chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 23-FEB-2017, the patient was vaccinated with an improperly store dose of VARIVAX, subcutaneously, lot number M038225 with expiration date 07-SEP-2018 (dose and anatomical location were not reported). The vaccine was exposed to temperatures between 6 F (Fahrenheit) (-14 C (Celsius)) to 14F (-10C) during 6 hours. There was no previous temperature excursion. Data logger was filled. No adverse effects were noted for the patient. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012499: US-009507513-1703USA003697:
Patient order was for Proquad  and Kinrix.  Patient received wrong vaccine of Pediarix.
Fever of 102 to 103, nausea, headache and fatigue for 24 hours
The next morning I was very weak.  I  had little or no appetite.  I was urinating approximately 15 times a day. I had cotton mouth and  slept 20 hours two days during the weak.
COVID-19; Missed his second dose/ told by his HCP he did not need to take the second dose because he has antibodies; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) and OFF LABEL USE (Missed his second dose/ told by his HCP he did not need to take the second dose because he has antibodies) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and OFF LABEL USE (Missed his second dose/ told by his HCP he did not need to take the second dose because he has antibodies). At the time of the report, COVID-19 (COVID-19) outcome was unknown and OFF LABEL USE (Missed his second dose/ told by his HCP he did not need to take the second dose because he has antibodies) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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.   No concomitant medications were provided. Treatment medications were unknown.
2/17 ; STARTED WITH CONGESTION/RUNNY NOSE AROUND 4:00 ;  BY AROUND 5-6PM STARTED WITH CHILLS;  HAD TWO BOUTS OF DIARRHEA THAT NIGHT;  ARM OF INJECTION SITE HURT;  WOKE UP AT 4:30 AM WITH HEADACHE ; STILL HAD CHILLS.   EVERY JOINT IN BODY HURT;  WOKE UP AROUND 10AM WITH CHILLS AND STILL HEADACHE;  WALKING FELT LIKE MY LEGS WEIGHED 100 LBS A PIECE.  I WAS VERY TIRED THE WHOLE DAY.   STARTED GETTING ENERGY AROUND 7 PM  ON 2/18. JOINTS STILL ACHY BUT NOT AS BAD.
Pt had onset of swelling  and tenderness to underarms bilaterally. I examined him in my clinic, determined to moderate bilateral axillary lymphadenopathy. Lymph nodes were soft and tender.   Pt had no fever or other symptoms. Treated with Tylenol as needed and supportive care. Symptoms improving, I believe prognosis to be good.  Likely immune reaction, no allergic reaction in my professional opinion. Vaccine given at  vaccine clinic, not at our facility.
Vaccination site warth; Vccination site induration; Vaccination site erythema; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warth), VACCINATION SITE INDURATION (Vccination site induration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warth), VACCINATION SITE INDURATION (Vccination site induration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warth), VACCINATION SITE INDURATION (Vccination site induration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) 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.   No concomitant medications were reported.  Treatment information was unknown.  She stated all of these occurred about 1 week after the injection.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Follow up received on 25-Mar-2021: Outcome of event was updated.
Patient returned home after vaccine and that evening she developed severe shivering and body pain. She stated that the shivering was severe enough to cause significant jaw pain and the body pain was bad enough to make the patient cry. She stated that her stomach was also affected and she experienced dry heaving and bloating. She said the symptoms lasted through the night interfering with her sleep and well into the next day. She said this afternoon the shivering was a little better but her body was "wiped out" and she asked if there was something over the counter to help with all of the stomach discomfort.
