chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles after dose 1 of Shingrix; This case was reported by a physician via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had shingles after 1st dose of Shingrix. The reporter consented to follow up. This case has been linked with US2020045152, reported by same reporter.
Started presenting a very itchy area around the injection site; Soreness at injection site; Experienced redness at injection site; A spontaneous report was received from a consumer concerning herself, a 80-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at injection site / vaccination site erythema, soreness at the injection site / vaccination site pain, started presenting a very itchy area around the injection site / vaccination site pruritus.  The patient's medical history was not provided. Concomitant product use was not provided.  On 13 Feb 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly on her left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced redness and soreness at the injection site. On 22 Feb 2021, the patient experienced started presenting  a very itchy area around the injection site which seems to be spreading out further.  Treatment details included acetaminophen, hydrochlorothiazide, a statin, atenolol, citalopram.  Action taken with mRNA-1273 in response to the events was not reported.   The event(s), redness and soreness at the injection site got resolved on 15 Feb 2021. The outcome of event, started presenting a very itchy area around the injection site was unknown.
Single febrile seizure; This 12-month-old female subject was enrolled in a blinded study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when Administered Concomitantly with Routine Vaccines to Healthy Infants. The subject received the 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 4th November 2019, for prophylaxis.   Co-suspect products included Mmr Ii for prophylaxis.   Concurrent medical conditions included upper respiratory tract infection.   On 17th November 2019 20:00, 13 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, the subject developed severe - grade 3 febrile seizure. Serious criteria included clinically significant/intervention required. The outcome of febrile seizure was recovered/resolved on 17th November 2019 20:03.   The investigator considered that there was no reasonable possibility that the febrile seizure may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines.   Other possible cause(s) of the febrile seizure included concurrent medication MMR II  and medical condition upper respiratory tract infection.   INVESTIGATOR TEXT Subject reported a temperature of 100.7F in their e_Diary the evening of 17Nov2019 and then subject experienced a febrile seizure (not tonic-clonic, simply blank stare and unresponsiveness for 2 to 3 minutes). Subject did not go to the emergency room for this but did have a visit with the PCP on 18Nov2019. According to the PCP's exam, subject has an upper respiratory infection. It is not known definitively if the fever and associated febrile seizure was a result of the URI or a reaction to MMR vaccination (timing of reaction falls with in parameters of a possible reaction to MMR vaccine). - Single febrile seizure - related to - MMR II;  This case contains an event assessed by the investigator as a serious Adverse Event of Special Interest (AESI).    Additional details:  On 17th November 2019 20:00, 13 days after 1st dose of MMR II (non GSK product, taken as prophylaxis), the subject  experienced febrile seizure.; Sender's Comments: A case of Febrile convulsion, 13 days after receiving 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, in a 12-month-old female subject. Causal relation to the vaccine product is indeterminate, considering possible alternative etiologies (MMR administration and upper respiratory tract infection) based on medical history.
Noticed on 10/23/11, red, warm, indurated. On 10/25/11 reaching 10-11 mm, started AUGMENTIN to r/o cellulitis. Induration improved/subsided 10/26/11. Rash.
Tested positive for Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for Covid-19) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Allergy to antibiotics). Concomitant products included VITAMINS NOS and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for Covid-19). At the time of the report, COVID-19 (Tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  It was reported that the patient had not taken any other vaccines within 1 month prior to receiving the Moderna COVID-19 vaccine.  It was reported that the patient had no medical history related to the adverse event and both acute and chronic illnesses at the time of vaccination.  Company Comment. This spontaneous case concerns a 62 year old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately 11 months and 3 days after receiving first dose of mRNA-1273.  She received first dose of mRNA-1273 on 3-Feb-2021 followed by a second dose on an unknown date.  She tested positive for COVID-19 on 06-Jan-2022.  Clinical course and treatment for COVID-19 were not reported.  At the time of reporting, the outcome of the event was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.     This case was linked to MOD-2022-500852 (Patient Link).; Sender's Comments: This spontaneous case concerns a 62 year old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately 11 months and 3 days after receiving first dose of mRNA-1273.  She received first dose of mRNA-1273 on 3-Feb-2021 followed by a second dose on an unknown date.  She tested positive for COVID-19 on 06-Jan-2022.  Clinical course and treatment for COVID-19 were not reported.  At the time of reporting, the outcome of the event was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Patient has allergies once a year with seasonal change.).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-239096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up included no new information
This is a spontaneous report from a contactable consumer (patient's daughter) via sales representative. A 89 years old female patient received PREVNAR 13 on unknown date, at single dose. The patient went to the dentist before having vaccination and had several teeth filled. Concomitant medications were not provided. On unknown date (on the night of vaccination) the patient experienced high fever. The next day she got really sick with high fever and extreme lethargy. The site of her injection was very red, swollen and hot. She went to the Emergency room and was admitted spending 3 days in the hospital spiking fevers on and off the entire three days. At discharge doctors and nurse agreed that her illness was due to the vaccine. After continuing with fever on and off for several days she went back to her regular doctor and he too agreed that her illness was due to the vaccine. Final events outcome was unknown at time of report. The reporter considered that the patient illness could possibly be due to her dental procedures.
