chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first 2 days were sore, warm, and about a 2 inch bump. By day 3, the bump spread to about 4 inches and brought on low grade fever (99-100°), extreme fatigue, nausea. Day 4-7 it progressed, area affected was about 6-8 inches in diameter, fever continued off and on, extreme headaches. Slept several daytime hours, then again all night.
FATIGUED; This spontaneous report received from a patient via a company representative concerned a male 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, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigued. This report was non-serious.
Initial information received on 15-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA232580 (same reporter). This case involves a two months old male patient who received Hib component, while he received vaccine PENTACEL lot C5408AB in the right thigh on 15-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PREVNAR 13 for Immunisation. It was also a case of actual medication error due to inappropriate reconstitution technique. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
CHILD WAS GIVEN IMMUNIZATIONS [DTAP, IPV, MMR, VARIVAX].  FEW MINUTES AFTER ADMINISTERED VACCINES, DEVELOPED RHINORRHEA, SALIVATION, LACRIMATION, COUGH AND BRONCHIOSPASM.  IMMEDIATELY WAS TREATED WITH ALBUTEROL VIA NEB AND EPINEPHRINE 1:10,000 SC.
8/22/2022 I woke up with a headache, fever that went up to 101. The headache was very prominent. I took a home test and it was positive. I had a virtual visit that day and was prescribed PAXLOVID. I began taking the PAXLOVID that day. The headache was off and on for about 24 hours. The fever lasted about 2 days. I took ibuprofen. By 8/24/22 my fever and headache were gone. I tested negative after about 6 days. Then the next day, I tested positive again, but had no symptoms.
Ovarian Cyst diagnosed on 01Mar2021 after the 1st dose(administration date 10Feb2021).; This is a spontaneous report from a contactable consumer. This 22-year-old female consumer(patient) reported that:   Report about covid vaccine: Yes Reporting type: AE Reporter type: Patient Current age: 22 Current age unit: Years Gender: Female Is pregnant: No Patient occupation: Other Health Professional  Covid vaccine details Product=COVID 19 Brand=Pfizer Lot number=EN6198 Lot unknown=False Administration date=03Mar2021 Administration time=02:15 PM Vaccine location=Left arm Dose number=2   Product=COVID 19 Brand=Pfizer Lot number=EN9581 Lot unknown=False Administration date=10Feb2021 Administration time=02:45 PM Vaccine location=Left arm Dose number=1  If other vaccine in four weeks: No Other medications in two weeks: Adderall (daily), Hydrocodone on 02Mar and 01Mar  Adverse event: Started feeling severely nauseous and fatigued. Fell asleep and slept through the night until 7:15AM. Woke up in sweat, pounding headache, feeling super weak and dizzy, tried to get water but started throwing up x3. Called out of work. Fell asleep and only woke up to intermediate alarms I set for myself. Too weak to get out of bed rest of day. Was awake for a total of 2.5 hours before falling asleep again at 6:30PM and waking up on 6:15AM on 05Mar. Feeling better than yesterday but still a severe headache.  Adverse event start date: 03Mar2021 Adverse event start time: 08:30 PM Ae resulted in: [None of the above] If patient recovered: Recovering If treatment ae: No If covid prior vaccination: No If covid tested post vaccination: No Known allergies: Gluten Other medical history: PTSD diagnosed 01Mar, Ovarian Cyst in 2021.  No follow-up attempts are possible; and no further information is expected  Amendment: This follow-up report is being submitted to amend previously reported information: Ovarian cyst updated as reaction of 1st dose and case is split case for 1st dose. Narrative the year for diagnosed with ovarian cyst 2021.
Information has been received from a nurse referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. on unknown dates the patient was vaccinated with three doses of (Oka/Merck) VARIVAX (dose, lot #, route and application site was not reported). Concomitant therapy was not reported. The patient did not experience any adverse reactions from receiving three doses of (Oka/Merck) VARIVAX. Additional information has been requested.
