chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse. A 22 year-old female patient received the first dose of TRUMENBA (Batch/lot number: AA9699, NDC number of TRUMENBA: 00005010001, Expiry Date: 30Apr2020) at the age of 21-year-old intramuscularly in the right arm on 05Apr2019 at 0.5 cc, once for scheduled vaccine. The patient had no medical history and concomitant medications. The patient received the product in the office on 05Apr2019 and that evening, a fever began, with soreness in arm, bruising began to develop and between Friday and Saturday morning (06Apr2019) the mother had noticed the black and blue bruising and swelling spread from the deltoid muscle to above the elbow and by the next day, the black and blue bruising and swelling was on the underside of the arm. On 08Apr2019, it was reported to be getting better and gone by 09Apr2019. The nurse considered the event of fever as non-serious as the patient (also referred to as "child" by the nurse), did not take medication to treat the fever. The nurse considered the soreness, black and blue bruising and swelling as medically significant as the nurse had seen local redness but not like this one. No investigations were performed. The outcome of fever was recovered on an unspecified date in Apr2019 while recovered on 09Apr2019 for the rest of the events. The nurse considered the events of soreness, bruising began to develop, black and blue bruising and swelling spreading as related to meningococcal group b rlp2086. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
the patient (no demographics provided) was administered ROTATEQ (date not specified) but subsequently "became sick with rota virus and developed diarrhea.; the patient (no demographics provided) was administered ROTATEQ (date not specified) but subsequently "became sick with rota virus and developed diarrhea.; Information has been received from a physician via a company employee referring to a 1 year old male patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was unknown.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(lot#, expiration date, strength, dose and frequency were unknown) orally for prophylaxis.         On an unknown date after the vaccination(reported as "a long time ago"), the patient "became sick with rotavirus and developed diarrhea" (diarrhoea rotavirus and vaccination failure). It was unknown if treatment was given for the events. The outcome of the events was unknown. The causality assessment was not provided by the reporter.  Upon internal review, diarrhoea rotavirus was determined to be medically significant.
pt exp fever 101.5, redness @ site of inject; pt given APAP & ice applied w/in 24 hrs; @ 4 1/2 mo there was noticeable head lag;
No adverse event; Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Obesity, Obesity, Renal disease (kidneys disease), Renal disease and Cardiac disorder (heart disease).    In May 2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In May 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023.).    Concomitant drugs were not reported.  It was reported that the vaccine which was expired on 17-May-2023 was administered to three patients one on 18-May-2023 and two on 19-May-2023.  Treatment medications were not provided.  This case was reported for 1 male patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-725910 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725910:(Female patient no-1)
got the vaccine subQ instead of IM; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and got the vaccine subQ instead of IM (Incorrect route of product administration).  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) subcutaneously for prophylaxis of COVID-19 infection.   A healthcare provider called to report a patient stated they received the vaccine subcutaneously instead of intramuscularly. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, got the vaccine subQ instead of IM, was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect route of product administration (patient received vaccine subcutaneously instead of intramuscularly) for mRNA-1273, lot # not provided.  There were no reported AEs associated with this case of Incorrect route of product administration. The reported event is unlisted and company causality was assessed s not applicable.
one of two pts vaxed from the same vial exp a local reaction 7x8cm consisting of erythema, inc warmth & sl raised skin; seen by MD;
He felt some uneasiness which was close to dizziness; Feels uneasiness when walking, like he is about to fall over; Feels uneasiness when walking, like he is about to fall over/dizziness is not like the world is spinning, but it feels like he is ready to tip over; He felt some uneasiness which was close to dizziness / light headedness; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 74-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 08Feb2021 at 11AM to 12PM (at the age of 74-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. Patient had the shot on Monday afternoon around 11 or 12 clock. Tuesday on unknown date he felt some uneasiness which was close to dizziness and lightheadedness on 09Feb2021. He would feel it when walking. It lasted for a while then went away. Then he woke up this morning and had this feeling again. It has now lasted for like 5 hours now. He stated he does not had a fever or sickness. He has this uneasy feeling when walking. It is like he is about to fall over and has to hold on to not top over, like a dizziness. Patient wanted to know if this was a symptom of the vaccine. Nothing occurs when he was sitting down, it was when he started moving around. He was wondering if that was one of the symptoms. Caller states the dizziness is not like the world is spinning, but it feels like he is ready to tip over. The outcome of the event dizziness was reported as not recovered and while other events was unknown.
