chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right lower lobe pulmonary infiltrate. prescribed azithromycin tablets to take for the next 6 days 250 mg/day and I ordered albuterol inhaler to take only as needed and she will monitor her oxygen saturation at home with her pulse ox. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Mother states dgt's right side of face began swelling approx 8pm including jaw and had several welts on face.  Contacted Pediatrician who instructed them to give her Benadryl and call HD next moring.  At the AM call mother stated the swelling was going down, denied any difficulty breathing.  Was to see Physician later that day.  After visiting Physician, RN spoke with the dgt, states Physician felt the swelling was not caused by the shots.
PAIN; NAUSEA; HEADACHES; FATIGUE; This spontaneous report received from a parent concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced pain. On SEP-2021, the patient experienced nausea. On SEP-2021, the patient experienced headaches. On SEP-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain, and had not recovered from nausea, headaches, and fatigue. This report was non-serious.
Fever of 102.6; red, swollen upper arm; extreme fatigue; loss of appetite.
Information has been received from a physician concerning a 76 old male patient with controlled type II diabetes mellitus and hypertension who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Eight days after vaccination the patient developed shingles. The shingles was described as a mild case (lesions were unilateral on the chest). Medical attention was sought. The patient was recovering. No product quality complaint was involved. Additional information has been requested.
PAIN IN SIDE OF FACE; TINGLING; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pain in side of face, and tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in side of face and tingling was not reported. This report was non-serious.
Heart fluttering/palpitations on and off (ongoing even to this day), increased feelings of anxiety, skin rash on upper eye lids, behind the left ear and on left side of the neck (lasted until July 2021), pain in left shoulder, could not lift up arm, pain in left elbow (ongoing chiropractic care helped relieve the pain, but elbow is bothering me until this day), occasional unexpected nerve pain (like an electric current) in hands and feet (comes and goes), worsening migraines this year as opposed to the past experiences (I've suffered from migraines for years, but the intensity and frequency post vaccine has increased). Extremely heavy menstrual flow first day/two with heavy clotting.
a 12-year-old male patient received a dose of Ipol vaccine that been involved in the excursion at 10.5 C for a cumulative time of one hour 5 minutes/No AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2019SA297983 and 2019SA302643 .  This case involves a 12 years old male patient who received a 0.5 ml dose of IPV (VERO) [IPOL] vaccine that been involved in the excursion at 10.5 c for a cumulative time of one hour 5 minutes lot N1K931M, expiry date: 18-NOV-2019 via intramuscular route in the left deltoid on 16-Oct-2019.  The patient's past 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), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  It was an actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  Doctor visit and date: 16-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Feeling a pressure on both eyes; Fatigue; Headache; Muscle pain; Joint pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Feeling a pressure on both eyes), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Heartburn, Cholesterol, Glaucoma and Prostate. Concomitant products included ATORVASTATIN for Cholesterol, LATANOPROST for Glaucoma, OMEPRAZOLE for Heartburn, IRBESARTAN for Hypertension, PROBIOTICS NOS, VITAMIN B COMPLEX (B COMPLEX (B50)), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMIN & CHONDROITIN) and for prostate for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced EYE PAIN (Feeling a pressure on both eyes), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, EYE PAIN (Feeling a pressure on both eyes) was resolving. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Localized erythema, swelling, tenderness from left deltoid to elbow. Ice, Benadryl 25mg TID, Motrin prn.
Information has been received from consumer her 23 year old daughter who on unspecified date was vaccinated with a second dose of Gardasil. Two weeks post vaccination with the second dose of Gardasil. Two weeks post vaccination with the second dose of Gardasil, the patient developed "bells palsy, which freezes one side of the face" as reported by the patient's mother. The patient sought unspecified medical attention. Subsequently, the patient recovered from bells palsy on an unspecified date. Additional information has been requested.
Patient was given 2nd dose of Moderna COVID vaccine 1 week early.  Her first dose of Moderna COVID Vaccine was given on 3/17/2021 (LOT 001B21A, EXP 9/6/2021--given IM in the left arm) -Patient was notified of the administration error by one of our staff.  Discussed known data regarding early 2nd dose.  Patient had not issues during the 15 minute waiting period after the immunization was given.  Asked to her to call back with any questions/concerns.
Dizziness, vertigo started on February 23, 2021, and still persists. Dr., ENT, diagnosed it as vestibular neuritis on February 24, 2021.
Headache, Myalgia, NauseaVomiting, INJECTION SITE PAIN Narrative:
Sickness; Whole body pain; Cant raise or move arms; Symptoms of covid; Extreme headache like my head was going to crack in half; Chills; Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), PAIN (Whole body pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Cant raise or move arms), SUSPECTED COVID-19 (Symptoms of covid) and PAIN IN EXTREMITY (Pain in her arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm). On 06-Mar-2021, the patient experienced ILLNESS (Sickness), PAIN (Whole body pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Cant raise or move arms), SUSPECTED COVID-19 (Symptoms of covid), HEADACHE (Extreme headache like my head was going to crack in half) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ILLNESS (Sickness), PAIN (Whole body pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Cant raise or move arms), SUSPECTED COVID-19 (Symptoms of covid), PAIN IN EXTREMITY (Pain in her arm), HEADACHE (Extreme headache like my head was going to crack in half) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 562 (High) Increased.         Concomitant medications were not reported. Ibuprofen helped the patient.   This case was linked to MOD-2021-036599 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-06-2021: No new information provided, Denied further contact
What to do if I missed the 6 month point for 2nd vx; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient wanted to know what to do if he or she missed the 6 month point for second Shingrix vaccine. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient call the day after receiving shot complaining of muscles spasming and weakness throughout her right arm and also states that her left arm has been experiencing the same since she got the first moderna shot on 5/14/21
This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Patient have blisters on neck and shoulders), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (situation is Interfering with patient's daily life), INSOMNIA (can not sleep at nights) and URTICARIA (Chronic Hives and Urticaria) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 056A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Prevnar 20 (Patient had a Prevnar20 on B14H00L but does not remember on what date). Past adverse reactions to the above products included No adverse event with Prevnar 20. Concurrent medical conditions included Multiple sclerosis (   ).   Reporter did not allow further contact
Right arm pain, swelling and redness starting 5/28 lasting 3 days. Chills x2 days starting 5/31/21. Constant cough starting 5/31/21 and continues.