No additional adverse events reported; a dose of PROQU AD that was administered improperly stored during a temperature excursion; This spontaneous report has been received from a medical assistant, referring to patient of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-SEP-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinantHumanalbumin (rHA)) (PROQUAD) (lot # T034614 with expiration date: 10-APR-2022, dose: 0.5 milliliter, strength and route were unknown) for prophylaxis during a temperature excursion found supported (Product storage error). No further information given. No additional adverse events reported. Permission for correspondence given.  Administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinantHumanalbumin (rHA)) (PROQUAD) experienced the temperature excursion under 6 degrees Fahrenheit (F) to 14F (8.5F) for 0 hours 18 minutes and 0 seconds; 6F to 14F (11.9F) for 1 hour 0 minutes and 0 seconds. The time frame was reported as cumulative timeframe: 1 hour and 18 minutes. The previous temperature excursions was not reported.
Heart rate 120-130; vomiting sensation; chills; nausea; bad headache; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate 120-130), VOMITING (vomiting sensation), CHILLS (chills), NAUSEA (nausea) and HEADACHE (bad headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TACHYCARDIA (Heart rate 120-130), VOMITING (vomiting sensation), CHILLS (chills), NAUSEA (nausea), HEADACHE (bad headache), MYALGIA (body aches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Heart rate 120-130), VOMITING (vomiting sensation), CHILLS (chills), NAUSEA (nausea), HEADACHE (bad headache), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Heart rate: 120-130.         The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication reported.
24 hours post injection there was a 21 x 18 cm indurated, tender erythematous (severe localized reaction) on the left upper arm treated with NSAIDS and ice.
I initially had a sore arm on Monday after the vaccine with redness and itching and swelling which I have been putting ice on. I have never had an issue with any covid vaccines and I have only had Pfizer for each one. I also had dizziness and lightheadedness yesterday (10/12/23).
Dose given from vial opened/punctured on 09/01/2021. Vial not discarded after the recommended 12 hours after puncture. Dose given on 09/03 from previously punctured vial.  Vial kept in refrigerator at appropriate temperature with no temperature excursions. Reported to Moderna.
Information has been received from a physician concerning a 9 year old male who on 01/16/1998 was vaccinated subcutaneously with a dose of varicella virus vaccine live.  The patient presented on 05/21/2004 with a breakthrough case of chickenpox.  The case was mild, with no fever and about 30-40 maculopapular lesions on the upper and lower extremities.  The child was given diphenhydramine for the itching.  No product quality complaint was involved.  Additional information has been requested.
Fatigue, nausea, vomiting  and aches and pains in chest area similar to  feeling when I had Covid19. This lasted for about 15 hours
Hospital called at 4:00 PM on 4/29 to let us know that the patient was being admitted due to several small PEs.
28 minutes after receiving the first dose of the Moderna, client complained of tingling lips. H/O anaphylactic reaction to bee stings and birch wood that started out in a similar way. Vital signs taken and normal, no complaints of SOB or chest pain. 25mg of Benedryl given, symptoms decreased. Client is an RN, another dose of Benedryl was given for her to take if she felt she needed it. No other symptoms presented.
Headache, joint pain, arm pain at shot location, fatigue, no appetite, aching. 2 days in and feel better but arm very sore and still not feeling normal
2/11/08 patient received MMR, Hep A, Varicella and Flu shot. On 2/19 symptoms of rash began at the head with purple lips.  Rash began moving down the rest of the body with fever of 101+.  On 2/20 she had a fever of 105.2 and rash fully covered body. On 2/22 she is having difficulty breathing...went to the doctor and was told that this will run its course and to give her Motrin.  Benedryl has not helped at all.
Adult COVID vaccine given to 11 year old.  Parent described no adverse effects/symptoms post vaccine, including normal expected side effects from this vaccine.
PT had severe vertigo, and emesis, which resolved after about 45 min.  Pt. had no further compliants of hx.  Pt refused EMS tx, and transporteed POV home to be observed by friends.  ADvised to call 911 if vertigo or other S/S continue.