Fever, chills ,muscle cramps, headache  approx 14 hours - all symptoms subsided approx 48 hours from time of vaccination
My arm is still very painful and I have the difficulty to wear the bra in the morning. Put the T shirt on or off. I need use of my right hand to help a lot for the jobs which used to be handle by the left hand. Any actions related to use left upper arm muscle (which is so stiff now) will give me a hard time and I cannot bend my left arm to my back which I used to do it easily. But I think I get better. I did not see any doc yet and also did not take any medicine as of now.
pt recvd vax;exp severe local inject site vesicular rxn;fever of 104.8;local tenderness & redness,systemic flu like sxs;was tx w/diphenhydramine HCL,erythromycin,cold compresses & cefazolin sodium;sxs resolved over 1 wk;
The patient received her second Moderna dose at the left deltoid on 04/17/2021 at 12:15 PM. she stated that at 8 pm of the same day she started feeling Pain, redness, sorness and swelling at the injection site. The symptoms  started getting better within few days after the shot except for the pain that was consistent and increasing over days. the pain as she prescribed is in the middle of her upper arm muscle and gets worse when she lift her arm up. she tried to use aleve and aspirin but it seems it did not relieve her pain. After 3 weeks of injection she calls the pharmacy to report the incidence on 05/11/2021 stating that the pain after the injection is not going away and getting worse to the point she cannot even sleep at night.
I had muscle aches, headache and fatigure for four weeks after the first COVID 19 vaccination on 1/14/2021.   I took alternating doses of Tylenol and Advil to try to relieve the symptoms.  My primary doctor advised me to get the second vaccination even though symptoms continued.  I received the second vaccination 2/12/2021.   After about 3 days, my symptoms got much worse. Muscles aches made it difficult to riase my arms. I saw a rheumatologist (Dr.) who prescribed Prednisone for these PMR symptoms.  However, the symptoms continued and I also developed jaw pain.  Blood tests indicated high level of inflammation.  Giant cell Arteritis was suspected and I had a biopsy that confirmed this diagnosis.  After the biopsy confirmed that I had Giant Cell Arteritus, Dr. prescribed prednisone 60 mg per day.  This releived the symptoms and after several weeks the blood tests indicated that my inflammation readings had returned to normal.  I am continuing to take predbisone at lower doses.  It is hoped that tapering the prednisone doses will prevent a return of the GCA symptoms.  Dr. says it is not possible to tell if the Covid vaccines caused the GCA.  However, since it began right after receiving the vaccinations, I believe that the vaccines acted as a trigger for the GCA.  Thus I am very reluctant to get a booster shot.
The PATIENT FAINTED WITHIN 10 MINUTES OF RECEIVING THE DOSE.  PATIENT WAS ALERT AND DRINKING WATER WITHIN 5 MINUTES OF THE INCIDENT.  WAS EVALUATED BY EMS
Patient was 12 years old at time of vaccination but received Pfizer dosage (10mcg/0.2mL) of vaccine for 2nd dose. Patient should have received regular Pfizer vaccine (30mcg/0.3mL) dosage.
I was vaccinated on the 17th. I begin to feel sick, started with nausea and began to throw up which lasted for three weeks. I developed a fever, body aches, and headaches that lasted for two weeks. I went to the ER at the end of the second week (April 24th). And at the third week I went back to the ER (April 30th). Symptoms continue until May when they began to subside. For weeks I was incapacitated and had to rely the help from family.
Received shingles shot 01-07-08.  Shingles broke out 01-30-08.
Chest pain, fever, flu like symptoms - began 2/3/21 at 3:00 a.m. Chest pain became more severe so went to ER on 2/4/21
I had severe flu like symptoms: headache and body aches, on and off fever. The injection site where my steroid shot was extremely sore, joints sore, nausea, acid reflux, constant urination and bowel movement, extreme dizziness and light-headedness.
Red pin began to grow 1:52 PM 03/06/2013. 03/07/2013 4:49am Injection site redness grew to 1.5 inches. 03/08/2013 6:30AM Injection site redness grew to 2 inches. 03/08/2013 06:15 P< injection site redness grew to 4 inches, itching accompanied with headache.