within 15 minutes developed dysphagia, tongue tingling. : transferred to ED  : Observed for 4 hrs and d'cd to home
10/02 vaccine administered. 10/02 Evening: patient began running fever. 10/03 Patient unable to walk due to dizziness; dyspnea on and off since 10/02. 10/05 Mother thought bloated; gave suppository and he died.
hearing little voices every once in a while only in the mornings; arm hurt, both of his arms hurt; bad dreams/dreamy thing; getting tired; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION, AUDITORY (hearing little voices every once in a while only in the mornings) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024 and 007) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HALLUCINATION, AUDITORY (hearing little voices every once in a while only in the mornings) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm hurt, both of his arms hurt), NIGHTMARE (bad dreams/dreamy thing) and FATIGUE (getting tired). At the time of the report, HALLUCINATION, AUDITORY (hearing little voices every once in a while only in the mornings), NIGHTMARE (bad dreams/dreamy thing) and FATIGUE (getting tired) was resolving and PAIN IN EXTREMITY (arm hurt, both of his arms hurt) had resolved.            The patient had concomitant medication of thyroid medication and high blood pressure medication.  Arm hurt which took a long time to go away and 3 weeks ago patient started to experience hearing little voices. Occasionally he did get tired but never experienced this before. Health care professional advised him to see a doctor as he was not able to take a booster dose. His symptoms went away a little bit and he had never had a dreamy thing before.  No treatment information was provided.  Company Comment: This is a Spontaneous case concerning a 73-year-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Hallucination auditory. The event occurred on a date after the second dose of mRNA-1273 vaccine. Patient reports that he started hearing little voices every once in a while only in the mornings. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a Spontaneous case concerning a 73-year-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Hallucination auditory. The event occurred on a date after the second dose of mRNA-1273 vaccine. Patient reports that he started hearing little voices every once in a while only in the mornings. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Per my 2nd vaccine, I had bled for 28 days total about 6 months after getting my vaccine. A few months after my booster shot, 02/03/2022 I started bleeding very heavily after having a period 8 days prior. In between 2nd shot and booster I had a pelvic ultrasound that showed no reasoning behind why I was bleeding so much and for such a long duration.
Approximately 18 hours receiving the shot, I woke up with flu like symptoms and was very lightheaded. At one point in the morning while sitting at my kitchen table I collapsed to the ground. About 6 hours after these initial symptoms I was fine.
7 Month old infant developed fever to 104 following DTP/Measles Immunization.
Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine observation.   At 1035 customer called out to provider. Customer reports feeling acute nausea and she states she feels as if she is going to throw up. She appears slightly pale and significantly anxious.   Customer is moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports feeling sweaty, with waves of nausea and intermittent ULQ pain that she describes as sharp and bandlike across the diaphragm. She episodically calls out in pain and clutches her left chest below her ribs stating that it feels better when she puts pressure at the site. Customer admits to having significant anxiety and a history of panic attacks. HR 102, 02 99%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 1043. Customer monitored at site. Over the course of the next 15 minutes, she reports feeling better and more relaxed. Customer reports full resolution of symptoms @ 1100. BP 108/82, P 101, O2 100% RA, RR 16.    Customer is agreeable to extended monitoring after receiving Benadryl. She has been driven to the vaccination site by a family member and states she will not be alone at home. She is instructed to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED.    Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer agrees with plan and denies further questions/concerns. Customer released from site at 1115, ambulating independently with steady gait, no obvious s/sx of distress.