This case was reported by a physician via call center representative and described the occurrence of sniffles in a patient who received RABAVERT NVS. On an unknown date, the patient received the 2nd dose of RABAVERT. On an unknown date, 2 days after receiving RABAVERT, the patient experienced sniffles and nasal congestion. On 1st August 2016, the outcome of the sniffles and nasal congestion were recovered/resolved. The reporter considered the sniffles and nasal congestion to be unrelated to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The physician mentioned when calling in for other information on vaccine. He said, he felt the events were not from the vaccine. No patient or product information was provided.
rash in her mouth and throat; This spontaneous case was reported by a physician and describes the occurrence of ORAL MUCOSAL ERUPTION (rash in her mouth and throat) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL MUCOSAL ERUPTION (rash in her mouth and throat). At the time of the report, ORAL MUCOSAL ERUPTION (rash in her mouth and throat) outcome was unknown.        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.   No relevant concomitant medications were reported.  No treatment information was not provided.   Reporter did not allow further contact
No Adverse event; Immunocompromised patient received booster dose of 0.25 mL from Monovalent vaccine instead of Bivalent dose on 15Dec.2022; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Immunocompromised patient received booster dose of 0.25 mL from Monovalent vaccine instead of Bivalent dose on 15Dec.2022) and NO ADVERSE EVENT (No Adverse event) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015B22A, 037A22B, 047C21A, 002A21A and 012M20A) for COVID-19 prophylaxis.     Never diagnosed with COVID-19. No known allergies. No parental vaccine exposure.  Concurrent medical conditions included AIDS.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Immunocompromised patient received booster dose of 0.25 mL from Monovalent vaccine instead of Bivalent dose on 15Dec.2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Immunocompromised patient received booster dose of 0.25 mL from Monovalent vaccine instead of Bivalent dose on 15Dec.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 WRONG PRODUCT ADMINISTERED (Immunocompromised patient received booster dose of 0.25 mL from Monovalent vaccine instead of Bivalent dose on 15Dec.2022).    Concomitant medication list was not provided. Treatment information was not provided.
Headache pain/Persistent and often sharp; Worse at end of the day resulting in migraine level pain that impacted quality of life; Worse at end of the day resulting in migraine level pain that impacted quality of life; Gastrointestinal issues (Ulcer symptoms) grew out of stomach ache/cramping; Gastrointestinal issues (Ulcer symptoms) grew out of stomach ache/cramping; pain moved from a stomach ache to a burning at sternum level; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 11:30 (Batch/Lot Number: ER8733) as DOSE 1, SINGLE for covid-19 immunization at age of 31 years old. Medical history included PCOS (polycystic ovaries) from an unknown date. Concomitant medications included curcuma longa (TURMERIC); vitamin b complex (B-COMPLEX); colecalciferol (D3); magnesium; zinc; metformin. The patient experienced the following adverse events on 06Apr2021, which required physician office visit: gastrointestinal issues (ulcer symptoms) grew out of stomach ache/cramping and lasted for over a week. Pain was escalating until treated by doctor's appointment. Stomach cramping started day of vaccine by slowly, over time, the pain moved from a stomach ache to a burning at sternum level. Pain managed with 20 mg aluminum hydroxide gel, dried magnesium carbonate (PEPCID) 2x a day prescribed by doctor after she reached out after 1 week of symptoms. Headache pain started day of vaccine and persisted, lasting almost 3 weeks. Persistent and often sharp. Worse at end of the day resulting in migraine level pain that impacted quality of life. Treated with headache shot/migraine shot after she reached out to ask her doctor if this was an unusual reaction to vaccine and what she could take for pain that wouldn't contribute to acid reflux as Tylenol and other gentle on stomach pain relievers were not working at all. The patient didn't have COVID prior vaccination and was not tested for COVID post vaccination. The outcome of the events was resolving.
Child jumped during TDAP administration.  DTAP given in left arm intramuscular on 08/15/2005.  Returned to clinic 08/17/2005.  Left arm red and swollen, injection site 2cm.  Moved arm without difficulty.
The second day after my vaccination I had all kinds of side effects, my arm got swollen, red and painful. I had swelling of the lymph node under my arm and on my neck. I was nauseous I had fever and this went on for at least 4 days. During this time I also had burning arms and had to be careful with what type of fabric I wore and where I placed my arm, I also had body aches.
