chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gallbladder problem; This spontaneous case was reported by a patient and describes the occurrence of GALLBLADDER DISORDER (gallbladder problem) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no known allergies. Patient was never tested positive for COVID-19.  Concurrent medical conditions included Blood pressure high (Taking 4 medications) and Diabetes (on metformin and insulin). Concomitant products included METFORMIN and INSULIN for Diabetes.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced GALLBLADDER DISORDER (gallbladder problem). At the time of the report, GALLBLADDER DISORDER (gallbladder problem) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, Computerised tomogram: normal (normal) normal.         Concomitant medications included 4 Unspecified medications for High blood pressure. It was reported that the patient was scheduled for his 2nd booster dose on 25-May-2022 afternoon and wanted to know that was there  going to be any problem as he had a CT Scan 2 days ago due to a gallbladder problem and was injected with a nuclear medication.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning an Adult patient of unknown age and gender who on 12-MAY-2015 was vaccinated with a dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 103 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Pt states she is dizzy and has a red swelling area around her arm. it is hard and hot to touch.
Severe nausea and vomiting that began within 12 hours after receiving the bivalent Covid booster that was so severe I could not tolerate fluids, even sips of water. Vomiting persisted for next 4 days until I eventually had to go to urgent care for prescription of ondansetron to stop vomiting.
Morning after vaccination pt.'s arm was painful and inflamed and she couldn't raise her arm more than 12". A physician advised her to take BENADRYL.
Pt called call center regarding symptoms after getting J&J vaccine  on 4/10. Pt was upset that she had to repeat her symptoms when she was transferred to advice nurse. Pt stated multiple times that her symptoms were only on both arms. She denied any emergency symptoms and declined to answer the rest of call center staff questions. I advised the patient that I need to ask screening questions prior to making a telephone MD appt. Pt stated again, that her symptoms were localized only to both arms and had some pain. Staff explained to the interpreter, at this time there are no urgent care appts available, pt would need to go to Urgent Care or ED to be evaluated. Translator repeated once more, and no response from pt. Pt disconnected from the call. called patient back, no answer.
Sore arm for the night, slight fever 99.9 but the big issue is I had two seizures the morning after the first at 4 am and the 2nd at 7:30 am... missed no doses of me seizure meds
Tired on Saturday, chills and bone pain near the ear on sunday, and facial paralysis got progressive.
I had chills, a temperature of 99.5 degrees, my feet upper and lower legs were in severe pain. I had a cough start and coughed up a mucous plug in addition shortness of breath with achy joints and muscles my urine was amber in color with abdominal discomfort and a loose stool. My Co2 stat was at 94%.
Patient stated he developed severe pain in his left arm at his injection site two days after his vaccine. He stated he had torn-rotator cuff repair surgery on that arm in December. His orthopedic doctor stated he had "froze up" his arm again and would need to resume physical therapy for this.
PHARMACIST COMBINED VOLUME FROM SEPARATE VIALS; OFF LABEL USE; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced pharmacist combined volume from separate vials, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pharmacist combined volume from separate vials and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210334020.
Localized erythema to left deltoid. Size is irregular shape circle 3 inch diameter. No itching, and no other symptoms.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified) Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
No adverse event. No signs, symptoms.  Error:   Pt given COVID-19 Pfizer vaccine 9/22/21. Pt had received the JJ/Janssen COVID 19 vaccine on 9/16/21
Headache, Dizziness, Muscle or body aches, Physical and mental fatigue, Racing and Palpitations..etc
My arm stated hurting; I got a headache; Felt feverish; Feel like I have the flu; This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix and Flu vaccine. On 4th September 2019, 4 hrs after receiving Shingrix and Flu vaccine, the patient experienced pain in arm. In September 2019, the patient experienced headache, feeling hot and influenza like illness. On an unknown date, the outcome of the pain in arm, headache, feeling hot and influenza like illness were unknown.   It was unknown if the reporter considered the pain in arm, headache, feeling hot and influenza like illness to be related to Shingrix and Flu vaccine.  Additional case details were reported as follows: The patient got the first Shingrix vaccine the day before reporting. The patient received vaccine in unknown arm. The patient's husband did as well. They asked their local pharmacist about side effects, and he didnt seem to think there were any unusual ones. The patient arm stated hurting about 4 hours later, got a headache and felt feverish overnight and still do. The patient felt almost like that she had the flu. It has been about 30 hrs. since the injection. The patient reported that we did also get the flu shot at the same time, but we had got it many times with no side effects.  Our pharmacist said it should not cause a problem. The reporter requesting consent to follow up.
