chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 immunisation.     The patient's past medical history included Recreational drug use and Ectopic pregnancy (one past pregnancy). Concurrent medical conditions included Multigravida, Attention deficit hyperactivity disorder, Type 2 diabetes mellitus, Blood pressure high, Hyperthyroidism and Polycystic ovarian syndrome. Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 immunisation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), LEVOTHYROXINE from 19-Feb-2021 to an unknown date, METFORMIN from 19-Feb-2021 to an unknown date, ATENOLOL from 05-Apr-2021 to an unknown date, BUPROPION HYDROCHLORIDE (BUPROPION HCL ER) from 19-Feb-2021 to an unknown date and ACETYLSALICYLIC ACID (ASPIRIN LOW) from 12-Mar-2021 to an unknown date for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 19-Feb-2021 and the estimated date of delivery was 26-Nov-2021. On 25-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 25-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body mass index: increased (High) increased.         Treatment  medication was not reported. The patient had been pregnant before.   Reporter did not allow further contact
This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23. Dose, route, lot number and expiration date were not reported. The health care worker reported that PNEUMOVAX 23 was improperly stored and administered to unspecified number of patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Tdap was administered at 11am 11 Sept 09. By that evening I started experiencing severe heart rhythmn problems, irregular heartbeats, skipping beats, fluttering. This lasted all that night and into Saturday and Saturday night. By Sunday the arm soreness spread to my armpit and my left rib cage. Irregular heartbeats persisted in to Monday morning, they were so severe I went to the ER at about 6am. They recorded continual PVC activity on the monitor, every other beat. The took blood tests, chest xray and nuclear stress test and found no cause for the PVCs, even after I told them about the vaccination. They sent me home at about 4pm. I have had continual PVCs all week with dizziness and nausea. Only relief comes from taking 1mm Ativan but that is only temporary. PVCs seem to increase after eating or moving around. One week later, PVCs continue the same intensity. Stiff neck and back. Soreness in armpit and left rib cage gone. Take about 2 1mm ativan daily to try to control. Also on 50 mg lopressor for HBP. No indication PVCs are subsiding.
The patient noted feeling chills after receiving the vaccines that lasted until that upcoming Monday (shots were given on a Thursday). She also complained of abdominal cramps and bloody diarrhea that lasted on both Saturday and Sunday. At the time of notification - she felt that nothing in her diet or foods eaten had been different during that time period.
Patient stated that a few minutes after the injection (approx. 1:35pm) she experienced some eye lid swelling. Later that afternoon she developed a massive headache which she had until the following afternoon and is still complaining of today (9/16). That night at approx. 11pm, the patient developed a fever, chills, severe aches and hallucinations that she was being assaulted. She said she thought she might be having another stroke but the symptoms subsided the following morning except for the body aches and the headache.
Hematoma, right deltoid for 3 days non tender. Tx cold compress which resolved after 3 days.
Patient had MODERNA COVID-19 vaccine on 01/12/2021 . 3 days later developed severe left great toe gout flare. Had second shot on 02/23/2021 and within 24 hours developed bilateral foot gout symptoms.
pt recvd vax;23oct noticed jaundice & dark vine;adm to hosp on 7nov95 w/ progressive jaundice;bilirubin:26.5;liver biopsy shaved periductal inflammation w/ neutrophils;progressive liver failure; tx w/ iv steroids;
Awoke at 1:30 am on 5/23/21 with horrid achy leg pain which continued until 5/24/21--achiness is gone , but lower legs still feel weak.  also, headache, neck ache, joints ache and kidney area felt tight and achy too.  also, slight fever with chills.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ashtma" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: BENICAR; QVAR.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
headache, nausea, dry heaves. swollen lymph node under arm, pain and itching at injection site.   lymph node under arm was painful and swollen for 1 week.  Out of work on 1/12 due to inability to lift arm and use as node was very painful.   fully resolved as on 1/15/21
Vaccine was administered after the 10 week BUD after receiving vaccine. No reported ADE from patient
Patient was administerd Covid Pfizer vaccine IM. While still in vaccine booth patient stated her tongue was feeling numb. She was moved to a recliner and given water to sip. Her breathing rate started to increase, she bacome diaphoretic and pale. She stated her left arm was numb. Her pulse felt rapid. a monitor was placed on the pt. at 2:05pm- Pulse 108, p02 100%, Resp 20, 2:10pm Pulse 120, p02 100%, respirations 24. Rapid response called, advised to call adult medical emergency. Vitals at 2:15pm Pulse 133, p02 100% Respirations 28. Rapid response team arrived, assessed patient and Patient transferred immediately by wheelchair to the Emergency Dept.
