chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist. A 67-years-old male patient received when 66 years old PREVNAR 13, (Lot Number: 539564, Expiry date: 30Sep2018), via an unspecified route of administration at 0.5 ml single in left arm on 21Sep2017 for immunisation. Medical history was none. There were no concomitant medications. Since that vaccination, the patient had to go and do allergy testing for another reason. The wife wasn't specific about what test they did, maybe pulling testing for antibodies. The report came back that he was eligible to get a pneumococcal vaccination and the patient had no antibodies.
Information has been received from a consumer concerning her 25 month old daughter with no pertinent medical history and no drug reactions or allergies who on an unspecified date was vaccinated with a dose of ROTATEQ. There was no concomitant medication. The mother reported that on 25-APR-2010, the patient developed Kawasaki disease and was hospitalized from the end of April to the beginning of May. Patient stated she was not sure if her daughter was given ROTATEQ, but she thought did get it. She could not remember when she got it. The physician reported information concerning the patient in telephone follow-up. The patient was vaccinated on 02-JUN-2008 (Lot # 660681/0210X), on 17-JUL-2008 (Lot # 660878/0502X) and on 24-SEP-2008 (Lot # 661031/0467X) with the first, second and third doses respectively of ROTATEQ (dose and route not provided). At the end of April 2010 (also reported as 25-APR-2010) patient had a fever. On 01-MAY-2010, patient was hospitalized with a diagnosis of Kawasaki disease. The patient was treated with IV immune globulin (IVIG) X2. On 04-MAY-2010, the patient was discharged. The patient fully recovered on 05-MAY-2010. The physician felt there was no relationship between Kawasaki disease and ROTATEQ. Lab diagnostics studies were not performed. No further information is available.
12:16pm Tachycardia and feeling hot.  12:40pm Stated she is feeling a little better.  Advised by EMS to call 911 or contact primary care if still having symptoms.  Understanding verbalized. B/P 178/94, HR 118, O2Sat 99%.
blindness in one eye; floater in eye; A spontaneous report was received from a consumer concerning a 72-year-old male patient of unknown race and ethnic group who received Modern's COVID-19 vaccine (mRNA-1273) and developed floater in eye and blindness in one eye.  The patient's medical history included diabetes and hypertension. Concomitant medications taken by the patient reported were blood pressure medications and diabetes medications.  On 18-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route of administration and at an unknown anatomical location for prophylaxis of COVID-19 infection.  On 01-Feb 2021, the patient was seeing floaters in eye. On 03-Feb-2021, the patient was blind in one eye and was hospitalized with the issue till the date of reporting.  No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome for floaters in eye was recovered on 02-Feb-2021 but the outcome for blindness in one eye was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Couple days later was sore to put arm down and noticed lumps. Went to see doctor and did MRI. Determined it was enlarged lymph nodes. They were removed in March. The doctor stated it was definitely from the vaccine.
Erythema, edema, pruritis at injection site Diaphoresis Nausea  Vomiting  Diarrhea Abdominal pain
48 y/o female with past medical history of Ovarian Cyst and Menopause who presents with dizziness and sweating post vaccination. Patient states that this is her 2nd vaccination in the two-dose series. Patient states that after the first vaccination the only reaction she had was a sore left arm, that remains. Patient received todays vaccination to the left arm. Patient states prior to arrival she had a headache and took Tylenol x2. NP and Paramedics at patient side. Patient provided bottle of water and placed in Trendelenburg. Patient vitals within normal limits, 135/82 BP, 74 HR, 98%RA, Resp 12, Glucose 135 (mildly elevated either due to stress or eating a big breakfast per patient). Within 5 minutes patient with resolution of symptoms. Patient states that she no longer feels dizzy and sweating has resolved. Patient vitals upon discharge also within normal limits. Patient aware that if symptoms worsen or persist to seek further medical care. Patient discharged home in stable condition.