A vaccine error was made.  The vial of Pfizer vaccine was diluted with 0.8 mL of saline (instead of 1.8 mL of saline).  The patient received a 0.3 mL dose.  The patient received a higher-than-normal concentration of vaccine due to the dilution error.
Ringing in the ears after 2nd dose after moderna vaccine/Tinnitus in the ears after 2nd dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ears after 2nd dose after moderna vaccine/Tinnitus in the ears after 2nd dose of moderna vaccine) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     It was reported that patient did not had Covid test.  Concurrent medical conditions included Sulfonamide allergy (Sulfa).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in the ears after 2nd dose after moderna vaccine/Tinnitus in the ears after 2nd dose of moderna vaccine). At the time of the report, TINNITUS (Ringing in the ears after 2nd dose after moderna vaccine/Tinnitus in the ears after 2nd dose of moderna vaccine) outcome was unknown.            No concomitant drug was reported. It was reported that patient received 1st and 2nd dose 1 month apart and stated that patient received all 3 doses in the recommended time frame. It was also reported that the patient stated that she had read a bit online regarding the side effect of ringing in the ears but never had this before but after the 2nd dose of moderna vaccine, she had rang in the ears and tinnitus in the ears. No Treatment medications were reported.
Went for a routine checkup and found a blood clot in right leg....had catscan that showed both lungs full of blood clots
I got the chills; the injection was very painful to begin with; I got the chills; the injection was very painful to begin with; I felt dizzy in the afternoon; naturally tired/I just slightly light headed; I felt dizzy in the afternoon; naturally tired; I felt as I vomited; I vomited up a lot of phlegm; I felt as I vomited; I vomited up a lot of phlegm; My arm was really sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "I got the chills; the injection was very painful to begin with"; DIZZINESS (non-serious), outcome "unknown", described as "I felt dizzy in the afternoon; naturally tired/I just slightly light headed"; FATIGUE (non-serious), outcome "unknown", described as "I felt dizzy in the afternoon; naturally tired"; VOMITING (non-serious), PRODUCTIVE COUGH (non-serious), outcome "unknown" and all described as "I felt as I vomited; I vomited up a lot of phlegm"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm was really sore".  Additional information: Patient got the chills the injection was very painful to begin with, also felt dizzy in the afternoon naturally tired, patient had the chills and patient don't know if this is from the vaccine which had Saturday about noon but patient could not realize, felt as vomited, vomited up a lot of phlegm, it was reported that patient don't know if this was from esophagus or just what but in off course patient arm was really sore is this, patient guess this is normal reaction from the COVID-19 and patient was seeking a getting a acupuncture in fingers because and have arthritis here or possibly even a surgery now that COVID-19.  No follow-up attempts are possible. No further information is expected.
He was given the  vaccine and walked to the post vaccination area. He sat down called his mom and she did not answer then he fell completely out of the chair face first onto the floor. His eyes where open and he was not responsive for around 2 mins, he also had a odd color to his skin and he was sweating. He was breathing in a odd manner then he could hear me and see me and was able to answer my questions. We called 911 at the start and the ems arrived and he talked with them they took the blood pressure 2 times and we made him stay 30 mins. He would not leave with ems so he left with his mother. When he left he was walking and talking and stated he was ok.
This is a spontaneous report from a contactable consumer (who was also a patient) reported for a 16-years-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported ), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm hurt on an unspecified date. The event was non-serious. The outcome of the event arm hurt was unknown. Follow-up attempts are required; information about Lot/batch number will be obtained.