INJECTION SITE REACTION ALONG WITH BODY; TINGLING ARM; SENSITIVE AT THE SITE OF INJECTION; BODY ACHES; ITCHINESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A23A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included vitamins nos.  On JUL-2021, Laboratory data included: Blood test (NR: not provided) reports were not received., and COVID-19 virus test (NR: not provided) Negative.  On 26-JUL-2021, the subject experienced body aches. On 26-JUL-2021, the subject experienced itchiness at the injection site. On 26-JUL-2021, the subject experienced tingling arm. On 26-JUL-2021, the subject experienced sensitive at the site of injection. On an unspecified date, the subject experienced injection site reaction along with body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site reaction along with body, and was recovering from body aches, itchiness at the injection site, tingling arm, and sensitive at the site of injection. This report was non-serious.
About half  hour after receiving the vaccine, she was having leg pain that then progressed to back pain in the spine mostly in the lower back and buttocks felt numb.  She went to the ER on 2/19/2022 and was prescribed  Norco.  She continues to have the spine pain on 2/21/22 and is needing to continue with the Norco.
Several hours after the shot pt developed a pruritic Arthus type reaction of the upper arm.  No fever, no difficulty breathing, just itchiness.  I discussed the pt with Dr., an allergist, and I'm giving Clarinex 5 mg daily till clear.
22 days after receiving vaccine developed acute transverse myelitis at T6 level.  8/14/2007 MR received for DOS 4/25-5/1/2007.  Initially presented with sudden onset weakness in the legs, 10/10 abdominal pain and trouble walking. Numbness and tingling of extremities as well. Admitted with DX of weakness. Discharge DX:  Transverse myelitis.  UTI. 1/4/10 Leg weakness to Transevere Myelitis
The client was vaccinated on 7/28/2022 with an expired Moderna vaccine. The vaccine was thawed and accidentally used 1 day following the marked B.U.D. date of 7/27/2022.  Pt tolerated vaccination well on 7/27/2022. The vaccine administration error was not realized until after vaccination clinic ended and RN returned thawed/non-punctured Moderna vaccine to Pharmacy. Safety event completed in Pharmacy, team leadership aware. Additional safety checks and protocols put into place to mitigate future risk of administration errors in both the Pharmacy as well as on our City Mobile vaccination team.
I contracted COVID-19 on 10/30/22 with symptoms of cough, congestion, sneezing, runny nose, myalgia, fever and fatigue. I was prescribed PAXLOVID. I was ill for 14 days before my symptoms began to resolve, and I experienced lingering fatigue for an additional week. I am fully recovered with no lingering symptoms.
20 y/o male presents for smallpox reaction. Pt received the smallpox vaccine on 24 Feb 14. Pt has for the past 6 days noticed red itchy bumps to his lower arms, toes, and lower legs. Pt was seen by both Urgent Care and the ER over this last weekend. Pt was given a Medrol pack 4mg for 6 days (on day 3), clobetasol cream, and hydroxyzine. Pt states the itching has greatly reduced since starting the Medrol as well as the overall scope of the outbreak. He does live in the dorms and shares a bathroom with someone else. He has also been going to work. He does not have a history of skin disease. He denies any fever, chills, nausea, or vomiting.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved. No concomitant meds were provided. No treatment information provided.
Not feeling well/didn't feel very well for 24hrs; headache/wicked headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well/didn't feel very well for 24hrs) and HEADACHE (headache/wicked headache) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well/didn't feel very well for 24hrs) and HEADACHE (headache/wicked headache). At the time of the report, MALAISE (Not feeling well/didn't feel very well for 24hrs) and HEADACHE (headache/wicked headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received and events: headache(wicked headache) and malaise(didn't feel very well for 24 hrs) have been updated.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Palpitations  Narrative:  Employee received vaccine at 8am on 12-29. 45 minutes later  experienced flushed feeling, heart palpitations, chest pain. See in urgent care at  work, EKG showed ectopy. She was sent to the nearby emergency room, where  she was monitored and given iv fluids, oxygen, and tylenol. She is feeling better  today one day later, and will have follow-up with cardiology. Vaccine  administration may have set off underlying predisposition for PVC's, ectopy. Was  aware of PVC's previously but well-controlled on diltiazem. Has now been  switched to metoprolol.
Pt states she had immediate intense pain upon immunization, followed by two days of fever and seven days of arm swelling.
