chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix was administered to a 9 month old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old patient who received DTPa-IPV (Kinrix) for an unknown indication.   On 01-NOV-2023, the patient received Kinrix. On 01-NOV-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 9 month old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-NOV-2023 Pharmacy Intern states Kinrix was administered to a 9 month old on the day before reporting which led to inappropriate age at vaccine administration. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter. HCP did not have any additional information at the time of call.
This a spontaneous case initially received from a physician, via pharmaceutical manufacturer (Pfizer), on 14-Feb-2019, concerning a female patient of an unspecified age. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication. On an unspecified date after vaccination, the patient was very ill and was hospitalized. The outcome of the event was not reported. It was considered, that the patient experienced allergy to the flu vaccination. The reporter assessed this case as serious due to hospitalization. Reporter's Comments: A female patient of unknown age was very ill and was hospitalized, on an unspecified day after administration of INN Flu Vaccine. Considering the minimal information regarding the exact onset latency between vaccination to symptoms onset, concurrent medical condition and investigations to provide alternate aetiologies, the causal role of suspect vaccine was assessed as unassessable.
Fever to 101 and myalgias starting evening of vaccination (11/24) resolved after 2 days; 11/27 with hotness to upper arm, rash developed 11/28 below area of injection, ?cellulitis vs allergic reaction vs possible shingles.
headache, body aches, chills. Took Tylenol and headache improved but came back the next day. Continued to take Tylenol PRN with relief.
Sore throat developed roughly 48 hours after vaccination. Still lingering 8 days after symptoms started.
Per mom the actual date of onset was not known however 4-5 days ago child complained to dad about pain at injection site. Dad noticed a little redness at that time. Then on 11/15/16 in the evening the child complained that his pants were bothering the injection site. It was then that the parents noticed the redness was larger and hard warm to touch and painful for the child. Per mom she put cortisone cream on the site as the child also complained about itching. The parent called for an appointment with doctor and was seen in clinic. Bactrim antibiotic was prescribed by doctor on 11/16/16.
Initial and follow-up information has been received from an office manager who reported that she received an email from a friend concerning a girl who was vaccinated with a dose of GARDASIL and began having seizure episodes within weeks of getting the shot. The office manager reported that she knew nothing of the patient or situation except through the email which was circulated to her. Upon internal review, seizure episodes was considered an other important medical event. Attempts to verify the existence of an identifiable patient have been unsuccessful. This is one of several reports from the same source. Additional information is not expected.
Fever; Chills; Nausea; Vomiting; Headache; Tiredness.
This spontaneous report as received from a medical assistant refers to an 11 year old male patient. On 10-JAN-2014 the patient was vaccinated with GARDASIL lot # H017698, .5 ml, intramuscular. Other suspect therapies also administered on 10-JAN-2014 included DTAP (manufacturer unknown) and MENVEO. About a week after onset of therapy the patient experienced rash all over his body. No treatment was given and the outcome of rash all over was reported as recovered/recovered on an unspecified date. Additional information has been requested.
Fever 100.2 at 12am. Took Tylenol, fever of 101.0 at 8am. More Tylenol consistently, temp didnt go below 99.5 until Saturday morning.
I received my 2nd booster shot on 04/16/2022. My Covid symptoms started on 05/09/2022-05/10/2022 I wasn't feeling well. I woke up with a scratchy throat and a little headache. I was feeling like flu like symptoms. I took antigen test on the 05/17/2022 was positive. Then I went to the pharmacy drive through and it was positive. I took COVID test on 05/18/2022 (PCR). I treated like a mild cold. I took Tylenol to get better. I had cough, fever, runny nose a little. Everything was mild to moderate.
consulting MD reported 3 deaths which occured in a particular family over a 5 yr period following 1st/DTP vax; autopsy dx SIDS in all 3 pts; 1 of the 3 pts who was vax @ 71 days of age was found dead in bed 7AM 13 dasy p/vax in 1984;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several hours after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the injection site rash and fever were recovered/resolved. It was unknown if the reporter considered the injection site rash and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the arm. After receiving SHINGRIX, the patient developed a rash that radiated from the injection site down to her elbow that lasted about 7-10 days and a low grade fever.
