chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was like someone turned the ringing/buzzing up in his right ear, the sound as the high pitch ringing like from a fax machine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (It was like someone turned the ringing/buzzing up in his right ear, the sound as the high pitch ringing like from a fax machine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced TINNITUS (It was like someone turned the ringing/buzzing up in his right ear, the sound as the high pitch ringing like from a fax machine). At the time of the report, TINNITUS (It was like someone turned the ringing/buzzing up in his right ear, the sound as the high pitch ringing like from a fax machine) had not resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.  The patient stated that the symptoms increased after the second dose.   This case was linked to MOD-2021-118049 (Patient Link).
pt recvd vax 24SEP93 & 30OCT93 exp paroxysmal coughing spells leading to occasional apnea; hospitalized x 3 days; pos fluorescent antibody test for bordetella pertussis; neg nasopharyngeal culture to B. pertussis; pt recovered;
Patient developed ITP; got booster on 09/20/2021; then developed PEs and DVTs, also found to have kidney cancer, needing surgery
Pt developed a mottled appearing area on his arms prior to and following injections. His mother reports that he did not return to school as he did not feel well. His skin rapidly became rash like then turned to hives. Mother gave pt Benadryl and called the health department. Mom was advised to have him seen by an MD. The MD prescribed Allegra.
Breast Cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Breast Cancer) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M2019 and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced BREAST CANCER (Breast Cancer) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (Breast Cancer) outcome was unknown.            Patient  was asking if she can get Moderna booster dose, as she was over (age given) and fixing to do radiation for cancer.  She was diagnosed with breast cancer in her left breast in May.  She was not certain what type, but thinks it is noninvasive.  Concomitant product use was not provided by reporter.  Treatment information was not provided.  Company comment: This case concerns a    66 years-old, female subject without significant clinical history, who experienced the unexpected  event of BREAST CANCER. The event occurred approximately three months after the first dose and  two months  after the second dose of [Spikevax]. The rechallenge was not applicable. The event was considered unlikely related to the study drug per the reporter's assessment. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a    66 years-old, female subject without significant clinical history, who experienced the unexpected  event of BREAST CANCER. The event occurred approximately three months after the first dose and  two months  after the second dose of [Spikevax]. The rechallenge was not applicable The event was considered unlikely related to the study drug per the reporter's assessment The benefit-risk relationship of the vaccine is not affected by this report
Patient was injected by MA for his booster dose. His first dose was Janssen on 06/18/2021. Today, he requested Moderna for his booster dose. MA injected the Moderna 0.25 mls booster to patient's left arm, with another MA witnessing.  Per MA, there was a leak on the syringe while she was injecting, and there was nothing administered to the patient.  Patient was informed, and he agreed for another injection on the same arm, this time given by MA. Patient tolerated the procedure well and was observed for 15 minutes with no reaction to the vaccine.
Within a couple minutes of injection, I started to feel incredibly light headed, a pain and tingling sensation started spreading through my arm. Swelling and redness began approximately 5-10 minutes following injection. Intense itching that originated at injection site but would later progress to entire body began in a similar 5?10 minute timeframe. Hives slowly started forming around 10-15 minutes after injection which were accompanied by a rapid heartbeat. The last symptoms to appear were body aches and chills. I was advised to rest and take an anti-inflammatory rather than follow up with a doctor. All symptoms ceased after 2-3 days.
24hr p/vax ran fever to 103-had 101 oral for 5 days even w/APAP;saw MD dx as viral;7 days later low grade temp for 1wk later devel swollen joint (knee) spread to ankles & hands;devel rash 11 days p/vax;
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Aug-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion). Concomitant medications details were not reported by the reporter. It was reported that there were 2 incidents of potential temperature excursions. The vaccines were stored in a frozen condition. On 26-Jul-2022 for a few minutes, temperature dropped while other things were being (Unknown duration on 29-Jul-2022). Maximum or minimum temperatures reached, as applicable was reported as 9.3 degrees Fahrenheit, 33.2 degrees Fahrenheit. The Vials were returned into refrigerators with some administrations. There was no visual changes, appeared frozen for both. Proposed desired date for administration was this afternoon. Total 8 vials were impacted and 3 vials were administered unknown number of patients. No symptoms reported. Patient did not received any additional doses medications or treatments.
C/O red, inflamed arm at site of Hib inject. from deltoid to elbow high temp.
