chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she can't raise her arm; very sore; a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (she can't raise her arm), PAIN IN EXTREMITY (very sore) and PERIPHERAL SWELLING (a little swollen) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced MOBILITY DECREASED (she can't raise her arm), PAIN IN EXTREMITY (very sore) and PERIPHERAL SWELLING (a little swollen). At the time of the report, MOBILITY DECREASED (she can't raise her arm), PAIN IN EXTREMITY (very sore) and PERIPHERAL SWELLING (a little swollen) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-066762 (Patient Link).
12 x 12 cm area of erythema, increased temp of area/pain; fever of 102.0 2 hours after Motrin 600mg; joint and muscle pain 2 days after Adacel injection.
Pt. states that after receiving the 2nd dose of Phizer 03/20/2021, started experiencing symptoms 03/30/2021 of "water-filled" blisters throughout the body. Light Headiness' and Headaches lasting 72hrs. Blisters continuing with self-treating with Alcohol, Dermatologist visit 12/03/2021 Dr., Diagnosed with Bullous Pemphigoid follow-up with Steroids and Vaseline. Appt. scheduled for 01/05/2021 for follow-up. Cardiologist appt. scheduled for 12/17/2021 for overview check-in following Steroid use.
I woke up the next morning and I was hurting all over. Any time I moved any part of my body it hurt. I had a headache, fever, and I had to pick up my daughter 2 hours away. I had a headache all day, muscle aches all over, and a fever (100-101). Around 5pm that evening I started feeling better.
Initial misuse report received from a healthcare professional on 03 June 2013. A 12-year-old female patient was given DAPTACEL instead of ADACEL. No adverse event was reported. List of documents held by sender: none.
Chronic headaches post 2nd dose of Shingrix; This case was reported by a consumer via media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was wondering if there are any cases of chronic headaches post 2nd dose of Shingrix. No further information was reported. Follow up not possible as there was no contact details provided. GSK note- it was not clear if the patient experienced these adverse event or was just inquiring but since follow up was not possible, case kept valid with worst case approach.
Left shoulder very painful, swollen, red, sore shoulder joint for over one week, stiff. Hard to sleep on left shoulder for one week. I talked to my pharmacist about my reaction she told me pneumococcal conjugate vaccine (PCV13) is only given every 5 years. My Dr. gave me the same injection 6-14-16. Just because I have seasonal asthma Dr. said I need this every year. Please look into this injection and actually how often is it required. The office staff injected too close to my shoulder joint.
didn't feel well; Headache; Body ache; Got a Covid-19 test and received a positive Covid-19 diagnosis; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got a Covid-19 test and received a positive Covid-19 diagnosis), ILLNESS (didn't feel well), HEADACHE (Headache) and PAIN (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (Got a Covid-19 test and received a positive Covid-19 diagnosis). On an unknown date, the patient experienced ILLNESS (didn't feel well), HEADACHE (Headache) and PAIN (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (Got a Covid-19 test and received a positive Covid-19 diagnosis), ILLNESS (didn't feel well), HEADACHE (Headache) and PAIN (Body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
PATIENT GOT THE VACCINE COVID 19 FIRST DOSE, SHE WAS TOLD TO SIT FOR 15 MINUTES BEFORE LEAVING! ABOUT FEW MINUTES LATER, SHE PASSED OUT AND DROP HER BODY ON THE FLOOR! WE PUT HER BACK IN THE CHAIR , GAVE HER SOME WATER. SHE FELT OK AFTER THAT, DENIED TO CALL AMBULANCE! HER VITAL SIGNS WERE OK, WE CALLED THE MOM TO PICK HER UP! FOLLOW UP CALL  PATIENT IS DOING OK!
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored VAQTA, lot # M038572 with expiration date on 11-MAR-2018 and lot # M047658 with expiration date on 28-OCT-2017 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0 to 1 degree Celsius for 40 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001280: US-009507513-1706USA001284: US-009507513-1705USA011819: US-009507513-1706USA001283: US-009507513-1706USA001279: US-009507513-1706USA001281:
About 3 weeks after I got the vaccine I found out that I was in acute renal failure. I had broken my wrist, and then I went to have surgery for it. That's when the doctor found out that I was in renal failure. I stayed at an intensive care hospital for 3 days. The doctor said it is possible that I had an allergic reaction to either Percocet or the Lisinopril that I was on. I think I was prescribed some pain pills to take. My doctor told me to get my 2nd COVID vaccine so I went on and got it. I had a slow recovery after having renal failure. I didn't get the booster because I felt it was too risky. Sometimes I get tired really fast and feel exhausted. I started developing burning pain in my left breast last week. The doctor thinks I have atypical shingles in my left breast. They did find a nodule in my breast as well. They did an ultrasound to see if there was any breast cancer. They said that the pain in my breast is not from cancer.
