if ongoing. List of any other medications the patient received within 2 weeks of vaccination reported as yes (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. 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 experienced sore arm and fatigue on 09Feb2021 15:00 (reported as Sore arm next day and fatigue by late afternoon). The patient did not receive any treatment. The clinical outcome for events was recovered on 10Feb2021.  Follow-up attempts completed. No further information expected.
Patient called to let pharmacy know she had a red rash spreading from her injection site over onto her chest.
Patient received vaccine dose #1 Moderna (Lot #011L20A) on 1/12. Pt had no noticeable reaction until 1/20 when she developed a raised injection site with pain, redness, warmth, swelling, and itching. Pt went to a Urgent care at this time and was told to monitor symptoms. Symptoms got worse over the following 24 hours - Swelling and redness expanded down patients arm of injection site. Pt presented to ED for evaluation.
I have really bad neck pain and several chronic issues. I got a MRI on my brain and spine and we discovered the sinus infection but accident.  I have been taking antibiotics for the sinus infection and it still didn't clear up. I don't think it was because of the vaccine. I tested positive for COVID-19 on 08/16/2022. I had fatigue, muscle aches, hard to breath; it felt like the flu. I was prescribed Paxlovid which upset my stomach but it did the job.
Dose given from partial vial that was under continuous refridgeration at temp of 42 degrees, greater than 6 hours after inital opening.
Fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 37-years-old female patient received second doe of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Right on 24Mar2021 10:30 (Age at vaccination: 37-years-old) as single dose for covid-19 immunization. (Vaccination Facility: clinic). Vaccine was not Administered. Medical history included Allergy, Cholesterol, Blood pressure high all from an unknown date and unknown if ongoing. Concomitant medication included levocetirizine (LEVOCETIRIZINE) taken for hypersensitivity from an unspecified start date and ongoing, simvastatin (SIMVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing, lisinopril (LISINOPRIL) taken for hypertension from an unspecified start date and ongoing. Prior vaccination within 4 weeks was reported as none. Historical vaccine included first dose of BNT162B2 (Batch/lot number-EN6202) in the right arm on 03Mar2021 10:30 (Age at vaccination: 37-years-old) as single dose for covid-19 immunization. It was reported that Consumer states she got the second dose and she had a raging fever all day long of 100.7. She noticed the fever this morning on 05Mar2021 06:30AM. She took Tylenol but it has not gone down even with Tylenol. Provides for Tylenol rapid relief gels 500mg, lot number AAA041, expiration Oct2022. Additional vaccines on same day was reported as none. Adverse event was not resulted in Emergency Room or Physician Office visit. The patient underwent lab tests and procedures which included body temperature: 100.7. The outcome for the event was reported as not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
12/26/21 SARS-CoV-2 (COVID-19) by NAA detected
Patient received a expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 46-year-old male patient who received HAV (Havrix 1440) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th March 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 15th March 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: Medical assistant reported that, the patient received a havrix expired dose, which led to expired vaccine used. The reporter consented to follow up.
sensitivity in nerves; pain in nerves/ sensitivity in nerves; This case was reported by a consumer via call center representative and described the occurrence of sensory neuropathy in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure. Concomitant products included medication unknown (Blood Pressure Medication).   On 15th January 2019, the patient received the 1st dose of Shingrix 50 ug. On 18th January 2019, 3 days after receiving Shingrix, the patient experienced sensory neuropathy and nerve pain. On 19th January 2019, the outcome of the sensory neuropathy and nerve pain were recovered/resolved.   It was unknown if the reporter considered the sensory neuropathy and nerve pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced all nerves were very sensitive lighted like a large tree. The pain in all nerves. This was lasted for 1 day. Three months after getting the shot the patient had contacted her healthcare professional regarding her experience. The case has been linked with the case US2019AMR083024, reported for the dose 2 of the same patient.