3-4 days of mild cough, mild congestion, sneezing, itchy throat (1/4 to 1/7). Treated with generic OTC cold symptom relief medication
mild headache all day; body aches developed throughout the day; drenched in sweat; vomited; This is a spontaneous report from a contactable other healthcare professional, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 17May2021 at 15:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC); all for an unknown indication from an unknown date. The patient previously took Reglan, Tetanus and Ceftin on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 26Apr2021 at 17:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 18May2021, the morning after the 2nd vaccine the patient had a mild headache all day, body aches developed throughout the day, she woke up at midnight drenched in sweat and vomited. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the events. The clinical outcome of the events body aches developed throughout the day, drenched in sweat, mild headache all day and vomited was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
A nurse reported that a female in her 40's did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  The subject had no relevant medical history or concurrent conditions.  Concurrent medications were not reported.  The subject received her first series of Engerix-B injections on 07/27/2001 (Lot # ENG5294B6).  On 05/14/2002, a hepatitis B antibody titer was less than 10 mIU.  The subject received her fourth injection of Engerix-B on 07/26/2002 (Lot # ENG5294B6).  On 09/12/2002, a hepatitis B antibody titer was less than 3 mIU.  The subject received her fifth and sixth injections of Engerix-B on 11/27/2002 (Lot # ENG533A6; not a complete lot number) and 02/19/2003 (Lot # ENG5305A6), respectively.  On 04/09/2003, a hepatitis B antibody titer was less than 3 mIU.
pt was seated and fainted apporx 5 mins after vaccine, did hit hear on ground. Pt regained consciousness right after.  Gave water and a banana and pt felt fine 10-15 minutes after. did report headache. advised to have md check him out if headache does not lessen
12 hours later belly cramps. 24 hours later shortness of breath. Still can't take more than a few steps without getting out of breath.
Minor patient was scheduled for COVID-19 Moderna vaccine. It was not caught until after administration of the vaccine that patient did not meet the vaccine age requirement. Manager was on site at the time of occurrence and notified immediately. Patient and mom were informed and agreed to continue series. No adverse reactions.
Every since the shot my eyes are infected itchy watering; Itchy eyes; Watering eyes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (Every since the shot my eyes are infected itchy watering), EYE PRURITUS (Itchy eyes) and LACRIMATION INCREASED (Watering eyes) in a patient of an unknown age and gender 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 EYE INFECTION (Every since the shot my eyes are infected itchy watering), EYE PRURITUS (Itchy eyes) and LACRIMATION INCREASED (Watering eyes). At the time of the report, EYE INFECTION (Every since the shot my eyes are infected itchy watering), EYE PRURITUS (Itchy eyes) and LACRIMATION INCREASED (Watering eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient stated when he lifted his arm that was vaccinated (right arm) he noticed there was a bulging of his lymph nodes in the armpit area that was noticeable, which he never had before. Patient stated it is improving now. He has not contacted the doctor and will contact if it worsens or doesn't resolve.
Expired vaccine dose administered to 1 patient/It was a booster dose/Gave a patient booster dose of covid vaccine from a vial that was punctured for 24 hours/Dose administered greater than 12 hours post puncture; Patient received 2nd booster dose as 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/It was a booster dose/Gave a patient booster dose of covid vaccine from a vial that was punctured for 24 hours/Dose administered greater than 12 hours post puncture) and ACCIDENTAL OVERDOSE (Patient received 2nd booster dose as 0.5ml) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 032F21A, 026A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Levofloxacin).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/It was a booster dose/Gave a patient booster dose of covid vaccine from a vial that was punctured for 24 hours/Dose administered greater than 12 hours post puncture) and ACCIDENTAL OVERDOSE (Patient received 2nd booster dose as 0.5ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/It was a booster dose/Gave a patient booster dose of covid vaccine from a vial that was punctured for 24 hours/Dose administered greater than 12 hours post puncture) and ACCIDENTAL OVERDOSE (Patient received 2nd booster dose as 0.5ml) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was reported that number of doses or vials was 1. The vial was initially stored in the refrigerator on 30-Jun-2022. The vial was first punctured on 13-Jul-2022 at 8am. Vaccine was administrated on 14-Jul-2022 earlier than noon. The vial was stored post puncture in room temperature. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was around 24 hours.The vial was not exposed to room temperature for more than 24 hours.
Initial misuse report received from a healthcare professional on 29 JULY 2013. A patient had received first dose of post exposure IMOVAX in the gluteal muscle (buttock region). No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none
bruising, multiple, green to black, varying from 1/2 inch to 2 inches in diameter, many around 7-10 days post vaccine, eventual unusual bruising mild, after 2 months of full vaccination
redness at injection site; swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number KC9C4, expiry date 30th March 2020) for prophylaxis.   On 30th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The batch number of Shingrix was reported as KC9G4. However, based on a safety lot number review, the batch number was updated to KC9C4.