Parent wrote that patient's age was: 03/24/2016 when in fact, the child was born on 03/24/2017 (per Database).  This date modification was noted after the immunization was given.  Several attempts have been made to contact Parent via phone, but our office is unable to leave a message and/or Parent does not answer her phone. A letter will be sent from the Immunization Coordinator to Parent addressing this concern. No adverse reaction has been reported to Immunization Clinic about Patient's Pfizer Covid #1 vaccination.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patients medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N019822, expiration date 13-JUL-2019  for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6° Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA002453: US-009507513-1804USA003062.
to ER for severe reaction. Received Decadron 75 mg and Keflex 500 mg tid seen there 11/6/07 @ 1848.
Pt received Japanese Encephalitis #2 and had pruritus with inflammation at the injection site, 24 hours later. Also, had swollen hand.
General malaise, ill feeling the day after vaccine given. Slept all day. Developed 10x10mm erythema at site of injection. Mild induration. Pain. No fever.
Patient was given flu shot at approximately 4:15pm on 9/5/17. Patient came back at 7:45pm (after getting off work) with a swollen area around the shot area. It was slightly red and sore (tender to touch). The swollen area was swollen more than usual post-shot swelling. She also stated that the area was itching badly. Pt reported no problems breathing or any other signs of allergic reaction. Patient reports getting flu vaccine for years previously with no adverse side effects. I advised patient to apply a cold compress to the area, take ibuprofen, and BENADRYL. I also told patient to seek medical attention if she begins to have any trouble breathing or worsening of any symptoms. Pt stated she was going straight home and would do that.
Pain and swelling in both feet and ankles, pain started evening of injection, swelling 2 days later. Still tender/swollen 4 days later. Headache/Nausea on day 2.
pt stated that after getting the vax his are was sore.  He woke up next day and had developed a severe itchy red rash all of his entire body.  His face and eyes are swollen. He took some Benadryl and went to work.   His boss sent him home from work and told him to go to a Doctor.  Pt called us to make a report and is on his way to Urgent Care in .   He is continuing to get more reds dots on his body as we speak that are starting to blister.
Right dorsal medullary stroke leading to dysphagia and left-sided sensation changes. First noticed symptoms on 2/25 but did not present to emergency room until 2/27/2021. Patient was hospitalized 2/27/2021; anticipate discharge 3/4 or 3/5 2021. Patient lost ability to swallow; requires tube feeding.
fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 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 fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Feb-2023 Reporter's Comments: The patient received vaccine and he/she had a fever for 2 weeks, that was the reaction in his/her body. The reporter hopes everyone was fine.
Fever; Nausea; Tired/fatigue; Chills; Light headiness; General Weakness; Shaky; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headiness), ASTHENIA (General Weakness), TREMOR (Shaky), MYALGIA (Achiness) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Tired/fatigue). In January 2021, the patient experienced DIZZINESS (Light headiness), ASTHENIA (General Weakness), TREMOR (Shaky), MYALGIA (Achiness) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Light headiness), ASTHENIA (General Weakness), TREMOR (Shaky), MYALGIA (Achiness) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Tired/fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-223091.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-jun-2021 had start date of the events updated and outcome of the events updated from unknown to recovered/resolved.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Left shoulder pain since day after vaccination.  reported to Agency in september 2020.  patient in pain whole time. Patient visited her PCP who referred her to an orthopedic surgeon for follow up.  Possibly an aggravated bursa per PCP from the shot.
fever; chills; flu like symptoms; sore throat; aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number CX5BG, expiry date 30th April 2020) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd May 2019, 6 days after receiving Shingrix, the patient experienced fever, chills, flu like symptoms, sore throat and pain. On an unknown date, the outcome of the fever and pain were not recovered/not resolved and the outcome of the chills and flu like symptoms were unknown and the outcome of the sore throat was recovering/resolving.   It was unknown if the reporter considered the fever, chills, flu like symptoms, sore throat and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife.  The patient received the Shingrix vaccine into the left deltoid and before the night of the reporting, he began to have chills, sore throat, flu like symptoms.  The patient was achy on the day of reporting with continued fever but sore throat was not as bad. The reporter provided the consent to follow up.
This spontaneous report as received from a nurse practitioner refers to a 5-month-old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 15-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB (lot # K008874, dose, strength, route of administration and expiration date were not reported) which had temperature excursion. The lot source was public. No information on patient's concomitant medication was provided. There was no adverse event experienced. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received two COVID vaccines. Was supposed to receive one COVID vaccine and one Influenza vaccine, but instead received two COVID vaccines in error.
