chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of fever in a 62-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX with an associated reaction of pyrexia (patient had a similar reaction to ZOSTAVAX 2 years prior). On 9th April 2018, the patient received SHINGRIX. On 10th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The patient was feeling febrile. No additional information was reported.
Signs/Symptoms: fever 102.7, chills, headache, tiredness, restlessness, pain in arm, loss of appetite, malaise.  Time: midnight 01/15- 12pm, administered theraflu relieved most symptoms and slept for 4 hours, headache, malaise, and fever 100.9 returned at 5pm, took another theraflu at 9pm. All symptoms resolved overnight.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (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) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever(101 degrees), Sever body aches, chills, sweats, dizziness, restless & tiredness
Broke out in Hives mainly around lower waist, armpits and neck spreading to his chest, stomach and back.  Gave him Zyrtec (allergy med) and it cleared in a couple of hours.
PATIENT EXPERIENCES RED, ITCHY RASH THAT APPEARS AT DIFFERENT LOCATIONS. WILL RESOLVE IN 1/2 A DAY BUT WILL REAPPEAR AT DIFFERENT LOCATION THE NEXT DAY. RASH IS RESOLVED WITH HYDROCORTISONE CREAM BUT WILL COME BACK.
back red; breast red; sharp pain from under the arm to the breast; headache; horrible back ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (horrible back ache), BREAST PAIN (sharp pain from under the arm to the breast), HEADACHE (headache), ERYTHEMA (back red) and ERYTHEMA (breast red) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012420A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced BACK PAIN (horrible back ache). On 05-Feb-2021, the patient experienced BREAST PAIN (sharp pain from under the arm to the breast) and HEADACHE (headache). On 07-Feb-2021, the patient experienced ERYTHEMA (back red) and ERYTHEMA (breast red). At the time of the report, BACK PAIN (horrible back ache), BREAST PAIN (sharp pain from under the arm to the breast), HEADACHE (headache), ERYTHEMA (back red) and ERYTHEMA (breast red) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment: No.
08/10/2022  I felt very tired my blood pressure was  extremely  low;   I had high heart rate.  I called my cardiologist and told him what was going on so he ordered a heart monitor.  I am being monitored for 3 days. After 3 days my cardiologist will review the readings and will decide what I have to do next. He either will give me medications or something else.  I will be going for a follow up with my PCP a week from tomorrow and cardiologist on  the month of September.
MD skin tested pt w/ACEL immune & HIB both negative so pt recv vax;p/HIB pt devel bronchospasm;
All gotten covid 19; All gotten covid 19; Have problems; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient(her nephew). A male patient of unspecified age received first dose BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number were not reported) dose 1 via unspecified route of administration on unspecified date as DOSE 1, SINGLE and also received second dose BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number were not reported) dose 1 via unspecified route of administration on an unknown date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that about receiving the 3rd booster shot for her and her husband. She had lupus and fibrosis of the heart and her husband is diabetic. The reporter also reported that her brother, sister in law have all gotten covid 19 after being fully vaccinated. On an unspecified date patient (nephew) have all gotten covid 19 after being fully vaccinated. It was reported that they are mostly heathy but they have problems, her sister in law just got out of the hospital and her brother is still there. The outcome of the events are unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow up (02Sep2021): No follow-up attempts are needed. No further information is expected.
9/27 Within minutes of injection experienced a sharp pain up into my neck just below my left ear followed by tingling of my lips and left facial numbness. Tingling resolved within a couple of minutes but numbness and dull pain below my ear continued.9/28 Facial numbness continued with pain under left ear. Left eyelid was swollen. Went to ER for eval. Diagnosed with numbness and a sty.Facial numbness  completely resolved approximately 24 hours following injection.9/29 Experienced the pain under left ear with left eyelid swelling ,burning and redness of face(cheeks and around lips).9/30Experienced increased redness and swelling of face-.Went to ER again for eval. Diagnosed with allergic reaction.. Treated with IV meds with improvement of symptoms.
