chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red bump at the injection site; red bump at the injection site; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (red bump at the injection site), VACCINATION SITE ERYTHEMA (red bump at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE MASS (red bump at the injection site), VACCINATION SITE ERYTHEMA (red bump at the injection site) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE MASS (red bump at the injection site), VACCINATION SITE ERYTHEMA (red bump at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information was reported.
The patient received PNEUMOVAX twice in the same year. The first one was given on 2/4/2014 and the second one was given on 09/17/2014 but the patient never reported adverse reactions on those vaccines.
NAUSEA, WARMNESS, LIGHTHEADEDNESS ALL PRESENTED TO MEDICAL STAFF 2 HOURS LATER. VS 151/75 P 85.
Intense shivering. Temperature in the house was 68 degree F, not an abnormal cold temperature and consistent or higher than previous days/weeks. Intense shivering lasted about 30 minutes. I wrapped myself in blankets and turned on heater but shivering lasted.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # K008679 and expiration date 05-MAR-2017, lot # K026533 and expiration date 07-AUG-2017; exact doses and route of administration were not reported). It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a physician refers to approximately 24 year old female patient. The patient's pertinent medical history included anxiety, drug reactions/allergies to sulfa. On 04-OCT-2013 the patient was vaccinated with a dose of GARDASIL (lot: J003727; expiration: 07-NOV-2015 (also reported as unspecified) and on 10-JAN-2014 (lot: J012212; expiration: 18-FEB-2016 (also reported as unspecified), intramuscular. The patient also received FLUZONE (manufacturer unspecified) on 10-JAN-2014. Concomitant therapies included CELEXA and NORCO. The patient became pregnant with last menstrual period (LMP) of 10-DEC-2013 and estimated delivery date (EDD) of approximately 16-SEP-2014. The patient was confirmed as pregnant by a blood pregnancy test performed on 29-JAN-2014. Trimester exposure to GARDASIL was at first trimester. The pregnancy outcome was pending. On 11-JAN-2014, the patient experienced flu-like symptoms. No treatment received for the event; however, the patient sought medical attention. The event flu-like symptoms were recovered on 29-JAN-2014. Additional information has been requested.
"freezes" for a few seconds; generally feeling "bad; sore arm; He experienced slight fever; feels weak; condition aggravated; This non-serious case was reported by a consumer via call center representative and described the occurrence of preictal state in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included neurofibromatosis, preictal state (She stated that these episodes were once every few weeks) and weakness.   On 12-OCT-2023, the patient received Shingrix. On 12-OCT-2023, less than a day after receiving Shingrix, the patient experienced feeling bad (Verbatim: generally feeling "bad), pain in arm (Verbatim: sore arm) and fever (Verbatim: He experienced slight fever). On 13-OCT-2023, the patient experienced preictal state (Verbatim: "freezes" for a few seconds). In OCT-2023, the patient experienced feelings of weakness (Verbatim: feels weak) and condition aggravated (Verbatim: condition aggravated). On 13-OCT-2023, the outcome of the pain in arm and fever were resolved.  On 14-OCT-2023, the outcome of the feeling bad was resolved. The outcome of the preictal state, feelings of weakness and condition aggravated were not resolved.   It was unknown if the reporter considered the preictal state, feeling bad, pain in arm, fever, feelings of weakness and condition aggravated to be related to Shingrix.     It was unknown if the company considered the preictal state, feeling bad, pain in arm, fever, feelings of weakness and condition aggravated to be related to Shingrix.   Additional Information: GSK receipt date 17 Oct 2023: The mother of the patient was the reporter. She stated that her son, received the SHINGRIX vaccine. He experienced slight fever, sore arm and generally feeling bad for about 24 hours.  She also reported that he had a history of episodes where he freezes for a few seconds. She states that he could tell when an episode was coming on, and feels weak after.  She stated that these episodes were once every few weeks, but since receiving the SHINGRIX vaccine, they were happening multiple times per day. The reporter did not consent to follow-up. Also because the patient's doctor was unaware this was happening. It was advised encouraged the mother to encourage her son to speak with his doctor about these episodes as soon as possible.
I am having issues with my smell . Everything smells the same. I cannot place the smell. It is not a bad smell but I smell the same smell everywhere.
ER then sent to another hospital for admission. The patient is a 6-month-old who had her routine six-month immunizations at Pediatric office today and was doing fine all day. She was given formula at approximately 1900 hour per the mother and laid in bassinet and at approximately 2155 hours mother found she felt warm and found her seizing. Infant was brought to the ER by the EMS to be in status epilepticus. IV was established and Lorazepam was given. After third dose of lorazepam, seizure activity did resolve. Infant was also given normal saline bolus, as well as IM injection of phenobarbital 100 mg. At that time I arrived and infant was having some increased tone and jerking and felt to be further seizure activity, and lorazepam was given. Anesthesia was called and she was successfully intubated with a 4-0 uncuffed tube at 13 cm at the lip. Propofol was given prior to this. ET tube was checked with auscultation and chest x-ray was obtained which did show in the right main stem bronchi and this was later pulled out 2 cm. Infant again had some seizure-like activity, more of posturing and was given 2 further doses of the lorazepam. This seemed to stopped the seizures. The infant also received 100mg/kg of ceftriaxone IV.