Patient got 3rd booster dose of Pfizer vaccine and Fluad at the same time on 11/8/21 and was sitting for 15 minutes to make sure she does not have an allergic reaction. The tech who was monitoring the patient, notified the pharmacists that patient stated she was feeling very dizzy. Pharmacists went out to check on the patient. Patient was alert, and told us that she's feeling very dizzy and wants to faint. She denied breathing trouble and was alert.  Suggested patient to lay down on the floor, but patient declined. Asked the patient if they wanted us to call 911, patient declined first but we decided to call 911. While on the phone with 911 & EMT, patient was not responsive for 5 seconds with eyes open and we told 911, and patient started gasping for air. We immediately started laying her down with her back on the floor, during the process, noticed that patient urinated. As soon as she's on the floor with her back, patient was no longer gasping was awake. and stated she's feeling better. Patient was alert with name and location, and was able to give a list of her medications. We had her feet up on a tote and EMT arrived on the scene and took over. Pharmacist called on 11/9/21 to follow up with patient, patient stated she decided to go to the hospital ER after, and they did a lot of tests, all the tests came back fine. She was back home on 11/8/21 8 or 830pm. She's feeling better today and is just resting up. She expects to be back to normal tomorrow.
Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4 Nausea loss of appetite headache
Moderna COVID?19 Vaccine EUA  I developed a inflamed, stiff, hot, itchy rash on my left arm (where I got vaccinated) on 1/27/2021. It went away after 2 days. Then another red rash appeared on the same left arm again 2/1/2021. It is currently a big red blotch on 2/2/2021.
When it started I had congestion in my upper sinuses and a sore throat. The sore throat got worse and in the middle of the night I woke up with a bad sore throat. I took Tylenol for the sore throat and I took a Home COVID-19 Test on July 5th and was positive. I texted my doctor and I got Paxlovid. I started that within 90 minutes. I have also taken Dayquil and Nyquil along with Tylenol. I also took Tussin cough syrup. I developed diarrhea so I took Imodium at a half a dose. I think the diarrhea is from the Paxlovid. My systems have improved about 90%. I still have a runny nose, coughing and I'm still tired. I am still testing positive on the home COVID-19 Test as of today. I took a PCR
When I awoke on Thursday morning (after receiving shot on Tues afternoon), my heart was racing. It continued to get worse as the day progressed. I eventually stopped working and laid down in bed around 4:30pm. I had not experienced this level of palpitations since my 2017 ablation. When I awoke Friday morning, it was a little better. On Saturday, my heartrate was normal again. I did not seek treatment as it never got worse than what I had experienced with bouts of SVT in the past.
Full body diffuse rash red circles all over body, (completely covered) head to toe, extremely itchy. Patient was prescribed medrol dose pack and the rash is now almost completely gone 2/23 when I called and check on her again.
Dizzy; Can't Sleep; Forgetful; Very Tired; Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), DIZZINESS (Dizzy), INSOMNIA (Can't Sleep), MEMORY IMPAIRMENT (Forgetful) and FATIGUE (Fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In December 2020.) in December 2020.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (Soreness) and FATIGUE (Fatigue). On 17-Mar-2021, the patient experienced DIZZINESS (Dizzy), INSOMNIA (Can't Sleep), MEMORY IMPAIRMENT (Forgetful) and FATIGUE (Very Tired). On 04-Mar-2021, PAIN (Soreness) and FATIGUE (Fatigue) had resolved. At the time of the report, DIZZINESS (Dizzy), INSOMNIA (Can't Sleep), MEMORY IMPAIRMENT (Forgetful) and FATIGUE (Very Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
I'm having uncontrollable muscle spasms in my jaw. My jaw also locks causing my speech to slur. My hands have muscle spasms as well. They also shake uncontrollably. As a result I've spilled hot coffee on myself, it's cost me lucrative job offers at the time of the interview my jaw locks causing me to slur my speech.
