chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by an other and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 29-year-old female patient (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Depression and Anxiety. Concurrent medical conditions included Drug allergy (drug-cefprozil) and Drug allergy (cefprozil). Concomitant products included ZINGIBER OFFICINALE (GINGERPRO) from 01-Jan-2020 to an unknown date for Nausea and Digestion impaired, DOXYLAMINE from 27-Jul-2020 to 09-Mar-2021 for Nausea and Insomnia, MAGNESIUM from 01-Jan-2019 to an unknown date for Sleeplessness and Constipation, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 01-May-2020 to an unknown date for Vitamin supplementation, DOCOSAHEXAENOIC ACID (OMEGA 3 DHA [DOCOSAHEXAENOIC ACID]) from 01-May-2020 to an unknown date for an unknown indication.    On 11-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Jun-2020 and the estimated date of delivery was 19-Mar-2021. On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The vaginal delivery occurred on 10-Mar-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, the birth weight was 1388 grams (3lbs 1oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2020, Ultrasound antenatal screen normal: normal (normal) Normal, no abnormalities founds. On 18-Dec-2020, Glucose tolerance test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's reported last menstrual period was 12-Jun-2020, date of positive pregnancy test was on 06-Jun-2020.  Meconium stained amniotic fluid without complications was reported. No infant abnormalities were reported during pregnancy and 1 month post-partum.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Initial additional - pregnancy outcome form : Added revised patient initial, updated lab data, delivery details and concomitant medications drug information
drug allergy; This case was reported by a nurse via other manufacturer and described the occurrence of drug allergy in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included amoxicillin for an unknown indication and levofloxacin (Levaquin) for an unknown indication.   Concomitant products included pregabalin (Lyrica).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose, amoxicillin at an unknown dose and frequency and Levaquin at an unknown dose and frequency. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, amoxicillin and Levaquin, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown.   It was unknown if the reporter considered the drug allergy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient's Height was reported as 5'-06" and Weight: 130 lb. It was reported that the patient had drug allergies to Amoxicillin, Flu vaccine and Levaquin. It was unknown whether the reporter had consented to follow up.
Sister had chicken pox 13 days ago. Today 3/3/06 child has about 50 chicken pox lesions on trunk. Came for Dx - Rx: Benadryl prn. Child had varivax 4/24/02. (Sister not seen by us for Dx but was vaccinated at another practice 3/9/98 - No lot # or site info available to us)
This case was received from a health care professional on 06-August 2009. A 30-year-old female patient, with no reported medical history, received a left deltoid intramuscular injection of ADACEL (lot number C2994BA) on 03 August 2009. It was not known by the reporter the date on which the patient had received her last tetanus injection. On 04 August 2009, approximately 24 hours after vaccination, the patient developed injection site pain and induration, described as a two-inch hard, red lump. The patient also complained of pain in the entire arm extending to the axillary area. She was seen by a physician for her symptoms, which had not yet resolved at the time of the report. Follow-up information was received 19 October 2009 from a health care professional. Based upon this new information received, it was determined that the event meets seriousness criteria and has been upgraded from non serious to serious. The patient had no concurrent illness at the time of vaccination. The patient had questionable cellulitis at the site and KEFLEX was ordered. According to the reporter, the patient recovered. No additional information was provided. Documents held by sender: None.
Information has been received from a nurse practitioner through the pregnancy registry for GARDASIL vaccine (yeast) concerning an 18 year old female with no medical history and allergic to penicillin, who on 30-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (Lot # 660389/1968U). There was no concomitant medication. On 30-JUL-2008 the patient was found to be pregnant. No problems reported. Date of LMP was 29-JUN-2008. Estimated delivery date is 05-APR-2009. Urine pregnancy test, PAP and STD test (sexually transmitted diseases) were performed. There was no product quality complaint. Follow up information has been received from a nurse practitioner concerning an 18 year old Native American female with a history of 1 previous pregnancy and 1 full term delivery, with no significant past medical history who on 30-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (Lot # 660389/1968U) (Lot # reported as "1968 U"). Concomitant medications included prenatal vitamin daily for pregnancy started on 30-JUL-2008. Birth defect(s) in previous pregnancies and infant complications in previous pregnancies were reported as unknown. Estimated conception date was on 13-JUL-2008. Date of last menstrual period was on 29-JUN-2008 and estimated delivery date is 05-APR-2009. Additional information has been requested.
Low fever (100 deg F), alternating chills and hot spells, drowsiness, light headedness for approx 12 hours. I had to take the day off work because I was too sick to work. Spent most of the day sleeping, didn?t want to eat anything.