On 1/10/2021.......Chills, body ache, headache, sore in the injection site On 1/11/2021...... Face feels hot, low grade fever
This serious initial spontaneous case, was received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with 20 of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 18-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 24-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the document review, it was stated, that FLUCELVAX (batch number: 185888) was manufactured in compliance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No deviations were found for any temperature excursion of the final packaged product for Batch 185888. The results from the stability protocol do not indicate any issue with the stability of the 2016/2017 commercial season. No evidence was found that the LOE (lack of efficacy) complaint was the result of the fill finish or bulk manufacturing process and no trends were identified for the batch, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX commercial season. Therefore, no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (reference number 1022277) received from quality assurance department on 29-Jul-2017: Quality assurance investigation results were updated and the narrative was amended accordingly. Non-significant case correction received on 10-Aug-2017: The narrative and case comment were corrected.
Sudden Idiopathic Sensio Neuro Hearing Loss in the my left ear, severe/profound loss
Started with weakness and muscle aches on thursday the 7th. Fever and severe muscle aches and stiffness, diarrhea and dizziness at rapid breathing and heart rate on friday daytime and worse in the evening. 4am on Saturday woke up to drenched in sweat and then at 7am a rash and hives covering my entire body. Itchy and painful and everywhere. I am 34 weeks pregnant so i called my ob and they suggested extra strength tylenol and benadryl. and go to hospital if  breathing got worse or didnt feel better.
pt recv vax & devel a rash covering the lt deltoid & upper arm, chest, abd & back;also exp sl itching;
Facial dropping on right side; Pain in muscles of arms which is radiated up into muscles in edge of neck; Pain in muscles of arms; injection site pain; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (Reference number- 00327750) and transmitted to Sanofi on 22-Oct-2020.  This case involves a 65 years old female patient who experienced facial dropping on right side (facial paralysis), pain in muscles of arms which is radiated up into muscles in edge of neck (myalgia and pain) and injection site pain (vaccination site pain), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   On 22-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Prefilled syringe, lot uj453ab, expiration date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On 22-Oct-2020, the patient developed a serious facial dropping on right side (facial paralysis), one month following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  On 22-Oct-2020, the patient developed a non-serious pain in muscles of arms which is radiated up into muscles in edge of neck (myalgia and pain) and injection site pain as well (vaccination site pain), one month following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of events was reported as unknown, at the time of reporting.; Sender's Comments: This case concerns a 65 years old female patient who experienced facial dropping on right side, pain in muscles of arms which is radiated up into muscles in edge of neck and experienced injection site pain as well, one month after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Fever, rash, irritability for 48 hrs 3-4 days after vaccine, also slight ataxia. Resolved after 48 hours.
17 year receiving moderna vaccine; A spontaneous report was received from a consumer concerning a 17-year-old patient, who received the vaccine/product administered to patient of inappropriate age.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received one of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the 17-year-old patient received the vaccine.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome event, product administered to patient of inappropriate age, was considered recovered.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Subclinical hypothyroidism; and they are inflamed and you are able to see them.; they said her antibodies were low and she had to get re-dosed; chain of lymph nodes in her neck; This spontaneous report was received from a 47 year old white female patient reporting on herself. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.  On unspecified date in 2014 (also reported as: "around 2014"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis.  On unspecified date in 2014 (also reported as: "around 2014"), the patient experienced subclinical hypothyroidism, chain of lymph nodes in her neck and they are inflamed and "you are able to see them". In addition, her antibodies were low and she had to get re-dosed.  The outcome of hypothyroidism, antibody test abnormal, lymph node palpable and lymphadenopathy was not provided.  Causality assessment between hypothyroidism, antibody test abnormal, lymph node palpable and lymphadenopathy and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not provided.  Upon internal review, hypothyroidism was determined to be medically significant.
MUSCULAR PAIN SKIN RASH RED SKIN HIGH BLOOD PRESURE 11/13/06 Received medical records from VAMC which reveal patient experienced HTN, high cholesterol & high triglycerides, right knee & left shoulder pain, obesity, NIDDM. Per 60 day follow up: Muscle and joint pain, skin problems or rash, red skin, eye problems, memory problems, cramps leg and cramps arm, drowsiness, fatigue, headaches, appetite problems. Follow-up: Dry skin problems and rash. Red skin, vision problems, memory or brain problems, headache frequently, drowsiness, fatigue, muscle and joint paint, cramps in my legs and arms, appetite lost, diabetes, high blood pressure. After that vaccination I report this symptoms and I am not be the same person before this vaccination.
