chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Nurse Practitioner, for the pregnancy registry for GARDASIL, concerning a 27 year old female patient, with depression, anaemia and allergy to CECLOR, BENADRYL, and ADVIL, who on 01-SEP-2009 was vaccinated with the first dose of GARDASIL (route and lot number not provided). Concomitant therapy included influenza virus vaccine (unspecified) and H1N1. On 01-SEP-2009, an urine pregnancy test was performed and was negative. The Nurse Practitioner stated that patient went to her office for urine pregnancy test on 12-OCT-2009 and it was positive. Early ultrasound performed on 14-OCT-2009, showed patient was 9.4 weeks pregnant at that time with an expected delivery date on 16-MAY-2010. On 12-FEB-2010 the patient, who was 27 weeks pregnant at that time, was hospitalized overnight, with bleeding which nurse practitioner stated was caused by a low lying placenta. The patient was treated with betamethasone (manufacturer unspecified) and released the next day. Bleeding issue was resolved. Additional information has been requested.
Abrupt new onset vocal tic disorder, repetitive ?stimming? behaviors, sudden new onset frequent bed wetting, sudden onset emotional liability. Child needed to be withdrawn from school due to the above symptoms.  Prompted pediatrician visit (appt date 10/18/20) and referral to neurologist ? neurology (appt date 11/18/20) referred to the following: eeg to rule out seizure (ruled out), A-dos testing to rule out autism (ruled out), extensive genetic testing to rule out genetic explanations for symptoms (ruled out), referral to Tourette?s clinic (re: new vocal tics), ongoing physical therapy, ongoing occupational therapy, behavioral therapy to manage symptoms.
patient did not have any adverse effects but as a 12 year old patient she was meant to only receive Pfizer bivalent vaccine as a COVID booster - this report is to document the administration of Moderna Vaccine instead of Pfizer but there was not been any adverse reactions as of yet since the time of administration
Patient received covid vaccine on 3/4/2021 and his arm was a little sore for a couple of days after. Pain then went away. O3/20/2021 he started having pain from his left shoulder to his elbow with tingling in his fingers. The pain is intermittent and worse when he is more active. Patient has been taking ibuprofen throughout the day.
2" x 3" warm, red, raised and hard-like welt, bruised in center area, sore itchy. Iced area to relieve the soreness.
12 hours after vaccination, severe joint and muscle pain, fever, lower abdominal pain lasting 38 hours.  Still having abdominal pain and intermittent hot flashes-temperature normal at 96.
By the eve of same day as injection patient states her left deltoid was the size of an apple.  By the time she woke up the next morning, her entire upper arm was swollen, red, sore to her elbow. The following day the swelling had passed her elbow, was extremely painful.  Patient self treated w/ ice, Benadryl and elevation.  States it took a week for swelling to go down and tenderness to resolve.
Narrative: COVID infection following COVID vaccine series 054/30 COVID vaccine dose #1 05/21 COVID vaccine dose #2 07/07 son tested positive for  COVID, pt reports feeling "terrible" with pain on breathing, cold-like symptoms, headache, swollen throat, tested negative for COVID 12/16 pt c/o fever, cough, sore throat, myalgia, productive cough with yellow sputum, congestion, 12/18 pt seen in ED c/o sore throat, nausea, fever, fatigue, feeling foggy, runny nose, body aches, diarrhea, chest pain with breathing, COVID positive; discharged home, declined treatment
Information has been received from a consumer, the patient's mother, concerning her 4 year old son who on 7/9/01 was vaccinated with a dose of varicella virus vaccine live. The consumer reported that on 7/14/04 the patient developed a case of chicken pox. It was noted that the patient has red sots over his trunk both front and back and some of the spots have yellowish heads. The patient is using diphenhydramine hydrochloride to treat the itching. It was noted that the patient is doing fine. The lot number was not provided. There was no product quality complaint reported. Unspecified medical treatment was sought. Additional information has been requested.
Arm with injection was painful and has persisted with numbness and tingling for greater than one week.  Symptoms come and go throughout the day.
patient received vaccine and shortly became warm and felt her arms were getting red and splotchy.    Patient taken to ER and was given PO Benadryl 50mg and observed.  Discharged 2 hrs later
Back pain is bad and waking her up last night, radiating pain; Chest hurts after 3rd shot; Chest feels tight after 3rd shot; Feel cold after 3rd shot; Chills after 3rd shot; Body Aches after 3rd shot; Fever 102F after 3rd shot; Headache after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain is bad and waking her up last night, radiating pain), CHEST PAIN (Chest hurts after 3rd shot), CHEST DISCOMFORT (Chest feels tight after 3rd shot), FEELING COLD (Feel cold after 3rd shot) and CHILLS (Chills after 3rd shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart rate abnormal (irregular heart beat) and COVID-19 in January 2021. Concurrent medical conditions included Asthma and Immunocompromised (not specified). Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Asthma.    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced BACK PAIN (Back pain is bad and waking her up last night, radiating pain), CHEST PAIN (Chest hurts after 3rd shot), CHEST DISCOMFORT (Chest feels tight after 3rd shot), FEELING COLD (Feel cold after 3rd shot), CHILLS (Chills after 3rd shot), MYALGIA (Body Aches after 3rd shot), PYREXIA (Fever 102F after 3rd shot) and HEADACHE (Headache after 3rd shot). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain is bad and waking her up last night, radiating pain), CHEST PAIN (Chest hurts after 3rd shot), CHEST DISCOMFORT (Chest feels tight after 3rd shot), FEELING COLD (Feel cold after 3rd shot), CHILLS (Chills after 3rd shot), MYALGIA (Body Aches after 3rd shot), PYREXIA (Fever 102F after 3rd shot) and HEADACHE (Headache after 3rd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Body temperature: 102 (High) Fever 102F.         This case was linked to MOD-2021-315546, MOD-2021-315706 (Patient Link).