19-year-old male administered injection I am into left deltoid became diaphoretic quite quickly after injection then started to feel unwell. Patient was then sick sick to my stomach code green called vital signs stable patient started to feel well after sitting. Was able to walk over to observation area with assistance. Patient refused any further medical attention and was able to walk to obervation with mother.
B/P 180/120, T-99.9, sever H/A, sever body / joint pain, including jaws, weakness
After pt was vaccinated went to restaurant to eat breakfast with mom. Ate eggs. Mom called at 1 pm stating she noticed child's face get red, and feeling as though getting temp. Pt came back to doctors office at 1:30. Child presenting with face redness, generalized rash, and temp of 103.6. Child sent to ER.
This patient developed body aches, chills, and nausea an hour and a half after receiving Bexsero. She went to the ED where she was febrile to 103 and tachycardic to the 140s. She was admitted overnight and discharged the next day.
Noticeable fatigue and headache day one and two after vaccination.  Raised red rash with itching on arm site of injection on day 6 after the injection.  Still ongoing as of day 10 after injection
Pt recv vax on 10/19/98; on 10/20/98 pt exp red, erythema, warmth at vax site; tx=Benadryl & cold compresses
Patient received COVID 19 vaccine 01/14/2021. Patient died in his sleep 01/16/2021.
Patient was given .5ml instead of .25ml of Moderna vaccine for 2nd covid booster.
The subject received his first shot at scheduled time from a female staff. During his 15 minutes observation period, another male staff gave him a second full dose shot by accident.; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) in the arm left on 15May2021 at 14:15 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 14:30, the patient had received first shot at scheduled time from a female staff. During the fifteen minutes observation period, another male staff gave a second full dose shot by accident. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of this event. The clinical outcome of the event medication error occurred as another male staff gave him a second full dose shot by accident was unknown at this time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a psychiatrist concerning to a 61 years old female patient with rash after 8 days on amoxicillin. The patient's medical history included mild asthma. On 03-DEC-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (Lot and dose not reported). No other co-suspects were reported. Concomitant medications included SINGULAIR, ALLEGRA and cholecalciferol. Psychiatrist mentioned that at received ZOSTAVAX and had on her left arm at the injection site a 3.5 inch x 1.5 inch inflammation or erythema and her left arm was a little sore. Psychiatrist stated there was no rash. No treatment information was reported. No lab diagnostics were reported. The outcome of the events were not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
patient received the Pfizer monovalent booster instead of the Pfizer bivalent booster
After both the first and second dose I received my period for an extended period (longer than normal). The bleeding was a bit heavier than normal as well; This is a spontaneous report from a contactable consumer (patient herself). A 23-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: ew0164) as DOSE 2, SINGLE; via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: er8736) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history included acne. Concomitant medication(s) included spironolactone. The patient was vaccinated in a hospital. The patient did not have no known allergies. On 21Apr2021, the patient after both the first and second dose she received her period for an extended period. The bleeding was a bit heavier than normal and the timing was in line with the vaccine. The patient had an intrauterine device (IUD) and didn't have a period for 3 months before the vaccine. She was on medication for acne, and noticed that has thrown my period off as well. The patient on 29May2021, underwent sars-cov-2 test (nasal swab) which was negative. The patient did not receive other vaccine in four weeks. The patient did not receive any treatment for the adverse event. The patient did not have covid before vaccination. The outcome of the event was recovered on an unknown date in 2021.
Persistent head ache, starting as mild headache on the evening of March 16, 2021, and increasing in intensity in the morning of March 17, 2021. I felt chilled and spent much of the day in bed covered with a sleeping bag/quilt, while putting ice packs on my head and neck. The pain lessened by the night of March 17, 2021. There were twinges of headache pain on March 21, 2021. (I have had very few headaches in my life.) There was also some nausea and intestinal distress.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 25-FEB-2016, the patient was vaccinated with an improperly stored ROTATEQ 2 ml oral injection (lot# L008997, expiry date 04-DEC-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 544 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius) and the second one lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
NAUSEA; RACING HEART; SWEATY/SWEATY PALMS; FELT DIZZY; CHILLS; HEADACHE; FEVER; DECREASED APPETITE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced decreased appetite. On 05-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) unknown. On 05-APR-2021 20:00, the subject experienced chills. On 05-APR-2021 20:00, the subject experienced headache. On 05-APR-2021 22:00, the subject experienced racing heart. On 05-APR-2021 22:00, the subject experienced sweaty/sweaty palms. On 05-APR-2021 22:00, the subject experienced felt dizzy. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, sweaty/sweaty palms, chills, headache, and fever on 06-APR-2021, and nausea on APR-2021, was recovering from decreased appetite, and the outcome of felt dizzy was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
I received the first dose of Pfizer's Covid 19 vaccine on April 22nd. That same day I started with Covid symptoms, so I took a test and it came out positive.; This is a spontaneous report from a contactable consumer. This female consumer(patient) reported for herself that:  An unspecified age of female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on 22Apr2021 at single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 22Apr2021 (the day of vaccination), the patient experienced Covid symptoms, so took a test, and it came out positive. The patient recently had a PCR test, and it is negative. Her second dose scheduled for 15May2021. The outcome of event is unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
on day 1 and 2, pt reported facial rash, itching, and injection site soreness, symptoms resolved after day 2  Narrative:
Chills, dizziness, heart rat up to 120 for now 3 days. Both shots of flu shot and Covid were given together.
