chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My anxiety\OCD issues, after the shot, became more intense and prolonged.; My anxiety\OCD issues, after the shot, became more intense and prolonged.; My anxiety\OCD issues, after the shot, became more intense and prolonged.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date 10Apr2021 09:30 (Lot number: EW0158) as dose 1, single for covid-19 immunisation. Relevant medical history included: "OCD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; CEPHALEXINE; MUPIROCIN. The following information was reported: CONDITION AGGRAVATED (non-serious), OBSESSIVE-COMPULSIVE DISORDER (non-serious), ANXIETY (non-serious) all with onset 11Apr2021 08:00, outcome "recovering" and all described as "My anxiety\OCD issues, after the shot, became more intense and prolonged.". The event "my anxiety\ocd issues, after the shot, became more intense and prolonged.", "my anxiety\ocd issues, after the shot, became more intense and prolonged." and "my anxiety\ocd issues, after the shot, became more intense and prolonged." was evaluated at the physician office visit. Therapeutic measures were taken as a result of condition aggravated, obsessive-compulsive disorder, anxiety.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination were reported as Escitalopram 10mg, Cephalexin 500mg, Mupirocin 2%. It was reported that the patient haven't had this bad of an attack in quite a long time. It happened again after the 2nd shot. Treatment was reported as Counseling appointment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
On 10/25/2000, the patient developed 50 vesicles and complained of itching. Other signs and symptoms were denied. On 10/27/2000, it was reported that the patient was recovering. The patient's mother stated that all the lesions were scabbing over and looked to be drying. Additional information has been requested.
Soreness on left upper part of body and Headache at 230 a. Upon waking, face was swollen with the left being worse than the right. Joint pain and stiffness on left side, neck pain on left side. Temperature 100.5 @ 25mg benadryl  were taken at 0800.
COVID 19 Pfizer dose given beyond use date. Patient tested positive for COVID 19 one week after receiving vaccine dose.  Patient had body aches and headaches for 2 days.  Patient received Tylenol.  Patient made a full recovery. There was no treatment necessary.
A mother reported that her 6 year old son received a dose of Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 12/09/03.  The pt's concurrent illness includes unspecified allergies.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/09/03.  Dose regimen was 1 dose 1 time per day (IN).  Concomitant therapy included Zyrtec and Nasonex.  Concomitant vaccines were not administered.  On 12/10/03, the child developed a runny nose and cough.  He was treated with Robitussin CF.  The mother reported that the child "was in the waiting room for 45 minutes with a bunch of sick kids" immediately prior to immunization.  As of 12/11/03, the cough and runny nose persisted.  No additional information was available at the time of this report.
Injection Tdap given in right arm. The day of and next day arm was sore. By Saturday, Nov 22, 2008 her arm pit(right) was very swollen and painful. She started running a fever (100.6-100.8-101) that lasted all day Sat 11/22 and Sunday 11/23. MOTRIN administered every 4 hours and cold compress to arm pit. Swelling reduced Mon 11/24 but arm still sore. Fever finally normal 11/23/2008.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. It was stated that on an unknown date in 2012, the patient might have received ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). On 07-OCT-2016, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # M024700 and expiration date 18-JUL-2017) and with influenza virus vaccine (unspecified). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-OCT-2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 09-OCT-2013, the patient was treated by a physician for the onset of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related.
A week later after the vaccine administration, the patient came to the pharmacy complaining  that she suffered of fever,  pain at the site of administration, swelling of the injection side,  pain under the arm  and itching at the injection site area.
Patient had vasovagal reaction about 10 minutes after the vaccine was administered.  Patients vitals were normalized and patient left the clinic with her mother and was feeling better.
pain in armpit and breast after receiving her second covid vaccine; pain in armpit and breast after receiving her second covid vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer survivor" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:1), for COVID-19 immunization, reaction(s): "No reaction". The following information was reported: BREAST PAIN (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "pain in armpit and breast after receiving her second covid vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He was shaking; He got chills, He is freezing, Absolutely freezing; Headache, Splitting headache; He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing; He could not sleep because he was so cold even with the heater in the same room; It does not matter if my arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (He was shaking), FEELING COLD (He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing), SLEEP DISORDER (He could not sleep because he was so cold even with the heater in the same room), PAIN IN EXTREMITY (It does not matter if my arm is sore) and CHILLS (He got chills, He is freezing, Absolutely freezing) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Patient got his first and second dose from Pfizer and that those left his arm useless for a few days and he could not lift up weight. He was someone that can lift 150 pounds and after the vaccines he could not lift 20 pounds.). Past adverse reactions to the above products included Arm discomfort with Pfizer. Concomitant products included GELATIN and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced FEELING COLD (He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing), SLEEP DISORDER (He could not sleep because he was so cold even with the heater in the same room) and PAIN IN EXTREMITY (It does not matter if my arm is sore). On 07-Jan-2022 at 2:00 AM, the patient experienced TREMOR (He was shaking), CHILLS (He got chills, He is freezing, Absolutely freezing) and HEADACHE (Headache, Splitting headache). At the time of the report, TREMOR (He was shaking), FEELING COLD (He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing), SLEEP DISORDER (He could not sleep because he was so cold even with the heater in the same room), PAIN IN EXTREMITY (It does not matter if my arm is sore), CHILLS (He got chills, He is freezing, Absolutely freezing) and HEADACHE (Headache, Splitting headache) outcome was unknown.            Patient stated that with 7 blankets over him, he was not getting warm. Patient stated that he hates to be cold and had never been cold before. He also explained how he was able to go outside in the cold with his thermal and was not getting cold and how he was using an axe to chop wood and how he was lifting up weight in his normal life.  No treatment medications were reported.