1. Immunization administered 8/10/2012 (MMR, Tdap, Hepatitis B).  2. Client returned to clinic on 08/15/2012 with c/o and visible swelling to upper lip (onset 08/14/2012) and c/o diarrhea on 08/11/2012. Denied any prior reaction to any vaccine or vaccine components. Also c/o pain to (r) flank area with deep breath. One prior occasion of similiar incident several years ago, not corresponding with vaccine. Referred to ER for evaluation, instructed to call with update.  3. 8/16/2012 no call from patient on 8/15/2012 as instructed. Call placed to client informed writer that ER MD diagnosed with reaction to current BP med. (Lisinopril) and introduction of vaccine into system creating an adverse event. States given a cortisone shot, BP med changed, and relieved from work until Saturday.
SWOLLEN ARM AROUND INJECTION SITE FROM SHOULDER DOWN TO ELBOW.  WENT TO DR. AND GOT STEROID SHOT.
Due to miss communication with tech, entire vial was injected, including multiple doses at once.  When error discovered Pfizer profession hot line called.  Pfizer informed us of next steps to take.  Patient then called and informed of error and was told to monitor for exaggerated common side effects and how to treat.  Also informed to contact physician if anything above the common side effects occurs.  After numerous calls to patient,  the last being 12 hours after event, no sign of any side effects of any kind. Patient continuing to be monitored.
I started experiencing problems with low blood pressure within a few weeks of my second Moderna shot. After a series of visits to my GP and two cardiologists, I have been diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS).  The diagnosing physician said that sudden onset of POTS (I had no symptoms prior to March 2021) can be related to an immune response from a viral illness. I have not been ill since February 2020, but I did have a very strong immune response to the second Moderna shot (I spent 2 days in bed). So it seems plausible that the POTS is related to the vaccination.
Hot flashes, temperature of 100.1F, body aches, symptoms resolved after approximately 24 hours.
Moderna dose 1- After the first Moderna shot, Period was 2 weeks late,  period is always on time, never late, so this was very abnormal for my menstrual cycle. Late period had NOT occurred before the covid vaccine. I am not pregnant. Moderna dose 2- After the 2nd  Moderna shot, 13 hours later I had chills, muscle aches in my legs & felt very tired. 6 days after that, I had chills again & felt nausated.
3/13 12 pm I got the shot.  30 mins after the shot, I got strong numbness for the whole body(especially face and arms), palpitations, dizziness, shaking chill at a time. I called 911 and went to ER. I got an IV. My symptoms were getting minor and I went home. The doctor said my symptoms are from a bad reaction to the medicine," Adverse Drug Reaction". I still have numbness on my face(left side cheek) a little bit.
Initial report received on 24 February 2009 from the patient's parent.  A 16-year-old female patient had received a dose of MENACTRA on an unspecified date.  Immediately following the vaccination, the patient experienced a fever of 102.0 degrees Fahrenheit with red swelling about the size of a baseball (site not identified).  The patient could not lift her arm past her waist.  She also experienced severe headaches and the "doctor could not help relieve these symptoms."  Per the reporter, the patient's swelling, pain and fever lasted for two weeks straight.  It was not reported whether the patient received any treatment or if any diagnostic tests or laboratory data were performed.  It was also not reported whether the patient fully recovered.  Documents held by sender:  None
Did Not Receive the Full Dose; "Some Dripped Down the Patient's Arm"; Vaccine Leaked Out Due to User Error; Initial Report Received on 13-Oct-2021 and 14-Oct-2021.  A pharmacist reported that a 29 year-old female patient (race and ethnicity unknown) did not receive the full dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as some had dripped down her arm.  The patient had no known drug allergies and allergies to dietary gluten. No other medical history was reported.  No relevant concomitant medications were reported.    On 12-Oct-2021, the patient received dose 1 of HEPLISAV-B (Lot # 934973, expiration date 24-Jul-2022, NDC # on syringe 43528-003-01, NDC # on box 43528000305 and serial # 302622208001) in the right deltoid from the pharmacist (reporter).  