chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant/ maternal exposure; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant/ maternal exposure) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy and Pregnancy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Sep-2020 and the estimated date of delivery was 16-Jun-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant/ maternal exposure). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant/ maternal exposure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2020, Pregnancy test positive: positive (Positive) positive. On 14-Dec-2020, Ultrasound foetal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. It was reported that this was the third pregnancy and gestational age was 17 weeks of pregnancy. On 14 Dec 2020 Noninvasive prenatal testing was performed which showed low risk for genetic complication. Patient had two previous pregnancies which was live, full term birth and 36 weeks 4 days and was live and pre-term birth.   Case comment: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
About 10 hrs after giving immunization another noted maculo-papular rash all over the body.  Follow up check up rash all over the body.  Given Benadryl 12.5/3.5 ml.
This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 59TS2, expiry date 31st May 2019) for prophylaxis. On 16th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In October 2018, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema and injection site swelling. The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient visited the doctor, the day before reporting and brought medicine that cause her additional expenses.
Information has been received from a consumer for the pregnancy registry for GARDASIL concerning a his a 24 year old wife with allergic to many drugs but unspecified which ones and no pertinent medical history who on 21-JAN-2009 was vaccinated with first dose of GARDASIL (Lot # not reported). There was no concomitant medication. On 21-JAN-2009 after she received the first dose of vaccine she found she was pregnant. She had a pregnancy test done before getting the vaccine and it came back negative, however when she did pregnancy test again couple days after got the vaccine it came back positive. Follow-up information has been received from the patient's husband. The patient's husband provided the information as his wife did not speak English. The husband provided the following pregnancy outcome information. He reported that his wife never went to the original physician whose name he provided since her insurance changed and that person didn't accept it. She was seen by a group of physicians at a clinic and delivered a baby on 02-OCT-2009 in a hospital. He stated the baby was fine and healthy. His wife, however, had complications during pregnancy. This was her first pregnancy and at the time of delivery it was discovered that she had a heart enlargement, she was diagnosed with cardiomyopathy, and her cardiac function was reduced to 15%. She had a vaginal delivery and the baby was very healthy and a normal to big size. After the delivery his wife was transferred to the cardiac unit in the hospital where she spent the next week being treated (not specified). She couldn't breastfeed because of the heart medications (not specified) she was taking. The patient's husband added that after two months her cardiac function increased from 15% to 18% and then by six months she was up to 25%. He said his wife had continued to improve and had a follow-up appointment with her cardiologist on 01-OCT-2010. His wife and he were also advised that she not have any more pregnancies or children. The husband also reported that the baby was one year old on 02-OCT-2010. The husband added that the patient's clinic where she received prenatal care was closed and the obstetrician was retired. Additional information has been requested.
pt experienced nerve pain, memory loss, and fatigue for months - years after administration. she presented to pharmacy today with this info.
Shortly after receiving the vaccine patient reports of dizziness and nausea.  After throwing up patient felt better.  She sat in the waiting area for a while to make sure she has is not nauseous anymore and waiting for her ride to pick her up.  Before leaving patient reported of no more nausea or dizziness.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S010727 and expiration date 27-JUL-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
I started my period after not having a period since Oct2019.; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), via an unspecified route of administration, administered on the right arm at the age of 50 years, on 09Apr2021 08:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma/COPD, stroke, avascular necrosis both hips; all from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (GABAPENTIN); atorvastatin (ATORVASTATIN); pantoprazole (PANTOPRAZOLE) and colecalciferol (VITAMIN D [COLECALCIFEROL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and experienced drug hypersensitivity. The patient stated, "I started my period after not having a period since oct2019" on 09Apr2021 12:15. No treatment was received for the event. The outcome of the event was not recovered.
approx 3yrs p/vax pt devel full blown chickenpox that consisted of a diffuse, erythematous, vesicular rash.
Severe persistent pain in left shoulder where vaccine was administered, followed 2 weeks later by a vesicular rash in the same distribution (approx C6 dermatome) consistent with Zoster eruption.