1. COVID-19  POCT COVID-19 PCR 2. Sore throat  POCT Strep A, PCR 3. Fever, unspecified fever cause    ED to Hosp-Admission Discharged  8/8/2021 - 8/10/2021 (2 days)  Hospital Problems    * (Principal) Weakness COVID-19 UTI (urinary tract infection) Sepsis (CMS/HCC)
C/O burning in arm; numbness to lips/tongue; diff swallowing within 30' of vaccination. 50 mg BENADRYL PO given. HR WNL/Resps even and unlabored. EMS initiated, parent notified and present on EMS arrival. 11/17/09 ER record received for DOS 11/12/09. Pt. c/o tingling all over, trouble swallowing; treated with benadryl, prednisone; symptoms resolved. DX: Allergic reaction.
Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022; Administered expired Moderna COVID-19 vaccine to several patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine to several patients) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine to several patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine to several patients) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. No treatment medications were provided.  Vial did not undergo any temperature excursions.
This case was reported by a healthcare professional and described the occurrence of positive serology for hepatitis B surface antigen in a 46-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 3 March 2007 at 11:10 the subject received 1st dose of Engerix B (two lot numbers provided: AHBVB260, AHBVB2878) at 40 mcg, intramuscularly, in the right arm.  On 6 March 2007, 3 days after vaccination with Engerix B, the subject experienced positive serology for hepatitis B surface antigen.  At the time of reporting the outcome of the event was unspecified.
Pt. read influenza vaccine on 10/22/08 to Lt deltoid. On 10/23/08 she returned to the office with localized rash to the injection site. No difficulty breathing noted. Hydrocortisone cream given
LAb work discovered on 4-23-2021, physician called and reported that red blood cells and platelets were very low. After a second blood test 10 days later, doctor reported that blood transfusion may be necessary.  Transfusion was not received. At that time, bone marrow biopsy was ordered by hematologist.  Blood condition had changed to myelofibrosis.  Additional testing pending CAT scan and ultrasound for thrombosis lower extremities. Continue to suffer from extreme fatigue and feeling  of despair.
This spontaneous report was received from a nurse practitioner regarding a patient of unknown demography. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 31-MAY-2016, the patient was vaccinated with one dose of improperly stored GARDASIL (route unknown) lot # K008931 with expiration date of 04-MAR-2017. The vaccine was exposed to a temperature of 8 degree Celsius for 80 hours. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old male patient who received SHINGRIX (batch number LT533, expiry date May 2019). On 8th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On 8th May 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and overdose. On 9th May 2018, the patient experienced fatigue, hoarseness and injection site erythema. In May 2018, the outcome of the fatigue, injection site pain, hoarseness, injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the overdose was unknown. The reporter considered the fatigue, injection site pain, hoarseness, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: At 13:00, the patient received SHINGRIX in the left deltoid. The reporter had the pharmacy label which states he was administered 1 ml dose of SHINGRIX. The patient called back and said that the 1ml dose was written on the paperwork that he gets from the vaccine. It was not written on the label. Thus, it led to possible overdose. The swelling and pain at the injection site started the same day hours later and lasted for about 5 days. The patient experienced fatigue and hoarseness that started 24 hours later after receiving vaccination, and lasted for about 2 days. Redness at the injection site started 24 hours later, which was 2 inches in diameter and lasted for about 6 days. In May 2018, all the events were resolved.
Pale, nausea, and slight headache with first dose of Pfizer-BioNTech mRNA COVID-19 vaccine IM in left deltoid. Elevated the patient's legs, gave him juice and an alcohol pad to smell. Monitored patient, and symptoms resolved after 15 minutes. Monitored for 15 more minutes and patient left feeling normal.
PATIENT REPORTS PAIN IN NECK RADIATING UP FROM LEFT ARM AT VACCINATION SITE
On 1/23/01 the pt experienced redness and burning. The pt's whole arm hurt. The next day, large red whelp and hardness, but was still red. Two days later the whelp is beginning to resolve.
