chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Signs and symptoms of pericarditis onset approximately 3 weeks following the 2nd dose of the Pfizer vaccine presenting with intermittent chest pain which was worse with deep breathing. Pain was sharp and stabbing in nature and would come and go without warning. Not associated with increased heart rate. Symptoms have persisted, so I sought a cardiologist, who ordered a Holter monitor and showed a Type II mobitz AV block that is moderately severe.  Symptoms now have subsided mostly, however, cardiac MRI with contrast and Echo show mild weakening of the heart (decreased ejection fraction) and mild left ventricular hypertrophy. Blood work has been extensively run which shows normal values for all potentially related issues.
Patient was administered a Pfizer Bivalent Vaccine, despite parents request for Moderna Booster. Since patient is under age five and received Moderna for both shots (1) and (2) in his primary series he was only eligible to receive a Moderna Booster. Therefore, this should classify as a vaccine administration error.
The patient was suppose to receive the monovalent vaccine as the first dose in her series (she had never received a covid vaccine before) but instead she received the bivalent vaccine.
Erythema, swelling of left deltoid to elbow, on 09/25/14, c/o pain on 09/26/2014.
Information has been received from a 60-year-old female, "vascular patient", consumer with diabetes, who on an unspecified date was vaccinated with a "single dose" of zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. No further information was available. No product quality complaint was involved. Additional information is not expected.
Hospitalization for COVID-19 infection after COVID-19 immunization. This 84-year-old female with a history of advanced medullary thyroid cancer presented to her medical oncologist with symptoms of cough and breathing difficulties associated with a positive home test for SARS-CoV-2. She was found to be hypoxemic requiring O2 supplementation at 2L/min with CT scan changes consistent with COVID-19 pneumonia. She was transferred to hospital and admitted. She is receiving treatment with dexamethasone, remdesivir and enoxaparin. She now is afebrile and shown improvement in symptom severity. The management coordinator is actively planning for comprehensive follow-up healthcare after discharge.
Fever,101.3,muscle pain ,fatigue, sorethroat,heasach
The pharmacist stated that she administered one of the Varivax doses that underwent a temperature excursion; This spontaneous report has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 08-OCT-2020, the patient was vaccinated with one of the varicella virus vaccine live (oka/merck)(VARIVAX) doses that underwent a temperature excursion, 0.5 ml (strength, route of administration and anatomical site of vaccination were not reported; lot number S032351, expiration date 14-OCT-2021) given as prophylaxis.   The vaccine administered experienced a temperature excursion of 41 Fahrenheit (F), time frame 120 hours, as recorded by a data logger. There was no previous temperature excursion reported.
This consumer report (initial receipt 01-Apr-2015) concerns a 58 year-old female patient. On an unspecified date in September 2014 or October 2014, the patient received a Influenza virus vaccine (manufacturer and batch number not provided). The patient also received HIZENTRA (batch number not provided) when she was enrolled in a post-marketing study (see 2015050191). On an unspecified date in November 2014, the patient experienced the flu. She continued to get sick with various infections. On an unspecified date in January 2015, she became very sick and was in the hospital for four days. In response, the doctor increased the patient's weekly dose and the patient felt that this helped her significantly. The outcome was not reported.
Approx. 2:45pm had unusual feeling/light pressure in chest area. 7:15pm tightness in R shoulder, severe pain in R lower back teeth. Concerned heart attack symptoms, 911 was called. 7:45pm,EMT took BP 218/98/138. Ambulance was called and proceeded to Hospital.  ECG 12 leads performed 2x`s; XR Chest, 1 view; CBC w/differential, Comprehensive metabolic panel, D-dimer, quantative; Troponin 1, high sensitivity performed 2x`s. All tests showed ormal
7PM-had coughing fit from deep inside; got home, relaxed;face got red, not hot; eyes felt like sand in them really dry; sweating but chilled & hot; chest felt tight/breathless/shallow;arm real sore; states took APAP q 3hrs;tightness in ches
fever of 105 degrees Fahrenheit; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient experienced fever of 105 degrees F. The asked pharmacist further questions about temperatures in clinical studies. This case has been linked with US2020148713, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020148713:same reporter
I was achy and my arm was sore that night. I was fine until I started experiencing symptoms on the 1/5. So that night, I checked my temperature and had a low grade fever. I took a COVID test on 1/6 and was positive and I got treatment on 1/7. I ended up being out of work for two months due to a sinus infection and pneumonia. I'm still experiencing symptoms such as lung inflammation and SOB, so I'm on an inhaler, nasal spray, allergy meds and I did a sputum test today. I'm also scheduled to see a pulmonologist, who I also saw prior to COVID for breathing issues. I've had to do 3 rounds of antibiotics to resolve my pneumonia.