Patient was waiting his 15 minutes after the vaccine and began to feel light headed and passed out. He first hit a woman in a wheelchair with his face / lip and then fell back and hit the back of his head on the floor. An ambulance was called, we got him water, took his BP, HR, and O2 levels.
Received Pediarix, HIB, Prevnar on 12/13/04 in am (2nd series).  Developed uncontrollable crying and elevated temperature approximately 10 hours later.  Temperature spiraled to 104 degrees (R) Follow up report received 02/18/2005 Diagnosis was confirmed from medical records as Leukocytosis (not Leukopenia).
Miscarriage one week after shot pain in left arm consistent for three days weakness fatigue vomiting
Arm was a little sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little sore at the injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (First dose) on 26-Apr-2021 and Pfizer (Second dose) on 17-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced VACCINATION SITE PAIN (Arm was a little sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm was a little sore at the injection site) had resolved.            Concomitant information was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-437393 (Patient Link).
28 yo girl presented to clinic at 4:05 pm stating began feeling tingling over all of body, difficulty speaking, chills, pain to bilateral hands since 3:00pm. Pregnant 33 weeks. ENC-09/20/09. While at clinic, pt began to be unable to speak. Continued pending to hospital. Well, difficulty forming words, began with difficulty breathing arms became very rigid, Also hands very rigid. Pt denied pain. No pain to vaccine site. Pt was placed on NST (non stress test) which showed baby reactive with FHR 150's. Pt was transported to VRMC via ambulance at 4:30pm
Three weeks post-vaccination, experienced constant vertigo/dizzyness along with "brain fog". Difficulty concentrating especially when using computer screen. Felt like being on a boat or a dock that is moving. Still experiencing these symptoms intermittently for the past 2 weeks.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 16-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit, the second lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit, the third lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit, the fourth lasting for 24 hours, with the highest recorded temperature of 46.6 degrees Fahrenheit and the fifth lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Got tested for antibodies and he has none; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST (Got tested for antibodies and he has none) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L02A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant. Concomitant products included ANTIVIRALS for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST (Got tested for antibodies and he has none). At the time of the report, ANTIBODY TEST (Got tested for antibodies and he has none) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment were provided.
CLIENT WAS 16 YRS AT DATE OF VACCINE AND WAS SPANISH PEAKING ONLY
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 08-AUG-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Only a few days after being vaccinated, on or about 29-AUG-2014, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir and prednisone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Narrative: Pt is a 69 yo M with PMH of HLD, PVD, HTN, EtOH dependence, tobacco use, aortic embolism, RCA stenosis, subclavian artery stenosis, and vertebral artery occlusion. Per CPRS, Date of Death: MAR 12, 2021, Source of Notification: Agency.
serious:  fast heartbeat at bedtime; woke up the next morning gasping for breath; other:  soreness, swelling at injection site; hoarseness; sore throat; cough; aches; headache; fatique; runny nose and sneezing
Attendee received second dose Pfizer vaccine at 12:35. Lot# EW0179. Attendee was directed to observation area.   At 12:50 attendee attempted to stand and started to fall, someone was able to catch her and assist her back to the seated position.  Attendee's skin was cool and clammy.  Attendee's respirations were not tachypneic or dyspneic. Attendee was then assisted to the cot to lie down, with her legs elevated.  HR:  83   BP:  106/80   RR:   16   O2Sat%:  97      12:55 - Attendee stated she felt better, no longer clammy or pale.  Sat up in the cot. 13:10 -No voiced complaints- skin warm and dry.  Took another set of vital signs before discharge without documentation.  Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with her friend.   Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.
Patient came in for HIV & STD testing.  She was administered an HPV immunization and later found out that she is pregnant.
