chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; lab test done & revealed bilirubin 2.6 & direct bilirubin 1.6; repeat tests showed serum bilirubin 2.3 & direct bilirubin 0.9;
Pt received Menactra vac on 09/21/2005 calls Monday 09/26/2005 with headaches and vomiting several times this am.
Swelling and some bruising of upper right arm and right hand and finger pain generalized pain and malaise and about 8 hours after vaccination-continued into next day.
pt recv vax 15OCT93 & pt became pregnant for a 5th time (LMP 19OCT93) & devel spotting; 16JUL94 pt went into labor; p/2 hr labor slowed & pt given Oxytocin; 1hr later pt delivered vaginally 7lb 7oz female baby-Apgar 8 & 9;
After 7 days left arm became itchy, red and swollen. It is hot to the touch and  tender or the touch.
Client given Hep B and MMR vaccines at approximately 15:15 on 08/18/2003; became pale and complained of "I don't feel very well." with in minutes of receiving shots, assisted to exam table and placed in supine position with legs flat.  Blood pressure monitored.  Clients color improved from very pale to normal within minutes of moving to supine position.  Blood pressure monitored in lying sitting and then standing positions.  Client released to mothers care without symptoms at 15:40.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vacciantion.     Concomitant products included VITAMINS NOS, FOLIC ACID, IRON (PRENATAL [FOLIC ACID;IRON]), ESCITALOPRAM and BUPROPION for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Oct-2020 and the estimated date of delivery was 20-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Nov-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The date of positive pregnancy test was 07-Nov-2020 and gestational stage was second trimester. Treatment information was not provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 26-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 26-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Patient vaccinated at 1715.  Almost immediately after vaccination patient experienced dizziness and tongue tingling.  Diphenhydramine 50 mg IM was administered at 1726.   Patient progressed to swollen tongue and inability to swallow.  Epinephrine 0.3 mg IM administered at 1800.   Patient transported to ED.    In ED patient received fluids, famotidine 20 mg at 1840, and dexamethasone 12 mg IV at 1858.    Patient symptoms resolved and she was discharged.
Difficulty breathing, hoarseness, wheezing, weakness, fast heart beat, dizziness, throat swelling, eye swelling. Symptoms worsened over 30 minutes.  Called physician who prescribed Benadryl and Prednisone.  Within 3 hrs of meds, symptoms decreased.  At 48 hours still have some weakness and shortness of breath and some chest congestion, with one dose of Prednisone left.
Breakthrough case admission after 5 vaccines Moderna 2/17/21 Lot# 038K20A;  Moderna 3/17/21 Lot# 030A21A;  Moderna 8/16/21 Lot# 088D;  Moderna 4/12/22 Lot# 005M21A;  Moderna 9/23/22 Lot# AS7148B
This case was reported by a consumer via call center representative and described the occurrence of vomiting in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced vomiting, pain in arm, swelling arm and skin warm. On an unknown date, the outcome of the vomiting, pain in arm, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the vomiting, pain in arm, swelling arm and skin warm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The reporter's daughter received BEXSERO vaccine but she had severe side effects which included vomiting and an extremely sore arm. It was swollen and warm to the touch and it literally took almost a week to feel better. She wound up missing two days of school. Her doctor said she should get the second dose but the reporter was afraid to give it to her. In the frequently asked questions it said those who had an allergic reaction shouldn't take it. The reporter asked for any advice.
I have experienced severe muscle spasms on left side of body, both legs spasm like shooting pain ascending downward, severe cramping in pelvic area, headache, reduction in lactation- milk production, low-grade fever 99 degress Fahrenheit.  I am a lactating mother and after the vaccine- my breast milk production was adversely impacted and my breast are not filling up as normal.  My nursing baby has started vomiting.  There have not been any dietary changes or exposure to anything new aside from the vaccine.