After the vaccination, the patient got up for a moment, then stated that she felt dizzy and had to sit back down.  I went to check on her immediately as I heard her say she was dizzy. By the time I reached the patient, she started to lose consciousness and was unresponsive for about five to ten seconds.  The patient was checked out and cleared by the paramedics.
Typical "covid arm' started same day, lasted three days, left and reappeared  9 days after shot,vthen lasted 3 days Raised red, itchy burning circle
This spontaneous report was received from a pharmacist concerning a 71 year old female patient. Medical history and concomitant medications were not provided. Historical medications included PREVNAR 13 in 2015. On 25-OCT-2016, the patient received PNEUMOVAX 23 (lot # not specified). That evening, the patient experienced pain rated as a 6 on pain scale and injection site redness and soreness. The outcome of the events was not provided. Additional information is not expected as the reporter did not provide consent to follow up.
HEART NOT WORKING RIGHT; THYROID DIDN'T WORK CORRECTLY ANYMORE; BAD EKG (ELECTROCARDIOGRAM); BOTTOM PART OF HAIR FELL OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: rare disability (No cure). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced heart not working right, thyroid didn't work correctly anymore, bad ekg (electrocardiogram), and bottom part of hair fell out. Laboratory data (dates unspecified) included: Electrocardiogram Bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart not working right, thyroid didn't work correctly anymore, bad ekg (electrocardiogram) and bottom part of hair fell out was not reported. This report was non-serious.
medication leaked around the needle,defect in the syringe where the luer lock connects to the needle,No AE.; while giving flu vaccines where the medication leaked around the needle, no AE.; Initial information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves four patients (age and gender unknown) for whom it was reported that while giving flu vaccines the medication leaked around the needle due to defect in the syringe where the luer lock connects to the needle for the vaccine QUADRIVALENT INFLUENZA VACCINE [FLUZONE QUADRIVALENT].  The patient' medical history, treatments, vaccinations, family history and concomitant medications were not reported.  On an unknown date, these patients were vaccinated with a dose of the QUADRIVALENT INFLUENZA VACCINE [FLUZONE QUADRIVALENT] (lot UT6656KA and expiration date 30-JUN-2020) via unknown route and site of administration.  It was an actual medication error case due to vaccine underdose and Syringe issue.  It was reported that 4 different people while giving flu vaccines where the medication leaked around the needle. One employee received a needlestick because of the malfunction. In my opinion, there is a defect in the syringe where the luer lock connects to the needle.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' 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.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed.  No treatment information was provided.
Patient complain of acute allergic reaction after receiving immunizations. Patient reported burning rash on bilateral upper arms denies throat swelling, difficulty breathing  or GI distress. Patient given benedryl and observed for an extended period with improvement in rash appearance. Benedryl prescribed and next day follow up scheduled with precautions to seek emergency treatment for oral, respiratory or GI distress.
This spontaneous report as received from a physician's nurse refers to a 24 years old female patient who on 18-JUN-2012,was vaccinated with a 0.5 ml dose of GARDASIL (lot number 0754AE) (route not reported). No other co-suspects were reported. No concomitant medications were reported. It was stated that about an hour after the vaccination, on 18-JUN-2012, the patient developed an excruciating headache that lasted about 8 hours. No lab diagnostics studies were performed. Ibuprofen was given as a treatment for the experience. At the time of the report, the patient had recovered (date of recovery reported as 18-JUN-2012 or 19-JUN-2012). The patient sought unspecified medical attention. The relatedness for patient developed an excruciating headache was unknown for GARDASIL. Additional information has been requested.
Generalized sz x 30-40" (rhythmic jerking); 20FEB91 MD & mom talked MD told mom to bring pt in next day mom did not recall; Md felt further vax should delete pertussis;
Initial unsolicited report received from consumer on 27 Sep 2017. This case involves 85 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HD (Frequency: once, batch number and expiry date was not reported) arm intramuscularly on 23 Sep 2017. The patient's medical history and concomitant medication were not reported. On 23 Sep 2017 in Saturday afternoon same day post vaccination, she started with some pain in her arm at the injection site, by the night few hours post vaccination her arm was red hot and 2 times the size it should have been, had swelling (Gigantic; it hasn't improved by today) and now she was having difficulty moving her arm. On 24 Sep 2017 in the morning few hours post vaccination she also had a temperature of 101 with aches and chills. She describes the site as at her shoulder near the top. She has not seen a provider. She has never had a vaccine reaction like this before in all her years. She is a small woman wears a size 6 dress. Other laboratory investigation and corrective treatment were not reported. On an unspecified date, patient was recovered from aches, fever and chills and patient was not recovered from other events. List of documents held by sender: none.