chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registerd nurse, referring to a 4 year old female patient. The patient had  none pertinent medical history, concurrent condition, concomitant medications, allergies or drug reactions. On 05-DEC-2018, the patient was vaccinated with VARIVAX lot # R018932, expiration date 02-JUL-2020, subcutaneous (strength, frequency, anatomical site and dose were not provided), and M-M-R II lot # R000551, expiration date 08-JAN-2020 (strength, frequency, dose, route of administration and anatomical site were not reported) both for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT)  subcutaneously (strength, dose, frequency, lot number and expiration date were not reported). On 15-DEC-2018, the patient experienced headache, easy breathing (respiration abnormal), irritability and abdominal pain, reported by her mother on 03-JAN-2018. Also, was reported that the patient sought for medical attention but has not received any treatment  and laboratories or clinical studies were not performed. At the reporting time, the patient has not recovered from the events. The causality assessment between the aforementioned events and VARIVAX, M-M-R II and sterile diluent(STERILE DILUENT) was not reported. This report meets the criteria for a Reporter Concern AEQIR, since the nurse requested a lot check of both vaccines with the results provided within two weeks.
Covid19 breakthrough.  1st vaccine received on 03/09/2021.  53 y/o PMHx  of Hemochromatosis, CAD, MI, depression, Pulmonary Emboli, Pancreatic cancer/Neuroendocrine tumor, Whipple, pancreatitis presents to ED with c/o severe abdominal pain, Nausea and vomiting.  Pt states tested positive for Covid on 02/03/2022.  Afebrile, Room air sats 96% and CXR with mild infrahilar atelectasis.  Pt treated with pain medication at the time.
Approximately 24 hours after injection, low fever but intense chills.  These only lasted a few hours.  Approximately 48 hours after injection, experience sudden hearing loss in right ear.  I have experienced this before not associated with vaccination.  It was treated with prednisone and resolved.
she noted rashes; her arm hurt; she had headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her arm hurt), HEADACHE (she had headache), CHILLS (chills) and RASH (she noted rashes) 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 02-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced VACCINATION SITE PAIN (her arm hurt), HEADACHE (she had headache) and CHILLS (chills). On 04-May-2021, the patient experienced RASH (she noted rashes). On 04-May-2021, VACCINATION SITE PAIN (her arm hurt), HEADACHE (she had headache) and CHILLS (chills) had resolved. At the time of the report, RASH (she noted rashes) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment medication include Benadryl .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-106457 (Patient Link).
Pt inadvertently received insufficient dose of Moderna COVID vaccine; no signs or symptoms of adverse reaction
A report has been received from a Health Professional concerning a 48 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 15-Oct-2013. The patient received FLUMIST QUADRIVALENT last night nothing went into first nostril and in other nostril ran out of nose into mouth and onto shirt which started on 15-Oct-2013 and experienced mild congestion which started on 15-Oct-2013. The outcome of the event of patient received FLUMIST QUADRIVALENT nothing went into first nostril and in other nostril ran out of nose into mouth and onto shirt and mild congestion is unknown. The report was considered to be non-serious.
Palpitations SOB Narrative:  Employee developed SOB approx 24 hours after receiving the vaccine. She presented to the ED where it was noted that she had a trigeminy arrhythmia. Observed for 24 hours during which time the arrhythmia resolved and she was discharged.
Information has been received from a consumer concerning her daughter 4 years old who at 15 months old (2005) was vaccinated with a dose of MMR II (Lot not reported). On the same visit the patient received a dose of influenza virus vaccine (unspecified). The child is now 4 years old and had the speech abilities of a 2 year old. The child also developed a "rough cold" and was "really sick" after vaccination. At the time of reporting, 16-MAR-2009, the patient outcome was unknown. Additional information has been requested.
