chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves female patient (more than 65 years) who experienced loss of taste and tongue tingling, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. The patient had previously received FLUZONE QUADRIVALENT without problems. On an unknown date in Sep 2017, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported via intramuscular route in unknown administration site. On an unknown date, the patient developed a non-serious loss of taste with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious tongue tingling with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was tongue tingling and loss of taste. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for tongue tingling and as Recovered / Resolved on an unknown date for loss of taste. Events lasted for six months. List of documents held by sender- none.
Itchy skin reaction; This case was reported by a consumer via interactive digital media and described the occurrence of itchy skin in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was unknown.   It was unknown if the reporter considered the itchy skin to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was unknown. Several weeks after receiving Shingrix, the patient experienced itchy skin reaction.
Localized erythema day 2 to morning of day 5 not exceeding shoulder of elbow. At 10:30am on day 6 after receiving shot developed intense pruritus and urticaria covering arm from shoulder to elbow Rx with allergra and Zantac. No improvement in skin symptoms. Also received smallpox same day.
female with a past medical history significant for CAD, ischemic cardiomyopathy, DM, CKD, hyperlipidemia, hypertension, prosthetic joint infection on chronic antibiotics, and dyslipidemia who presents to Facility due to weakness and fatigue. Patient states that she developed a cough on Sunday and family noted over the next two days, she was much weaker, needing more assistance with transfers. No falls. She never complained of shortness of breath, fever, chills, or sweats. She was brought to the Facility ER via EMS. On arrival she was noted to mildly hypoxic, requiring one liter of oxygen. Covid PCR obtained returning positive. Of note, she received the covid vaccine X2.   Patient admitted to Facility as inpatient on 12/22/21 due to acute hypoxic respiratory failure due covid pneumonia. Patient was tested for COVID-19 and was positive on 12/22/21.
After getting vaccinated, exactly 23 days later I developed an allergy to alcohol or that?s what the dermatologist thinks. I have never been allergic to something and I have developed allergies after the vaccination that show up as vasculitis, it only appears on my feet with more on the foot plant. I thought it was rum allergy but it started to show up on other alcohols and also in some certain foods like salmon or shrimps and it shows up the same way with vasculitis
feeling a little bit dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling a little bit dizzy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (feeling a little bit dizzy). At the time of the report, DIZZINESS (feeling a little bit dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.
This spontaneous report was received from a pharmacist referring to 66 year old male patient. The patients medical history included bypass surgery performed in 2010. Patient had a history of developing cold sores. On 24-OCT-2007 the patient was vaccinated with ZOSTAVAX vial (lot # 1080U, expiry date 12-JAN-2009) 0.65ml, subcutaneous. Concomitant therapies included LYRICA, TRIBENZOR, LOVAZA and meloxicam. After receiving ZOSTAVAX, the patient did not developed cold sores for almost 7 years. On an unknown date in 2014 the pharmacist reports thta hte cold sores are starting to develop in the patient again. No lab diagnostic test performed. The patietn received treatment with acyclovir for cold sores (treatment received also reported as "no"). The patient did not sought medical attention. No intervention required to present the seriousness criteria. There was no signifcant disability, no hospitalization, and the event was not life-threatening. The outcome of cold sores was unknown. The causality of the event was unspecified. No PQC reported. No further information was provided. Addiitional information has been requested.
Woke up several times during first night after injection. Woke up next day extremely tired, aches and soreness in knees and lower back, injection site extremely sore and painful to the touch (but not swollen or red), developed headache late in day behind forehead. During second night after injection, woke up twice with cold sweat - soaked bedclothes, sheets and pillow cases. Woke up on second day feeling somewhat better - no fatigue, with less soreness in back
Child stated that at 10 a.m. she noticed numbness, redness and itching below eye on L side of face.  Reported to nurse at 10:45 a.m. Nurse observed that face appeared red on both cheeks and on forehead; swelling not obvious; no complaints of tingling of lips or shortness of breath.  BP 116/76, P72, R26.  Benadryl 50 mg IM administered at 10:55 a.m. BP 102/64, P64, R22 at 11:10 a.m. and child reported itching relieved and numbness remained. No shortness of breath. Child monitored and returned to class at 11:27 a.m. Follow up with mother and she states patient is doing fine; back in school with no problems.