headache, fatigue, chills and fever, and generalized muscle soreness for greater than 24 hours
This spontaneous report was received from a registered nurse and refers to a 5 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-FEB-2019, the patient was vaccinated with one dose of PROQUAD for prophylaxis ( lot # R017799, expiration date on 19-DEC-2019; exact dose, route and site of administration were not reported) and one dose of VARIVAX for prophylaxis ( lot # R017947, expiration date on 24-JAN-2019; exact dose, route and site of administration were not reported). No adverse effects were reported.
when the needle was removed, the injection site bled.; when the needle was removed, the injection site bled.; when the needle was removed, the injection site bled./hard to determine if the patient got a full dose; injection site bled; This case was reported by a other health professional via call center representative and described the occurrence of injection site hemorrhage in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th August 2019).   On 14th January 2020, the patient received the 2nd dose of Shingrix. On 14th January 2020, immediately after receiving Shingrix, the patient experienced injection site hemorrhage, inadvertent exposure to vaccine, accidental underdose and exposure via skin contact. On an unknown date, the outcome of the injection site hemorrhage, inadvertent exposure to vaccine, accidental underdose and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The Other health professional reported that a patient got first dose of Shingrix on 27th August 2019 The patient got the second dose on 14th January 2020. However, when the needle was removed, the injection site bleed. It was hard to determine if the patient got a full dose or not. The HCP was considering giving a 3rd dose or re-starting the complete series. This led to product administration error, accidental underdose and exposure via skin contact. The reporter consented to follow up.
VOMITING; FLU; BODY ACHES; CHILLS; GENERALLY UNWELL; HEADACHE; MUSCLE ACHES; FEVER; NAUSEA; LEFT ARM PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included immunocompromised medical issue, gi upset, and digestive issues, and concurrent conditions included chronic idiopathic urticaria, cigarette smoker, non alcohol user, respiratory allergy, hives, and chemotherapy, and other pre-existing medical conditions included patient had history of drug abuse or illicit drug use of recreational drugs in her college days not recently and had not for a long time. patient has intermittent symptoms. gastrointestinal upset following episode of hives. speculate unrelated. patient had multiple drug allergies, highly sensitive immune system, had respiratory and pre-existing allergy with no known diagnosis. medical diagnosis: chemotherapy injection, 2 injections every 4 weeks. patient was sensitive to pharmaceutical products, and had multiple drug allergies opioid allergy. The patient was previously treated with omalizumab for hives, severe allergic reactions, urticaria, and cortisone for urticaria. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included epinephrine for allergy. On 09-JUL-2021, the subject experienced vomiting. On 09-JUL-2021, the subject experienced flu. On 09-JUL-2021, the subject experienced body aches. On 09-JUL-2021, the subject experienced chills. On 09-JUL-2021, the subject experienced generally unwell. On 09-JUL-2021, the subject experienced headache. On 09-JUL-2021, the subject experienced muscle aches. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced left arm pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, headache, fever, and nausea on 12-JUL-2021, flu, body aches, generally unwell, and muscle aches on 13-JUL-2021, and left arm pain at site of injection on 16-JUL-2021. This report was non-serious.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 30-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sore Arm; This is a spontaneous report from a contactable consumer reported for herself. This female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Apr2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included tetanus vaccine toxoid (TETANUS TOXOID) on 06Apr2021 for dog bite. The patient previously received first dose of BNT162B2 on 24Mar2021 for COVID-19 immunization, and on 06Apr2021, she had tetanus shot at her doctor because she was bit by a dog. The patient experienced arm being sore on 14Apr2021 after second dose. The outcome of event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved.            No concomitant medications were reported. On unknown dates patient had just started skyrizi when she got the covid vaccines and it seemed to be very slow in clearing, normally patient was very fast in clearing when she was on biologics. Patient experienced chronic plaque psoriasis flare/break out. On 30-Nov-2021 patient mentioned an issue with one Skyrizi syringe liquid was clear, colorless and the usual. Punger was not held when syringe was removed from the carton, not was when the needle guard was removed. Injection site that was selected was on her arm. Skin was squeezed to raise the injection site and syringe was placed at a 45-degree angle. Solution went all over the injection site. She had used her arm as the injection site. Patient had a pen misfire where the medication came out of her arm. Patient did not feel she got all the medication and went to physician. Patient was in a flare at the moment. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Follow up-narrative updated and event added
