chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Laryngitis; coughing like there is something is in his thorat; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGITIS (Laryngitis) and COUGH (coughing like there is something is in his thorat) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Yearly intramuscular Flu vaccine) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Blood pressure high (No Recent change in status such as improvement or worsening.), Penicillin allergy and Drug allergy.    On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 05-Apr-2022, the patient experienced LARYNGITIS (Laryngitis) and COUGH (coughing like there is something is in his thorat). At the time of the report, LARYNGITIS (Laryngitis) and COUGH (coughing like there is something is in his thorat) had not resolved.            Relevant concomitant medications reported high Blood pressure medication of unknown brand.  Patient did not had COVID positive test or diagnosis.  No treatment information was provided.   This case was linked to MOD-2022-547050, MOD-2022-547043, MOD-2022-547048 (Patient Link).
aside from typical response (shaking chills, muscle aches, fatigue, headaches, nausea). patient became short of breath for approximately 2 hours (1230am-230am). chills and headaches started at the same time. no respiratory compromise/anaphylaxis/hives.
Started having  fatigue, low grade fever, headache, injection site pain and body aches 1 day after vaccination that lasted for three days.  She had two days of feeling normal and symptoms started again yesterday with the addition nausea and diarrhea.
This spontaneous report was received from a healthcare worker professional referring to a unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with an improperly stored dose of PNEUMOVAX23 lot # L019836 with expiration date of 24-MAR-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. The healthcare worker stated, that PNEUMOVAX23 was exposed to a temperature excursion of 11.8 degrees C for a time frame of 2 hours and 35 minutes. It was called due to a data logger. Previous excursions also were reported, with a minimum of temperature of -0.3 degrees C for 15 hours and 42 minutes and a maximum of 11.8 degrees C for 18 hours 55 minutes. Furthermore, no adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This literature marketed report has been received from the author of a published literature. BACKGROUND The effect of a third dose of the M-M-R II vaccine in stemming a mumps outbreak is unknown. During an outbreak among vaccinated students at the University, health officials implemented a widespread MMR vaccine campaign. The authors evaluated the effectiveness of a third dose for outbreak control and assessed for waning immunity. METHODS Of 20,496 university students who were enrolled during the 20152016 academic year, mumps was diagnosed in 259 students. The authors used Fisher's exact test to compare unadjusted attack rates according to dose status and years since receipt of the second M-M-R II vaccine dose. The authors used multivariable time-dependent Cox regression models to evaluate vaccine effectiveness, according to dose status (three vs. two doses and two vs. no doses) after adjustment for the number of years since the second dose. RESULTS Before the outbreak, 98.1% of the students had received at least two doses of M-M-R II vaccine. During the outbreak, 4783 received a third dose. The attack rate was lower among the students who had received three doses than among those who had received two doses (6.7 vs. 14.5 cases per 1000 population, P<0.001). Students had more than nine times the risk of mumps if they had received the second M-M-R II dose 13 years or more before the outbreak. At 28 days after vaccination, receipt of the third vaccine dose was associated with a 78.1% lower risk of mumps than receipt of a second dose (adjusted hazard ratio, 0.22; 95% confidence interval, 0.12 to 0.39). The vaccine effectiveness of two doses versus no doses was lower among students with more distant receipt of the second vaccine dose. This report concerned 221 patients of unknown age and gender. On unknown dates, the patients received two doses of M-M-R II (dose, route, lot# and expiration date unknown) for prophylaxis. On unknown dates, the patients experienced mumps. The outcome of the events was unknown. This is one of the several reports that received from the same literature article. Sender's Comments: US-009507513-1709USA012424:US-009507513-1709USA014640.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Pharmacist reported that on 13-MAY-2014 the patient received injection of ZOSTAVAX which expired on 11-APR-2014 and Lot number J000444. Pharmacist reported that no adverse effects were reported. Additional information has been requested.
Approx 2 hrs. after imm. given complained of sudden onset headache, dizziness, chills, blurred vision, pain at injection site. Seen in office approx 4 1/2 hrs. after imm. headache continued, less dizziness, chills, blurred vision.