SOB; Sepsis; aspiration pneumonia; This is a spontaneous report based on the information received by Pfizer. A contactable Other HCP reported that a 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration at the age of 59-year-old on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic UTI, and splenectomy for unknown reason, RMS (Rhabdomyosarcoma). Concomitant medication included ocrelizumab (OCREVUS). On 02Apr2021, it was reported that patient experienced: Went into hospital due to SOB (Shortness of breath) on 02Apr2021, died on 07Apr2021 related to aspiration pneumonia on an unspecified date. Patient developed Sepsis as well on an unspecified date. Patient became a DNR on 06Apr2021 then passed on 07Apr2021. The patient was hospitalized for SOB from 02Apr2021 to an unknown date. The patient died on 07Apr2021. It was not reported if an autopsy was performed. The outcome of event aspiration pneumonia was fatal. The outcome of events SOB and Sepsis was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available and known drug safety profile, the reported events more likely represented intercurrent illnesses, but not related to Bnt162b2.  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 RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: aspiration pneumonia
Headache, Fever (at highest 100.6), chills, mild muscle aches, fatigue
She stated it was most likely due to the COVID shot messing up my menstrual cycle and causing excessive bleeding; vaginal bleeding was out of control/causing excessive bleeding; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (Patient) reported.  A 43-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in arm right on 10Jun2021 09:00 (at the age of 43-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After the vaccination, the patient did not have a menstrual cycle the rest of the month or most of July. Then on Sat. 31Jul2021 7:00 AM patient started bleeding bright red blood vaginally and Sunday 01Aug2021 she was rushed to the Emergency Room because the vaginal bleeding was out of control. she went to her Doctor on 04Aug2021 and was tested for everything. Nothing came back abnormal. She stated it was most likely due to the COVID shot messing up my menstrual cycle and causing excessive bleeding. The patient was not diagnosed with covid prior vaccination and patient didn't test for covid post vaccination. No allergies reported. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
paralyzed in one leg; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (paralyzed in one leg) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MONOPLEGIA (paralyzed in one leg) (seriousness criterion medically significant). At the time of the report, MONOPLEGIA (paralyzed in one leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company comment: This case concerns a  patient of an unknown age and gender, with unknown medical history, who experienced serious unexpected MONOPLEGIA. The event occurred in an unknown temporal relationship to administration of mRNA-1273 (unknown dose). The rechallenge is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a  patient of an unknown age and gender, with unknown medical history, who experienced serious unexpected MONOPLEGIA. The event occurred in an unknown temporal relationship to administration of mRNA-1273 (unknown dose). The rechallenge is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
I have a tremor in my right hand; My ears just got totally clogged up and I am very uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 13:30 (Lot number: EN6205) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 immunisation. The following information was reported: EAR DISCOMFORT (non-serious) with onset 04Mar2021, outcome "unknown", described as "My ears just got totally clogged up and I am very uncomfortable"; TREMOR (non-serious), outcome "unknown", described as "I have a tremor in my right hand".  No follow-up attempts are possible. No further information is expected.
2 days p/vax pt had a sx has been having them ever since is now placed on phenobarbital per MD;
Received my 2nd shingle shot (Shingrix) on Thursday 3/5/2020. Woke up next morning at 6:00 am with a horrible headache starting at my right shoulder.  In the evening of 3/6/2020 about 8:00 pm my right ear popped and could not hear anything out of it. On Sunday  I felt weak all day.  On Monday 3/9/2020 I woke up at 3:00 am with dizziness and vomiting.  Went to the ER at around  8:00 am (after contacting doctors office and not able to get in until late afternoon). Blood pressure was very high.  At hospital an MRI, CScan, chest xray and a heart sonagram was performed.   Nothing on any of them to indicate a reason for hearing loss or high blood pressure.  The hospital kept me overnight.  I followed up with my doctor on 3/12/2020. Nothing  stands out as to my hearing or high blood pressure.  At her request I made an appointment with the ENT doctor at the same clinic on 3/19/2020 .  With the tests at hospital he did not have a reason for the  hearing loss since stroke and heart issues were ruled out.  He does want me to  go in for a hearing test to measure the loss I have now.  The shingle shot was the only thing out of the ordinary in my life.