On the afternoon of July 14,   2019; the adverse effects began.  My normal temp which runs 97.8 was up to 101.6   My arm was very swollen and extremely red.  I took a picture which even shows a couple of very small pustules out of which issued a white discharge.  I took a Tylenol and the fever dropped; it reoccurred for 3 more days.  I went to my primary doctor and she prescribed an antibiotic for 7 days.  It is now two weeks since the injection and the swelling and redness are not yet totally gone,
PAIN THAT GOES ACROSS THE TOP OF HIS SHOULDER AND THROUGH HIS NECK. PATIENT HAS TRIED TAKING TYLENOL BUT IT HAS NOT HELPED. I RECOMMENDED HE SEE A DOCTOR TO BE EVALUATED AND CAN DISCUSS WITH THE PRACTITIONER IF ADDITIONAL PAIN MEDICATION IS NEEDED.
Patient stated noted tenderness and itching at injection site on evening after receiving influenza injection. 48 hours later, noticed 4" x 9" rash/redness in upper arm at injection site.
Chills Sever pain in upper right back/lung Pain in right arm at injection site causing pain in raising shoulder
When the vaccine was administered when the needle entered the arm she felt pain immediately.  When the vaccine was administered it had a burning feeling.  That eventually resolved and then the muscle became sore.  The soreness has continued to come and go over the past two months and changes in intensity.  It sometimes will disturb her sleep.  It is sore to the touch.  Sometimes the pain will go down her arm.  Range of motion is good except for if she is reaching up and trying to get something heavy off of a shelf she will have pain.  This has lasted for the past two months and she has become concerned.
PATIENT REPORTED HIVES STARTING SOON AFTER SHE LEFT FOLLOWING HER FIRST DOSE OF PFIZER COVID VACCINE
Patient presented to the ED on 3/3/21, 3/22/21, and 3/28/21 when she was subsequently hospitalized. These visits were within 6 weeks of receiving COVID vaccination.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25G20-2) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (4 glasses of wine per week) on 28-Oct-2020 and In vitro fertilization (Fertility issues were due to the father). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 03-Jan-2019 to an unknown date and VITAMIN D NOS from 11-Jan-2019 to an unknown date for an unknown indication.    On 07-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 an unknown date and the estimated date of delivery was 16-Jul-2021. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 07-Jan-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2020, Pregnancy test: positive positive (Positive) positive. On 02-Mar-2021, Ultrasound foetal: normal normal (normal) No issue, baby in the 78th percent..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The causality of pregnancy was assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Internal review on 27-JUL-2021 resulted in update of patient details,Lab data,number of fetus,Birth type and fetal outcome. On 22-Mar-2021: Additional information received; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The causality of pregnancy was assessed as not applicable.
Initial case was received from a consumer on 12 MAY 2013. This 43-year-old female patient whose medical history included allergic to Zithromax and seasonal allergies. Concomitant medication was not reported. The patient had received an intramuscular dose of ADACEL (batch number, dose not reported) on right deltoid on 12 MARCH 2013. On 12 MARCH 2013, by the evening of vaccination, patient noticed swelling in her ankles and legs. Her swelling reduced to the some extent but was still present at the time of the report. She also reported soreness at the right deltoid. The laboratory details were not reported. Corrective treatment was not reported.  The outcome of the event was not reported. The list of documents held by sender: none
Booster; interchange of vaccine admnstered; Off label use; Feeling bad; Fever; Tiredness; COVID positive; COVID positive; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4226788-00 (Agency).  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), first regimen intramuscular from 2021 (Batch/Lot number: unknown) to 2021 at single (dose 2, single) and second regimen intramuscular from 01Apr2021 (Batch/Lot number: unknown) to 01Apr2021 at single (dose 1, single); adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till 20Dec2021 for colitis ulcerative. Relevant medical history included: "first and second dose COVID-19 Vaccine manufactured by Johnson and Johnson" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovered" (Jan2022) and all described as "COVID positive"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "interchange of vaccine admnstered"; OFF LABEL USE (non-serious), outcome "unknown", described as "Off label use"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "Feeling bad"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; FATIGUE (non-serious), outcome "recovered", described as "Tiredness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. The action taken for adalimumab was unknown.  Clinical comment: The reporter's causality for the event(s) of covid-19 positive with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of feeling bad, fever and feeling tired was not provided.     The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid19,interchange of vaccine admnstered,booster,off label use, feeling bad, fever and feeling tired.
Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 18-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Pulmonary embolism found during ER visit remained in hospital for 5 days on Heparin drip and Warfarin pill until numbers were good Warfarin pill (7.5 mg) and Enoxaparin shots in stomach for 4 days Warfarin  pill (7.5 mg) continuing basis
Chills, headache, fatigue, nausea and vomiting - in bed and unable to do normal activities for two days
burning; throat kind of burnt after this shot; weak; dizzy; Can't move around; Feels like some kind of allergic reactions; This is a spontaneous report from a contactable consumer (patient). A 18-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0176; Expiration Date: Aug2021), via an unspecified route of administration on 26Apr2021 (at the age of 18-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Apr2021 (on the same day), the patient experienced burning, throat kind of burnt after this shot, weak, dizzy, can't move around, feels like some kind of allergic reactions. It was reported that patient didn't feels the events all day (unspecified). The outcomes of events were unknown.  No follow-up attempts are needed. No further information is expected.
chills; feeling so poorly; woke up in the middle of the night; arm is killing her it is so sore where she got the vaccine; neck hurts; This case was reported by a consumer via call center representative and described the occurrence of chills in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 54TF4, expiry date unknown) for prophylaxis.   On 29th June 2022 11:00, the patient received the 1st dose of Shingrix. In June 2022, less than a day after receiving Shingrix, the patient experienced nocturnal awakening, pain in arm and neck pain. On 29th June 2022, the patient experienced chills and feels poorly. On an unknown date, the outcome of the chills, feels poorly, pain in arm and neck pain were not recovered/not resolved and the outcome of the nocturnal awakening was unknown.   The reporter considered the chills, feels poorly, pain in arm and neck pain to be related to Shingrix. It was unknown if the reporter considered the nocturnal awakening to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comment: The reporter was the patient. The patient received first dose of Shingrix yesterday (the day before reporting) around 11 am (Ante meridiem) into unspecified arm, last night around 8:30 pm (Post meridiem) patient got the worst chills.  The patient reported that the patient put three blankets on top of herself and then decided she had to go to bed because she started feeling so poorly. The chills had not resolved and patient was still having chills on and off. The patient woke up in the middle of the night.  The patient reported that her arm was killing her it was so sore where she got the vaccine, also her neck hurts.  The patient wanted to get off the phone because she felt so poorly. The reporter consented to follow up.
Patient was given a Pfizer booster one week after receiving an initial Johnson and Johnson vaccine.  There were no adverse symptoms noted.  Patient was observed in the office for 30 minutes.
Needle sank back into the syringe when needle touched patient skin. No vaccine was injected in patient arm. New dose was given to patient.
Bump and redness at injection site - grew from a quarter on March 30th to about 2 inches diameter on April 1.  Warm to touch.
Abdominal crampng; gas bloating; Severe/explosive Diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Severe/explosive Diarrhea), ABDOMINAL DISTENSION (gas bloating) and ABDOMINAL PAIN (Abdominal crampng) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 06-Jan-1980 and Obesity since 06-Jan-1980. Concomitant products included BIOTIN from 13-Aug-2008 to an unknown date, IRON from 13-Aug-2008 to an unknown date and MAGNESIUM from 13-Aug-2008 to an unknown date for Vitamin supplementation.   On 09-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021 at 4:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Severe/explosive Diarrhea). On 09-Feb-2021 at 5:00 AM, the patient experienced ABDOMINAL DISTENSION (gas bloating). On 09-Feb-2021 at 6:00 AM, the patient experienced ABDOMINAL PAIN (Abdominal crampng). On 12-Feb-2021, DIARRHOEA (Severe/explosive Diarrhea), ABDOMINAL DISTENSION (gas bloating) and ABDOMINAL PAIN (Abdominal crampng) had resolved.        Patient mentioned she takes blood pressure medications and thyroid medications (unspecified).  Medical Doctor informed patient to drink only clear broth for two days which she did. Patient stated she was unable to leave the house because of the explosive diarrhea event.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Moderna ADR form completed by reporter. Patient, event and outcome information updated.
