chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Vaccine administered after beyond use date 07-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 17-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) 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 EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022).    No concomitant medication was reported. Reportedly, the vaccine BUD date was 07-Jul-2022. No treatment information was provided.
Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC
Became nauseous at 9 pm, followed by 2 hours of fever and chills and intermittent vomiting and diarrhea. I was able to go to bed at that point and was feeling fine upon awakening in the morning.
extremities are burning/facial burning that comes and goes; ringing in the ears (constant); Phantom smells (cigarette smoke); This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunization. The following information was reported BURNING SENSATION (non-serious) with onset 2021, outcome unknown; TINNITUS (non-serious) with onset 2021, outcome unknown; PAROSMIA (non-serious) with onset 2021, outcome unknown. The events extremities are burning/facial burning that comes and goes, ringing in the ears (constant), and phantom smells (cigarette smoke) were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Patient had seen and been evaluated by ENT (Ear, Nose, And Throat doctor), Neurology, and had an MRI (Magnetic Resonance Imaging), which showed nothing, and no one had come up with anything. Patient was very upset. Pharmacist stated that he/she was a healthcare provider and would like to discuss how to treat an adverse event that occurred in the patient.  Follow-up attempts have been completed, information about lot/batch number cannot be obtained. No further information is expected.
Illness; high glucose levels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Illness"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "high glucose levels". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information:  It was reported that the patient had his first dose of vaccine on 08Mar2021, and missed his second dose, and would like to reschedule. Patient did not make his second appointment, and stated he was not feeling well as he is diabetic.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a lot of pain under her arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a lot of pain under her arm.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (a lot of pain under her arm.). At the time of the report, PAIN IN EXTREMITY (a lot of pain under her arm.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a medical assistant and refers to a patients of unknown age and gender. There was no information about the patient's current condition, concomitant therapies or medical history provided. On 11-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M009768 with an expiration date: 23-FEB-2018 (dose, frequency and route of administration were not reported). Administered dose of VARIVAX experienced temperature excursion of 13 degree Fahrenheit for 90 minutes, on an unknown date. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a patient's daughter and refers to a 62 year old female patient. The patient's concurrent conditions included drug reactions or allergies to penicillin. On 25-OCT-2016, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included NEURONTIN, CYMBALTA and ZEGERID. On 25-OCT-2016 within 4 to 5 hours after receiving the vaccination, the patient experienced headaches. On 26-OCT-2016 (the following day), the patient felt fatigued and had difficulty reading. The patient contacted the pharmacy where she received the ZOSTAVAX vaccine, but was not treated for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
A well defined erythematous area appeared after injection. Area is located below the injection site, about halfway down arm. Area is not painful and only slightly itchy. As of 5 days after injection, area is still prominently erythematous. Told to consult doctor
About 20-25 minutes after vaccine administration, the patient felt the left side of her face/jaw area was getting warm and felt like a rash was developing. I immediately went to observe the patient who was alert and oriented x4. I proceeded with checking vital signs: pulse 73, SpO2 98%, BP 144/102, breathing was normal and unlabored with clear lung sounds. The patient's left face/jaw area looked slightly red where the edges of the mask would normally lay on her face; no rash had developed during this time. Patient was given Benadryl (1 tablet, 25 mg) and was observed for an additional 30 minutes. The patient's left face/jaw area did NOT worsen and a rash had NOT developed during the observation period. Patient was checked before leaving - she was doing well and felt fine to go home. She left at 12:25 with her husband who was also driving her home. I advised the patient to recheck her BP at home, notify her PCP of the incident, and to call 911 or go to the nearest ER if symptoms worsen; patient verbalized understanding.
Breakthrough COVID Case: On May 7th, 2022 at approximately 09:00PM, I developed a cough. By May 8th, I experienced cold-like symptoms. I performed a rapid test which came out positive. The cold symptoms got worse and I felt like I had a bad cold for approximately 4 days. I, then, began feeling better. By the 7th day, felt almost normal.