Atrial fibrillation within 24 hours along with high heart rate 135; Atrial fibrillation within 24 hours along with high heart rate 135; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 31-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 21Sep2021 16:45 (lot number: EW0186) at the age of 31 years old as single dose for COVID-19 immunization. Medical history included known allergies: Penicillin. Concomitant medications were not reported. The patient experienced Atrial fibrillation within 24 hours along with high heart rate 135 on 22Sep2021 17:30. The events result in Doctor or other healthcare professional office/clinic visit. No treatment was received for the events. COVID test post vaccination: Nasal Swab, Pcr on 22Sep2021 with Negative results. The outcome of the events were unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Atrial fibrillation, heart rate increased and BNT162B2.  The impact of this report on the benefit/risk profile of the product is evaluated as part of 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.
Covid Arm ? itchy red rash in arm, swelling, appeared 8 days after first shot.  Two days later it is still itchy and has spread further down and inside the arm.
Spec of blood when blowing nose; Congestion; Headache; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), EPISTAXIS (Spec of blood when blowing nose), NASAL CONGESTION (Congestion) and HEADACHE (Headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 028A21A and 103A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), ASPIRIN [ACETYLSALICYLIC ACID], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and IRON for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2022, the patient experienced COUGH (Coughing), NASAL CONGESTION (Congestion) and HEADACHE (Headache). On 26-Jan-2022, the patient experienced EPISTAXIS (Spec of blood when blowing nose). The patient was treated with GUAIFENESIN (ROBITUSSIN [GUAIFENESIN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. On 26-Jan-2022, NASAL CONGESTION (Congestion) and HEADACHE (Headache) had resolved. At the time of the report, COUGH (Coughing) and EPISTAXIS (Spec of blood when blowing nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative.,Result received on 26-JAN-2022.
I have asthma, & every time I get a cold, it goes into bronchitis, even borderline pneumonia. Since I've gotten all 3 doses, I haven't experienced that,Booster dose Oct 2021; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I have asthma, & every time I get a cold, it goes into bronchitis, even borderline pneumonia. Since I've gotten all 3 doses, I haven't experienced that,Booster dose Oct 2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis and Cold. Concurrent medical conditions included Asthma.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I have asthma, & every time I get a cold, it goes into bronchitis, even borderline pneumonia. Since I've gotten all 3 doses, I haven't experienced that,Booster dose Oct 2021). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I have asthma, & every time I get a cold, it goes into bronchitis, even borderline pneumonia. Since I've gotten all 3 doses, I haven't experienced that,Booster dose Oct 2021) outcome was unknown.            No concomitant medication reported. No treatment information was provided.   Reporter did not allow further contact
Received vaccine on 06/28/17 and came to clinic on 06/29/17 right arm swollen, red, warm to touch and patient has a low grade fever.
Severe pain and inability to move my arm, or turn over in bed. Later in the night fainted, dizzy, nauseated.
swollen arm, followed by headache and fatigue and low grade temperature. Symptoms resolved in 48 hours
dizziness; malaise; aches and pains; carsick type feeling; lethargy; headache; Lack of coordination; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 11:00 (Lot number: 8737) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Major depression; "anxiety" (unspecified if ongoing), notes: generalized anxiety. Concomitant medication(s) included: BUPROPION; KLONOPIN; ESCITALOPRAM; VIT D. The following information was reported: COORDINATION ABNORMAL (non-serious) with onset 05Apr2021 13:00, outcome "not recovered", described as "Lack of coordination"; FATIGUE (non-serious) with onset 05Apr2021 13:00, outcome "not recovered", described as "fatigue"; DIZZINESS (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "dizziness"; MALAISE (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "malaise"; PAIN (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "aches and pains"; FEELING ABNORMAL (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "carsick type feeling"; LETHARGY (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "lethargy"; HEADACHE (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of coordination abnormal, fatigue, dizziness, malaise, pain, feeling abnormal, lethargy, headache.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have allergies to medications, food, or other products. Centrum and multi V medications received by the patient within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Patient developed crying 40 minutes out of each hour, periodically for 2 days.  No fever detected but mother describes cold sweats.
Pt had hip replacement weeks before receiving the booster dose of Moderna. He went to physical therapy after having his booster dose. The day after physical therapy, every muscle they had worked on in therapy as well as his surgery site was extremely sore and sensitive to the point he couldn't even walk, unlike his other physical therapy appointments. These symptoms got progressively better over the next day, and went away by day 3 after physical therapy.
her daughter took the vaccine yesterday and is having nausea today; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (her daughter took the vaccine yesterday and is having nausea today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced NAUSEA (her daughter took the vaccine yesterday and is having nausea today). At the time of the report, NAUSEA (her daughter took the vaccine yesterday and is having nausea today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Company comment: 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.   Reporter did not allow further contact; 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.
