chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle weakness; fatigue; vomiting; diarrhea; trouble sleeping; Pain in right leg; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of asthenia (for tolerance of 1st dose refer case US2022044822).   On 17th February 2022, the patient received the 2nd dose of Shingrix. In February 2022, 1 week after receiving Shingrix, the patient experienced muscle weakness, fatigue, vomiting, diarrhea, difficulty sleeping and leg pain. On an unknown date, the outcome of the muscle weakness, fatigue and leg pain were not recovered/not resolved and the outcome of the vomiting, diarrhea and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the muscle weakness, fatigue, vomiting, diarrhea, difficulty sleeping and leg pain to be related to Shingrix.     Additional details reported were as follows: After receiving Shingrix, the patient had muscle weakness, fatigue and pain in right leg. The patient also experienced vomiting, diarrhea, trouble sleeping a week after Shingrix, but had recovered from those symptoms.  The patient was referred her to healthcare professional. The patient did not consent to follow-up. The patient had no heathcare professional currently; Sender's Comments:  US-GLAXOSMITHKLINE-US2022044822:2nd dose case - same reporter same patient
This is a spontaneous report from a contactable physician via a sales representative. It was reported that a dose (0.5 ml single) of PREVNAR13 was given intramuscularly to an adult female patient at an adult clinic. They observed bad local reaction with redness and swelling in the upper arm (unknown which side). The physician stated that it was not complete cellulitis, the reporting company representative thought that the physician gave the patient antibiotics as treatment for the events. The outcome of the events was unknown. The company representative did not believe that the patient went to the hospital following the events and she thought that it would be okay to follow up with the physician for more information. Follow-up (24FEB2015): Follow-up attempts completed. No further information expected.
Started as muscle soreness then fatigue, dizziness.  Bone and joint pain.  Bone and joint pain extreme on day 4 and day 5.  Headache and muscle / joint paint day 6.
had a little aches and pains; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration on 20Jan2021 as single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient stated that, she received her first vaccine on 20Jan2021. Stated that she had a little aches and pains that day which resolved with Tylenol. Stated that she has a vaccination for tomorrow. Stated that she has been exposed to a Covid positive person in her family. Wanted to know if she should get a test, quarantining or get her second shot tomorrow. Stated that she does not want to miss the second vaccine and does not want to expose other people. Outcome of the event had a little aches and pains was recovered on 20Jan2021.
She is having trouble lifting her right arm high enough to put on a coat and she can not squeeze or hold anything with her right hand; She sits is having trouble lifting her right leg, she needs to use her hands to move it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset May2022, outcome "unknown", described as "She is having trouble lifting her right arm high enough to put on a coat and she can not squeeze or hold anything with her right hand"; MUSCULAR WEAKNESS (non-serious) with onset May2022, outcome "unknown", described as "She sits is having trouble lifting her right leg, she needs to use her hands to move it".  Additional information :Been about a week and a half. Having symptoms and not sure if they are related to the vaccine. Never had this happen before.  Symptoms: It's the right side of her body, right hand and right leg: Cannot use right hand .Cannot lift right leg. Caller states she received the Pfizer COIVD-19 vaccine about a week and a half ago. Caller states this was her first dose and she received it in the left arm but now complaining that she is having trouble lifting her right arm high enough to put on a coat and she can not squeeze or hold anything with her right hand. Also when she sits is having trouble lifting her right leg, she needs to use her hands to move it. Caller is wondering if this is a potential side effect of the vaccine. Made caller aware that after reviewing it does make mention of New or worsened muscle pain, New or worsened joint pain, Pain at the injection site, it did not find information regarding what you are experiencing. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing.  Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This child had a fever up to 104.2 (ax), eight days following his vaccination, loss of appetite, irritability, lethargy, rash with itching on the 11th day following the vaccine. Treatment after visit to the pediatrician was Advil and Tylenol for the fever, and alot of fluids.