Shortly after receiving vaccine, felt warm/nausea. moderate soreness (L) arm. Also, numbness peri-orbital area and (L) cheek. Today 1-6-21, she has persistent intermittent nausea, warmth throughout Body (afebrile) + continues with numbness (L) side face maxillary (all) and part mandiBular Branch. No redness/swelling (L) arm, mod. discomfort
pt adm to hosp for sz w/in 28hr p/vax;no fever, URI, diarrhea prior to sz; pt rolled eyes up, jerked arms, legs 4-6 times became unresponsive, unresponsive when amb arrived, recovered in ER;dx sz disorder secondary to vax;t100;
Almost immediately after patient received the second dose of vaccine he stood up and passed out to the floor. He slightly seized for a few seconds until it stopped. When patient came to he stated that his knee hurt but he didnt believe he hit his head and he felt a bit light headed. Patient laid down for a while with us until he started to feel better. His BP was 102/58, but normally  runs low. He said that he has passed out before and has been under a lot of stress, also had not eaten that morning before getting vaccinated. His significant other was with him and was planning to drive home. Patient was offered a call to EMS but refused.
Mother came in to the clinic with her 3 children (ages 10, 12 and 16). This nurse administered FLUMIST to all the children per mother's request. However, it was later discovered that the FLUMIST had expired 7 days prior on 12/30/2015.
I20.8 STABLE ANGINA 12/15/2022 ATRIAL FIBRILLATION, UNSPECIFIED I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 12/24/2022 ATRIAL FIBRILLATION, UNSPECIFIED R57.9 SHOCK, UNSPECIFIED 12/24/2022 ATRIAL FIBRILLATION, UNSPECIFIED I20.8 STABLE ANGINA 12/15/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 12/24/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA R57.9 SHOCK, UNSPECIFIED 12/24/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA I20.8 STABLE ANGINA 12/15/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 12/24/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA R57.9 SHOCK, UNSPECIFIED 12/24/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Temperature next day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature next day after receiving 2nd dose) 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 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PYREXIA (Temperature next day after receiving 2nd dose). At the time of the report, PYREXIA (Temperature next day after receiving 2nd dose) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
NKDA PMH: Positive TB test, Depression, Abnormal Pap Smear in 2001, Severe Cervical Dysplasia 2003 Unknown current medication list  Approximately ten minutes after administration of COVID vaccine dose 1 Moderna, pt was noted to be coughing and appeared to be in distress.  Pt brught back to observation room. Obvious language barrier so a translator was utilized during all interactions with patient and family.    Patient appeared to be diaphoretic and reported she felt warm. Mild chest discomfort was also reported (medial chest with no radiation). Patient reported "throat itching" with mild swelling midline along trachea. LSCTA. HRR. VSS, but elevated BP. Patient did not appear to be in immediate respiratory distress with oxygen saturations constant above 95%, but her cough persisted.    Patient reported no relevant medical history, with her most recent physical exam at medical center in November of 2020. Pt reports maternal history of HTN.   1624 Pt given 25mg Benadryl  PO.   Shortly after administration of PO Benadryl, pt reported improvement in symptoms. Pt continued to cough.    1640 Pt given second administration of PO Benadryl 25 mg.   Approximately 20 minutes after administration of second Benadryl, pt reported less symptoms. Patient appears stable at this time.    Patient's BP remained elevated during duration of visit. The following Bps were recording during this time   1615 172/101 HR 86 RR 18 O2 98-100% 1621 168/113 1629 158/100 1632 138/98 1646 164/100 1654 160/108  Due to the constant elevation of BP it was recommended at this time that pt F/U with urgent care. Appointment scheduled for 7/10/21 @ 1414 EVC UCC    VS at time of discharge @17:30 as follows: 154/95 99% on RA, HR 73, RR 16.    Patient educated on future vaccination administration. Patient to receive J&J for second vaccine in approximately 28 days. Patient verbalized understanding and voiced no further concerns or questions at this time. Patient stable at time of discharge and agreeable to plan of care. Patient given written discharge instructions which were language appropriate with appointment time for UCC, pt spouse informed of all interactions during visit. He voiced no further questions or concerns at this time and verbalized understanding of plan of care.