Information has been received from a nurse concerning a female patient who was vaccinated with a first dose of with GARDASIL (route and lot number not reported). The nurse reported that "after the patient received the first dose of GARDASIL", the patient called to physician's office and she stated that her menstrual period had stopped. The nurse reported the patient was going to be coming in to see the physician. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
After receiving the shot, I was required to sit down for 15 minutes. About 5 minutes in, I started to become dizzy, my vision started blacking out, my hearing was muffled, I became clammy, sweaty, and experienced mental disorientation. It became harder for me to breathe, but I never struggled to take a breath. I drank some water and waited for the symptoms to subside. I remained seated and these symptoms went away within 5 minutes. After feeling better for about 5 minutes, I felt cold and was shivering. The woman sitting next to me was completely fine after her shot. I've since felt a slight burning sensation on my skin in areas that I have scratched lightly. I'm also experiencing strange feelings throughout my body- specifically my head, leg, and hand. It feels like I can feel something in each area for a bit and then it subsides after several minutes.
had a bout of strep throat; This is a spontaneous report from a contactable pharmacist.   A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date in Jan2021 (3 weeks before this report) for Covid-19 immunisation, administered at a clinic as staff member.  The patient medical history and concomitant medications were not reported.  The patient experienced a bout of strep throat (mild) on an unspecified date after receiving the 1st dose and took an antibiotic in the past 24 hours. The outcome of events was unknown. The documentation stated still to give the vaccine.   Information on batch/lot number was requested.; Sender's Comments: Based on the available information, the event "a bout of strep throat" is attributed to an intercurrent medical condition that was unrelated to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
High dose flu shot, unknown manufacturer, lot number entered above by Walgreens  Patient developed acute onset vomiting, stridor and difficulty breathing, and mucosal irritation including eyes watering and burning within 10 hours after injection
sleepy since receiving their first Moderna COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy since receiving their first Moderna COVID-19 vaccination) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, CARVEDILOL (CARVEDIOL), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN and LISINOPRIL for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced SOMNOLENCE (sleepy since receiving their first Moderna COVID-19 vaccination). At the time of the report, SOMNOLENCE (sleepy since receiving their first Moderna COVID-19 vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
w/in 2 wks the pts eyes got a yellow discharge then started running a fever was having difficulty breathing; pt taken to see MD had mild pneumonia;
24 hours of flu like body aches; extreme tiredness; Sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown), via an unspecified route of administration on left arm at the age of 56 years old on 02Feb2021 at 14:30 at a single dose for COVID-19 immunisation at workplace clinic. The patient's medical history was not reported. Allergies to medications, food, or other products was none. Concomitant medications included atorvastatin calcium (LIPITOR), hydrochlorothiazide, irbesartan (AVALIDE), famotidine and amlodipine besilate (NORVASC). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown) on left arm on 12Jan2021 at 07:00 AM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced sore shoulder, 24 hours of flu like body aches and extreme tiredness all on 02Feb2021 at 04:30 AM. The patient assessed the events as non-serious. No treatment was received in response to the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has recovered from flu like body aches on 03Feb2021 while the patient recovered from the sore shoulder and extreme tiredness on an unspecified date in Feb2021.  The information on the Batch/Lot number has been requested.
tiredness after the second Covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 28Mar2021 (Lot number: ER2613) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1, single, Lot number: EN2003, Route of administration: Not reported), administration date: 26Feb2021, for covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness after the second Covid shot". No follow-up attempts are possible. No further information is expected.