VACCINE WAS GIVEN ALONE IN DELTOID AREA. NEXT DAY PT RETURNED WITH SWELLING, PRURITUS OVER WHOLE DELTOID AREA.
His body became full of rash 2 days; At injection site on left arm, it became very red after 2 to 3 days.; 2 days later, it became like a boil with yellow liquid inside.; The liquid started to come out.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE VESICLES (2 days later, it became like a boil with yellow liquid inside.), VACCINATION SITE DISCHARGE (The liquid started to come out.), RASH (His body became full of rash 2 days) and VACCINATION SITE ERYTHEMA (At injection site on left arm, it became very red after 2 to 3 days.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In October 2021, the patient experienced VACCINATION SITE VESICLES (2 days later, it became like a boil with yellow liquid inside.), VACCINATION SITE DISCHARGE (The liquid started to come out.) and VACCINATION SITE ERYTHEMA (At injection site on left arm, it became very red after 2 to 3 days.). On an unknown date, the patient experienced RASH (His body became full of rash 2 days). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE VESICLES (2 days later, it became like a boil with yellow liquid inside.), VACCINATION SITE DISCHARGE (The liquid started to come out.), RASH (His body became full of rash 2 days) and VACCINATION SITE ERYTHEMA (At injection site on left arm, it became very red after 2 to 3 days.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment indication include topical cream No concomitant medicine were reported by the reporter
Diarrhea about 5 hours after the vaccine, followed by vomiting  starting at about 34 hours after the vaccine and lasting until 48 hours after.
Warmth, redness, & swelling of injection site occurred within 1 minute of administration. 4mL Benadryl (12.5mg/5mL) given po 5 min after the reaction began. Ice pack given to hold on the site. No respiratory distress, vomiting, or wheezing occurred. Redness & swelling of the site improved within 30min of adm. Benadryl.
G45.9 - TIA (transient ischemic attack) I63.9 - Acute ischemic stroke (CMS/HCC)
Pt started w/105 fever the evening of receiving vax & lasted 4 days; Lt leg & thigh were very hot upon touching & swollen considerably;
Information has been received from a consumer concerning his 18 year old daughter with no pertinent medical history or no known drug allergies, who on approximately 29-AUG-2008 (reported as last week of August 2008) was vaccinated with the first dose of GARDASIL (Lot not reported). In December 2008 she received the second dose of GARDASIL (Lot not reported). There was no concomitant medication. On approximately 08-SEP-2008 (reported as the second week of September), the patient was diagnosed with aplastic anemia. She was having blood work every week and several other tests were performed. On an unspecified date, the patient stayed in the hospital for 10 days. As of 03-MAR-2009, the patient had not recovered from aplastic anemia. Additional information has been requested.  4/14/09 Received hospital medical records of 2/24-3/5/2009. FINAL DX: very severe aplastic anemia; profound pancytopenia Records reveal patient experienced progressive anemia & fever, HA, blurred vision, sore throat, epistaxis, gum bleeding, nausea, 1 episode of emesis x 1 mo.  Developed petechiae & wet purpura, tachycardia, HA.  Tx w/IV antibiotics, multiple blood & plt transfusion & immunosuppressive therapy.  Gradually improved & d/c to home on oral antibiotics, continued immunosuppresants to be f/u in clinic  4/14/09 Received PCP medical records of 2/21-2/24/2009. FINAL DX: none provided Records reveal pt had been seen in urgent care 2/21 for sore throat, fever, nausea, vomiting, fatigue, malaise.  Had been exposed to sick contacts at school.  Dx w/pharyngitis & URI.
Patient had generalized anxiety disorder. Onsite EMS was called vitals BP 138/96 HR 70. Patient refused evaluation or care without transport, released agianst medical advise.
This 13-month old female was given her 12 months vaccines on 2/19/11. She developed a fever on Sunday 2/20/11, of 103 degrees. She was taken to ER for persistent fever of 101 degrees.
