chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of premature delivery in a 27-year-old female patient who received BOOSTRIX for prophylaxis. On 5th October 2017, the patient received BOOSTRIX (intramuscular). The patient's last menstrual period was on 20th August 2017 and estimated date of delivery was 11th May 2018. The patient received BOOSTRIX at week 6 of the pregnancy and during the first trimester of pregnancy. On 8th February 2018, 126 days after receiving BOOSTRIX, the patient experienced premature delivery (serious criteria hospitalization). On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the premature delivery and vaccine exposure during pregnancy were unknown. The pregnancy ended in a stillbirth at greater than 22 weeks gestation with no apparent congenital anomaly present. On 8th February 2018 after 24 weeks and 4 days, the patient gave birth to a [gender] neonate via unknown delivery. It was unknown if the reporter considered the premature delivery to be related to BOOSTRIX. See case US2018GSK168756 for details regarding the baby case. Additional details were provided as follows: This case was reported by the patient for herself. The patient received BOOSTRIX while she was pregnant at 6 weeks and 4 days of gestation. On 5th February 2018, she was hospitalized (reason unspecified) and her baby was still alive. On 6th February 2018, the baby's heart had stopped beating. On 8th February 2018, 126 days after receiving BOOSTRIX, the baby was delivered prematurely at 24 weeks and 4 days of gestation. The contact details of the physician were provided.
patient reports 12 hours after vaccination having body aches and "weird pain" in heart region.  reports having  "weird feeling" in heart after 2nd moderna vaccination in the past.  for 3rd dose of vaccination, reports having swollen sensation in left collar bone region.  received covid vaccine in left arm for 3rd dose and also 1st and 2nd doses.
MIGRAINES; HEARING A CONSTANT HIGH PITCHED RINGING OR WHINE IN THE LEFT EAR (POSSIBLY TINNITUS); DIARRHEA; FULL BODY ACHE; LETHARGIC; DIFFICULTY WAKING UP; FELT LIKE HIT BY BUS; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 02-OCT-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient experienced full body ache. On 07-JUL-2021, the patient experienced lethargic. On 07-JUL-2021, the patient experienced difficulty waking up. On 07-JUL-2021, the patient experienced felt like hit by bus. On 07-JUL-2021, the patient experienced diarrhea. On 03-AUG-2021, the patient experienced migraines. On 03-AUG-2021, the patient experienced hearing a constant high pitched ringing or whine in the left ear (possibly tinnitus). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from full body ache, lethargic, difficulty waking up, and diarrhea, had not recovered from hearing a constant high pitched ringing or whine in the left ear (possibly tinnitus), and migraines, and the outcome of felt like hit by bus was not reported. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 71-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 26th April 2018, the patient received the 1st dose SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown. The reporter considered the nausea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter did not know, if any other vaccines had been administered within 4 weeks prior to the SHINGRIX administration. The patient received SHINGRIX on left arm. No other vaccines were administered on 26th April 2018 besides SHINGRIX. The reporter was the dispensing pharmacist and the patient called her early morning on the reporting date and said he had been feeling extremely nauseous since receiving the SHINGRIX. The reporter noticed the symptom of nausea described within the product package insert (PI) and called GlaxoSmithKline to discuss how long the reported symptom would last, because the patient asked her how longer the extreme nausea would last. She did not know the status of the symptom at the time of reporting and described it as unknown. The reporter's call was transferred to the Medical Information (MI) team for further discussion upon request. The reporter gave consent to be contacted.
pt recvd vax;@ 8:45 fainted;color pale;pupils dilated;hands & arms shaking;less than 1 min;aroused w/ amonia capsule;v;BP 80/52 at 9:10pm; P=82;color fine;discharged at 9:30pm w/ mom;
HPV 9 was injected left deltoid and patient was asked to remain in room for 15 minutes after injection. When nurse returned to check patient response to vaccine, patient complained of "cloudy vision and dizziness". Nurse asked patient to lie down and then asked physician to asses patient.  Physician note regarding assesment: Upon entering the room, she was sneezing numerous times and also complained of some scratchiness in her throat. This is similar to the reactions she has had to hand sanitizer and other perfumed items in the past. Felt that perhaps she was actually having a reaction to hand sanitizer used in the office, so gave benadryl 25 mg po x 1.  Approx 5 min later, went to reassess patient and she began complaining of chest pain. Complained of "stabbing" pain in center of chest and radiating through to the back. Chest pain was reproducible with palpation of the costochondral junction. Lungs clear. CV RRR without murmur. Ox Sat 99-100% and HR 72.  Reassurance provided; patient left in quiet room and cool washcloth on chest and reassessed shortly after and said she was feeling better. Still slightly dizzy but vision better (could identify number of fingers being held up, etc). Patient felt comfortable and ready to go home. Decided to have a nurse escort her out of office in wheelchair to ensure she continued to do well with standing, etc, getting into car. Did well getting from bed to wheelchair and seemed more comfortable upon leaving office. Nurse returned to office to retrieve O2 sat monitor and stated patient got into car and began complaining again of chest pain and now also of left arm pain and numbness. Went to reassess in parking lot and patient now complaining she could not move her left arm. Good pulse but left arm pale and upper arm and chest very red. No labored breathing.  Lungs CTAB and CV RRR without murmur. Sat 98%. Asked patient to squeeze my finger with both hands. Did so with right hand but states she is trying with left hand and cannot. Raises left shoulder but cannot bend left arm at wrist or elbow. When I raise the arm at elbow and leg go, she allows it to simply "flop" into the car seat. States she cannot feel anything and does not react to having the arm pinched, etc. Decided to have patient admitted for observation. Spoke with nurse to inform that patient directed to go straight to peds floor and with Dr. regarding observations in office and desire to admit overnight. Appreciate his assistance with patient.