Moderna COVID-19 Vaccine EUA Fever-100.3, body aches, headache, fatigue, Arm soreness
had DOE 3-4 days prior; fatigued; taste seems different; This is a spontaneous report from a non-contactable Other HCP. A 65-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported patient experienced DOE for the past 3-4 days and felt fatigued for the past week in 2021. His taste seemed different over the past couple of days in 2021. The outcome of events was unknown.   No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Pt was given 0.5 ml Fluzone regular instead of 0.25 ml Fluzone with preservative. No adverse event.
ABOUT 10 MINUTES AFTER PATIENT HAD HER MODERNA VACCINE SHE STATED SHE WAS FILLING DIZZY. WE PLACED COLD PACKS ON HER CHEST AND BACK OF NECK AND SAT WITH PATIENT UNTIL SHE LEFT. AT THE TIME SHE LEFT PATIENT WAS FINE AND NO LONGER DIZZY.
No adverse event; First dose on 13-MAR-2021 and second dose on 18-APR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-MAR-2021 and second dose on 18-APR-2021) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a, 001b01a, 061e21A and 005M21A) for COVID-19 prophylaxis.     The patient's past medical history included Breast cancer stage I (19 years ago, radiation but no chemo). Concurrent medical conditions included Drug allergy.   On 13-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2022 at 12:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021 at 2:30 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-MAR-2021 and second dose on 18-APR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-MAR-2021 and second dose on 18-APR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-MAR-2021 and second dose on 18-APR-2021).    DOB was reported. No concomitant information was provided. No treatment information was provided.
Received the injection on Wednesday, January 27 and by Friday morning, Jan. 29 the area was itching slightly below the injection site.  The itching has continued to get worse .  Now there is an area approximately 3 inches in diameter that itches, is red, slightly swollen, hurts and the skin feels slightly bumpy.
crohn's disease flare up; sore arm after getting pfizer vaccines; Discomfort; Upset stomach; Low grade fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4157953-00.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 12Sep2021 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 22Aug2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm after getting pfizer vaccines"; DISCOMFORT (non-serious), outcome "unknown", described as "Discomfort"; CROHN'S DISEASE (non-serious), outcome "not recovered", described as "crohn's disease flare up"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Upset stomach"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  Additional information: Causality for Humira (Adalimumab) The reporter's causality for the event(s) of crohn's disease flare up with humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of discomfort and upset stomach was not provided. The  reporter's causality for the event(s) of low grade fever and sore arm after getting pfizer vaccines with  humira (ADALIMUMAB) was no reasonable possibility.; Sender's Comments:  Based on available information the events of  Crohn's disease, Vaccination site pain, Discomfort , Abdominal discomfort , Pyrexia are assessed as possibly related to the suspect vaccine BNT162B2 based on  temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 19.78.  Batch number 044B21A underwent temperature excursion on 15-April-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 06-April-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-April-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported. No concomitant medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Hives, Rash, Itching. Given Prednisone, Benadryl, and Triamcinolone Cream for rash.
This case was reported by a healthcare professional and described the occurrence of Bell's Palsy in a 66-year-old male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). Concurrent medical conditions included allergy to TOPROL XL and ULORIC noted and end stage renal disease for which the subject started chronic dialysis on 09 May 2014. On 06 May 2014, the subject's hepatitis B surface antibodies were found less than 3.5 MIu/ml. On 6 June 2014, the subject received 1st dose of ENGERIX B adult (40 mcg, intramuscular, unknown injection site). On 27 June 2014, less than one month after vaccination with ENGERIX B adult, the subject presented to the reporter's clinic with facial drooping. The subject reported that he had been diagnosed with Bell's Palsy by his primary physician. The healthcare professional considered the events were clinically significant (or requiring intervention). On 21 July 2014, the subject received 2nd dose of ENGERIX B adult (40 mcg, intramuscular, unknown injection site). On 25 July 2014, 4 days after vaccination with ENGERIX B adult, the subject experienced left side of face swollen. The subject was treated with prednisone. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 01 October 2014 from the physician: Some of the patient's details were provided. VAERS details were also provided. In an e-mail correspondence was stated that there is no relationship between the ENGERIX B and Bell's Palsy. The physician and the patient agreed to proceed with the second dose on 21 July 2014 (batch number 35F27, expiry date unknown). On 21st July 2014, the patient received the 2nd dose of ENGERIX B adult (intramuscular) 40 mcg. On 30 July 2014, 9 days after the last vaccination with ENGERIX B adult, the patient experienced swelling face. Rechallenge with ENGERIX B adult was positive. ENGERIX B adult was interrupted and the immunisation serie delayed. At the time of the follow-up reporting, the outcome of the Bell's Palsy, facial droop were not recovered/not resolved and the outcome of the swelling face was recovered/resolved. The reporter considered the Bell's palsy, facial droop and facial swelling to be possibly related to ENGERIX B adult.