Angioedema swollen lymph nodes, itching Narrative:  swollen lymph nodes day 2-6. itching day 6. no intervention needed
Patient received 2 vaccines on Friday, January 28, 2011: the meningococcal MCV4 and Varicella in the upper right arm. Within a few hours his arm was sore and there was pain to move it. He began to have a runny nose and wheezing. At his physical that same day his lungs were clear and no runny nose, although he had been sick beginning January 8th with bronchitis, pharyngitis, and upper respiratory infection. These symptoms continued the next day (Saturday), with the arm looking worse and it was very hot. We continued the nebulizer for wheezing and Ibuprofen for pain and swelling and also a cold compress. We did call the doctor and they said some redness and swelling was normal and should be gone in about 48 hours. By evening he also had a bad cough. On Sunday, January 30th, all symptoms continued and the redness was a large patch about 8 in. x 8 in. he was also having pain in his shoulder and across the top of his back. Another call to the doctor led us to the ER around 4pm. The ER doctor said that it was infected and the diagnosis was the skin infection, cellulitis. He thought that the wheezing, runny nose, and cough were a cold and just a coincidence. He prescribed antibiotics for the infection and steroids for the wheezing. That evening he was having more pain and the wheezing got worse, we almost went back to the ER, but we were able to keep things under control by using the nebulizer and Ibuprofen. We saw the doctor again at 3pm on Monday January 31st and he had improved, the arm was still red and hot, but slightly better and wheezing had subsided, although patient still felt a pain in his chest and it felt hard for him to breathe, but the doctor said there was no wheezing. The doctor thought it was a reaction and not infection, but said to continue both meds to be sure. From the location of the redness the doctor thinks the meningitis shot may have been the problem. The center of the redness does not seem to be in the place the nurse says she gave either shot, but it was within the meningitis vaccine area. He also thought that the respiratory symptoms were not related to the incident. He didn't feel well the rest of the week, but continued to improve. The arm would still be warm in the same spot at times and there are some pinhole scabs in the area. On Saturday February 5th he began to complain that the top of his back hurt and it was worse when I touched it. What he described sounded a lot like shingles, but I didn't see any rash. At this point he is done with the antibiotics and steroids and is using albuterol once or twice daily as needed. As of now the arm still is a little warmer in the spot and the little scabs are still there but it is not red and he is feeling much better.
pt recvd vax; complex feb sz 5 hrs after vax; pt adm to hosp; sz lasted for 45 mins; required IV vallium;
J and J vacinne. 2nd shot = the booster. 2 weeks after, I developed a horrid reaction to Monistat. Never had issues with allergies. My vagina swelled up to size of an orange,painful swollen, red. Rash inner things up abdomen.  Then 5 days later , a ucteria rash, . With welts, all over my back,neck, arms,legs.  ITCHY,painful, hot. THIS IS THE SAME REACTION I HAD WITH VANCOMYCIN. red man syndrome.  I bought benedryl  with minor helping of itching. Zertec dud not work. I went to my Dr. 5 days after rash kept spreading.  She put me on prednisone today.  I'll see if this works. I did not want to go to ER, because of all the covid cases in the hospitals. The rash is horrible, spots allover my body. I am itchy and miserable.  My skin was beautiful before this disease invaded my tissue. Due to vivid vacinne.
Per the provider the patient was given HPV and Tdap per a verbal order and registry results . These immunizations were not needed after further investigation. The patient had two records. There has been no known reaction.
Patient had nausea and vomiting about 5 minutes after receiving her second dose of Moderna COVID 19 vaccine.  It lasted about 20 minutes, then she felt fine and left the pharmacy.
Progressive short term memory loss beginning 4 days after IM flu shot into the deltoid. Ultra short term memory has been affected the most. Associated symptoms include nausea, dizziness, and continuous tiredness that is not relieved by sleep. Symptoms have fluctuated but, slowly worsened over the last 2 months.
pt fussy 2 hrs post vax; 6 hrs later crying would not stop fever 99 was on APAP immed; cried all noc; bowing back to MD who advised react to pertussis;
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 14-Mar-2008. It was reported that multiple patients received FLUMIST quadrivalent and tested positive for flu A. The outcome of the event of multiple patients received FLUMIST quadrivalent and tested positive for flu A was unknown. The report was considered to be non-serious.
Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortness of breath. Sore left arm all the way down arm. Rested and took ibuprofen.  Today I returned to work still having headache
Parent reported increased swelling in the (L) arm, both upper & lower 2 days after a DTaP & Hep B (DAPTACEL & ENGERIX B). It improved after 2 days but treated with cortisone, KEFLEX & BENADRYL.
Had First Dose of Moderna on March 4, 2021.  Awoke this a.m. March 12, 2021 with swollen, red, partially numb and itching left arm where injection was given.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that her pharmacist informed her that the patient who received SHINGRIX (unsure of which dose) came in to the pharmacy to report that he had red marks around his waist that he believed to be shingles. The caller stated that the pharmacist told her that although the patient believed it to be Shingles, the pharmacist did not think that the red marks were shingles. The caller did not had any additional information regarding this event. The reporter also reported an adverse event on behalf of herself, refer linked case US2018174665.
Several hours after receiving the vaccination, I experienced violent shaking/trembling as well as swelling of my limbs and tingling in lower extremities. Other symptoms included fever, sweats and nausea. Symptoms have not resolved completely at time of submission.
Feels like I have a really bad case of the Flu - fever, chills, aches, tired, dizzy, bad headache  - arm only hurts a little so that is not an issue.  Day after vaccine was the worse and I had to leave work - on day two now and much better but still really tired and have a slight headache.
Patient reports that as soon as he received he experienced tingling through out the his body - to the tip of his toes; experienced light headedness and slight nausea.  Shortly after experienced tightness of throat, though denies having difficulty breathing. Patient described as, "having a knot in my throat." Denies experiencing hives, nor itching, no nasal drainage, no cough.  States he waited 50 minutes post receipt of vaccine to ensure he could drive.  Reports on 03/17/2021 he again experienced tightness of throat;  denies difficulty breathing; states it felt like, "my throat was swollen." Again patient denies having difficulty breathing, no hives, itching, no cough.   Advised should he experience difficulty breathing to please call 911 since that could be a life threatening emergency; or nearest ER.  Denies tightness of throat today, no shortness of breath, nor difficulty breathing.
After receiving the vaccine, within 20 minutes, I immediately got sick to my stomach. My stomach was feeling woozy. Within 30 minutes I was throwing up. I had an unbearable headache, and I had diarrhea. I was sick like that for about 3 or 4 days.  I've always had headaches but since getting the vaccine the headaches have worsened. After that I had started fainting, and at that point I started seeing a cardiologist who is running all kinds of test on me. I will be getting those results on Monday 10/11/2021.
Hospitalized (10.24.21 - still admitted);  COVID-19 positive (10.21.21);  fully vaccinated  HISTORY OF PRESENT ILLNESS: Patient is a 86 y.o. female with past medical history significant for atrial fibrillation, hypertension, and CKD stage 3 who presented initially to the hospital.  The patient tested positive for COVID-19 on 10/20/2021.  Her symptoms started on 10/14/2021 with cough.  The patient denies any shortness of breath or chest pain.  She denies any nausea, vomiting or abdominal pain.  The patient typically gets checked on regularly by her neighbors her neighbor went to check on her today and the patient was "more less collapsed in her arms". EMS was notified. When EMS arrived, the patient was hypoxemic with oxygen saturation of 79% on RA and HR was greater than 170.  In the ED, her HR was was in the 170s. Systolic BP was in the 80s to 90s. She was afebrile. Labs were significant for Na-133, K-3.2, BUN-53, and Cr-1.85. Pro-BNP was 7,051 and lactic acid was 3.0. WBC-12.06. CXR showed prominent lung markings bilaterally may represent inflammatory changes secondary to COVID-19. No gross lobar infiltrates. Cardiomegaly with right heart prominence. EKG showed A. Fib with RVR. HR was 156. The patient was started on amiodarone gtt. She was given decadron. She was transferred to another Hospital for further evaluation and management.  