Information has been received from a licensed vocational nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of GARDASIL 9 lots # M007764 and M013636 with expiration dates 30-JAN-2018 and 15-FEB-2018 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. Temperature: 35F. Time frame: 12 hours. There was a call because of a data logger. There was no a previous temperature excursion. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.
This is a spontaneous report from a contactable consumer (husband). A female patient of unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration, on an unspecified date, single dose, for immunization. Relevant medical history and concomitant medications were not reported. The patient had a reaction to pneumococcal 13-val conj vac (dipht crm197 protein) on an unknown date (yesterday) also reported as severe reactions of the shot received last week. The injection site was red, very warm to touch and it sores. Outcome of the events was not recovered.
Injection site sore for a few weeks.  Muscle pain around injection site persists a year later, particularly when lifting arm above shoulder or reaching.  Pain constantly radiated down arm into hand for 6 months then became intermittent.  Had difficulty sleeping for several months on left side as arm and shoulder hurt.  Didn't seek treatment as I assumed a nerve was hit and damaged.
Approx. 15-20 minutes after being injected, he stated he was hot.  He then became nauseated, dizzy, pale and extremely diaphoretic.  Before we could administer an Epipen, he lost consciousness and had snoring respirations.  He regained consciousness about 30 seconds after the Epipen was administered.  He received O2 and was transported to a local hospital where he remained overnight for observation.  While there he rec'd steroids, IV therapy and cardiac monitoring.  - 4/5/06 Review of 4-page d/c summary confirms anaphylactic reaction as final diagnosis. Shortness of breath was noted. Tx. with Prednisone and Benadryl.
pains in her thighs; felt like things are off in the center of her stomach and her chest; felt like things are off in the center of her stomach and her chest; felt like it was all lit up all the major organs when laying flat on her back; States she turned to the side and it was pain on the other side really something like muscles having a problem; she had pains inside; this was after drinking that day and having a couple of drinks the next day and next day/bad move to take that drink even though it was only wine; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 22Mar2021 (at the age of 71-year-old) as dose 1, single for COVID-19 immunization. Medical history included multiple sclerosis from an unknown date and where it is relaxing remitting, has not had a flare up in 2 years. Concomitant medication included interferon beta-1a (AVONEX) for an unspecified indication. It was reported that, patient received quick, pleasant and fast efficient 1st shot on 22Mar2021 and she went home and had a drink and a few days later, she had pains in her thighs and felt like things are off in the center of her stomach and chest. It felt like banging, like would see in movies. She felt like, it was all lit up, all the major organs especially when laying flat on her back. Patient confirmed that, this was after drinking that day and having a couple of drinks the next day and next day. This whole weekend (Friday, Saturday, Sunday) she has not had anything. Also, she had pains inside, and it was a bad move to take that drink even though it was only wine. When she turned to the side, she felt pain on the other side, really something like muscles having a problem. At the time of report, (on 29Mar2021), she feels completely different. She has been drinking milk and juice and eating fruit. Patient acknowledges that it was the worst to take a drink with that medicine. At the time of report, she is feeling normal now, her stomach and everything is like old times and she does not know if she is able to take the follow up shot on 14Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1) Hair loss beginning between 2-3 weeks after vaccine, within 1-2 months suffered 90% hair loss with little to no new hair growth to date.  2) Swollen Lymph Node under left arm pit
Patient received second Moderna on 4/27/21. Next day had chills, body aches, felt hot, but did not take his temperature. Those symptoms are gone nowm but woke up today with swelling on both sides of his nose, on his face. No congestion or breathing problems per patient. He has appointment with his provider this afternoon.
Information was received from a nurse referring to 2 patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ for prophylaxis (incorrect product storage). The vaccines of lot numbers N005078 and N029868 were exposed to a temperature between 47 and 77 Fahrenheit degrees(F) (55 F) for 5 hours with previous temperature excursion between 47 F and 77 F(47.1 F) for 10 minutes as well as to a temperature between 47 F and 77 F (57.3 F) for 14 hours. No call for data logger was involved. No adverse effects were reported.