chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Covid-19: August 2019 & January 2023.  The patient's past medical history included COVID-19 in August 2019 and COVID-19 (Jan-2023).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. It was reported that patient had covid-19 in Aug 2019. April and May 2020 got vaccinated. In Jan-2023 caught covid-19 for 2nd time. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2023: Live follow up contains no new information.
Medical assistant diluting covid vaccines diluted the vaccine with sterile water instead of sodium chloride. She followed the rest of the steps of preparing the vaccine correctly other than what to dilute the vaccine with. It was not caught until a few month later that this MA had been diluting the covid vaccines with the incorrect diluent. Therefore many patients, including this patient, received the covid vaccine with the incorrect diluent. Pfizer, the manufacturer, was contact regarding this and no data is available if the incorrect diluent type is supported to be stable. Therefore this dose with the incorrect diluent should be considered invalid and should be repeated. This patient has not had any adverse effects from the incorrect diluent and has remained healthy since the event occurred. The patient has received the covid-19 bivalent booster vaccine on 10/29/22. Therefore he has been considered revaccinated. Family is being informed of the situation and is being educated on the dose from 6/2/22 being considered invalid, but the booster dose on 10/29/22 being considered valid and his revaccinated dose.
Woke up this morning with itchy, red rash on arms which has progressed to his legs and trunk.  Took BENADRYL and applied SOLARCAINE.  Denies difficulty breathing.  Referred for medical evaluation today.  Mother participated in phone conversation.
Systemic: Headache-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: pt reported that day after first dose experienced "worst migraine shes ever had" along with numbness in her fingers. reported that it went away within 24 hours
11/19/2014 at 1120 pt. seen at clinic for allergic rhinitis at 1200 pt. receives flu vaccine. Pt. states around 1500 arm starts hurting. On 11/20/2014 at 0730 pt. notices red rash near injection site, cont. tenderness to area. On 11/21/2014 at 1525, pt contacts clinic and reports rash, warm to touch and tenderness. Pt advised to apply ice, ibuprofen and BENADRYL. Pt. reports had influenza vaccine in past and never had a reaction. Denied any angioedema. Pt. then went to urgent care on 11/21/2014 at 1800 for eval. Pt. notes received scanned in (HAIMS). Physician assessment indicated (+) tenderness to palpation of (L) deltoid - pain at injection site - (+) red rash in lateral mid-arm about 5 cm in diameter, well demarcated, warm to touch. Fine macular rash on (R) upper arm. Pt. diagnosed with cellulitis and instructed to use cold compresses and BENADRYL and F/U with PCM if no improvement. 11/24/2014 at 1400 pt. contacted to see how she is doing. Pt. states doing better, rash slowly fading.
Three days after my first Moderna Covid shot in my left arm, I felt a pain/tenderness in my left armpit in the middle of the night.  The pain, swelling and tenderness worsened for 2 days until I was so uncomfortable I could hardly sleep even using ice packs and advil.  My armpit and breast glands  down my left side were enlarged and hot and tender to the touch. On day 6, I woke up with a 5 inch diameter raised bullseye type rash on my left arm. The itching and rash subsided after 2 days. However, I could not exercise or raise/use my left arm for 10 days from the onset of the symptoms.. Days 5 through 10 were very uncomfortable and I had to limit all activity and stay home to ice and rest my left side. On day 17, I resumed all normal activity including exercise.  Honestly, I still feel a slight tenderness and swelling in the left breast. I plan to get the 2nd shot in my right arm on April 2nd to give my left side a rest.
pt recv vax 5/20/99 11AM & same day 3PM pt exp sz which lasted approx 45min;pt taken to ER & adm to hosp;on admission pt T103;pt on dopamine & ceftriaxone sodium;CT Scan of brain & LP done 5/20/99 were nl;pt on ventilator & stable;
Patient received  bivalent Pfizer( lot # GK1667)(age 6months-4 years) vaccine 0.2ml. inadvertently instead of the Pfizer (lot # GJ6796) adult vaccine dose(0.3ml). Clinical nurse consultant was contacted immediately and instructed to vaccinate patient immediately with correct vaccine for adult (12+).
Patient report Arm swelling upto 14 inches --Patient thought it was a blood clot, went to the ER  to testing-- No blood clot, ER Doctor gave patient Doxycycline 100 mg -- 1 capsule twice daily for 7 days. Patient reports to us on 12/6/2019 --- The swelling has gone down.
Pt. developed reaction 2 min. after immunization was given.Pt. was pale, felt numbness to tongue & body, felt faint, and was nauseated for 5 min.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:41 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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.   Concomitant products were not provided.  The age of patient was provided as 77.85.  On 17-Feb-2021, Excursion time was 09 AM, temperature was 22, total doses given for the day was not reported, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vials were sent to clinic. Vaccine BUD date was 13-Mar-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 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.