Received 3 HEPLISAV-B injections [Extra dose administered] Initial Report Received: 21-Sep-2018. Patient is a 43-year-old male patient (race not provided) who was administered with HEPLISAV-B  for hepatitis B immunization. The patient, who is also a physician's assistant, reported that he received 3 HEPLISAV-B injections. Relevant medical history and concomitant medications were not provided. The patient received the first 0.5 ml HEPLISAV-B intramuscular injection in the deltoid in Jun-2018 and the second HEPLISAV-B injection in Jul-2018 (lot #/expiration date not reported, NDC 43528-002-01). On 21-Sep-2018, the patient received the third HEPLISAV-B injection (lot #/expiration date not reported, NDC 43528-002-01). The patient reported that "they lost track of how many injections he previously had and realized after he received the third injection he already had a second dose." There were no adverse reactions to any of the injections at the time of this report. No further information was provided. The reporter did not provide a seriousness assessment for the event. Company comment:  The company assessed the event of extra dose administered as non-serious. The event of extra dose administered is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of extra dose administered as non-serious. The event of extra dose administered is unlisted per HEPLISAV-B USPI.
Chills, headache, nausea, achy, sore arm, extreme fatigue.  Lasted 24 hours.
Patient discovered a raised, rectangular, pruritic, red rash at injection site the night of vaccination, approximately 12 hours later. Approximately 2 inches in diameter. No other symptoms. Has been improving since but is still present 5 days later. Reported to pharmacy today.
Information has been received from a physician concerning a female who on 12-OCT-2007 was vaccinated with a first dose of GARDASIL (lot # not reported). On 12-DEC-2007 the patient was vaccinated with a second dose of GARDASIL (lot # not reported). Subsequently the patient developed soreness and redness at the injection site which lasted for one week. It was reported that the patient "did not have this reaction after the first dose of GARDASIL." The patient sought unspecified medical attention. Additional information has been requested.
She woke uo with a knot on a the left side and I gave her advil and heating pad.
Narrative:  67y.o. M with a h/o idiopathic pulmonary fibrosis on 4L O2 at home, CAD s/p stents, pAfib, DM2, GERD, OA, and adjustment disorder was discharged from long inpatient ICU admission to home hospice on 11/12/2021. Pt then died at home in home hospice on 12/10/2021. Pt had received one covid vaccine on 5/20/21 (J&J). This death is not related to vaccine.
Low grade fever, chills, headache, lightheaded, body aches all over, slightly nauseous, injection sight pain. Lasted about 24 hours Tylenol was taken
a patient turned 46 years old before receiving her 3rd dose; No additional AEs; This spontaneous report was received from a pharmacist, referring to female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On unknown days, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, lot# expiration date, route of administration and anatomical location were not provided) for prophylaxis. The patient turned 46 years old before receiving third dose (Inappropriate age at vaccine administration). Pharmacist stated she did not administer third vaccine. No additional adverse event (AE) (No adverse event) and product quality complaint (PQC) reported (No adverse event).
Headache, sore throat, fever of 102 degrees F, trouble swallowing because child reported that her "throat is closed".
My son is 14, and has been on Jornay since August. It has been a game changer, amazing. He has had no side effects. However, this said, on 11/2 he received the bivalent COVID booster and the flu shot. Within days he was experiencing anxiety on a level I have never seen, he was experiencing paranoia, and he was experiencing severe agitation. He had barely any side effects from previous COVID vaccines and boosters. After consulting with his medical team they are thinking there maybe an interaction btwn the bivalent booster and Jornay, they have reduced his Jornay and we are trying to ride this out but it's serious. Has anyone looked into weather the bivalent COVID booster when given to patients on Jornay, can trigger a rather immediate psychosis response in Jornay, after previously having NO side effects for months on Jornay?