Information has been received from a certified medical assistant concerning a 13 months old male who on 07-MAR-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot #668544/1321Z expiration date: 07-OCT-2012). Concomitant medications include a vaccination with a dose of VAQTA in the opposite leg that VARIVAX (Merck) on a same date that previous vaccine at the "same office visit". On 14-MAR-2011, the patient's mother noted a "red raised area on the right thigh at the VARIVAX (Merck) injection site". On 15-MAR-2011, the office saw the patient and reported "the rash was 3/4 inch by 2 inches and no was not painful or itchy". No problem was noted in the opposite leg. Warm compresses to the area were the treatment given for the rash. No lab diagnostics studies were performed. At the time of report, the patient was not recovered. Additional information has been requested.
Pt reported Heart palpitations apprx 3 days following 1st dose.  Pt reports  the episode last for apprx 2hrs
He stated he is having an adverse event to the Shringrex vaccine. 4 out of 10 days he has had continuous pain in his chest. Cold sweats. Severe headaches and fatigue. He also has body aches, indigestion.
received vaccine 3-24-22, reaction occured 3-25-22, mom gave benadryl, by mpnday 3-27-23 reaction subsided and seen Dr. Arm itchy, redness down to elbow. Hot to touch and splochy rash.
Pt fainted, came to after a few seconds. alert and conversing. then started having severe cramping with pain in his hands. Emts were called to check him out. pt recovered and left with family member.
Pain and discomfort that night, weakness in the morning, then transient global amnesia later in morning, resolving that evening.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 10-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored PROQUAD (Merck) (Lot# K018143; expiration date: 10-APR-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient state the day after the vaccine she has been having shortness of breath and a  an irregular heartbeat. She  has been experiencing sweat episodes. Patient also stated that her arm is swelling near the injection site.
This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot number, expiry date and route unspecified). No concomitant medications were reported. On an unknown date, the patient developed a zoster like rash about 2 weeks after getting ZOSTAVAX. The patient sought an unspecified medical attention. The patient was treated with unspecified antivirals. It was unspecified if any lab tests were performed. The outcome of a zoster like rash was unknown. The relatedness for zoster like rash was unknown for ZOSTAVAX. Additional information is not expected.
Post-Vaccine onset of 30 minutes. Difficulty breathing, mild tongue swelling, coughing, wheezing, difficulty speaking, flushing.  Self-Injected EpiPen Xopenex 1.25mg/3mL solution  Famotidine 20mg tablet  Diphenhydramine 50mg  Adrenalin 1mg/ml  (0.5mg)
48 hrs p/vax pt exp redness, swelling & tenderness over 3"x3" area where inject was given; swelling spread to lt armpit & up into area above lt clavicle; pt called MD who stated it was pos side effect rom shot; t99;
Broke out in shingles, tender; Shingles blistered; Shingles were tender; Shingles blistered and now are starting to crust over; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2022, the patient received the 1st dose of Shingrix (intramuscular). On 4th March 2022, 1 days after receiving Shingrix, the patient experienced shingles, blister, tenderness and crust. On an unknown date, the outcome of the shingles, blister, tenderness and crust were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister, tenderness and crust to be related to Shingrix.  Additional details were reported as follows: The reporter is the patient's wife. The reporter stated that, her husband received his first Shingrix vaccine on 3rd March 2022, in the Left arm and broke out in a case of shingles the next day of vaccination. The reporter stated that, the shingles were on the right side of his belly that were now blistered and were started to crust over. The reporter stated that her husband told her that the shingles were tender but not painful. The reporter stated that their daughter was a Physician Assistant who looked to verify shingles. The reporter stated that, she also took pictures from the day of occurring (the outbreak) to the day of reporting, which she would be glad to share with GlaxoSmithKline. The reporter denied consent to follow-up and does not gave permission to contact HCP (health care professional).