Patient had Prevnar 20 immunization on 6/1/23. Patient reported having injection site swelling, localized redness/rash, and mild pain in her right arm. Patient had Shingles vaccine in the left arm that same day and said she didn't have any issues with that vaccine in the left arm. Patient contacted the pharmacy on 6/2/23 and notified the pharmacy of the reaction. I instructed the patient to take an over-the-counter antihistamine to help with localized swelling/rash on her right arm. Patient said she already took 1 dose of Benadryl 25mg capsule at home. I advised patient she can continue to take Benadryl 25mg and follow directions per official package labeling. Patient said she did NOT experience anaphylaxis and she did not have trouble breathing. I advised patient to continue to monitor symptoms: if symptoms worsens or patient has trouble breathing/experience anaphylaxis, then she must call EMS and go to ER immediately. Patient stated it is just localized reaction on the right arm. Also, advised patient to take acetaminophen or an NSAID to help alleviate symptoms due to mild injection site pain.
headache productive cough cough chest congestion sinus congestion nasal congestion post nasal drainage shortness of breath. starting 1/16/2022
Recurrence of Guillain-Barre syndrome with ophthalmoplegia, quadriplegia with acute hypercapnic respiratory failure, requiring intubation, trach placement and PEG insertion.
12 year old patient came to Clinic for 2nd dose of Pfizer Vaccine. Patient received 0.2ml of 5-11 yo Covid vaccine instead of 12 yo and older 0.3ml vaccine around 2:00 pn on 12/14/21. Patient did not have any adverse reactions after receiving the vaccine during the 15 minutes of observation time. MD informed parent later that evening of the mistake. Per notes Mom states patient seems to be fine and denies any side effects during the time of call.
Swelling at injection site with pain, noted 7 x 10 area of erythema.
Vertigo, vomiting, headache, weakness, tingling around mouth and tingling left and right hand, weakness left hand, loss of vision left and right eyes, hypertensive crisis.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-JUN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX injection, lot # M024698 with expiration date of 27-JUN-2017, reconstituted with sterile diluent (manufacturer unknown). This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA008744.
72y/o M with hx of DM, HTN, HL, Ulcerative Colitis presented to ER with c/o's of lip and facial swelling for several hours. Patient first noted the swelling at 5pm approximately 10 hours prior to current exam. Initially he just had swelling of his lips but later had itchy throat. Overall the swelling and throat symptoms have significantly improved. He is concerned he may not be able to swallow his medications. Denies CP, SOB, absolute dysphagia, change in voice, N/V, or abd pain. No previous episodes. No recent medications changes and he is not on an ACEI. He is not aware of any food allergies. Patient received flu vaccine yesterday and infusion of infliximab with ulcerative colitis. Methylprednisolone 125 mg, Famotidine 20 mg, Diphenhydramine mg.
Pt developed a local reaction (L) Deltoid region with pain, swelling & redness. She also developed flu-like symptoms as fatigue, malaise and weakness. Started several hours later - was evaluated on 08/28 and 08/29 - has continued to improve.
Very weak and tired the next day after the shot.  Went home sick and slept the entire day.  Three days after the shot came down with heavy bronchitis.  Patient stated he was also aware of two other people with similiar symptoms but not nearly as bad as his.
10 minutes post vaccination developed metallic taste in mouth, then scratchy throat and throat began to close up and was given PO Benadryl - no relief. Required Epinephrine and transport to ER
no additional adverse event have been reported; inadvertantly received a PROQUAD vaccine instead of MMR-II; This spontaneous report as received from a licensed practical nurse (also reported as consumer) refers to a 21 year old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.    On 26-JAN-2021, the patient was inadvertantly vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milligram single dose, lot# T005400 expiration date 12-AUG-2021) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (strength, dose, route, lot# and expiration date were not provided).    The reporter stated that the consumer returned on 26-FEB-2021 and received his second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) at that time. No additional adverse events were reported by the patient.
pt given half dose (booster).  We realized it right after administering the dose and gave within 10 minutes
Congestion; cough; headache; scratchy throat; backache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Lot number: EN6205) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: morphone for Known allergies: morphone. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 11Feb2021, when the patient was 51-year-old, for Covid-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 17Apr2022, outcome "recovering", described as "Congestion"; BACK PAIN (non-serious) with onset 17Apr2022, outcome "recovering", described as "backache"; COUGH (non-serious) with onset 17Apr2022, outcome "recovering"; FATIGUE (non-serious) with onset 17Apr2022, outcome "recovering"; HEADACHE (non-serious) with onset 17Apr2022, outcome "recovering"; THROAT IRRITATION (non-serious) with onset 17Apr2022, outcome "recovering", described as "scratchy throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion, cough, headache, throat irritation, back pain, fatigue. No follow-up attempts are possible. No further information is expected.