Pt. does take checks and dressing changes for vaccinees from whom VIG is obtained.  Vaccinated against smallpox as a child, but not recently.  Saw her PMD for a red left eye on 5/8/03 and was treated with erythromycin drops.  No improvement.  Seen by an ophthalmologist on 5/20/03.  Diagnosed as having purulent conjuctivitis and started on Vigomox drops.  Seen in follow-up 5/20/03.  Because eye was still draining and history of possible vaccinia exposure, Viroptic solution added to tx.
?Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports nausea, fever, headache, and axillary mass (painful, worsening, red, and unable to put arm down) after vaccination. Patient advised home management: antihistamines, topical steroids, ice (when able to tolerate) and to rest.
10 days after booster, hives and itching all over skin. If something touches my skin it causes hives.  Given steroid shot and 6 day 21 pill pack. Was taking Benadryl as needed but have stopped. Allergist said it may be Chronic Spontaneous Urticaria.   Increased cetirizine to 40 mg a day and  added famotidine 20 mg. Itching is mostly controlled with allergy medicine. Still experiencing severe dermographia.
Baby developed Hydrops foetalis between 31 week and 35 week ultrasounds. Baby was due end of December, but was deliver via emergency c-section in November. Birthweight at birth was 8 pounds 15.5 ounces. Pregnancy was completely normal until discovery of condition during 35 week ultrasound.
The lymph node under my arm became swollen and tender.  It was roughly the size of a golf ball after the second injection and the size of a softball after the booster.    Additionally, after the booster, my breasts were tender for about 2 weeks and, though I have had a hysterectomy, I had symptoms like constipation, abdominal cramps and irritability that would normally accompany a period or early pregnancy.
Pt. states that after receiving the 3rd dose of Phizer 12/30/2021, started experiencing symptoms 12/31/2021 of high heart rate 60-70 (randomly) and "A-Fib" fluttering. Cardiologist visit 01/2022 with no recommendations. Pt. still experiencing symptoms.
Pt recvd vax & exp sz 3AM; 14JAN94 & taken to ER; t102 & dx OM; was discharged then adm @ 1030Pm same day p/sz cont x 4; no further sz p/admission;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 66-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 02Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypogonadism" (unspecified if ongoing); "headache" (unspecified if ongoing); "GERD" (unspecified if ongoing); "mild leukopenia" (unspecified if ongoing). Concomitant medication(s) included: MORPHINE oral, start date: 07Jan2022; MIRTAZAPINE, start date: 15Jun2021; TESTOSTERONE intradermal, start date: 17Sep2021; PANTOPRAZOLE oral, start date: 15Sep2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive, notes: Symptom start date 10May2022 with a positive home antigen 11May2022; (19May2022) Negative, notes: 19May2022 tested negative by home test; (30May2022) Positive, notes: Tested positive 30May2022 by home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical details: Paxlovid started 12May2022 to 18May2022. 28May had a sore throat, nasal congestion, fatigue. Tested positive 30May2022 by home test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Pink skin color change around shot site with tenderness. Some streaking reported. No fever, vomiting, abdominal pain, breathing difficulties.
Hx of siezure activity since age 7 months 3/13/2003 Immunizations given 3/14/2003 Seizure activity post immunization  on seizures med daily, PMD referred for immunizations
Patient complaint of dizziness after receiving vaccine. Provided water and Powerade. EMS evaluated. Patient recovered. No other complaints ordered by patient.
The patient received the first dose of SHINGRIX in July, 2022 and has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and breast cancer. Previously administered products included Shingrix (first dose of shingrix in July 2022 ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: The patient received the first dose of SHINGRIX in July, 2022 and has not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-JUL-2023 The reporter was the patient. The patient received the first dose of SHINGRIX and had not yet received the second dose. It was not clear if the breast cancer was prior to or after the first dose of SHINGRIX. Limited information provided. Did not consent to follow-up.