Pt reports redness and some slight swelling at injection site. The redness is 3" x 3" starting subsiding on Thurs.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (strength, dose and frequency were unknown; lot # M011664 with expiration date 08-SEP-2017) subcutaneously. No adverse effects were reported. This is one of the ten reports that received from the same source. Additional information has been requested.
Developed red patch/rash  at site of vaccine-right arm. 8 days post vaccination. Occasionally itchy and swollen, heart rate higher that day than normal. Lasted 2 days and then cleared up completely.
deaf in left ear; Initial information received on 12-Sep-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp (patient).  This case involves an unknown age and unknown gender patient who experienced deaf in left ear after receiving vaccines COVID-19 vaccine and Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2022, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer and COVID-19 vaccine not produced by Sanofi Pasteur with unknown strength, formulation, dose, frequency, batch number & expiry date via unknown route in unknown administration site for prophylactic vaccination and COVID-19 Immunisation respectively.  Information on batch number was requested.  Reportedly Patient claims flu vaccine left her deaf in one ear last year.  Will definitely get flu shot as I always have for years, but not with COVID vaccine together. Left me deaf in left ear last November (deafness unilateral)(onset date :unknown date in Nov-2022 ,unknown latency)  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.  Seriousness Criteria: Medically Significant.; Sender's Comments: Sanofi Company Comment dated 19-Sep-2023: This case involves an unknown age and unknown gender patient who experienced deaf in left ear after receiving vaccines COVID-19 vaccine and Influenza Vaccine. Further information regarding past medical history, concurrent condition(s), time to onset, concomitant medication(s), allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Patient received vaccination on 11/12/2018. She contacted the office on 11/19/2019 stating she was having shoulder pain in the same arm she received the vaccination. Patient was seen for follow up in the clinic. X-rays were negative. She was treated with steroids and advised if not better would consider MRI. Patient completed steroids and continued to have pain. She was sent for MRI Left Shoulder on 11/29/2018 which revealed tendonitis. Patient was given the options of Physical therapy, Orthopedic referral or treatment with oral NSAIDs. Patient requested to think it over and call back with decision. On 12/3/18 patient called back stating that she would like to see an orthopedist and a referral was started.
Boostered; discoid Lupus; autoimmune deficient; I'm unable to walk that far; I can't remember if I started a whole new form all over again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (005570). The reporter is the patient.  A 85 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 85 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid- 19 vaccine (Dose 1 unknown manufacture), for Covid-19 immunization; Covid-19 vaccine (Dose 2 unknown manufacture), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Boostered"; CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "discoid Lupus"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune deficient"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I'm unable to walk that far"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "I can't remember if I started a whole new form all over again".  The lot number for bnt162b2 was not provided and will be requested during follow up.
After giving her the vaccine, about 5 to 10 minutes later, patient complained that she felt dizziness and slight degree of shortness of breath.  I checked her blood pressure,  and her blood pressure was 139/89.  About fifteen minutes after that, she said she felt a little better and wanted to go home to take a nap.  I called her around 3pm today.  She said she felt okay.
This spontaneous case, initially received on 29-MAR-2017 was reported by a Pharmacist and concerns a 62-years-old adult female patient. The pharmacist reported that, on an unspecified date, the vaccine was subjected for temperature excursion, which was further described as pre-filled syringe (PFS) went out of range for 4 hours and reached 52 degrees Fahrenheit. On 29-Mar-2017, the patient received intramuscular AFLURIA (0.5 ml, batch number: WT57008, Expiration date 30-Jun-2017). On 29-Mar-2017, the patient had administered the incorrectly stored drug. Action taken with AFLURIA was not reported. The outcome of events was not reported. Reporter's Assessment: The reporter did not provide the causality and company causality between events (incorrect storage of drug and drug administration error) and AFLURIA quad was assessed as not related. This report was not serious.