had spasm in feet; could not get comfortable in any position; spasms in his left shoulder where he had the injection, They continued all night; soreness in arms at vaccine site; This spontaneous case was reported by an other caregiver and describes the occurrence of MUSCLE SPASMS (had spasm in feet), DISCOMFORT (could not get comfortable in any position), MUSCULOSKELETAL DISCOMFORT (spasms in his left shoulder where he had the injection, They continued all night) and VACCINATION SITE PAIN (soreness in arms at vaccine site) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Oct-2022, the patient experienced MUSCLE SPASMS (had spasm in feet), DISCOMFORT (could not get comfortable in any position), MUSCULOSKELETAL DISCOMFORT (spasms in his left shoulder where he had the injection, They continued all night) and VACCINATION SITE PAIN (soreness in arms at vaccine site). At the time of the report, MUSCLE SPASMS (had spasm in feet), DISCOMFORT (could not get comfortable in any position), MUSCULOSKELETAL DISCOMFORT (spasms in his left shoulder where he had the injection, They continued all night) and VACCINATION SITE PAIN (soreness in arms at vaccine site) had not resolved.            No concomitant medication were reported.  Patient experienced the symptoms and they continued all night. No treatment was provided but reporter mentioned that she would give the patient Gatorade and Tylenol.
Received Janssen Lot 1808980 at 10:15AM on 4/1/2021. No symptoms at first other than missing appetite. Around 9:00pm started to feel chills and tired with low grade fever (100 C). Around 1:30am started feeling right side back pain in my kidney area that woke me up. By 2:15am the pain was almost unbearable, and I could no longer lay in bed. At 3:00am I took 2x 500mg Tylenol as I debated whether to call my doctor or go straight to ER. By the 3:45am pain was subsiding and was I able to get back in bed by 4am. Today no pain.
Information has been received from a pharmacist concerning a 65 year old female with blood pressure high who on 20-MAR-2009 was vaccinated with ZOSTAVAX vaccine (Merck). Concomitant therapy included lisinopril (manufacturer unknown). About 5 days after vaccination, on 26-MAR-2009 the patient developed shingles. The patient came to the phone and provided more information. The patient's most intense pain was on her right side back and front of her body. The rash was on the right side waist area and right side center back. The patient was prescribed acyclovir for 7 days and was still taking VICODIN for pain. Her physician had "cultured" the rash. The rash was at time of reporting improved, but her whole body was still in pain. The patient was seen in office for medical attention. At the time of reporting the patient was recovering from adverse events. Follow-up information has been received that on 20-MAR-2009 13:20 the patient was vaccinated with her second dose of ZOSTAVAX vaccine (Merck) (lot # 663671/1708X) into her left arm. On 26-MAR-2009 the patient's rash was consistent with zoster. The culture was taken but with no growth. Clinical picture showed pain consistent with zoster. The patient was treated with antiviral medication and "pain."  Follow up information was received from a Medical Assistant of the physician by phone on 05-MAY-2009 reported that the patient's age was 65 year old (not 45 years of age as previous reported). The description of the adverse event should read, "rash consistent with zoster, culture taken but no growth, clinical picture with pain consistent with zoster, treated with antivirals and and pain medicines". Event was not an other important medical event (event required medical intervention but the intervention was not to prevent a serious outcome); pain was not measured on the pain scale; patient was prescribed with VICODIN, as required, for pain relief; antivirals included acyclovir, 800 mg, five times daily for 7 days and VALTREX, 1 gram, three times daily; chart did not show if patient had history of chickenpox or any recent exposure to chickenpox; as of 28-APR-2009, the patient was still recovering from event. No further information is available.
Patient stated that this was the most painful vaccination she has ever had and perhaps the most painful direct infliction of pain.  She felt a stabbing pain in her right arm with pain extending to behind her ear lobe and all the way down to the base of my index finger.    By the time she was traveling home  was to the point of tears with pain shooting up and down her arm with any bump in the road.  She could not lift her arm.  It was not stiff and sore, it was pain, radiating pain.   Duration of pain unknown
Localized swollen Bil. thighs about at the vaccine site min redness bil. lump (right thigh).