After I got my Moderna vaccine in October I had lymph node swelling for several weeks that were palpable and tender.  They were still swollen by Christmas. .  Enough that I had rescheduled my mammogram 2 times.  When I finally did the mammogram March 17th,  it did show cystic changes that required a follow up.  I know patients are told to wait 8 weeks for mammogram after the covid vaccine.  Interesting that still 5 months later and my mammogram was abnormal.  A month after April 20th,  I had palpitations,  I work in a clinic and am able to a EKG that showed a PVC.   The follow week I had 2 episodes of fainting.  April 25 and 26th.   I had a neuro work up that was normal and started a cardiac work up.  I then had another syncopal episode in June 16th  and finally one on July 7th that showed a Heart Rate of 17 with multiple pauses up to 15 seconds.  I was admitted in the ICU for 9 days and ended up with a pacemaker.   Being a healthy person this whole thing is very bizarre, why out of no where I would develop sinus node disfunction and bradycardia.   I working in health care I thought it could be helpful to share the information incase other people are developing issues. SSS after getting covid vaccines.    At the time this started, I also had NO history of covid illness.
pt died @ ER due to unk COD; pt had recently recvd vax;  COD SIDS; dx visceral & pulmonary congestion; atelectasis; hemorrhages;
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 5/5/2022 HX OF STROKE I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 5/4/2022 HX OF STROKE I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 10/3/2022 HX OF STROKE I63.89 SUPERIOR CEREBELLAR ARTERY SYNDROME 10/12/2022 HX OF STROKE G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 5/5/2022 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 5/4/2022 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 10/3/2022 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY I63.89 SUPERIOR CEREBELLAR ARTERY SYNDROME 10/12/2022 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
This spontaneous report as received from an other health professional and a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2015, the patient was vaccinated with a first dose of improperly stored GARDASIL injection (intramuscular, lot # K007828, expiration date 02-MAR-2017, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left thigh has red, raised lump that is warm to touch and tender to touch near the injection site. Advised to use Benadryl, motrin and tylenol as needed. Call office if not resolved or gets worse.
2 weeks after each COVID vaccine, I experienced sudden drop in BP.  First vaccine on 3/17 was followed 2 weeks later with BP drop.  First BP reading on 4/1 was 88/58.  Minutes later, I double-checked & BP reading was 72/53.  Was cold and clammy; felt faint.  Grew nauseous and threw up.  Had no EPI pen.  Feared this was anaphylaxsis & took the most logical thing I could think of  37.5 mg phentermine.  Symptoms subsided in about 20 minutes(?)  2d Covid shot received 4/7.  2 weeks later  nearly identical reaction occurred:  BP plummeted, cold clammy.  Did not throw up this time.  I took 37.5 mg phentermine right away - and was OK.   Also, significant breast swelling (from C to D), which has NOT gone away.
Headache, nausea, vomiting, fever, chills, blood pressure up, fast heartbeat, fatigue
Side effect with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side effect with the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Side effect with the first dose). At the time of the report, ADVERSE REACTION (Side effect with the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medication information was provided.   Reporter did not allow further contact
I had basically no reaction. On 11/5/2021 I developed a severe case of hives. I had a low grade fever. I received treatment on Sunday 11/7/2021 via video visit and I was given a prescription of Methylprednisolone. I was also told to take Benadryl. The fever lasted a couple of days. I'm still dealing with the hives but they are resolving.
Patient received vaccine on 10-10-2019. On 10-11-2019 patient reports that she had a fever above 101 F. As of 10-13-2019, patient states that her arm has a softball size knot. Advised patient to continue taking Tylenol, apply ice/cold packs to the area, and contact physician if no improvement tomorrow.