Her itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Her itchy rash) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Her itchy rash). At the time of the report, RASH PRURITIC (Her itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient is scheduled for her second dose on February 24, 2021. Dermatologist prescribed Anitibiotics for itchy rash. Patient was asking  whether she is allowed to take this medication on 20-FEB-2021.
Left thigh reddened with knot at injection site (1.5x 1.5 inches) pin point bruise. Wed-temp 101.2, Thurs temp 102.3, luke warm bath and Tylenol given by mom. Fri 06/21/02 at 2:25 97.6 deg Taken started vomiting-late Wed night post each feeding (about 1-1 1/2 oz) Increase liquid (3-4 q day) usual 1-2 days. 06/21/02 PHN instructed mom to f/u with her family physician. mOm stated she has an appt with doctor on 06/24/02. PHN also instructed mom that if infant's condition worsens (increase in fever, vomiting, diarrhea) to go to ER. Mom verbalized understanding. 06/27/02 pc to mom, she stated pt feeling better; leg without knot, reddened or swelling; infant without diarrhea, vomiting or fever. Mom could not remember when vomiting, diarrhea subsided. Mom stated she f/u with physician on Mon 06/24/02. Baby fine mom stated.
Red area (approximately 2 inches x 3 inches) around injection site, warmth, tender to touch. Told pt to use BENADRYL & ice.
Fever &erythema multiforme  plus swelling of eyes,hands, and feet. Better for 9 days. Diarrhea and vomiting, fever x 4-5 days, joint pain and fever.
The day after I began to feel so dizzy that I could not walk properly. My skin all over my body was red and hot to the touch. I had nausea symptoms and a migraine.
Around 7:00 p.m. on 5/17/07 right arm became swollen, tender, har to touch and warm.  Swollen area is 80 mm x 80 mm.  Also, shoulder pain and discomfort began around 9:00 p.m. on 5/17/07.  Ice pack to affected area.
Approx 2 hours after flu vaccine felt like my throat was swelling, hard to swallow felt like something stuck in my throat.  Started coughing.  The medical clinic called me about something else and suggested I take a Benadryl, which I did.  Later that evening I had a fever of 101 and chills, muscle aches, and fatigue.  Mostly slept.  Woke up with headache took 2 ibuprofen and headache went away.  Next day woke up and besides feeling real tired and achy am otherwise okay.
Raised area with hardness with discoloration to the injection site.  Itching occurred on day #2 of administration.  Injection site is tender upon palpation.
This spontaneous report as received from a physician refers to an unknown number of patients of unknown age and gender. Medical histories, concomitant medications, laboratory data and drug histories were all unknown. On an unknown date, the patients were vaccinated with GARDASIL 9 (dose, frequency, route of administration were not reported, lot # M004116 with expiration date: 12-OCT-2017, as routine vaccination). The doses of GARDASIL 9 were involved in a temperature excursion. No adverse events were reported. At the time of the report, it was unknown it these patients would continue GARDASIL 9 for the possible off label indication of routine vaccination and the outcomes of these patients being exposed to GARDASIL 9 that was involved in a temperature excursion was unknown. Additional information has been requested.
Vaccine leaked while administering; vaccine began to leak out around the hub of the needle; Patient was then given the missed 0.2ml of the Moderna vaccine in the left deltoid muscle; patient had received less than half of the recommended dose; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED BY DEVICE (Vaccine leaked while administering), DEVICE CONNECTION ISSUE (vaccine began to leak out around the hub of the needle), INCORRECT DOSE ADMINISTERED (Patient was then given the missed 0.2ml of the Moderna vaccine in the left deltoid muscle) and UNDERDOSE (patient had received less than half of the recommended dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED BY DEVICE (Vaccine leaked while administering), DEVICE CONNECTION ISSUE (vaccine began to leak out around the hub of the needle), INCORRECT DOSE ADMINISTERED (Patient was then given the missed 0.2ml of the Moderna vaccine in the left deltoid muscle) and UNDERDOSE (patient had received less than half of the recommended dose). On 25-Mar-2021, INCORRECT DOSE ADMINISTERED BY DEVICE (Vaccine leaked while administering), DEVICE CONNECTION ISSUE (vaccine began to leak out around the hub of the needle), INCORRECT DOSE ADMINISTERED (Patient was then given the missed 0.2ml of the Moderna vaccine in the left deltoid muscle) and UNDERDOSE (patient had received less than half of the recommended dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: The patient information and event details were updated.; Sender's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.
