chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Description: Vaccinated with AVA 20 Jul 07. Febrile illness on 23 Jul, Sore throat 27 Jul followed by ear ache. Problems focusing on 4 Aug with tearing. Bells Palsy diagnosed on 7 Aug. Sx resolved mid Sep 05.
Pt reported on 2/11/2019 that ever since she got the second injection on 10/29/2018 that her left mid-deltoid has hurt down into her elbow. Pt stopped by clinic on 2/14/2019 and further reported that the pain is only with certain movements like putting on jackets and carrying things. It is a sharp pain that goes from mid-deltoid to elbow with those movements, and only when she moves it specific directions or lifts or moves stuff. A specific example was when hunting and carrying her gun. It aches when laying on it certain ways, but no numbness or tingling. At this point she also reported that she has chronic shoulder arthritis and that it had recently been worse. She also has a small non-painful pale bump that pt reports was not there prior to the immunization. Denied any red or pain at the injection site.
Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022; No Adverse reaction; Used Moderna Covid-19 vaccine last week beyond its use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022) and NO ADVERSE EVENT (No Adverse reaction) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022).    Patient had 2nd booster dose. No concomitant medications were provided. The vial did not undergo any temperature excursions. No treatment medications were reported.
Starting the day after the 2nd dose of the vaccine, I encountered severe fatigue, which continues to this day, along with severe diarrhea.  The diarrhea lasted approximately 3 weeks before I started a regimen of Immodium, which I have continued taking daily, or every other day.  I have also started taking a probiotic supplement daily along with a fiber supplement.   My bowel movements are "ok" while taking Immodium, but, if I don't take an Immodium at least every other day, the diarrhea returns.  My doctor has told me there is another he can suggest or do for me.  He suggested making an appointment with a GI specialist, so I have made an appointment with a GI specialist.
Light headedness; Fatigue; sore left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), ARTHRALGIA (sore left shoulder) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (sore left shoulder). On an unknown date, the patient experienced DIZZINESS (Light headedness) and FATIGUE (Fatigue). On 01-Jul-2021, ARTHRALGIA (sore left shoulder) had resolved. At the time of the report, DIZZINESS (Light headedness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Low grade fever (100.6 - 100.9) starting between 6 and 7 PM and back to normal by morning. Two nights in a row. A definite lack of  energy and very mild stiffness.
Upon getting up in the morning, I fainted , had dry heaves, chills, fever, was in bed until early evening. Did not eat, continued to be tired. Approximately 3-4 weeks later,  had a repeat of the same , as described above, except no fever.  I was not in bed all day but could not resume normal activities that day. I am not aware of any lingering issues since those episodes.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (30 years ago). Concurrent medical conditions included chronic lymphocytic leukemia and nerve pain. Concomitant products included acyclovir and gabapentin. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 28 days after receiving SHINGRIX, the patient experienced shingles, headache and painful rash. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the headache and painful rash were recovering/resolving. It was unknown if the reporter considered the shingles, headache and painful rash to be related to SHINGRIX. Additional details were reported as follows: The reporter was wife of the patient. The patient also reported the information. The patient received SHINGRIX on left arm. Four to five weeks later, the patient experienced a painful rash on his head. The patient also experienced shooting pains in his head, a low grade headache. The patient went to see his physician and he was diagnosed with shingles. The patient's physician prescribed acyclovir (7 day regimen) and gabapentin for the nerve pain.
I have my period for one month now; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAVY MENSTRUAL BLEEDING (I have my period for one month now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (I have my period for one month now). At the time of the report, HEAVY MENSTRUAL BLEEDING (I have my period for one month now) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a physician concerning a 60 year old male with no known medical history or allergies who in October 2006, was vaccinated with a dose of Zostervax. There was no concomitant medication. Subsequently in late April 2007, the patient developed a local reaction. Unspecified medical attention was sought. No laboratory test were performed. There was no product quality complaint involved.
3 cm local reaction at site of injection. Seen by Allergist. Resolved by time seen by Allergist 8/11/18.
Got the vaccine/ ( shingles of the spinal cord)./suspected vaccination failure; viral meningitis; shingles of the spinal cord; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), viral meningitis (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, viral meningitis and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, viral meningitis and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. Two months after receiving Shingles vaccine, the patient experienced viral meningitis (shingles of spinal cord). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Patient recedived vaccines.  While patient was leaving the building she fainted.  Patient quickly awakened, but was confused for a short time.  Patient then had nausea/vomiting for a short time.  Patient was given a cool wash cloth and door opened for fresh air.  Blood pressure obtained 98/62.  Patient's pink color started to return.  Patient given sprite and peanut butter crackers after nausea and vomiting gone. Patient said she was feeling better.  She then was stood up after approximately 15 minutes adn sat in a chair and recovered fully before leaving with her mom.