He got his vaccines, everything was fine.  His wife had gone to bed early.  Around 11:00 PM he woke up his wife, was vomiting, and stated that he was feeling terrible.  The next morning she got up and he had been sleeping, he had been in and out of bed all night vomiting.  She had to go to work, she brought him some gatorade, water and put it next to the bed.  She asked her son to check on him, and he said that he was fine.  About an hour later she asked her son to check on him, and he could not get him up.  He had a temperature of 105, and they could not wake him up.  They took him to the ER and told them what was going on and said that he had MRSA.  Wife states that he was unconscious still.  He was taken to the I ICU, and his breathing was so hard trying to breath and they told him that he was compensating that his kidney were going to go into failure.  She decided to put him on a respiratore.  They decided that he had a stroke, did not know if it was at the time of the inputting on the respiratory.  The blood that was being pushed out from the heart, he had 100 little strokes on his brain.  He does not think there will be any long-term affects as they were minor.  He is now in rehab as he is having problems with his left leg.    He was taken to Hospital.    He has a big wound on his right arm, and infectious disease is watching it, and if it had gotten any worse he would have to have had surgery to remove the skin around it.  He was then removed to rehab right now and admitted there on 10/31/23.  He will be in there for at least the first week in December.  He has a PICC line receiving antibiotics and will be there due to that.  There was nothing wrong with his valve as he was sent for 2 different tests, and they will have to watch that for a year.    He does go for pain management due to a work related incident in his 40s.  Dr. is his PM doctor.
Administered Shingrix reconstituted with other diluents.; Administered Shingrix reconstituted with other diluents.; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number X54CN, expiry date unknown) for prophylaxis.   On 21st January 2022, the patient received Shingrix. On 21st January 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had been administered Shingrix reconstituted with diluents other than the AS01B adjuvanted suspension provided, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered . The reporter did not consent to follow-up. The reporter provided limited information regarding patient.
Sore arm at injection site, headache, chills, fatigue, tired.  Started having hot flashes again right after 1st shot (in menopause but the natural Genius estrogen Balance supplements stopped hot flashes until 1st Moderna shot).  Then after my second shot the hot flashes were gone again.   Just reporting this for your information
Expected some site pain on day of Flu Vaccine but continued to hurt and arm tightness increased and moved up into my shoulder. Today, is 2 months later and arm/shoulder hurt and I had no injury. I am doing ROM exercises on my own.
Pt described feeling her heart rate high and feeling dizzy immediately after the vaccine, but she stated because she has a phobia with needles, she attributed the feeling to that. She felt tired when she went home and went to bed. When she woke up this morning, her tongue was swollen, as was the left side of her neck. She stated she was drinking lots of water, but it tasted like chemicals. I recommended to the patient to take 2 benadryl, and if the symptoms did not subside, to go to the emergency room.
erythematous, pruritic to back of R arm, Rx'd hydrocortisone 1% and diphenhydramine
Hearing loss; Allergic reaction to a flu vaccine; This is a spontaneous case reported by other non-health professional to agency (Case: SEQ19-05065) and initially retrieved on 18-Oct-2019, concerning a female patient of unspecified age.  The patient's medical history included drug allergy to amikacin, low blood pressure and gastrointestinal related (as reported).   The patient's concomitant medications included intravenous unspecified steroids.  On an unspecified date in 2017, the patient was administered INN Flu Vaccine [Influenza Vaccine, anatomical location: right arm, dose, route of administration, batch number, expiry date: not reported] for unknown indication.  On an unspecified date in 2017 after vaccination, the patient developed an allergic reaction to a flu vaccine.  On an unspecified date in 2017, 24 hours after vaccination, patient lost her hearing. Six months, later she was receiving intravenous steroids for low blood pressure and her hearing returned. At that time, she was pending Cochlear transplant, but that was not needed since her hearing returned.  On an unspecified date, the outcome of the allergic reaction was recovered/resolved.  The case was assessed as serious.  Company comment: The patient experienced deafness and allergy to vaccine after vaccination with the suspect product INN flu vaccine. Chronology is plausible. Medical history of low blood pressure may have contributed to development of the event deafness. Causality was also confounded by therapy with concomitant medications, intravenous unspecified steroids. Considering all the above mentioned, causal role of the suspect product is assessed as related.