The patient is a poor historian and history was obtained from the emergency department physician and medical records. Acute hypoxic respiratory failure-likely secondary to COVID-19 pneumonia CXR shows prominent lung markings bilaterally may represent inflammatory changes secondary to COVID-19. No gross lobar infiltrates. Cardiomegaly with right heart prominence Will cont supplemental oxygen to maintain SaO2 greater than 90 The patient is on 6L of oxygen  The patient has received Janssen vaccine on 6/8/21 Onset of symptoms: 10/14/21 COVID-19 PCR positive on 10/20 Will continue Decadron Daily COVID labs Will order Mucinex and benzonatate  Albuterol inhaler Will monitor respiratory status closely Severe Sepsis-likely secondary to COVID-19 pneumonia Will follow-up blood ctx Monitor VS and CBC Lactic acid was 3.0 Will repeat lactic acid now. Progress note from 10/28/21:  Acute hypoxic respiratory failure-likely secondary to COVID-19 pneumonia CXR shows prominent lung markings bilaterally may represent inflammatory changes secondary to COVID-19. No gross lobar infiltrates. Cardiomegaly with right heart prominence Will cont supplemental oxygen to maintain SaO2 greater than 90 Weaned to 2L  The patient has received Janssen vaccine on 6/8/21 Onset of symptoms: 10/15/21 (had called PCP's office so note confirms that) - ok to remove isolation 10/27 COVID-19 PCR positive on 10/20 Will continue Decadron Daily COVID labs Will order Mucinex and benzonatate  Albuterol inhaler Will monitor respiratory status closely
Patient stated after receiving the vaccine she felt a pain that radiated down her spine and pain could not be relieved by VICODIN. Patient was going to follow up with PCP.
Right arm swollen twice size, extremely inflamed and painful. Muscles in body sore. Had chills and fever for 16 hours. Muscles in upper back continue to hurt today one week later. Flu like symptom's.
Dizziness, Diarrhea, HYPERtension & Tachycardia Narrative:  Employee felt flushed, tachy and dizzy. Initial vitals BP 180/116, P 125, Pulse Ox 100%. Given ice pack and monitored symptoms & vitals. No medications/treatment provided. Employee notes h/o stress induced HTN, no medications. Smoker, last >2 hours prior. BP and Pulse remained elevated and employee was transferred to the ED for further monitoring.
2:20PM 5-7 MINUTES AFTER VACCINE ADMINISTRATION, PATIENT PALE, COOL AND C/D. FEELING DIZZY.  PLACED ON EXAM TABLE B/P 100/60; P 72. R 16; ANSWERED APPROPRIATELY; VITALS 108/60.  2l45 SAT UP.  C/O HEADACHE AND FEELING COLD.  EMS ACTIVATED 3 PM EMS EVALUATED.  NO NEED TO TRANSPORT.  PT STATES HE FEELS OK.
Pads of toes and fingers had mosquito-like faint marks that were extremely painful to the touch. Hurt to type, grab or hold things. Went away after about a week and then returned less severe in fingers only.
menactra was given early, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (with unknown demographics) who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was reported that the other product mentioned was Menactra by Sanofi and was administered to someone else; it was clarified by the transferring agent it was administered to the wrong patient. The caller explained it was not given to the wrong patient but it was actually given early.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
It was reported that a 14 year old female patient received a Rabies Imovax vaccination on 7/31/00. Reportedly the next day the patient complained of being tired and numb. These symptoms disappeared within 24 hours. From additional correspondence received on 9/22/00, it was reported that the patient received 5 doses of Rabies Imovax 9dates not specified). Reportedly the patient experienced a repeated pattern with each vaccination. No further information is anticipated for this report. Case is closed.
Patient had a fever and was lethargic after receiving 3 vaccines. We administered Tylenol per her doctor. She seemed to recover, but then began having extreme emotional problems. Within a few months she was having as many as 20 tantrums per day. We had her evaluated by a developmental pediatrician who said she was extremely sensory sensitive and high strung. We did not immediately associate this development with the vaccinations, but later realized that they were implicated. She has since been diagnosed with sensory processing disorder and is undergoing occupational therapy. Her sensory issues make her life very difficult but she is slowly improving.