Received statement from clinical support licensed practical nurse that she had spoken to a volunteer who coordinated a public flu vaccine clinic site that a woman who had received the flu vaccine on 11/13/02 had called to say that she had hives all over her body.  She added that she has had hives for 2 years and is taking Zyrtec every day with good control until she had the flu shot. Staff nurse phoned the individual at 3:20pm on 11/13/02.  The nurse determined that the woman does not have a primary care provider.  She denied shortness of breath, swelling or difficulty swallowing.  Nurse recommended that the woman go to  emergency treatment center, and if she developed any of the above symptoms, she should go by ambulance/rescue.  Telephoned individual on 11/14/02 and again on 11/15/02.  She did go to minor emergency room, received treatment, and the hives resolved.
pt recv vax; w/in 45 sec of vax,exp a "feeling of a hand across the throat";HA & devel d & v;did not devel wheezing or any change in voice;tx w/ diphenhydramine & subsequently recovered from tightness in her throat p/ approx 3 days;
No adverse symptoms reported; the patient was inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a pharmacist referring to a 72 year old patient of unknown gender. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.      On 30-JUN-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, strength, route of administration and anatomical location were not reported (Lot # S001832, expiration date 12-MAY-2020) for prophylaxis.   No adverse symptoms were reported. Product quality complaint was not involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; 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
Information has been received from a physician concerning a 30 year old female with cholesterol levels raised, asthma and allergies to CODEINE and penicillin who was vaccinated with two doses of MMR II (lot number not provided) as a child.  Now the patient had negative antibody titers for measles, mumps and rubella.  The patient recently received a flu vaccine, and now was experiencing achiness and a "mild injection site reaction" on her arm.  The patient visited the office and sought medical attention.  The outcome of the event was unknown.  Additional information has been requested.
I had extreme fatigue and exhaustion, it was unlike anything I've ever had. If I didn't have a dog to take out, I probably would have stayed in bed all day with little to no energy. It went on for weeks.
Within 12 hours after this 2nd Moderna vaccine I developed a fever over 100. The next day, I slept until fever broke @ 5:00 pm.
ADMINISTRATION ERROR: PHARMACIST ADMINISTERED PFIZER COVID-19 VACCINE FOR 12 YEARS AND ABOVE INSTEAD OF PFIZER COVID-19 VACCINE (5 TO 11 YEARS)
Pt experienced malaise, soreness at injection site and myalgia after receiving 5 doses of RabAvert for post exposure prophylaxis. Follow-up report is pending.
Signs and symptoms of COVID began on or around 11/21/2021, and included increased shortness of breath, SpO2 of 70% on room air. Hospitalized 6 days, 11/28/21 - 12/1/21
no adverse effecet; improperly stored doses of proquad was administered; This spontaneous report was received from a medical assistant regarding a patient of unknown age. Information related to pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 02-AUG-2019 the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S003171, expiry date:30-JUL-2020, dose, route and anatomical location were not reported) for prophylaxis (product storage error). The vaccine was stored at a temperature of -11.68 degree Celsius at a time frame of 2 hours and 15 minutes which was noted in digital data logger. There were no previous temperature excursions. No adverse affects reported (no adverse event). No PQC was involved.
Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Since 08-SEP-2015 the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L017144, expiration date 13-MAY-2017, dose and route were not reported). Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
sore arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYALGIA (sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided) since an unknown date. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Cold sores.    On 20-Jan-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) 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 concomitant medications were provided No treatment information provided
Headache, Myalgia, Arthralgia, Fever,  NauseaVomiting, chills, fatigue Narrative:
I had stomach pain that felt a bit like gas, that persisted for 7 days.  I finally went to the doctor who indicated it could be a hernia and to go to the ED if it got worse.  The pain got worse that night, so I went to the ED on 11/6 who found my lipase to be 2126.  No other labs were abnormal.  They diagnosed me with idiopathic pancreatitis despite the fact that I do not drink alcohol and am not on any medications that would cause pancreatitis.  I did not have vomiting or nausea.  I was discharged home on a clear liquid diet and am currently on day 9 of the pain, though it is getting better with the clear liquid diet.