Muscle twitching at injection site; Red warm spot at injection site; Red warm spot at injection site about 4 x 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Muscle twitching at injection site), VACCINATION SITE WARMTH (Red warm spot at injection site) and VACCINATION SITE ERYTHEMA (Red warm spot at injection site about 4 x 3 inches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis since 2000, Peripheral neuropathy since 2006, Drug allergy (morphine) and Allergy to antibiotic. Concomitant products included ROMOSOZUMAB AQQG (EVENITY [ROMOSOZUMAB AQQG]) for Osteoporosis, GABAPENTIN (NEURONTIN) for Peripheral neuropathy.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Red warm spot at injection site) and VACCINATION SITE ERYTHEMA (Red warm spot at injection site about 4 x 3 inches). On 09-Feb-2021, the patient experienced MUSCLE TWITCHING (Muscle twitching at injection site). On 09-Feb-2021, VACCINATION SITE WARMTH (Red warm spot at injection site) and VACCINATION SITE ERYTHEMA (Red warm spot at injection site about 4 x 3 inches) had resolved. On 14-Feb-2021, MUSCLE TWITCHING (Muscle twitching at injection site) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received on 28-APR-2021 Contains medical history, concomitant medication details, patient demographics updated and end date provided.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 30-SEP-2013 the patient was vaccinated with first dose of GARDASIL. Concomitant medications were not reported. On 30-MAY-2014 the patient was vaccinated with second dose of GARDASIL. On 27-JUN-2014 the patient was vaccinated with third dose of GARDASIL. No adverse effect reported. Additional information is not expected.
About 5 hours after the second dose I could not stay awake. I had horrible sweats all night. The following morning my joints were stiff, and I hurt all over.  I could not straighten my legs, and my fingers were curled. I could not straighten them. I had 102.2 fever, sore throat, headache, runny nose. Slept most of day 1. Day 2 I had sweats, fatigue, loss of appetite, but thought I was getting better.  I was able to straighten my legs and fingers. Day 3 I still had sweats, runny nose, sore throat, headache. Ok by day 4. I did not see my dr.
Scale of 1-10. 10 being severe. 1:30 am joint pain, 5; site tenderness, 4; nausea, 3. Joint pain lessened by 12 pm on 06/02. Nausea worsened all day on 06/02. Loose stools 11 times that same day.
Covid arm....rash on arm near injection site. Soreness, tender, itchy and skin feels hot to touch.
pt recv vax 17DEC96 & devel a fever w/in 24hr of vax of 105;had high pitched cry lasting <than 1hr;pt was warm to touch & listless;pt laid there for awhile;high fever was noted when mom picked pt up;
stomach cramping; she cant eat; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), EATING DISORDER (she cant eat), NAUSEA (nausea) and VOMITING (vomiting) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), EATING DISORDER (she cant eat), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), EATING DISORDER (she cant eat), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.  Patient gave consent for Follow-up.
This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered an unspecified number of improperly stores doses of ZOSTAVAX (lot # reported as L038929 is an invalid lot number for Zoster Vaccine Live, expiration date 06-JAN-2017) (dose and route of administration were not reported) for prophylaxis. The administered doses experienced a temperature excursion of 7 F for 1 hour and 35 minutes. There were no previous excursions. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Woke up with cold sweats on 6/22/2021. By late morning spiked a fever (100.4) and was very tired. Switched between cold chills and hot flashes. Sent home from work and slept for about 3 hours in mid afternoon.  Once awake, felt much better. Symptoms gone by dinner time.  Took Ibuprofin.
myocarditis; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset Mar2022, outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Abnormal; Electrocardiogram: Abnormal; Magnetic resonance imaging: Post event scarring on MRI; Troponin: High Tropinon. Clinical Course: A potential AE has been reported to the Contact Center. Reporter reported for their son that he was hospitalized and has been waiting patiently March, 2.5 days after the booster for myocarditis. The booster was a Pfizer Product. Lot Number was not provided. Any other additional information was not provided  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe headache unresponsive to OTC analgesics, body aches, chills, coughing, burning sensation in central chest, severe fatigue, nausea continuing for 5 days starting the second day after the initial dose.
patient was suppose to receive shingrix vaccine and immunizing technician performed appt vaccine without showing RPH on duty, technician administered pneumo20 and patient just received this shot last year
Subsequent to receiving three doses of Engerix B the pt was told that her titers were low and to receive an Engerix B booster. Within 24 hours of receiving the fourth dose of Engerix B the pt experienced nausea, urticaria, and a slight fever. She was seen by a physician. Outcome: symptoms resolved within a few days. The most recent information received reports the outcome of the event as resolved.