Woke up with blurred vision; Felt heart racing; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient felt that her heart was racing for 3 weeks after the vaccine. Recently on 13Aug2021, the patient woke up with blurred vision and looked up if this could be a side effect, and it was. The patient also reported that it had been 3 weeks and her eyesight was still blurred which happened over night. The events 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events felt heart racing and woke up with blurred vision was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT CAME IN 11/15/23 STATING THAT 3 DAYS AFTER RSV VACCINE HE BEGAN EXPERIENCING LOSS OF TASTE AND SMELL. I ASKED IF HE HAD TESTED FOR COVID WHICH HE STATES HE HAD AND IT WAS A NEGATIVE RESULT. HE COMPLAINS THAT HE STILL HAS LOSS OF TASTE AND SMELL EVEN TO THIS DAY AND WORRIES HE WONT GET IT BACK.
Dizziness x 3 days Systemic Urticaria  (Benadryl 50 mg, Famotidine 20 mg)
This spontaneous report was received from medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drug history, and allergies were not reported. On an unknown date, the patient started the treatment with GARDASIL 9, lot number R022533, expiration date 12-NOV-2019 (dose, frequency, formulation, indication, and strength were not reported). On 23-OCT-2018, the patient inadvertently received a 4th dose of GARDASIL 9. No adverse event was reported.
12/20/20 received first vaccine of Moderna Covid series. Only experience fatigue for first couple of days. 01/03/21 - Around 2pm noticed 3 inch welt across right cheek by 5pm swelling under eyes and random itching around head, neck and face. Headed to doctor 6pm. Saw a PA who said symptoms were not from vaccine when I asked about possibility because of my Hashimotos Thyroiditis. They gave me a steroid shot and called in scrip for Medrol Pack. Later that evening I started also having bad flares of my asthma. Also continued on Benedryl. 01/05/21- started Medrol Pack and continued antihistamines. Very fatigued. 01/10/21-finished Medrol. Still slight welt on right cheek but everything else pretty good. 01/20/21- mid morning noticed welt growing in right cheek and eyes puffing up. By 5pm itching has returned. By 7pm there are now welts and hives on both cheeks and they are  red and hot....asthma flaring badly. Took 30mg prednisone from my medication used for asthma. 01/21/21- things have calmed down redness wise but lots of fatigue. Took 20mg Prednisone. 01/22/21- back to doctor, another Medrol pack. 01/27/21- finished second Medrol pack. Still having slight welts and hives.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-FEB-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-FEB-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-FEB-2022) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2022 at 10:56 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Feb-2022 at 10:56 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-FEB-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. The patient received the booster dose.  No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
Tested positive with covid-19 after receiving first dose of vaccine; A spontaneous report was received from a consumer, concerning a 47-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Covid-19 positive after first dose of vaccine and take the appointment for second dose on 9May2021/missed dose.  The patient's medical history, as provided by the reporter, was high blood pressure, pulmonary issue, cholesterol.  Concomitant medications reported included pill for high blood pressure, ssue, statin for cholesterol and aspirin.  On 22 Jan 2021, approximately 6 days prior to the onset of the symptoms the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left hand for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient developed Covid-19 positive after receiving first dose. On Feb 2021 the patient received  monoclonal antibody infusion on doctor's recommendation. He wants to know if he should take the 2nd dose  of vaccine scheduled for 9 Feb 2021.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event  Covid-19 positive after first dose of vaccine and take the appointment for second dose on 9May2021/missed dose was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
cellulitis of right deltoid and started on 02/02/2021 day after getting vaccine injection. Cephalexin 500 mg by mouth QID for 7 days.
This initial spontaneous case, was received from other non-health professional (consumer) on 01-Nov-2017, concerning a 31-year-old, adult, female pregnant patient. The patient's historical drug included MIRENA (until 15-Jun-2017) as contraceptive prior to pregnancy. The patient had no relevant medical history. The patient had 1 previous pregnancy and had no stillbirth or miscarriage, birth defect or congenital anomaly in previous pregnancy. There was no maternal and paternal medical history relevant to pregnancy. Medications taken by father prior to conception was omeprazole. The patient did not receive any concomitant medications during the pregnancy. The patient's last menstrual period date was 20-Aug-2017. There was no evidence of a defect/adverse finding from a prenatal test and birth defect or congenital anomaly during the pregnancy. The patient was permitted to enroll in the pregnancy registry. On 01-Nov-2017, at gestation age of 10 weeks (1 trimester), the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular route, batch number: 195223, expiry date: Apr-2018) and no adverse event was occurred in the pregnant patient and fetus. The estimated date of delivery was reported as 28-May-2018. The reporter assessed the event as non-serious.