fever, muscles, joint, bone pains (severe), Vomiting x 1 day, with continuous gagging and vomiting daily since then, migraine
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: fast heartrate-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: patient was not feeling well sitting, so he laid on ground. went to check up on him, he felt clammy sweaty, but responsive. mom was there but not terrible concerned, declined 911 call. gave patient water and he was okay half hour later
Information has been received from an LPN concerning a female in her 80's who in 10/01, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. During the week of 10/15/01, while driving home from the office, the pt experienced injection site reaction of the upper arm: swollen, red, inflammed, "baseball size" area with weakness, nausea and dizziness. She went to the ER, was treated (therapy unspecified) and was released. Subsequently, the pt recovered. Upon internal review, injection site reaction, swollen, red and inflammed were considered "Other Important Medical Events". The LPN also reported that a female in her 70's experienced injection site reaction with swelling, redness and inflammation, weakness, nausea, dizziness and red rash while on therapy with pneumococcal vaccine 23 polyvalent (see WAES 0110095). Additional information has been requested.
Pt had brief near syncopal episode when she got up from exam table, less than 2 minutes after injection. Completely resolved in 10 minutes. Did not completely lose consciousness.
0908: (B) fingers itchy & swollen, face itchy. No rash. No resp. complaints. Lungs CTA (B). HR 74 BP 124/86 RR 16 O2 Sats 96%. T 98.1 0910: 50 mg im BENADRYL given. 0925: Symptoms significantly improved (but not resolved) 0940: Released from care.
Information has been received from a physician concerning an 81 year old male with no drug allergies with Parkinson's disease, chronic obstructive pulmonary disease and diabetes who on 7/20/06 was vaccinated with a 0.5ml booster dose of Pneumococcal 23v polysaccharide vaccine (lot 651357/0391F), IM in the left deltoid. Concomitant therapy included Carbidopa levodopa Sinemet, Donepezil hydrochloride Aricept, metformin HCL Glucophage, glipizide, paroxetine HCL Paxil, entacapone, acetaminophen Tylenol (in the evening) and Senna Senokot. On 7/21/06 the pt experienced severe pain in the upper left arm and the area was very red. There was no fever associated with the symptoms. On the morning of 7/21/06 the pts temp was 98.1 F. The pt could not use his arm due to the severe pain in the upper left arm. The pt was ordered on prednisone for 5 days and ranitidine hydrochloride Zantac. There were no relevant diagnostic tests performed. The reporter considered severe pain in the upper left arm and very red area to be disabling and other medical events (OMIC).  Additional information has been requested.
ProQuad (MMR-V) and Comvax given 9/13/06. Folliolitis at time of vaccines. treated with Keflex. Rash resolved after five days but had emesis, diarrhea (4-5 x day) 3-4 days after visit, increase temp, onset of macular papular erythematous rash,eyes red, watery, no vesicles. on 9/25/06 grouchy and warm few days prior.
Angina and shortness of breath believed to be myocarditis or pericarditis.
Tingling throughout body, burning sensations throughout hands and feet. Fatigue, digestive disturbances, pain on entire left side of body sometimes right.
Flu like symptoms for 12 hours after second Moderna covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after second Moderna covid-19 vaccine) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after second Moderna covid-19 vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after second Moderna covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. treatment medications were not reported.   This case was linked to MOD-2021-336846 (Patient Link).
The patient received his second dose of vaccine in his left arm at 4:24 pm. He did not report any prior history of syncopy. He was walking towards the EMT/Cot area and, at 4:28pm, experienced a syncopal like episode and began to fall to the floor. He was caught prior to hitting the floor by his father and EMT. The EMT guided the patient to the cot. RN's responded. Pt was alert and oriented at time of RN arrival to scene. Pt was assisted supine position, with legs elevated. AN ice pack was applied to base of his neck and pt was provided with juice and crackers. He reported to RN  that he has a history of syncope and that he faints when he gets shots. Pt vital signs were monitored for 10 minutes and pt was monitored by EMT x 20 minutes. Pt left facility  at 4:50 PM with his father, denies any pain, sob or discomfort.
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided  (removed from freezer 10-14-21 into refrigerator and never opened before today and temperature never compromised).
Extreme Fatigue (one day) followed by sores on tongue (3 days) followed by swollen lymph nodes and diarhea