Fever for 15 hours. Chills, aches, nausea, and  fatigue. Injection sight red warm and itchy.
Patient reported 10/29 that since receiving the SHINGRIX 10/22/18, she has experiencing dizziness several times a day. She noticed it the day after. It is worse bending over to rising up and getting up from a sit. This to PHN sounded like postural hypertension and inquired if on medications. Patient disclosed she is on hypertension medications. It could be unrelated and due to her hypertension but reporting. She also had influenza vaccine on 10/15/18 at Pharmacy--unsure if this is related. PHN advised patient to call and be seen by primary care provider. PHN reviewed that dizziness can be a rare reaction but usually associated with anaphylaxis and not lingering but acute. Patient stated she would call MD. PHN plans to check back in for status update.
At 10:16 patient's mother brought him to our attention regarding how he was feeling. She states that patient was feeling hot and took off his sweatshirt and complained that he was starting to feel "dizzy" - then he started looking "grey" and not responding to any of her questions. States that he was progressively getting worse over time. Patient was flushed and hypotensive (80's/40's) initially followed by bp of 90/50 then before he left 102/60 at 10:45am. Initially his heart rate was 74 bpm and before he left it was 82 bpm. His temperature was around 97.5. Patient had not had anything to eat or drink prior to appointment. Patient was given a snack and water before leaving.
Received 3 shots on June 20. LD KINRIX LA subq PROQUAD RD HepA. No reaction evident on (R) arm. Two areas of redness, swelling, pain, hardness on left arm where shots were given. Also had slight fever. 6/27/17 Band-Aid off 3 days ago-had little dried pimples around them. Muscle still a little swollen-but not red anymore.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th July 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. After receiving SHINGRIX, the patient felt slightly tired. This case had been linked with case US2018GSK216203, reported by same reporter for same patient.
positive test; positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number un-known, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Known allergies: No. Other medical history: No. Other medication in 2weeks: Yes. Concomitant medication(s) included: METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Anti-viral details: Product: Covid 19 Treatment Brand: Paxlovid, Treatment start date: 26May2022, Treatment Stop date: 01May2022 and Indication: Treatment of Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 2 x 3 inch slightly red raised area.  This reaction was first noticed one week after the injection.
Caught COVID after being fully vaccinated; Caught COVID after being fully vaccinated; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  An (10-17 years) adolescent female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome unknown and all described as caught COVID after being fully vaccinated.   Clinical course: It was reported that, the patient had COVID in January. She was due for her booster. Also reported that, she was fully inoculated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
11/21/21 presents to ED for "COVID symptoms, hypoxia". PMHx of "MS".
20JUL94 9PM-1AM 21JUL94 pt very restless; @ 1AM awake screaming & hot; given APAP cont crying, screaming, would not seattle - mom walked the floor w/pt until 7AM; went to sleep & slept until 2PM;
Moderna Covid-19 Vaccine EUA  Very itchy rash at left elbow (same arm as injection)--approximately 2 inch round redness with bumps. Lasting into third day post-vaccination. About 56 hours post-vaccine, Itchiness subsiding, red circle about 1 inch diameter. No rash at right elbow or elsewhere, so seems linked to vaccine. I will check Yes in Item 20, even though not fully recovered yet, but because I'm clearly going in that direction so best answer of choices you give.
received "all Pfizer Covid vaccinations" but still got Covid.; received "all Pfizer Covid vaccinations" but still got Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received "all Pfizer Covid vaccinations" but still got Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller states she received "all Pfizer Covid vaccinations" but still got Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment of Paxlovid. Reporter states patient received her last booster in May or Jun, would like to have information on the vaccine currently being developed to address the "4, 2" variant, and when a booster would be recommended with the new vaccine. Patient received "all Pfizer Covid vaccinations" but still got Covid. Reporter seeking information on when she may resume taking amlodipine and lovastatin. patient has not taken either medication while taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt had a localized reaction to Anthrax vaccine on left arm of a 3cm X 5cm area of induration and redness plus itching and swelling at site.
Patient had very bad pain in the arm/muscle where the immunization was administered.  It has been 2 months since the immunization, and she still has pain even though it has improved some.
Dizziness stiff & painful joints, difficulty walking r/t knees won't bend Narrative:  reports has hx of RA and is currently taking her RA medication in twice the dosage