Received the Moderna Bivalent booster on the same day at Pharmacy and "my husband's arm is still sore after 2 months/It is very painful; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Received the Moderna Bivalent booster on the same day at Pharmacy and "my husband's arm is still sore after 2 months/It is very painful) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 067H22A and 011H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, LOT 004M20A) on 28-Jan-2021, Moderna COVID-19 Vaccine (Dose 2, Lot 023M20A ) on 28-Feb-2021, MODERNA COVID-19 VACCINE (Dose 3, LOT 025C21A ) on 01-Sep-2021, Moderna COVID-19 Vaccine (Dose 4 and Lot 041J21A ) on 07-Apr-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 27-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 50 microgram. On 09-May-2023, the patient experienced PAIN IN EXTREMITY (Received the Moderna Bivalent booster on the same day at Pharmacy and "my husband's arm is still sore after 2 months/It is very painful). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Received the Moderna Bivalent booster on the same day at Pharmacy and "my husband's arm is still sore after 2 months/It is very painful) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the pain started about 9-May2-023, besides the usual normal pain on the day of injection. No treatment other than cold compress and Ibuprofen.
Patient had 3 seizures following her vaccinations. This took place approximately 18 hours after the vaccinations were administered. She had a mild fever (99.8-100.6) and had swelling in both of her thighs and reddness at the injection sites. The first seizure happened 10 minutes before the second, and then five minutes later the third happened. She gasped for air after each episode. She was upset after each one but seemingly normal. 911 was called and she was transported to Medical Center in stable condition. She was then transferred to another hospital. She had a spinal tap, CT scan of the head, blood work,  08/21/2008 MR received for DOS 8/05-06/2008 with no final dx. Admitted for seizure-like activity 18 hrs following 4 mon vax. Mother noted pt with arched back, shaking all 4 extremities, eyes gazing right. Appeared to have stopped breathing, then gasping and crying. 2nd episode 10 minutes later and 3rd 5 minutes after that. No further episodes. Had one vomiting/diarrhea episode prior to admission. PE (+) for injection site pain and swelling. Developed continued vomiting and diarrhea during stay, otherwise no further seizure like episodes. EEG to be done as outpt.
The 2 year old male patient received a dose of Influenza Virus Vaccine Tri-Valent Split 2010-11 45mcg/0.5ml IM Susp.in his Lt thigh. Patient had no adverse reactions at the time of administration, and no reported adverse events to date.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 22nd August 2018, immediately after receiving SHINGIRX, the patient experienced injection site pain and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got the 2nd dose late which led to lengthening of vaccination. The caller requested reimbursement for vaccine explained that the shot was very painful. The patient was upset and did not want to speak to the product team. The caller gave permission for someone to call her and ask questions in regards to side effects at a later date or time. The patient got a SHINGRIX shot late because the manufacturer did not provide the shot. The reporter ended up having to pay full price for the shot because our insurance did not cover it. The patient planned for the insurance to cover it, and it covered the 1st one but would not cover the 2nd one.
Information has been received from a nurse referring to a 40 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 07-JAN-2019, the patient was vaccinated with the first dose of GARDASIL 9 (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). On 07-FEB-2019, the patient received the second dose of GARDASIL 9. No adverse effects were reported.
Pt. awoke this am with whelps on arms and chest . Non itchy whelps
Patient had induration and erythema around injection site. Patient given Benadryl and waited for 30 minutes. Patient had no airway complications. Patient sent home with mom.
Patient received 4 previous Moderna COVID 19 vaccinations on 6/22/22, 12/6/21, 3/25/21, and 2/25/21.  She received above Pfizer  booster COVID vaccine exactly 30 days before a recurrence of her Thrombotic, thrombocytopenic purpura. She was hospitalized on 12/14/22.
Information has been received from a registered nurse (R.N.) concerning her 20 year old grand daughter who got a letter from her in late August or early September (WAES# 0809USA03784). The R.N. developed shingles on 01-SEP-2008. On 06-SEP-2008 her grand daughter was diagnosed with shingles on the left side of her face. At the time of this report, the outcome was unknown. Follow up information was received from the R.N. who reported that in the morning of 01-SEP-2008 her granddaughter with no pre-existing allergies, birth defects and medical conditions who developed blisters which fluid filled, painful line broke out on left upper cheek tracking to and into left eye. On 08-SEP-2008 the patient went to emergency room and was diagnosed with shingles. At the time of this report, the outcome was unknown. Shingles was considered to be disabling and an other important medical event. Additional information is not expected. This is one of several reports from the same source.