Diarrhea; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Lightheadedness; Weakness; Severe Headache; Left ear was hurting; Chest Tightness; chest feels funny; Throat Tingling and Tightness; Throat Tingling and Tightness; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Chills; disoriented really bad and confused and had a bit of a blurred mind; disoriented really bad and confused and had a bit of a blurred mind; Feels Very Off; Blood Sugar Level Dropped Below 60; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female consumer received first dose of bnt162b2 (Solution, injection; Batch/Lot Number: EW0164) via an unspecified route of administration, administered in Arm Left on 21Apr2021 at 08:35 as single dose (at the age of 28-years-old) for covid-19 immunisation. Medical history included drug hypersensitivity penicillin and anything that is a cousin to penicillin. She did not have any prior vaccinations within 4 weeks. There were no concomitant medications. She stated that she took the vaccine at 8:30 by 8:45, she felt very lightheaded and she signaled the nurse, and she was brought into a room. She stated that she took the shot in her left arm. After the vaccine it was like she was disoriented and confused and had a bit of a blurred mind, like she felt confused. States she thought she would be up and ready after but they put her to lay down. Caller states she was disoriented really bad. She felt her left ear hurting and then tingling in the front of throat and her throat and chest began to get tight. She stated that as she was trying to drive home, she had to pull over and she felt like her entire body was on fire. She stated it was on and off. She gets really hot inside and starts to sweat and had cold chills and then it goes away and comes back. She stated she felt hot on her left side of her body then her complete body felt hot until 10:00 PM. She felt hot and weak to the point that couldn't drive this morning. She stated her blood sugar level had dropped to below 60. She stated that many of her side effects come and go, they don't last very long. She was treated with Tylenol. She stated that she was in observation under a tent after her vaccine. On 21Apr2021, in the morning she still feels hot and now had diarrhea, severe headache, her chest feels funny and she felt very off. She asked is it common to have diarrhea. She stated that her main concern is if she should take the second dose since she had this reaction with her first dose. The outcome of all the event was not recovered while the outcome of the events disoriented really bad and confused and had a bit of a blurred mind and left ear hurting was recovered.  No follow-up attempts are possible. No further information is expected.
on 5/01/2021 member was with family and reported having a seizure which she does not remember having, stated she was drinking a Coke and spilled some and the next thing she remembers is being taken to hospital in ambulance, stated had Pfizer first covid shot on 4-12-2021. Stated started getting sick after this shot ?not felt well, didn?t feel like myself, achy, out in left field, had fever the following day after injection, loss of appetite and sense of taste, in a fog and not feeling well,?
Area of injection was warm to touch; Area of injection was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area of injection was warm to touch) and VACCINATION SITE ERYTHEMA (Area of injection was red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, 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 WARMTH (Area of injection was warm to touch) and VACCINATION SITE ERYTHEMA (Area of injection was red). At the time of the report, VACCINATION SITE WARMTH (Area of injection was warm to touch) and VACCINATION SITE ERYTHEMA (Area of injection was red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Additional information added on 07JUN2021 contains no significant information. Patient declines to filling form over a simple reaction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Tics started the next morning with head shake and eyebrow lifting Over the next 7 months he began having facial grimacing as well now as vocal tics.  Continued eyebrow lifts although head shake is a bit better
Red, very painful, swollen injection site started small six days after vaccination and grew  doubling in size. The pain takes up from the neck on down to the whole arm. Patient has only taken Naproxene 500.