Patient presented at Altec for her first covid vaccine shot. Patient stated she has had a reaction to a previous immunization.  Patient was counseled about possible side effects and reactions and was counseled to stay in observation area for a minimum of 30 minutes. Vaccine given at 1008.  At 1019 patient appeared to be anxious and stated that she felt her heart was racing, eyes started watering and a tightness in her neck. C/O headache.   25mg PO Benadryl given.  Pulse 80 BPM.  Patient continued to appear anxious and redness noted on neck like hives.  911 called to evaluate patient.  Patient declined the need to go to the emergency room. Patient was reported by human resources at Altec that she was able to return to work and they have been keeping a close eye on her.
I wasn?t feeling right so I took my blood pressure at home.  I had triple digits both systolic and diastolic.  I went to the emergency room; they gave me fluids.  The admitted me over night to see a cardiologist the next morning.  He out me on 10mg of Lezoapen. About after a month it went back to normal.  It started out of no where and went away after a month.  It is under control.
did not leave at room temperature for 15 minutes prior to drawing up the doses; frost-like ring on the bottom of the vial, 5 patients received doses; This spontaneous case was reported by a physician and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (did not leave at room temperature for 15 minutes prior to drawing up the doses) and POOR QUALITY PRODUCT ADMINISTERED (frost-like ring on the bottom of the vial, 5 patients received doses) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (did not leave at room temperature for 15 minutes prior to drawing up the doses) and POOR QUALITY PRODUCT ADMINISTERED (frost-like ring on the bottom of the vial, 5 patients received doses). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (did not leave at room temperature for 15 minutes prior to drawing up the doses) and POOR QUALITY PRODUCT ADMINISTERED (frost-like ring on the bottom of the vial, 5 patients received doses) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-095367, US-MODERNATX, INC.-MOD-2021-095302, US-MODERNATX, INC.-MOD-2021-095633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095367: US-MODERNATX, INC.-MOD-2021-095302: US-MODERNATX, INC.-MOD-2021-095633:
Elevated heart rate. 10 bpm resting, 25 bpm with easy exercise, walking and slight shortness of breath. Measured using watch. This was the Moderna booster. I believe I also experienced elevated heart rates after dose 1 and 2. I have not been able to return to the same level of fitness as before the second dose. After the second dose I was referred for an echocardiogram because a heart murmur was detected. This had not been detected during any previous doctor exams even during more extensive heart tests during my 50 year old physical.
It was reported that a pt (2 of 2) received a Menomune A/C/Y/W-135, a TD Adult, a Flu (unspecified) vaccination and a PPD Tubersol skin test during the time of 6/8/00 and 6/10/00 (exact date not specified). Reportedly, sometime post vax, the pt developed reactive arthritis. Further information requested. On 9/6/00, additional correspondence was received from the responsible physician, no additional information was provided.
Information has been received from a pharmacist, on behalf of a consumer, concerning the consumer's wife, a female patient of an unknown age.  The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU (strength, dosage schedule, anatomical location, route of administration, lot number and expiration date were not provided) reconstituted with a sterile water diluent (DILUENT MRK) for prophylaxis, the patient thought that the dose was exposed to an unknown warmer temperatures prior to it being administered to her for 1 hour and 30 minutes (no digital data logger) and the reporter did not known if there was any previous temperature excursion. It was reported that this occurred because the patient transported the ZOSTAVAX from an unknown pharmacy, where it was dispensed, to an unspecified physician's office. It was unknown how the sterile water diluent (DILUENT MRK) was stored. On an unspecified date (reported as "later"), the patient developed shingles. At the time of the report, the outcome of the patient regarding the shingles and the causal relationship between the shingles and the vaccination with ZOSTAVAX reconstituted with a sterile water diluent (DILUENT MRK)) were not reported. Additional information is not expected since the reporter did not consent for further follow up.