It was reported that a pt received TD vaccine (1st dose in series) on 6/11/99. Reportedly on 6/12/99, the pt became pale and developed a fever, malaise and achy legs. From additional received on 6/22/99, it was reported MD stated ADR not vaccine related, stated pt had a throat infection. From follow-up #1 correspondence received on 4-May2003, the correct reporter infroamtion was provided. This case is closed.
Narrative: 95-year-old male received Pfizer COVID vaccination #3 on 12/2/2021. He received Moderna vaccines #1 and #2 in the spring of 2021. On 12/5/2021 he presented to the ED with falls, increased sleeping, and weakness with dizziness. Noted patient did have a fall fall 1 month prior. ED provider felt these symptoms were secondary to Covid vaccination and possibly mild dehydration. No medications were prescribed for the patient; however, he did receive 1000ml of 0.9% normal saline at a rate of 250mL/hour.
I had the Moderna shot on Friday at 10:00 am. Sunday at midnight was very nauseated, vomiting, fever of 100, diarrhea, body aches, chills.
Patient came in to receive her booster Covid-19 shot. She didn't have her card and I didn't verify when her second dose was, only confirmed verbally with her that she's here to get her booster shot. After talking  to her friend, who presented her card, I  told the friend she's too early for her booster, who then told me the patient and her had the second shot at the same time, which was 8/28/2021. The booster was given on 1/16/22. No adverse reaction was observed. I apologized to the patient, and told her that she doesn't need to get another shot, and that I will report this administration error on my end.
Case number PHEH2012US016064 is an initial spontaneous report received from a physician on 15 Aug 2012. This case refers to a 23-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: X11064) intramuscularly on 14 Aug 2012. On the same day after vaccination he experienced paranoia and was anxious. He also had bleeding gums after brushing teeth, and was not able to sleep all the night. The patient's outcome was reported as unknown. No other information was available.
This is a 79-year-old male with a history of hypertension, hyperlipidemia, BPH, depression, kidney transplant recipient and chronic back pain who presents to the emergency room after a trip and fall at home and being unable to get himself up.  He states since that time his back pain has gotten increasingly worse and is now 6/10, sharp and worse with any type of movement.  He says he usually just takes Tylenol and tramadol for the pain.  According to the emergency room physician patient's wife was initially a bedside and stated that "I can not take care of him anymore" And therefore he is being admitted for weakness and assistance with OT/PT/CM.  Patient was also found to be COVID posit Tested positive on 01/05/2022 This is a 79-year-old male with a history of hypertension, hyperlipidemia, BPH, depression, kidney transplant recipient and chronic back pain who presents to the emergency room after a trip and fall at home and being unable to get himself up.  He states since that time his back pain has gotten increasingly worse and is now 6/10, sharp and worse with any type of movement.  He says he usually just takes Tylenol and tramadol for the pain.  According to the emergency room physician patient's wife was initially a bedside and stated that "I can not take care of him anymore" And therefore he is being admitted for weakness and assistance with OT/PT/CM.  Patient was also found to be COVID positive but he has no rhinorrhea, sore throat, shortness of breath, palpitations, chest pain, fever or chills.  He has been vaccinated x3   Patient denies any fever, cough, chills, rhinorrhea, sore throat, chest pain, shortness of breath, palpitations, orthopnea, paroxysmal nocturnal dyspnea, nausea, vomiting, diarrhea, constipation, hematuria, dysuria, frequency, melena, hematochezia or focal neurological complaints
This is a spontaneous report from a contactable pharmacist. This pharmacist reported for two patients with similar events. This is the second of two reports. A 91-year-old male patient started to receive PREVNAR (lot number M56442, expiration date Jun2017), intramuscular from 23Oct2015 to 23Oct2015 at 1 DF, single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced reaction to the injection site with symptoms of more red, swollen and sore/ red swollen area that extended down below the injection site on 28Oct2015 with outcome of not recovered. The action taken in response to the event for PREVNAR was not applicable. Therapeutic measure provided was cold compression. Follow-up (12Nov2015): This follow-up is submitted to amend previously reported information: reaction data coding. Follow-up (11Dec2015): Follow-up attempts completed. No further information expected.
No adverse reaction: Client was given second dose of pediatric Hep A vaccine too early. Recommended date is 11/16/2023 Dose was given 10/23/2023. Guardian was contacted and informed that the dose was in error and another dose would still be required to complete the series.
Pain at the injection site that will not go away. 2 months ago she had a lot of pain in her left arm where she couldn't open her hand which lasted about about. She went to the Chiropractor got x-rays on that hand and it showed a lot of swelling. She now has a tremor on her left side.