It was reported that the Luer-lock needle did not have a good seal and some of the vaccine leaked out. It appeared to be a fairly small amount that dripped out. The patient did not receive the full dose of HEPLISAV-B as some had dripped down the patient's arm. The pharmacist had inspected the syringe and did not see anything wrong with the syringe; however, she discovered that the needle was not tightly on the syringe due to user error. No additional information was reported.   No potential device malfunction requiring investigation was identified.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a mother concerning her 12 month old son with allergy to azithromycin who on 13-MAR-2009 was vaccinated with VARIVAX (Merck) (lot# not reported) and another vaccine (name and manufacturer unspecified). On the night of 15-MAR-2009 the patient developed a 103 F fever without medication and then on medication (name and manufacturer unspecified) the fever went down to 100 or 99 degrees that lasted until the afternoon of the 16-MAR-2009. On 18-MAR-2009 the patient developed a pimply rash on his inner thigh that resembled the chickenpox and then disappeared later that day. On the night of 19-MAR-2009 the patient developed a rash on his chest and then on 20-MAR-2009 the rash was on his body from head to toe, but it was not a full blown case of the chickenpox. The mother reported that the patient did see a physician and diagnosed the patient had having a reaction to VARIVAX (Merck). No lab diagnostics studies were performed. It was reported that the rash disappeared by 23-MAR-2009 and the patient had recovered. The mother also reported that "when the patient received his 9 month old vaccinations (name and manufacturer unspecified), the patient spiked a fever, loss of appetite for 48 hours." In follow-up, the physician indicated that the patient was not seen in the office but made phone calls. The physician had no idea who turned this case in. Additional information is not expected.
Child with history of anaphylaxis, c/o itchy throat and eyes approximately 10 min after receiving vaccines, brought to urgent care and noted to be wheezing, given SOLU MEDROL and nebulizer and transferred by ambulance to hospital. Given epinephrine and IV BENADRYL and observed for 4 hours prior to discharge home.
Pt diagnosed with GBS 11-20-08-Adm >Hospital 11-20-08.  11-19-08-Headache, low back pain, difficulty swallowing, chills-T-98.2, muscle weakness both legs and feet.  Paraseheais  of both legs & feet, difficulty holding a cup, skin sensitive to touch.  12/2/08 Reviewed hospital medical records of 11/20-11/21/2008. FINAL DX: Viral syndrome, tonsillitis, Arnold Chiari I, HA. Admitted for acute onset of subjective UE & LE weakness; HA & backpain w/minimal weakness; normal DTRs.  Records reveal patient experienced congestion, rhinorrhea & cough x 1 week, HA x 3-4 days, back & neck pain, sore throat, swallowing difficulty, leg tingling, and progressive weakness x 1 day.  Initial exam revealed normal DTRs.
I experienced a stroke on 06/15/2021 (woke up with slurred speech and has trouble writing). I ended up going to the ER on 06/17/2021. The ER doctors asked me what was wrong because my speech was slurred and immediately ordered an MRI of my head and neck area along with a CT Scan. The final diagnosis was that everything was normal with the exception of my speech. I was prescribed Plavix 75mg and Aspirin (81mg) to take every day. I decided not to stay in the hospital and was released (went in to see my PCP for further follow up). My doctor sent me for an Echo Cardiogram and wants to continue following up since my speech is now impaired.
Muscle aches at site and other parts of my body,chills and very tired and just felt like I had a virus but just for one day,felt back to normal the next day
A non-serious spontaneous report of erythema multiforme has been received from a Registered Nurse concerning a two year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient received FLUMIST on 21-Oct-2008. The patient received a total of one dose before onset of the event which occurred three days later. On 24-Oct-2008 the child was diagnosed with erythema multiforme. It was described as "raised lesions on buttocks, legs and abdomen." The event remains unresolved with the rash present.