This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. On 08-APR-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous, lot# and expiration date were not reported) instead of VARIVAX (Merck). No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. Since 20-JUL- 2017, the patients were vaccinated with improperly stored dose of VAQTA lot #s M047658, expiration date 28-OCT-2017 and N012324, expiration date 05-APR-2018 (dose and routed were not reported). The vaccine was exposed from 47 degree Fahrenheit  (°F) to 77 degree Fahrenheit  (°F) (52.7°F) for 2 hours and 15 minutes. There was no previous temperature excursion. The call was made because there was a "data logger". No side effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA001164: US-009507513-1708USA004837:
Violent chills and shaking, diarrhea, vomiting, headache, fever, weakness, nausea
Maternal exposure during pregnancy; Fetal Distress; This is a spontaneous report from a contactable consumer (parent). A female fetus received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EH9899) via transplacental on 02Jan2021 (gestational period at time of initial exposure: 02 months, 1st trimester) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EL3248) via transplacental on 23Jan2021 (gestational period at time of initial exposure: 02 months, 1st trimester), both as a single dose for COVID-19 immunization. Medical history was not reported. Maternal medical history included diabetes mellitus type 2, PCOS, depression, cholesterol and GERD. The mother had two previous pregnancies and the outcome of previous pregnancies was miscarriage. The mother did not smoke, drunk alcohol or use illicit drugs during the pregnancy. The mother did not have any treatment for infertility. First day of last menstrual period was reported as 25Oct2020. Estimated date of conception was reported as 10Nov2021. Estimated delivery date was reported as 01Aug2021. Paternal relevant history was reported as environmental allergies. The father did not smoke, drink alcohol or use illicit drugs during the mother's pregnancy. Paternal exposure to products was reported as: multivitamin (Centrum men's), 1 tab daily; mesalamine ER for IBS, 4 tab in AM; Zyrtec for allergy, 1 tab daily; symista for allergy, 2 sprays daily and hyosayamine for IBS, 0.125mg 3-4 times daily, start date for all was reported as prior. Concomitant medications included escitalopram oxalate (LEXAPRO) via transplacental taken for depression on unspecified dates at 20mg, daily; acetylsalicylic acid (ASPIRIN BAYER) via transplacental take to prevent preeclampsia from 12Jan2020 to an unspecified date at 81 mg, daily; minerals NOS/vitamins NOS (PRENATAL VITAMINS; tablet) via transplacental for pregnancy from 12Jan2020 to an unspecified date at 1 DF, daily; insulin glargine (LANTUS) via transplacental taken for type 2 DM (diabetes mellitus) from 02Jan2020 to 09Aug2021 at 12-24 units bedtime; fish oil (FISH OIL OMEGA 3; tablet) via transplacental taken for cholesterol on unspecified dates at 2 DF, daily and famotidine (PEPCID AC) via transplacental taken for GERD on unspecified dates at 20 mg, daily. On 27Jul2021, that patient experienced fetal distress and on an unspecified date the patient experienced maternal exposure during pregnancy. The outcome of the pregnancy was reported as full term live birth. Date of outcome of pregnancy was reported as 27Jul2021. Gestation age at birth in weeks was 39 weeks. The outcome of infant was reported as normal newborn; Apgar Score: 1min 1; 5min 7. Malformation/anomalies diagnosed were none. Developmental assessment was normal-47th percentile. The patient underwent ultrasounds on 11Dec2020, 02Mar2021, 13Apr2021, 07May2021, 11May2021, 08Jun2021, 15Jun2021, 22Jun2021, 29Jun2021, 06Jul2021, 15Jul2021 and 20Jul2021, all with unknown results. The clinical outcome of the events fetal distress and maternal exposure during pregnancy were unknown.
Patient developed a single hive adjacent to MMR-V vaccine injection 1 minute after injection. Responded to cold pack. No progression after 15-20 minutes. No other hives, no swelling, no SOB.
Pain, redness, swelling at injection site; Pain, redness, swelling at injection site; Pain, redness, swelling at injection site; This is a spontaneous report from a contactable other healthcare professional (HCP) via company representative. A female patient of an unspecified age (65+, Unit: unknown) started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain, redness, swelling at injection site on an unspecified date after vaccination. Pain lasted 2 weeks. The outcome of events was unknown.
8:10 p c/o numbness, tingling, no sob, no dizziness, 120/76, 92 98% given H2O, rechecked 8:25p no changes in symp or V/S. Stayed on site for 40 mins symptoms resolved.
On January 22nd to at 9:27 a.m. He received the Pfizer Covid-19 vaccine in his right arm.  By 3:00 p.m. That day he had soreness at the injection site and by 10:00 p.m. he noticed difficulty using his arms to the transfer.  There was particular difficulty with the proximal left upper extremity and bracing himself and he fell to the floor.  He feels that both arms are weaker since the injection.  He had some pain in the arms particularly at the injection site initially but that has resolved.  He had dry mouth up until February 2nd.  By February 2nd he could start to transfer a bit better from a chair to his driver seat in the van.  He is still not back to his baseline function.
Dizzyness, vertigo, rapid heart rate, heart palpitations, slight chest pain, lightheadedness, slight ear pain, ringing in ears. All symptoms went away 4 days after first symptom except dizzyness, vertigo, and ear pain and ringing in ears.