developed a tingling sensation 45 minutes post vaccination. Came on gradually and increased in sensitivity; Lips also had a tingling sensation similar to a sunburn feeling on lips/But lips Continue  to have a weird sensation to lips; This is a spontaneous report from a contactable nurse (patient). A 49-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EK5730, intramuscularly on 23Dec2020 16:00 (at the age of 49-years-old) as a single dose in the left arm  for COVID-19 immunization. Medical history included hyperactive thyroid for which was treated with radioactive iodine thus makes her hypothyroid. Concomitant medication included levothyroxine sodium (SYNTHROID).  The patient previously took hydrocodone/acetaminophen (VICODIN) and experienced drug allergy. The patient did not have allergies to food.The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Dec2020 16:45 the patient developed a tingling sensation (45 minutes post vaccination). It came on gradually and increased in sensitivity. Her lips also had a tingling sensation similar to a sunburn feeling on lips. Tingling sensation gradually subsided to body lasted 4 hours. Tingling sensation to lips also gradually decreased 6 hours later but lips continue to have a weird sensation to lips. The events developed a tingling sensation 45 minutes post vaccination. Came on gradually and increased in sensitivity, Lips also had a tingling sensation similar to a sunburn feeling on lips/but lips continue  to have a weird sensation to lips did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events tingling sensation 45 minutes post vaccination. Came on gradually and increased in sensitivity, lips also had a tingling sensation similar to a sunburn feeling on lips/but lips continue to have a weird sensation to lips.  Outcome of the event developed a tingling sensation 45 minutes post vaccination. Came on gradually and increased in sensitivity was recovered on 23Dec2020 20:45. Outcome of the event lips also had a tingling sensation similar to a sunburn feeling on lips/but lips continue to have a weird sensation to lips was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
This spontaneous report has been received from a pharmacist and refers to 5 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # N012614, expiration date 16-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. The vaccines were reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of vaccines experienced the temperature excursion of 23.1 degrees Fahrenheit for 11 hours. Digital data logger was involved. There were no previous excursions reported.
Symptoms were chills, fever higher than 101, diarrhea, headache, body aches, fatigue. I just rested. I felt better without fever by 7:30 am on 04/09/2021.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history information was provided.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 11-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked .
Rash in leg, red, macular, mildly indurated in both legs, right 30 by 45 millimeters, left 15 by 40 millimeters for one day.
Patient received both ADACEL and PNEUMOVAX on the right arm and has a rash about a size of a hand. It is going away. Not sure which vaccine caused this. Patient also has some tenderness/soreness around injection site.
C/O L arm pain post flu shot. Saw family MD D/T "knot" on side of neck L. Ordered Sulfa x 10 days. Refused neurology consult-took Medrol dose pack with relief. Thinks shot was given "too high."
Client c/o nausea and dizziness.  Client evaluated by  Fire Rescue, Symptoms resolved.  Vitals WNL. Per Fire Rescue, no further evaluation needed.  Client transported home by husband at 4:30pm.
Patient received flu shot and PNEUMOVAX in same deltoid area one inch apart. Patient claims PNEUMOVAX was too high up into the shoulder area and she has been experiencing pain and motility issues ever since. This is especially bad when she moves in certain ways. Patient has requested medical treatment.
constantly getting sick/ after second dose felt sick after a couple hours; Sore throat; It is like he is sweating every pinch of liquid out of his body; Headache; Fever; Cold chills; Fatigue; body pain; felt sick came back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), ILLNESS (felt sick came back) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (felt sick came back). On an unknown date, the patient experienced ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Cold chills), FATIGUE (Fatigue) and MYALGIA (body pain). At the time of the report, ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours) had resolved and OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), ILLNESS (felt sick came back), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Cold chills), FATIGUE (Fatigue) and MYALGIA (body pain) outcome was unknown.            No concomitant drug information  was provided. No Treatment drug information  was provided.  On 26-Aug-2021, the patient went to the emergency room, and they told him he does not have COVID. He was good for a week, then the symptoms came back.
3-12-21  5 minutes after eyes began to feel warm/hot   latsted about a minute 3-13-21   Early afternoon neck and shoulders began to ache followed  sharp pains to my right eye and right foot 3-14-21   Morning began to feel a tingling sensation throughout whole body..  Pins and needles. 3-17-21   Went to primary physician.   No knowledge of this side effect left with no real information and or treatment. 4-22-21   Symptoms have subsided, but still very present and activates upon anxiousness do to condition of sensations.
Became lazy on 1-12-07 and very ill with high fever of 102.1 for next 2 days. Temp 101 next few days. Went to our physician was put on Hydrodone/qualfennesin- MY Tannictahtheudquin 500 mg. It is now 1-12-07 and patient still weak, unsteady, tired, etc.