Aches; Headache; tube was leaking  she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot; Tube was leaking  she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot; Tube was leaking  she she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), HEADACHE (Headache), ACCIDENTAL OVERDOSE (tube was leaking  she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot), DEVICE CONNECTION ISSUE (Tube was leaking  she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot) and PRODUCT ADMINISTRATION ERROR (Tube was leaking  she she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (tube was leaking  she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot), DEVICE CONNECTION ISSUE (Tube was leaking  she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot) and PRODUCT ADMINISTRATION ERROR (Tube was leaking  she she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot). On 29-Oct-2021, the patient experienced PAIN (Aches) and HEADACHE (Headache). On 28-Oct-2021, ACCIDENTAL OVERDOSE (tube was leaking  she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot), DEVICE CONNECTION ISSUE (Tube was leaking  she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot) and PRODUCT ADMINISTRATION ERROR (Tube was leaking  she she thought it wasn't connected properly and just squirted down the arm, but then she opened a new tube and administered the full booster shot) had resolved. On 30-Oct-2021, PAIN (Aches) and HEADACHE (Headache) had resolved.            No concomitant medication was provided. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Dec-2021: significant follow up received. Reporter's details updated, patient demographics updated, stop date and outcome of events (headache and aches) updated.
Developed rash over neck chest back and stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed rash over neck chest back and stomach) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Developed rash over neck chest back and stomach). At the time of the report, RASH (Developed rash over neck chest back and stomach) outcome was unknown.            No concomitant medications were reported by the reporter.  The patient had the event a month after second dose.  Treatment medication was not provided by the reporter.
dizzy; She was nauseous and got very hot, like a hot flash; She was nauseous and got very hot, like a hot flash; Did throw up a little one time; Arm got just the least bit sore from injection; This is a spontaneous report from a contactable consumer. This 81-year-old female patient received bnt162b2, dose 1 parenteral, administered in deltoid left on 09Feb2021 10:00 (Batch/Lot Number: EN9581; Expiration Date: 31May2021) at 0.3 ML as single dose for vaccination in Career center nearby hosted by a public county health center. The patient medical history and concomitant medications. The patient experienced arm got just the least bit sore from injection on 09Feb2021, dizzy, she was nauseous and got very hot, like a hot flash and did throw up a little one time; all on 11Feb2021 19:00. The patient stated that she got her first Pfizer vaccine on 09Feb at 10 am and had no reaction until late yesterday around 7 pm, approx. 55 hours after vaccine. She was watching TV and all of a sudden, she felt dizzy. She got up and had to hold onto something. She was nauseous and got very hot, like a hot flash. It all lasted about 15 minutes and then she felt fine. She went to bed right away and got up at night to go to the bathroom and drink a lot of water. Dizzy: Onset time about 19:00. She was sitting her chair and all of a sudden felt dizzy. She tried to stand up and had to hold on to something. She recovered completely event, seemed fine after that duration of roughly about 15 minutes that this event was ongoing. Hot Flash: Onset time about 19:00. Had a hot flash where she could hardly stand her clothes on her. She recovered completely event, seemed fine after that duration of roughly about 15 minutes that this event was ongoing. Nauseous: Onset time about 19:00. She recovered completely event, seemed fine after that duration of roughly about 15 minutes that this event was ongoing. Did throw up a little one time: Onset time about 19:00. She recovered completely event, seemed fine after that duration of roughly about 15 minutes that this event was ongoing. Outcome of recovered of the event injection site pain on 10Feb2021 while rest of the events was recovered on 11Feb2021.  Follow-up attempts completed. No further information expected.
Fifteen minutes after injection... Right side of face was swollen, and top lift was swollen. Took two Benadryl , and it helped within 30  minutes.  Couples day after to the present day, left arm has been painful and swelling, continuously.
Rash (itchy, sore, welt about 4x4"). Appeared 2 days after injection. Pt applied BENADRYL cream.