Increasing levels of fatigue since the booster shot. Also increasing muscle aches in arms and legs
severe fever; body aches; nausea; head aches; constipation; vomits; has been sick; This is a spontaneous report from a contactable consumer or other non hcp reporting for a patient (wife).  A 36-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151, expiry date: unknown) via an unspecified route of administration on 06May2021 (at the age of 36-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, after vaccination on 06May2021, reporter stated that his wife experienced severe fever, body aches, nausea, headaches, and some constipation to the point that she doesn't eat or drink, and if she does she vomits. Reporter stated that his wife was currently in contact with their physician, but asked if these were possible side effects of the vaccine. Patient stated she got the vaccine on 06May2021 since then she has been sick and has had all the symptoms such as nausea, fever, body aches, headache, not able to eat food and as soon as she eat she vomits, and constipation. Patient stated she needed to report this and ask what she should she do. Patient stated she was in contact with the physician and talking to them. Reporter stated his wife the last couple of weeks had not been able to eat anything or drink anything. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
The patient did not receive the second IMOVAX dose on day 7, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00640450) and transmitted to Sanofi on 14-Jun-2021.  This case involves a female patient (age unspecified) who did not receive the second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] on day 7 (Product dose omission issue)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 01-Jun-2021, the patient received a first dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site for pre exposure immunisation.  It was a case of an actual medication error due to Missed dose (latency same day).  Nurse stated that a patient received the first dose of IMOVAX on the 1st of June and they are in today for their second dose but she was unable to find information or guidance on giving the dose on the 10th day instead of the recommended 7th. The health care professional (HCP) was verifying whether she could receive her second dose and does not have to restart the series.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information available on the batch number for this case.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 12:42 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 12:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant products reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. The body site was mentioned as deltoid. The previous doses route and body site was reported as intramuscular and deltoid.  No adverse reactions reported for the patient.  No treatment products reported.
Three weeks after the vaccine my ankles were swelled up. I gained 30 pounds over the course of fourteen days. I was having trouble breathing. I was admitted to the hospital and diagnosed with Atrial Fibrillation and Congestive Heart Failure. I also had water in my lungs. I have not had any heart symptoms before that. I tested positive for Covid-19 antibodies in June of 2020. I had multiple tests on every organ. There were no clogged arteries and no heart problems except for AFIB. My blood pressure is fine but I am taking half a blood pressure pill. I am trying to lose weight. I am scheduled to see a cardiologist on 05/25/2021
Pt developed a large red swollen (10cm X 11cm) notice 24 hours post injection. Pt says site is painful and warm to the touch.
Per Dr.: Mother states patient has a small bubble like bump with redness around it on left thigh. Checked immunization details. Patient received Varicella on left thigh. Reassured that its mild form of chicken pox. Advised to limit contact with little babies and immunocompromised individuals. Keep the area covered and use BENADRYL 3.75ml every 6 hours prn itching.
Four days after she received the 1st dose, she developed a swollen eye lid  that resolved on its own. She really didn?t think anything of it and did not report it to anyone or take any medication for it.  On 1/12/2021 she received the 2nd dose.  On day 7 of her vaccine she developed hives on her lower extremities. She took Benadryl that day and they improved, but did not got away.  On day 8 the hives reapproved and she took a dose of Claritin and that got her through working.  On day 9 (yesterday) the hives have migrated from just her lower extremities to her arms and shoulders.  She took both Zyrtec and Benadryl yesterday, but she is not getting any relief.
Diarrhea, back ache, head ache, swollen lymph node in neck
This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMPAIRED WORK ABILITY (couldn't do much of anything) and PYREXIA (fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Nasal allergy (Nasal) and Skin cancer. Concomitant products included METOPROLOL, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, VITAMIN D NOS and CREATININE for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, the patient experienced IMPAIRED WORK ABILITY (couldn't do much of anything) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date at an unspecified dose and frequency. On 30-May-2022, PYREXIA (fever) had resolved. At the time of the report, IMPAIRED WORK ABILITY (couldn't do much of anything) outcome was unknown. Concomitant medications also included Create (D). The patient had never been diagnosed with/ tested positive for COVID-19. The patient had received first booster dose of Moderna vaccine on 12-Oct-2021. The patient took second booster dose on 27-May-2022 both at the same facility. This case was linked to MOD-2022-580263, MOD-2022-580265, MOD-2022-580266 (Patient Link).
Severe hives for 5 days including angioedema (swollen lips and eyelids) - Ranitidine 150 mg PO twice daily was given + Allegra once daily  180 mg was given + Benadryl 50 mg every 3-4 hours + Prednisone 20 mg once daily  with no relief. I sought care at an allergy/dermatology clinic and was prescribed Prednisone 60 mg PO for several days and then a slow taper over 5 weeks. The hives and itching decreased after 1-2 days of taking the Prednisone.
Pain to injection site,  body aches, severe headache, approximately 15 hours after injections vomiting occurred every 15 min for 4 hours and 2 times after, unable to eat or drink, weakness, fatigue, into second day after.