Severe red rash over 90% of body, head to toe. Chills, Shivering, nausea,
Pt has had fever every day since vaccine - @ 101.3 & watery diarrhea, spitting up after breast feedings, more lethargic. No rednes or swelling at sites.
This case was reported by a consumer via call center representative and described the occurrence of celiac disease in a 23-year-old female patient who received Hepatitis B vaccine (batch number 1154B2 ?, expiry date unknown). GSK note: the reported lot number did not match with any GSK lot number. Clarification has been requested. Co-suspect products included Hepatitis B vaccine (batch number 1115B2 ?, expiry date unknown) and Hepatitis B vaccine (batch number 1309B2 ?, expiry date unknown). On 9th July 1993, the patient received the 1st dose of Hepatitis B vaccine. On 6th August 1993, the patient received the 2nd dose of Hepatitis B vaccine. On 9th March 1994, the patient received the 3rd dose of Hepatitis B vaccine. On 9th March 1994, not applicable after receiving Hepatitis B vaccine and Hepatitis B vaccine, not applicable after receiving Hepatitis B vaccine and Hepatitis B vaccine, and an  unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On 21st December 2016, the patient experienced therapy non-responder. On an unknown date, the patient experienced celiac disease (serious criteria GSK medically significant). On an unknown date, the outcome of the celiac disease, therapy non-responder and drug dose administration interval too long were unknown. The reporter considered the celiac disease to be unrelated to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: This case was reported by the patient's father. The patient had received the hepatitis B vaccine series when she was an infant. On 21st December 2016, the patient was tested for hepatitis B antibodies and it showed she had no antibodies. Thus, leading the patient to be a therapy non-responder. The pediatrician's office was able to provide the lot numbers, but did not know what company's vaccine it was. The patient was diagnosed with celiac disease and her gastroenterologist had proposed her to get 2 ml doses of ENGERIX-B so she would develop antibodies against the virus. She went to a pharmacy to receive the 2 ml dose, but the pharmacy refused to administer it. The patient would be seeing her gastroenterologist at the time of reporting to further discuss the vaccination. The patient's father was not concerned about the celiac, since the patient also had the disease, he was only calling with questions about the dosing of ENGERIX-B vaccine.
no patients experienced symptoms; unspecified patients were administered improperly stored doses of PEDVAX HIB, ROTATEQ and VAQTA; This non-valid spontaneous report was received from a healthcare professional and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On or after 16-APR-2020,  the patients were vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) 25/0.5 (units not provided), lot # S032358 with expiration date 11-JAN-2021 intramuscularly (dose, frequency and anatomical location were not provided); Hemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S007079 with expiration date 24-JAN-2022 or lot number S023219 with expiration date 03-MAR-2022 intramuscularly (dose and anatomical location were not provided and, rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # S017642 with expiration date 28-FEB-2021 orally (dose was not provided) all the vaccines were administered for prophylaxis. No patients experienced symptoms. Administered doses of vaccines experienced the temperature excursion of 47.3 degrees Fahrenheit for 1 hour and 22 minutes (also reported as multiple excursions). Digital data logger was involved. There were no previous excursions reported.  This report is non-valid due to lack of patients' identifiers. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
itching the place on their arm where they had the shot; real red on arm; arm where they had the shot was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching the place on their arm where they had the shot), VACCINATION SITE ERYTHEMA (real red on arm) and VACCINATION SITE PAIN (arm where they had the shot was sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ04) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching the place on their arm where they had the shot), VACCINATION SITE ERYTHEMA (real red on arm) and VACCINATION SITE PAIN (arm where they had the shot was sore). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching the place on their arm where they had the shot), VACCINATION SITE ERYTHEMA (real red on arm) and VACCINATION SITE PAIN (arm where they had the shot was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
FEELING WARM; SORE ARM; CHILLS / FREEZING; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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 and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 vaccinated on the left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced chills / freezing. On 07-APR-2021, the patient experienced headache. On 07-APR-2021, the patient experienced sore arm. On 07-APR-2021, the patient experienced feeling warm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, chills / freezing, and headache, and the outcome of feeling warm was not reported. This report was non-serious.