On 3/12/21 I began to have facial drooping to the left side of my mouth being unable to drink for a cup or straw.  That progressed over night and then my left eye began to droop.  On the 3/13 my speech became very garbled and I sought emergent care at ER facility.  I was dx with Bells Palsy and given tx of steroids and antiviral medication.   My blood sugars elevated and I missed work on 3/14/.   My speech was garbled and symptoms lasted 3 weeks before slowing resolving and at this time I still suffer with eye twitching.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a physician concerning a previously healthy 8 year old male with no past medical history and no known allergies who on 23MAR1998 was vaccinated with a dose of varicella virus vaccine live when he was approximately 1 to 1.5 years of age. There were no concomitant medications. Subsequently, the patient developed breakthrough varicella. The specimens from the child were DFA negative for herpes, and DFA for varicella only had a few cells. A specimen from the child's vesicular lesions were in viral culture and will be submitted for PCR. Follow up information received on 23JAN2004 indicated that the specimen received for PCR analysis was inadequate. Follow up information indicated that the specimen was obtained on 09JAN2004 and sent to the laboratory on 09JAN2004. The source of the specimen was a lesion and it was mixed with vesicle and papule. The specimen arrived in the laboratory on 20JAN2004. The VZV DNA was not amplified. The B-globin, and no strain ID. The type of adverse experience was a rash on the right elbow. The herpes zoster was on the "right elbow; 3 times".  The child had no recent exposure to chickenpox or to shingles.  Follow-up information confirmed the diagnosis was herpes zoster. The reporter stated that the initial description of breakthrough varicella was not correct. The patient had herpes zoster three times by clinical description and had not had any natural disease by history. Subsequently, the patient recovered. Additional information is not expected.
Patient received an expired dose of Ipol with no reported AE; Initial information regarding an unsolicited valid non-serious case was received on 12-May-2021 from a Other Health Care Professional via Agency (Reference number- 00598493) and transmitted to Sanofi on 12-May-2021  This case involves a 4 year-old female patient who was vaccinated with expired dose of IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination  On 29-Mar-2021, the patient received third dose 0.5 mL of suspect IPV (VERO) (lot R1B251M and expiry date 13-Mar-2021) via an subcutaneous route at the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not reported.  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 2001/83/EC 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.
Severe pain in shoulder muscle where shot was given and around the area and severe pain left shoulder, difficulty raising left arm
headache; diarrhea; Arm soreness; This case was reported by a consumer and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, diarrhea and pain in arm. On an unknown date, the outcome of the headache, diarrhea and pain in arm were unknown.   It was unknown if the reporter considered the headache, diarrhea and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Husband stated that his wife received the dose of Shingrix and she experienced headache, diarrhea and arm soreness. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246522:same reporter
Arm at inj site inflamed and red. Pt. developed fever. Went to Dr and treated for cellulitis with Cephalexin 500 mg 1 TID for infection and Ibuprofen & TYLENOL for fever 7 day treatment.
red, it is big of a like a ''shape of the holler'' and it is kind of hot and it is little raised up a little bit; red, it is big of a like a ''shape of the holler'' and it is kind of hot and it is little raised up a little bit; it is kind of hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Lot number: ER8737) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date Oct2021. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: RASH PAPULAR (non-serious), ERYTHEMA (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "red, it is big of a like a ''shape of the holler'' and it is kind of hot and it is little raised up a little bit"; FEELING HOT (non-serious) with onset Oct2021, outcome "not recovered", described as "it is kind of hot".  No follow-up attempts are possible. No further information is expected.
About 12 hours after the vaccine, I experienced excruciating pain in my head and body. My fever rose to 102 and stayed there for 36 hours after being vaccinated. I was also nauseous and was unable to keep food down until 48 hours after being vaccinated. I was taking both Tylenol and Advil, but getting sick almost instantly after taking them.
R ankle swelling/pain 4 hours after injection of both Zostavax and flu vaccine given at a local store. pt has had flu shots in past without problems.
the Vial was opened a day before but no Date or time was placed on the Vial. not sure if patient would need an additional vaccine.
Premedicated 1 hour prior to injection with oral Benadryl 1.5 tsp 5 minutes after injection-tachycardia (121 bpm) which resolved within 10 minutes, scratchy throat which resolved in two days 3 hours after injection- diarrhea and localized erythema, edema at injection site (size of quarter), diarrhea resolved the next day, localized reaction continued Benadryl continued to be given orally twice daily at 1.5 tsp, aleve taken PRN 1/28/21 Arm began itching at site of injection, within 12 hours erythema tripled in size, became warm to touch.  Benadryl cream added with no noticeable impact appreciated 1/29/21 allergist consulted topical triamcinolone 0.1% cream applied twice daily beginning night of 1/2.  Lesion currently still noticeable and has not reduced in size.