On 21-JUN-2001, a 25 year old female, with low blood sugar, receives a Lymerix vaccination while unknowingly pregnant. Pt also received an injection of tetanus toxoid. Concurrent conditions include asthma, unspecified allergies, an irregular menstrual cycle and polycystic ovary syndrome. The pt had no known drug allergies and no known prior pregnancies. It is not known if she had previous Lyme disease. Concurrent medication included Singulair, Vanceril and Proventil. The pt had been prescribed a course of doxycycline for an unknown indication in June 2001.  At 6pm on 21-JUN-2001, the pt passed out and was taken to the local ER. A diagnosis of low blood sugar was made and the pt was treated with "some food". An unspecified pregnancy test was positive. It was determined that the pregnancy was at 24 weeks gestation; the pt reported that she did not know she was pregnant earlier in the day, when she was immunized. Her last menstrual period was in December 2000; her estimated delivery date  is 06-OCT-2001. The ER physician did "not relate incident (low blood sugar) to vaccines". The pt was released from the ER. Additional information was received from the pt's obstetrician on 28-AUG-2001. The OB first saw the pt on 15-JUL-2001; she reported to him that she did not appreciate that she was pregnant until "a few days" prior. She reported to the OB that her last menstrual period had been in "late November 2000";the pt did not recall her last prior menstrual period. She had received no prior prenatal care and had not taken prenatal vitamins. Estimated date of confinement to be 06-OCT-2001. The follow up states the emergency room physician did "not relate incident (low blood sugar) to vaccines." The vaccinee was released from the ER. Additional info was received from the vaccinee's obstetrician on 8/28/01. The obstetrician first saw the vaccinee on 7/15/01; she reported to him that she did not appreciate that she was pregnant until "a few days" prior. She reported to the obstetrician that her last menstrual period had been in "late November 2000"; the vaccinee did not recall her last prior menstrual period. She had received no prior prenatal cars, and had not taken prenatal vitamin supplements. Estimated date of confimement was confirmed to be 10/6/01. The most recent info was received from the vaccinee on 2/1/02. She reported that she delivered a female infant on 10/6/01. The vaccinee stated, "No complications with preganncy after the day of the injection. Baby was born full term on he rdue date. Baby's health seems to be perfect to date. Mom is also doing fine."
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown demographics. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with incorrectly stored doses of PROQUAD lot # N016993, expiry date 29-NOV-2018 (albumin status: recombinant human albumin, dose and route of administration not reported) for prophylaxis. The doses of vaccine underwent a temperature excursion of -14 degrees Celsius for 7 months. There were no previous temperature excursions. The call was because of a "data logger". No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA005518.
Patient noticed sensation spreading across his chest area. Vaccine administered in Left deltoid. Pt also stated that "it was starting to get warm in here". Also noted pain in joints. More specific to the hip area. Pt given several cups of water and monitored for 15-20 minutes, before being released.
24 hours after injection, intense migraine headache (a 12 on a scale of 1-10), and a facial rash - red, painful/itchy/irritated. Both migraine and rash has lasted for each day since injection.
fever, chiills, and sweats Narrative:  Patient begin experiencing symptoms the next day following shot #1 of COVID Moderna. Symptoms report; chills, body aches, fever 101, and sweats. Did not report any therapeutic intervention or duration of symptoms rather wanted advice if should receive shot #2 based upon these symptoms.
Patient vomited after receiving first dose of Pfizer COVID vaccine Lot EP6955 on 3/29/21.  Monitored for 30 minutes. Patient felt better after bottled water.  Pt went home with mother.
Felt like being shot; sharp shooting pain in the leg and head; Could barely lift head from bed; hurt all over/ body was hurting all over/everything hurt/felt like muscle pain; hurt all over/ body was hurting all over/everything hurt/felt like muscle pain; Running a fever; Sharp shooting pain in leg and head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like being shot), PAIN IN EXTREMITY (sharp shooting pain in the leg and head), HEAD DISCOMFORT (Could barely lift head from bed), the first episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain) and the second episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced FEELING ABNORMAL (Felt like being shot), PAIN IN EXTREMITY (sharp shooting pain in the leg and head), HEAD DISCOMFORT (Could barely lift head from bed), the first episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain), the second episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain), PYREXIA (Running a fever) and HEADACHE (Sharp shooting pain in leg and head). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt like being shot), PAIN IN EXTREMITY (sharp shooting pain in the leg and head), HEAD DISCOMFORT (Could barely lift head from bed), the last episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain), PYREXIA (Running a fever) and HEADACHE (Sharp shooting pain in leg and head) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Motrin did not help the patient.
On 10/22/98, the pt experienced arthralgia and myalgia. From additional information received on 11/30/98, it was reported that as of 11/13/98 the pt has not yet recovered, the symptoms are persistent. From additional information received on 12/15/98, it was reported that the pt's signs and symptoms had subsided on 12/8/98.
leg where shot was given was red entirely from knee to hip;cried very hard for 1 1/2 hr, poss due to leg pain;leg appeared to cause extreme pain when touched or moved;APAP helped sl;pt taken to MD during time of react;muscle was swollen
This spontaneous report was received registered nurse regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (therapy type digital logger) (lot # L048467, expiry date 02-DEC-2017) dosing details and route unknown. Concomitant medications were not reported. The vaccines were subjected to temperature excursion of -0.9 degrees C for a time frame of 2 hours  and 33 minutes. No other symptoms reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Redness, raised at site. Duration >3 cm. Temp. 101. Diameter 7 x 6.5, measured by dr.
mo female had immunization on 8/27/12. Healthy at the time. Had fever <101 that night. Next day appeared well breast fed, no fever, then went limp. Call the ambulance - hospital. Received ATIVAN. Dx afebrile atonic seizure. Transferred to major hospital, admitted. Septic work up done, all negative. 3 days in hospital. Came to office on 9/11/12. This child received vaccines on 8/27/12 and had an afebrile seizure the following day and was hospitalized in ICU and regular unit for three days. Unable to get lot # for vaccines.