cold shivers, metallic taste in mouth, excessive saliva, sweating, rapid heart rate, weak legs, thickened tongue, throat closing, shallow breathing, nausea within 3 minutes of shot.  ER visit with epinephrine, Benadryl, iv fluids, solumedrol, pepcid injections- 6 hour observation released  with prescriptions of above, and instructions to return to ER if symptoms worsen
Dermatomyositis wih serious myopathy. Corticotherapy, IgG, MMF
State had headache when arriving at the health department felt "goofy headed, like I was going to fall out". States this happened again while shoppping about 6:30 PM and lasted around 20 minutes.  Client reported her symptoms to the health department today at 10:30 AM.
This spontaneous report as received from an office manager, was received to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (lot # L037924 and expiration date 22-JUN-2017) (lot # L039638 and expiration date 23-AUG-2017) orally, dose was not reported. The reporter stated that she was not aware of any adverse effects and no product quality complaint was involved. Temperature: 19.9 Fahrenheit degrees. 4 cycles below 24F. Time Frame: unspecified at the time of his reporting. Temperature excursion (cumulative time): 255 hours. Was a data logger involved. Yes. This is one of several reports received from the same reporter. Additional information has been requested.
no additional adverse events; nurse administered an expired ROTATEQ to a 6-month-old patient; This spontaneous report as received from a licensed vocational nurse refers to a 6 month old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On 27-OCT-2020, the patient was inadvertently administered an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # S001101 has been verified to be a valid lot number, expiration date: 21-OCT-2020, dose not reported). No additional adverse events were reported.
Unusually high level of fatigue / exhaustion. Feeling ?fluish? Headache Feeling feverish but no actual fever. Has lasted So far from 12/24 to 12/29. Six days. A bit better day 6.
Summary: Syncopal espisodes x 2   16 yo patient received his Covid-19 vaccine and as he was going to sit down in observation, he leaned on his mom and passed out. His mother gently lowered him to the ground (@ 1804). Patient's mother stated he just passed out and that this was his first injection ever in his life. Patient was immediately assessed by multiple nurses. Patient did not fall or hit his head or injure any part of his body. Patient took less than 60 seconds to respond to verbal commands and comprehend what had happened. Patient's legs were immediately raised and vital signs were obtained. He was diaphoretic and pale but both were dissapating.  Patient denied difficulty breathing, pain, discomfort. Patient was moved to a reclined chair. Patient and family at side (mother and father) agreed to be monitored. At 1828, Patient complained of feeling "a star" on the left side of his chest. Patient was unable to describe this further. I asked if he was feeling anxious and he said yes. I instructed patient to take several deep breaths in through his nose and out through his mouth. After doing this 3 times, patient stated he did not feel anything funny in his chest anymore. At 1835, while still seated in a reclined chair, patient passed out again. He was pale and diaphoretic. A few team members saw him jerk/twitch and it was questionable if he was having a seizure. The jerking did not last but a few seconds. 911 was called @ 1826. Patient was transferred to a wheelchair and put in the ambulance @ 1841. Vitals were obtained throughout and charted. Pulse ox saturation levels were not below 96%. Immediately after the patient passed out the second time, his pulse was measured at 38 bpm and his lips displayed slight cyanosis. His pulse quickly rose to 52 bpm, within less than 10 seconds. One minute later his pulse was up to 68 bpm.
Pain at injection site, hot, red, swollen, Pain under arm in arm pit with huge swollen lymph node side of baseball, Fever 100.7, Body aches, chills, tired, flushed, headache, brain fog. Next day low grade fever 94.8.  Plus all the above. Today is the 3rd of November and I still have the pain at injection side, hot, red, swollen. Lymph node down by half, temperature 96.4.
Administration of expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist reported that two patients received the expired vaccine. The vial was opened on 14 MAY 2021 at 3:30 PM MST and administered on 19 MAY 2021 which exceeds the viable time for the vaccine. No adverse events were reported.