Patient received his first COVID vaccination and was waiting his 15 minutes following his vaccination.  He reported feeling light headed and sweating about 10 minutes after receiving vaccination.   We had him sit down and continued to monitor him in the vaccination booth.  We did ask if he would like us to call 911 so we did.  He then informed us that he had not eaten all day and had also taken a pain pill (unaware of name) for a possible tooth/ear infection.  He was triaged by the paramedics at the store and then released.  We did give him one dose of Benadryl prior to the arrival of the paramedics due to symptoms.
Pt walked into clinic this morning with complaints of pain in left arm, redness and swelling.  Pt received immunizations in that arm two days ago. Pt reports symptoms began the night of the 28th of October. Pt reports the swelling has gone down some, but the pain is still present. Denies any known allergies, denies SOB or chest pain.
sore arm; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included pain in arm. Previously administered products included Flu shot (received flu shot on an unknown date).   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm).  The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 15-Sept-2023 The patient received a dose of Arexvy  and had no side effects other than a sore arm, less than or comparable to a flu shot. The reporter denied to follow-up.
Fine red, raised, pruritic rash noted over both arms two days after vaccine was given. No fever. No other complaints. Fading as of day five after vaccine given. Treated by school nurse with Benadryl 25mg p.o. Pt. repeated Bendaryl over next two days.
Mild fever, swollen lymph nodes, headache/confusion, joint pain, general fatigue, soreness.
Shingrix administered without the powder; Shingrix administered without the powder; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2022, the patient received the 2nd dose of Shingrix. On 20th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment:The reporter was looking on information because, a colleague administered a Shingrix to a patient without the powder. The reporter did not consent to follow-up. Additional Supportive Information: The reporter was looking on information because, a colleague administered a Shingrix to a patient without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 22-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
MISSED THIRD DOSE OF VIVOTIF; This spontaneous case report (PVX2019-1992) was received from a healthcare professional on 01-Aug-2019. It described a male consumer who "missed third dose of Vivotif" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took the first and the second dose of Vivotif on 25-Jul-2019 and 27-Jul-2019, respectively. The consumer missed to take the third dose.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed third dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed third dose of Vivotif" was considered as not applicable.
Within the first 3 sec. of administering the FLUZONE intraderm 2012-13 syringe -> patient got lightheaded and was sweating and hot.
her left arm that is swollen; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 03Apr2021 11:00 as SINGLE DOSE (at the age of 57-years) in Arm Left for covid-19 immunization. The patient had no relevant medical history. The patient did not receive any prior vaccinations (within 4 weeks). The patient's concomitant medications were not reported. On 03Apr2021 at 12:00, the patient's left arm was swollen after her first shot. She reported that her left arm that is swollen, the arm she got the shot in. It was still swollen and worsened. She enquired whether she should go to the hospital. The patient did not receive any treatment. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient with 2 Pfizer COVID vaccinations, last dose 02/10/21, who admitted to hospital with complications from COVID.  Provider D/C note below:  "Brief Summary of Hospital Stay:  Patient had a Fall at home without suffering any injuries but due to  Weakness generalized she could not get up off the floor.  When evaluated she was found to have evidence or Acute respiratory insufficieny with hypoxia.  The respiratory disturbance and weakness appear to be due to a COVID 19 infection.  Though the patient was vaccinated she may not have had as robust response due immunosuppression from METHOTREXATE and PREDNISONE she takes for Adult-onset Still's disease.  She was started on DECADRON (course continued at discharge) and REMDESIVIR (course not completed).  Patient's weakness improved quickly and she did well with physical therapy.  Her oxygen requirements were improving rapidly as well.  She was discharge with supplemental oxygen but suspect she will not need support for long."