Patient experienced redness and swelling 2-3 hours after injection, and pain which continued to worsen through 8/12/15. She went to urgent care and was diagnosed with cellulitis. Filled a prescription for 7 days of BACTRIM DS dosed BID.
None as per PT's mom, sore arm next day and he is fine following day.  Pfizer vaccination lot # FL2757 was potentially received short-dated and recently expired.
Started feeling achy and felt feverish; Took a home COVID-19 test and it was positive; Went to ER and was prescribed PAXLOVID, azithromycin and albuterol inhaler; Started feeling better 4 days after medication.
Indentation - Near Injection Site; Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE STREAKING (Indentation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 307K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE STREAKING (Indentation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site). At the time of the report, VACCINATION SITE STREAKING (Indentation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine (flu) given 11/3/04. Fever 102.4. 11/5/04, 11/6/04 and 11/7/04. Hives developed 11/6/04 begain on trunk then neck and face and then down legs and arms. Doesn't seem to be "itchy" . Hives continue to be present 11/8/04. No nasal drainage or other "cold-like" symptoms. Did not take to MD.
swelling in her lymph nodes in her left armpit; lymph nodes were sore and tender/ lymph nodes were tender; Left arm, tenderness of armpit; Initial information received on 22-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2022SA400984(CLUSTER).  This case involves a 65 years old female patient who experienced swelling in her lymph nodes in her left armpit, lymph nodes were sore and tender/ lymph nodes were tender and left arm, tenderness of armpit after receiving vaccine influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On unknown date in October 2021, the patient received a  dose of suspect  influenza quadrivalent recombinant vaccine (dose, formulation, strength, lot number and expiry date not reported) via unknown route in the left arm for Immunization.  On an unknown date the patient developed swelling in her lymph nodes in her left armpit (lymphadenopathy), lymph nodes were sore and tender/ lymph nodes were tender (lymph node pain), and left arm, tenderness of armpit (vaccination site pain) (latency: 24 hours). Patient is asking  if she can receive FLUBLOK again since she did have that reaction last year and is also wanting to know if there is any information on swollen lymph nodes being a side effect. Also stated she did not want to get the FLUZONE QIV vaccine. Patient asking if swollen lymph nodes have been reported as a side effect with FLUBLOK. Patient states that she never had a reaction like that (swollen lymph nodes in her armpit) to any other vaccine in her life. Patient states that the swollen lymph nodes in her left armpit happened within 24 hours of receiving her FLUBLOK injection last year in her left arm. Patient states that her lymph nodes were sore and tender, and her left armpit was swollen. Patient states that it took a good week to calm down and for the tenderness to subside and nothing helped, not even Tylenol. Patient states that she asked a couple doctors and pharmacists if they had heard of swollen lymph nodes with the flu shot and they said that they had only heard of that with the Covid shots. Patient states that she had sore arms with the Covid vaccine and booster.  Action taken : not applicable.  The patient was treated with PARACETAMOL (TYLENOL) for Lymphadenopathy, Vaccination site pain and Lymph node pain.  Outcome : Recovered / Resolved on an unknown date after one week.; Sender's Comments:  01292145: 01292148: 01292155: Please see related inquiry number: 01290623: Please see related inquiry number: 01292148: Please see related inquiry number: 01292155: Clone made of inquiry number: 01290623 regarding FLUZONE HIGH-DOSE QUADRIVALENT:
This spontaneous report was received from a Registered Nurse and refers to a 15 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 25-FEB-2016, an unspecified infant was inadvertently administered the first dose of ROTATEQ (dose, frequency, lot# and expiration date was not reported), orally. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there is no consent to contact with the physician.
COVID vaccine breakthrough case. Janssen 204A21A on 05/19/2021 and boosted with Janssen 1822811 on 11/23/2021
2 weeks from the vaccine I stared with diarrhea. Admilttle to hospital with infectious colitis. Treated released still with diarrhea.  It?s now November and I had bloody diarrhea every single day. Now I have Crohn?s disease. I?m failing all meds. And back in the hospital for a second admission.  I?m losing weight. I?m anemic.  I did not have any issues before the vaccine.