Hypotonic, hyporesponsive episode lasting for 5-10 minutes, temp of 101. Medical records states cyanosis, pallor. msv
Urticaria (hives) that would develop on random areas of my body. Hives were constant, but placement was not. For 1 month I took Pepcid twice a day, and Allegra AM and Zyrtec PM, without much relief. Sometimes took Benedryl for extra antihistamine support. After 1 month doctor prescribed a 7 day course of Prednisone. Symptoms were then easier to control with Allegra and Zyrtec. Still had itching and some hives occasionally (especially if eating higher histamine foods like vinegar). On 2/18/2022 took a second course of Prednisone (this one 10-day course) and itching is gone as long as I'm maintaining Allegra, Zyrtec and Pepcid. I've decreased to half a pill of Zyrtec and I am slightly itchier in the evenings, but no visible hives (just occasional redness).
Information has been received from a physician for GARDASIL vaccine, concerning an 18 year old female patient with no previous medical history reported who on 09-SPR-2008 was vaccinated with the first dose of GARDASIL. On 15-JUN-2008 the patient was vaccinated with the second dose of GARDASIL and on 05-NOV-2008 with the third dose of GARDASIL. On 04-DEC-2008, a home pregnancy test was performed and the result was positive. The patient reported to the physician that she was tired. The patient sought medical attention, by phone call. Additional information has been requested.
Recieved the flu vaccine on  9/21/2020, he started complaining of pain in the arm that night and the next day and he would not let guardian look at or touch the area, guardian said it looked red at shower time on  9/22/2020 and was red and hard, there is more redness/ larger area of redness this morning than last night,and the redness is spreading away from flu vaccination site.  It was reported he was nervous for the vaccine and squirmed and tensed up but  then was fine. Afebrile. Was seen by staff on 9/23/2020  at 11:30 am, and she diagnosed cellulitis , went over symptom care, and prescribed cephalexin 250 mg/5ml oral suspension reconstituted 9 ml orally twice a day for 7 days.
Patient had red, puffy & puss filled eyes,swelled lips, bad cough & cold feeling. Was taking CLARITIN for reaction but was told to discontinue & take BENADRYL liquid 1 teaspoonful every 4 hours. Followed up on 9/3/12 and patient was feeling better. Puffy & red eyes and cough better after 24 hours on BENADRYL.
Information has been received from a medical assistant concerning a 63 year old female patient with allergy to tetanus shot and a history of bowel irregularities, spastic colon and seasonal allergy who in January 2009, was vaccinated with one dose of ZOSTAVAX (Merck). Concomitant therapy included SYNTHROID and BONIVA. In February 2009, the patient developed a big cold sore. The patient had never had a cold sore and believed it was from ZOSTAVAX (Merck). The patient had been seen physician for medical attention. On an unspecified date, the patient recovered from the big cold sore. Additional information has been requested.
Information has been received from a registered nurse concerning a 66 year old female who on 05-OCT-2009 was inadvertently vaccinated with a dose of PREVNAR instead of PNEUMOVAX 23. The reporter indicated that the registered nurse who inadvertently administered the wrong vaccine was not as familiar with the immunization to realize that there were 2 different pneumonia vaccines. Follow up information has been received from a registered nurse concerning a 66 year old female with sulfa allergy and no illness at time of vaccination, who on 05-OCT-2009 was vaccinated with a first dose of PREVNAR (lot # P87186) instead of PNEUMOVAX 23 in the right deltoid. There were no labs and diagnostic tests performed. No adverse effects were reported. Follow up information has been received from a registered nurse indicating that the patient on 05-OCT-2009 was vaccinated with a first dose of PREVNAR (lot # D87186) IM in the right deltoid. The patient did not received any Merck vaccines and did not have any adverse event. No further information is available.
Pt developed an itchy rash on the arm that the injection was given. Arm became swollen and red. Effects lasted about 10 hours. Itching was severe. Skin felt hot to the touch.
Cold symptoms starting 3/16/2022, ongoing symptoms continued and I sought treatment for sinus infection on 4/1/2022.
7 days p/ vax, pt exp a febrile sz which lasted 5min;pt was hosp overnight for observation & discharged;pt experience was considered an important medical event;
Myalgia and Arthralgia. Ibuprofen PRN, Acetaminophen PRN.