Pt received shingles vaccine on 4/1/16 in the clinic. That day she developed small blister type rash to both hands and forearms. She also had some soreness around the injection site.
This spontaneous report was received from a healthcare worker via company representative regarding a female patient of unknown age. Patient's medical history, current conditions and concomitant therapies were not provided. On an unknown date in November 2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiration date were unknown) as routine vaccination. On an unknown date, the patient experienced injection site to be swollen (infusion site swelling) and a hard knot (injection site nodule). Outcome and causality not provided.
This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, muscle pain and chills. On an unknown date, the outcome of the fever, muscle pain and chills were recovered/resolved. It was unknown if the reporter considered the fever, muscle pain and chills to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient experienced all the symptoms for 3 days. The patient had denied permission to contact their physician. The reporter refused to provide date of birth. This case was linked with case US2018190184 (wife's case), reported by same reporter.
Developed big red lump on right outer thigh area. Redness was the size of a quarter.  The lump was 2-1/2 to 3" in diameter.  Tender. black dot in the middle of the area. The area was firm.
Left thigh became red & swollen after receiving vaccines on 02/23/11. 02/25/11 left leg increase in size & was warm to touch.
3 days after vaccine arm became swollen, red, and itchy. Called doctor on day 6 and told to use ice and BENADRYL. Saw NP on 7th day. Prescribed antibiotic. Went to walk-in on 9th day and received steroid shot and prescription. Much better on 13th day.
Flu like symptoms; I have dizzy spells; Runny nose; Coughing; In my head, top of the skull I feel a pressure and its moving around; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (I have dizzy spells), RHINORRHOEA (Runny nose), COUGH (Coughing) and HEAD DISCOMFORT (In my head, top of the skull I feel a pressure and its moving around) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 085F21A, 030A21A and 213MC0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (I have dizzy spells), RHINORRHOEA (Runny nose), COUGH (Coughing), HEAD DISCOMFORT (In my head, top of the skull I feel a pressure and its moving around), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (I have dizzy spells), RHINORRHOEA (Runny nose), COUGH (Coughing), HEAD DISCOMFORT (In my head, top of the skull I feel a pressure and its moving around), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Adverse Event: pt felt swelling in throat area (same that occurs when pt drinks alcoholic beverage). Side of tongue felt numb. Pt felt like something was stuck in back of throat. No dizziness, no trouble breathing. No GI symptoms. No swelling or hives at site injection.  Treatment: 12.5mg IV Benedryl; 60mg IV Solumedrol Outcome: Swelling went down in throat. Tongue no longer numb. Pt sent home with Epipen for emergencies.
Information has been received from a registered nurse. It was reported that GARDASIL vaccines was stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 03-JAN-2013 (lot number 670048/0963AA, expiration date 09-NOV-2013) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Seizure-Medium
-Swelling, mass/lump -mild edema at injection site per ultrasound (05/25/23) -pain interfering with activities, referred to orthopedics and physical therapy.
hot + cold, achy joints, swollen hands + feet, smashing headache in the back of the head, ringing of the ears, swollen tonsils, nausea.
Initial misuse report received from a healthcare professional on 16 May 2013. It was reported that 1 diluent was left in the box, and sterile water was used to reconstitute ACTHIB and administered. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None.
On Thursday i took the Pfeizer shot and have since developed a rash on my collar bone 2 days later that was not there & severe headache primary doctor instructed to to go to hospital once doing so the Hospital doctor said he was unsure it would be related and sent me home with Zyrtec medicine, Following up with Primary doctor
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided.
This spontaneous report as received from a pharmacist via company representative refers to 2 patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, strength and lot # not provided). On an unknown date the patients experienced injection site reactions after administration of ZOSTAVAX. The outcome of injection site reactions was reported as recovered/resolved within four days. Relatedness between injection site reactions and ZOSTAVAX was not reported. Additional information has been requested.
p/vax pt exp fever & chills; T101; symptoms resolved w/in 3 days