A 67 year old female reported that she received an injection of Flu Shield '00-'01 on 11/30/00 and subsequently experienced an increase in pain.
Woke up with intense arm pain at injection site on 15th day after vaccine. Radiated down arm , subsided after approximately 30 minutes. Deep tissue, burning pain. Remained only slightly sore remainder of day. Had not experienced arm pain at injection site since day 3 previously.
Pt received Pfizer 05/25/21 unable to receive second dose of Pfizer due to transportation issues. Pt verbalized he is willing to receive moderna vaccination
pt recv vax;next day c/o fever & aching;n & coughing 28may;29may cont to be ill, red area on rt arm (vax given on lt arm);adm to hosp & dx of pneumonia 30may;pos legionella titer(500+),hep B core antibody pos, hepatitis C antibody pos;
Vaccine administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 07-Jan-2021 at 11:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 11:31 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.92.  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 08-Jan-2021. 20 vials were sent to clinic. Vaccine BUD date was 04-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Neuropathy in both feet, occasional neuropathy in left hand, buttocks, and pubis
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 27-AUG-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a health care facility/office for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed a burning sensation and shooting pain originating in her upper back and radiating into her neck. In response to these complaints, the patient presented to her primary care physician and was diagnosed as suffering from shingles. 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown.  Additional information has been requested.
Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old patient who experienced excessive irritability.  The patient received a dose on an unspecified date.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose.  Concomitant medications were not reported.  The patient experienced excessive irritability on 25-Nov-2007.  The patient recovered on 18-Dec-2007.  It has been determined that US-WYE-H01867307 is a duplicate report of US-WYE-H01938708.  Therefore, the reports are being consolidated into US-WYE-H01938708, which will remain the official case of record.  No additional information was available at the time of this report.
No adverse event; first dose received 0n 27-May-2022 and second dose on 27-Jul-2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose received 0n 27-May-2022 and second dose on 27-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose received 0n 27-May-2022 and second dose on 27-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose received 0n 27-May-2022 and second dose on 27-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose received 0n 27-May-2022 and second dose on 27-Jul-2022).    Concomitant medications were not reported.  It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. Treatment medications were not reported.   This case was linked to MOD-2023-714991 (Patient Link).
Patient had some confusion on and off after vaccine so reported it to Dr and she ordered a Ct of head which was advised as wnl on 2/25/21 at his apt.. Had Vaccine #2 on 3/10/21 and continued to have episodes of brain fog, but i didn't worry about it until 3/19/21, he was asking questions he normally knew the answer to, so I asked him to check his blood sugar.  It was 405 and over the next few hrs i had him take an additional metformin and recheck it and was still high, so i took him to the er.  They did a repeat CT of the brain, blood work which was all normal except for the high blood sugar. They gave him a liter of fluid but the blood sugar remained high. after almost 4 hrs, they wanted to give him another liter of fluid and no insulin, and we said we could push fluids at home and see our PCP on monday.  PCP increased Metformin to 1,500mg bid for 3 days and to return call wed. at that time blood sugars were still running 200- to 300 so recommended starting insulin to control. Patient's blood sugars have never been over 160 and had not had any problems with brain fog so we are not sure what precipitated this, but talked to both our Drs. and they suggested we report his symptoms.
Covid19 breakthrough.  Pt received Johnson and Johnson vaccine on 05/06/2021.  Presents with Lethargy, cough and fever.  Pt was exposed to family member + with Covid.  Treating with IV steroids/Abx and Remdesivir.
This spontaneous report as received from a nurse to a female patient of an unknown age. The patient's pertinent medical history was unknown. On 10-JAN-2007 the patient was vaccinated with first dose of GARDASIL (dose reported as 0.5 ml) (Route of administration: intramuscular) and approximately on 08-APR-2014 (reported as "is currently in the office") the patient was in the office of the reporting nurse to receive her second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
High Blood pressure; tachycardia; This is a spontaneous report from a contactable nurse (patient). A 36-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK 5730) intramuscular in the left arm on 18Dec2020 17:00 at a single dose for COVID-19 immunization. The patient received COVID-19 vaccine in a hospital facility. Medical history included asthma, high blood pressure, and allergy to seafood. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient is taking unspecified concomitant medications.  The patient previously had allergies to acetylsalicylic acid (ASPIRIN) and iodine (IODO). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced high blood pressure and tachycardia then 2 minutes after receiving the vaccine. The patient did not receive treatment for the adverse events. The outcome of the events was recovered in Dec2020. The report is considered non-serious.
Within 5 minutes of administration pt began to experience difficulty breathing and vigorously shake, transported to gurney and obtained vitals, pt with O2 Sat 70%, HR 88, administered one dose of epinephrine, placed 10L of O2 via facemask, pt began speaking, was alert and oriented to name and place, continued to report tightness of the chest and itching, called EMS, continued to monitor vitals, and patient transferred to ER without incident.