Information has been received from a mother concerning her 9-week-old daughter with no medical history or allergies who on 26-APR-2007 was vaccinated with a 2.0 mL dose of Rotateq. There was no concomitant therapy. On 02-MAY-2007, the patient developed rotavirus. Unspecified medical attention was sought and "blood work" was done. At the time of this report, the patient's rotavirus persisted. Additional information has been requested.
I have a large lump on the lower portion of my neck on the same side as my shot was administered; Most likely lymph node very swollen.; This is a spontaneous report from a contactable 52-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9264) via an unspecified route of administration from 02Feb2021 at 08:30 am to 02Feb2021 at 08:30 am at single dose on left arm for covid-19 immunization. Patient was 52 years old and not pregnant at the time of vaccination. Patient's medical history included allergies to medications, food, or other products; Cipro and Keflex (dates unspecified). Historical vaccine included (other vaccine 4 weeks details, Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine; yes) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL0142) via an unspecified route of administration from 12Jan2021 to 12Jan2021 at single dose on left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as other. Concomitant drugs (List of any other medications the patient received within 2 weeks of vaccination: No) were not reported. Patient reported that on 04Feb2021 at 04:00 pm 'I have a large lump on the lower portion of my neck on the same side as my shot was administered. It is about the size of two grapes. Most likely lymph node very swollen. Treatment received for the adverse event was reported as no. The reported events were considered as non-serious (serious; no, seriousness criteria-results in death; no, seriousness criteria-life threatening; no, seriousness criteria-caused/prolonged hospitalization; no, seriousness criteria -disabling /Incapacitating; no, seriousness criteria-congenital anomaly/birth defect; no). Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19 was reported as no. The outcome of events was recovering.
Patient returned 2 days post vaccination with swelling around the injection site. Upon examination the area is raised and drawing heat. Slightly red. The area was marked with permanent marker and patient was instructed to monitor if swelling continued. Her PCP was contacted. Patient instructed to use cool compresses 3-4 times per day for a period of 10-15 minutes. If the patient desired, she may also take a pain reliever-acetaminophen or ibuprofen.
Erythema and induration (2 x 2 cm) at (R) anterior thigh. Mild erythema and induration (0.5 cm). Fever at (L) anterior thigh. Rx - cold compression and TYLENOL.
The first day was fine. I had a huge gulf ball size knot at the injection site  by the next morning, sore and warm to touch (not too unusual). The second night, and since, I can?t sleep. I have severe restless leg syndrome. My limbs feel heavy, but my legs literally ache to the point into painful when trying to sleep. I felt a bit sluggish the day after, but that has since passed. The restless legs is not letting up.
This spontaneous report as received from a physician via field representative refers to a 13 to 14 year old female patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dosing details were not reported). Concomitant medications were unknown. On an unknown date following the administration of the vaccine, the patient experienced severe syncopal episode. The patient sought medical attention (patient was in office) and unknown if treatment was provided for the event. The outcome of the event was unknown. The relatedness of the event with GARDASIL was not reported. No product quality complaint (PQC) was reported. Additional information has been requested.
pt says she was nauseated, started throwing up, her heart was racing, dizziness.  The stomach cramps and vomiting comes and goes.  Her arm is very sore and a raised lump on the injection site and the pain goes into the shoulder.  Pt has been taking Tylenol for her symptoms.
At 4PM. on 08/05/2020 rashes appeared on my chest and back. Due to their itchiness I applied vaseline based hand lotion and itchiness stopped. At about 7 P.M. I became extremely tired and went to bed. At about 9 PM I awoke shivering. I placed wool blanket over myself and put on knee-high socks. At about 11 P.M. I awoke. I was perspiring and had pain on the left side of my body. I had been sleeping on my left. I turned to sleep on my right side. The shooting pains on my left side continued for some time. The pain was from the left side of my head, neck, shoulder, lower ribs, hip, knee, mid-calf and ankle. When I awoke at about 7 A.M. I was fine. Note: 20 years ago I ripped the rotator cuff and I often have pain in the left shoulder. FYI: My 1st dose of Zoster Vaccine Shingrix was from the same pharmacy on 02/10/20. I had no side effects.