Two episodes of urinary incontinence during the night, in the bathroom trying to get to the toilet, which I?ve never had before.  I had not had any more liquid than normal.  There were some other symptoms, a sore arm which I expected, a mild fever which wouldn?t be unusual, and the only other symptom was major joint pain everywhere overnight, some achy, some sharp. But it?s the urinary incontinence I want to report, because that was so unusual.
I had fever up to 99.8, leg pain, arm soreness, and a sharp pain in left groin area throughout the night April 1st and throughout the day April 2nd.  I also had a headache on April 2nd.  Tylenol was taken twice on April 2nd.  The morning of April 3rd, all symptoms were gone.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (shooting pain ) and HYPOAESTHESIA (numbness/feeling like "electricity in her hand") in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CLOMIFENE CITRATE (CLOMID), LABETALOL, LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN, CETIRIZINE, FOLIC ACID, CITALOPRAM, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), EXENATIDE (BYDUREON), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), OMEPRAZOLE, CEFIXIME (FLEXERIL [CEFIXIME]), NAPROXEN and PANTOPRAZOLE for an unknown indication. On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (shooting pain ) and HYPOAESTHESIA (numbness/feeling like "electricity in her hand"). At the time of the report, PAIN (shooting pain ) outcome was unknown and HYPOAESTHESIA (numbness/feeling like "electricity in her hand") had not resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment drugs were reported. The patient also has been to her doctor for the condition and provided contact information. This case was linked to MOD-2021-106976.
Patient experienced a localized reaction around the injection site on her right arm after receiving the PNEUMOVAX vaccine. Reaction started in the early evening with soreness that limited range of motion and then progressed on to a red, inflamed, itchy circular area around the injection site about 3-4 inches in diameter. The area was warm to the touch. Resolved 2-3 days.
pt w/focal sz 2hr gen in office;pt noticed to have fever 101.5;sz lasted approx 15min;in PICU no further sx noted;pt felt to have poss atypical febrile sz;
pt recv vax & devel cellulitis @ the inj site;tx w/keflex & warm compresses & recovered;
This case was reported by a consumer and described the occurrence of rash in a 55-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 3 days after receiving SHINGRIX the patient experienced rash and shingles. On an unknown date, the outcome of the rash and shingles were recovered/resolved. It was unknown if the reporter considered the rash and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she had a dot on her chest three days after she received the SHINGRIX vaccine. The patient stated the rash had gone away. The patient did not provide the date or any additional information about her symptoms.
TESTED POSITIVE FOR COVID-19 PCR NASAL SWAB ON 1/20/2021. HER SYMPTOMS BEGAN ON 01/19/2021 AND INCLUDED COUGH, NASAL CONGESTION, BODY ACHES, HEADACHE, TEMP 99.6 PEAK TEMP TO DATE, CHILLS, SWEATS, DECREASED APPETITE, NAUSEA, SORE THROAT, RHINORRHEA, LIGHTHEADNESS.
pain right arm; pain in the back; pain in the chest; feels like flu; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain right arm), BACK PAIN (pain in the back), CHEST PAIN (pain in the chest) and INFLUENZA (feels like flu) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain right arm), BACK PAIN (pain in the back), CHEST PAIN (pain in the chest) and INFLUENZA (feels like flu). At the time of the report, PAIN IN EXTREMITY (pain right arm), BACK PAIN (pain in the back), CHEST PAIN (pain in the chest) and INFLUENZA (feels like flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient described tingling and numbness in right arm after 15 minute wait . Otherwise no complaints of side effects.
After first dose sore arm; Muscle spasms; Fingers stiff and curled; Spot has been there for 2 to 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After first dose sore arm), MUSCLE SPASMS (Muscle spasms), MUSCULOSKELETAL STIFFNESS (Fingers stiff and curled) and VACCINATION SITE REACTION (Spot has been there for 2 to 3 weeks) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE PAIN (After first dose sore arm), MUSCLE SPASMS (Muscle spasms), MUSCULOSKELETAL STIFFNESS (Fingers stiff and curled) and VACCINATION SITE REACTION (Spot has been there for 2 to 3 weeks). At the time of the report, VACCINATION SITE PAIN (After first dose sore arm), MUSCLE SPASMS (Muscle spasms) and MUSCULOSKELETAL STIFFNESS (Fingers stiff and curled) outcome was unknown and VACCINATION SITE REACTION (Spot has been there for 2 to 3 weeks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information includes Vitamin C   This case was linked to MOD-2021-376923 (Patient Link).