Information has been received from a medical assistant, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of ZOSTAVAX 19400 PFU, lot # M036297 and expiration date on 14-NOV-2017 (dose, anatomical location and administration route were not provided) for prophylaxis. No adverse effects were reported. The vaccine had an unspecified temperature excursion (reported as more than 14  Fahrenheit (F) and less than 46 F) with a time frame of 7 weeks. It was reported no previous temperature excursions and a digital data logger involved. No product quality complaint (PQC) was involved Additional information has been requested.
This spontaneous report has been received from a nurse practitioner referring to a patient (age and gender were unknown). The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with 2 doses of GARDASIL (batch/lot#, expiration date and route were unknown) for prophylaxis. The patient would now like to received a third dose of GARDASIL 9 (batch/lot#, expiration date and route were unknown) for prophylaxis (interchange of vaccine products). No adverse symptoms reported. The outcome of the events was unknown. No PQC presented.
Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept for the majority of the last 3 days. I wake up foggy and disoriented. Takes a while to focus and become alert.  I use the restroom and maybe I'm able to be active for 15- 20 minutes then I'm back asleep, or too tired to keep my eyes open.  Today is the first day I have been able to stay awake more than an hour.  I had energy for about an hour and then felt like I was unplugged I'm just too tired to function. All I can do is go back to bed.
Suspected SIRVA.  (Shoulder Injury Related to Vaccine Administration)  Right arm hurts to raise above my head or in front of my body.  Hurts only for certain movements--not all of the time.  Am currently seeking physical therapy treatments related to shoulder tendonitis, for which I've had no previous injury or condition.
lightheadedness; Increase in blood pressure; Intermittent stomach pain; Two injections of Shingrix on the same day; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th March 2020, the patient received Shingrix and Shingrix. On 7th March 2020, less than a day after receiving Shingrix and Shingrix, the patient experienced light headedness, increased blood pressure, stomach pain and overdose. On an unknown date, the outcome of the light headedness, increased blood pressure and stomach pain were not recovered/not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the light headedness, increased blood pressure and stomach pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient's brother reported this case. The patient received two doses of Shingrix on the same day, which led to overdose. No other specific details were known. The patient experienced lightheadedness, increase in blood pressure, and intermittent stomach pain. The symptoms have not yet resolved or improved. The reporter did not consent to follow-up.
13:20 Injection H1N1 R deltoid, felt shaky. 13:35 c/o hot and itching. 13:55 sore arm, hot arm, cotton mouth, nausea, and vomiting. 14:00 B/P 134/62, R 20, P 74. 14:10 B/P 116/60, R 16, P 60. 14:00 BENADRYL 50 mg IM L deltoid 107030 lot exp 10/2009. 14:25 112/70, R 16, P 60.
First and second shot was very sick/felt like my head was going to explode for a few days after second shot along with extreme shacking and cold feeling that started app 12 hours after shot#2 and lasted a week. Tired all the time and extreme brain fog that is still here and has not stopped some days are better than others but some days are really bad. will start to feel better than without any cause I feel really bad. I try to work through it but many times it is debilitating and extreme frustration. Then in October admitted my self into emergency my heart felt like it was going to explode and was all over the place which the ekg recorded was given a shot of Protonin (if I remember properly) . they were going to give me a second shot and my heart went back to normal. I have not seen a cardiologist  as of  yet.
Immunization was given after BUD of 12-8-22. Moderna manufacturer was notified and it was assigned a case #. The Lot of AS7166B was tested and found per Moderna the vaccine DID have the necessary activity to protect against the SARS-CoV-2 virus at the time of administration. Patient and patient's PCP notified.
having shortness of breath; Doing a great deal of coughing; Really panicking; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having shortness of breath), COUGH (Doing a great deal of coughing) and PANIC REACTION (Really panicking) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DYSPNOEA (having shortness of breath), COUGH (Doing a great deal of coughing) and PANIC REACTION (Really panicking). At the time of the report, DYSPNOEA (having shortness of breath), COUGH (Doing a great deal of coughing) and PANIC REACTION (Really panicking) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-Jun-2021 contains significant information. Changed outcome of the event from unknown to recovered/resolved.