5/21 in pm pt was showering and noticed back of arm was tender. Looked in mirror. Had deeper red with knot approximate size of a half-dollar in center with redness extending approximately 6 inches up the back of the arm, 2.5 inches wide. 5/22: redness had lightened, but extended a little further on the arm. 5/23: lighter and red area starting to shrink down, knot resolved. 5/24: arm appeared bruised. 5/25: mostly resolved. Pt did have some itchy, but not incredibly bothersome. Placed some ice to help with discomfort. Pt looked up symptoms online and chose to monitor at home/not report to the pharmacy or her PCP. Was in today and mentioned reaction. Today, pt said everything has fully resolved.
spectacular edematous rash about 15 x 7cm around injection site; local pain at injection site; local redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (local pain at injection site), VACCINATION SITE ERYTHEMA (local redness at injection site) and VACCINATION SITE RASH (spectacular edematous rash about 15 x 7cm around injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Food allergy.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (local pain at injection site) and VACCINATION SITE ERYTHEMA (local redness at injection site). On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (spectacular edematous rash about 15 x 7cm around injection site). At the time of the report, VACCINATION SITE PAIN (local pain at injection site), VACCINATION SITE ERYTHEMA (local redness at injection site) and VACCINATION SITE RASH (spectacular edematous rash about 15 x 7cm around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included antihypertensives. Treatment information was not reported.
PT AS RPH TO CHECK ARM AFTER 6 MIN. ARM APPEARED TO BE RED AND WAS TENDER TO TOUCH WITH MINIMAL SWELLING.
lost her taste; she felt cold inside; got really hot while in bed; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her taste), NASOPHARYNGITIS (she felt cold inside) and FEELING HOT (got really hot while in bed) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006A21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced NASOPHARYNGITIS (she felt cold inside) and FEELING HOT (got really hot while in bed). On an unknown date, the patient experienced AGEUSIA (lost her taste). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 26-Mar-2021, NASOPHARYNGITIS (she felt cold inside) and FEELING HOT (got really hot while in bed) had resolved. At the time of the report, AGEUSIA (lost her taste) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-060880 (Patient Link).
A magnet will stick to her arm at injection site; This is a spontaneous report from a contactable Nurse. The caller knows of 8 individuals (7 females and 1 male) who have also reported. This report was 4 of 9.   A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in Deltoid Left (arm) on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unknown date, the patient after received COVID vaccine the patient felt magnet stuck to her arm at the injection site. The patient knows 7 women within her friend group and within her family who was able to have a magnet stick to their injection site after receiving the Pfizer COVID vaccine. Caller would like to know if Pfizer has any information or guidance regarding this. The caller does not have any more information on this event. No further information or details were captured at this time. The outcome of the event was unknown.   Information on the lot/batch number and Additional information has been requested.
8/15/08 approx 1 1/2 hrs after receiving MENACTRA c/o neck pain radiating down the spine/ hands and feet. Temp 100 degrees. Call physician instr take Ibuprofen as directed. Called again 8/18/08 symptoms improved had seen doctor over the weekend.
Little white circle with red spot in the middle the sizer of a nickel; Itch a lot; Red spot the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Little white circle with red spot in the middle the sizer of a nickel), ERYTHEMA (Red spot the size of a silver dollar) and PRURITUS (Itch a lot) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (Red spot the size of a silver dollar). On an unknown date, the patient experienced SKIN DISCOLOURATION (Little white circle with red spot in the middle the sizer of a nickel) and PRURITUS (Itch a lot). At the time of the report, SKIN DISCOLOURATION (Little white circle with red spot in the middle the sizer of a nickel), ERYTHEMA (Red spot the size of a silver dollar) and PRURITUS (Itch a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Patient went home and developed chills later that night. The pt felt fever-ish and achy a few hours after the vaccine wwas administered . The chills did not last long, just throughout the night.