Patient was given the 3rd dose of HPV vaccine too early based on recommended tracking schedule/interval. Parent (mother) and patient made aware of incident. Parent instructed to bring patient back to clinic for 3rd dose of HPV on or after 07/02/2020. Parent and patient made appointment for 07/06/2020 to receive the 3rd dose of HPV within the appropriate time frame. Patient denies previous reactions to vaccine. Instructed parent and patient to return to clinic or go to Emergency Room if side effects occur. Parent and patient verbalize understanding.
She's had a fever of 100-101 off and on since Friday night. She became very nauseous and threw up on Saturday. She has low energy, watery eyes, congestion and a headache. Today, Dec 8th, she's also got an awful sounding cough, too. She started to get better and mostly was on Monday, Dec 6th, but it has gotten worse since that day.
Vaccine administered in left deltoid. Patient reported arm pain, swelling, bruise. Bruising cleared after 3 weeks, arm pain continues intermittently, dull ache, then sharp "bee sting"
Noticed small, scattered bruises inside left thigh; they went away with time.  After second vaccine 3/1 I began to have leg cramps at night, after 1 week still tired and sore.
Clinic notified me - pt. in hospital for severe reaction to VZV. (L) arm red/swollen from deltoid to elbow. 14cm x 14.5 cm, lg. blister with smaller surrounding blisters. Blister lanced - IV ampicillin started. 8/25/11 MD states looks much better today.
On 1/24/02 mother called to report child had 3-4 bumps like rash on back, neck and genital area. No fever. Advised to see MD if symptoms persist or worsen. Mother agreed.
SHARP HAND PAIN; SWOLLEN INJECTION SITE; FATIGUE; INJECTION SITE PAIN; BODY ACHES; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206a21a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced swollen injection site. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced sharp hand pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen injection site on APR-2021, and injection site pain on 08-APR-2021, was recovering from body aches, had not recovered from fatigue, and the outcome of sharp hand pain was not reported. This report was non-serious.
first one in July, Need a second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose in July 2021).   On an unknown date, the patient received 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 details were provided as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter wanted to know the maximum amount of time between 2 doses. The reporter stated that, he/she needed a second dose and didn't wanted to wait too long. The reporter also stated that, his/her doctor was aware about the 2nd dose and had booked the same.
Caller states sister had second dose and reports a bruise a month later on arm.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a bruise on arm a month later after the second dose of BNT162B2. The patient indicated that she did not know if she could have acquired it working in the yard but asked if it is a reported adverse event. Outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Lightheadedness, pale, sweating, and nausea immediately after the injection was given with c/o sx when bandaide was being applied to arm w/full recovery within one minute - after legs were elevated. Tx - legs were elevated, ice pack to neck/chest, oral fluids and crackers to eat.
And very warm to touch Round Re a of injection, very sleepy\ tired, loose runny stools,
This spontaneous report as received from a medical assistant refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # L050560, expiry date: 14-DEC-2017, (dose#, route and site of administration not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the six reports received from the same reporter.
Within a few hours post vax the pt experienced injection site swelling. Additionally pt felt as if he had Lyme disease again and experienced joint pain in every joint and muscle aches. He was unable to work for four days. Pt was treated with over the counter NSAIDS and rest. Symptoms resolved in 4-5 days. Joint complaints were not evaluated by a physician. The most recent information reports the outcome of the event is resolved.
Adverse Events: Flu like symptoms; mild headache and aches starting ~7 hours after injection. Uncontrolled shivering and fever and lack of sweating  starting ~8-8.5 hours after injection. Fever broke and sweating resumed ~8-9 hours after fever began. Loss of appetite persisted for a full 24 hours after onset of symptoms. Treatment: Bed rest starting ~7.5-8 hours after injection. Drink water ~60 oz of water over following 8-9 hours. Take OTC pain reliever & sleep aid ~12 and 15 hours after injection to alleviate fever and assist with sleep. End bed rest 18 hours after injection. Basic rest and recovery for following day. Outcome: Full recovery obtained ~26 hours after onset of initial symptoms.
Sever left knee pain. Don't know if it is related to vaccine, but occurred within one day of vaccine and no other causes.