The following day she developed red splotches on her face that have not resolved.; This is a spontaneous report from a contactable consumer This 79-year-old female consumer (patient) reported that: A 79-year-old female patient received first dos of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 06Feb2021 at 08:54 (at the age of 79-year-old) as single dose for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. History of all previous immunizations with the Pfizer vaccine considered as suspect reported as none. No additional vaccines administered on the same date as the Pfizer Suspect. Patient was not received any other vaccine four weeks prior vaccination. Patient stated she had her first Pfizer Covid vaccine on 06Feb2021, and the next day on 07Feb2021 she developed red splotches on her face that have not resolved. She wants to know if this was a reported side effect of the vaccine. Commented she had to look up the phone number for the doctor's office because she does not trust her memory. Patient did not have full HCP contact details to provide. The red splotches she believes she saw it that Sunday Morning, but it was not as prominent. As the day went on it became more prominent. Her husband did not remember seeing it that day. Her daughter had called her on video call, and she saw it. The patient then mentioned she ran her hands over her face, and she could feel it when she ran her hands over her face. She could see it in the mirror. Patient not visited to Emergency Room or Physician's Office for the event. The outcome of the event was reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Initial unsolicited case received from a consumer via social media on 29 Mar 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date after receiving the flu vaccination the patient became permanently, 100 percent paralyzed and blind. The patient lab tests and corrective treatment was not reported. The outcome of the events were not reported. Upon internal review the company decided to consider the events as serious because of important medical events blind and paralyzed. List of documents held by sender: none.; Sender's Comments: This case involves a female patient who received an Influenza vaccine (manufacturer unknown) and was paralysed and became blind after the vaccination. This is a poorly documented case. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, time to onset, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine had been given after being stored in a fridge for over 30 days) and PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination. It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before.     On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine had been given after being stored in a fridge for over 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine had been given after being stored in a fridge for over 30 days) and PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and/or at the time of the adverse event.  The vaccine was given in the deltoid (anatomical location).  Number of doses/vials were reported as 2 - not positive; not full vial was administered. The vial was initially stored in the refrigerator was on 27-May-2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-600655 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-600655:Master case
chills, dizziness, vomiting, diarrhea, fatigue, stomach cramps, weakness
This spontaneous report as received from a 53 year old female patient refers to herself. None of pertinent medical history was reported. None of drug reactions/allergies were reported. On 24-SEP-2014, at 6:00 PM, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously in the right arm (dose number and lot # not reported) at an unspecified pharmacy by an unspecified pharmacist. Concomitant therapies included hormonal contraceptives ("unspecified birth control pill"), Omeprazole, EFFEXOR XR. On 25-SEP-2014, patient experienced a "tiny raised area" appeared on her right arm where the injection site was, and she also reported itchiness and warmth at the injection site, and the patient further reported pain that spanned her entire right arm into her finger tips. On 26-FEB-2014, the patient reported that there was an orange size area around the injection site that was red and inflamed. The outcome of events was reported as not recovered/not resolved. The ZOSTAVAX was not reintroduced. The causality was not reported.  Additional information has been requested.
Low grade fever - transient. Flu like symptoms - transient. Myalgia (R) arm - severe. Myalgia (R) leg - mild. Restricted movement (R) arm - severe. Restricted weight bearing (R) arm - severe. Fatigue. Fibromyalgia.
Soreness on arm, increased migraines, some light headedness, fatigue- all lasted for 3 days Slight bruising on point of injection  (still present)
This am - arm sore noticed redness around 12:00pm - Here at 1:00. Redness, heat & swelling covering approximately 1/2 of upper arm & deltoid. Advised Ibuprofen, Benadryl and cold compress.
Client reported onset of itching on the arm where she received the second Pfizer COVID vaccine about 30 minutes after administration of the vaccine. The client stated the itching lasted about 30 minutes. The client denied any visible redness or rash on the arm.
Nose bleeding; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's mother) reported that a 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28May2021 (at the age of 13-year-old) (Batch/Lot Number: EW0168) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28May2021, the patient experienced nose bleeding. The mother asked if nose bleeding was common with age 13-year-old. The mother further stated, "You tell whether it is normal or not. It was right after the shot." The outcome of the event was unknown.
I have a weird tightening on the right side of my face.  My right eye lid is droopy all the time and the right corner of my lip always pulls up, its kind of the opposite of bells palsy and the mornings are much more prominent.  I have had occasional chest pain and R arm tingling when this first started.  My vision is fine but my eye is very irritated and watery.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB intramuscularly in the right upper leg (lot number and expiration date were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of RECOMBIVAX HB experienced the temperature excursion of 55 degrees Fahrenheit for 3 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002776: US-009507513-1706USA006113:
Mild erythema around injection site and severe progression muscle pain around the site. This pain increased for 2 days then gradually decreased over 2 days. NSAIDs were used during this time. The pain was completely incapacitating.
It started out with me waking up from sleep, I was tachycardia, sweating, and SOB. I was diagnosed with cardiac arrhythmia. PVC, PAC and SVT which is around 180-200 BPM. I have never had any cardiac issues. I am a very healthy individual who also participates in sports and never had an issue like this. For the last 3 months I haven't had any symptoms at all but up until 3 months ago I was having a constant issues.
This spontaneous report was received from an office manager via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL 9 intramuscularly (strength, dose, anatomical location, lot number and expiration date were not provided), for prophylaxis.
Pt recvd a series of 3 Engerix-B vax on 13APR90, 17MAY90 & 4OCT90 subsequently tested for Hep B antibodies & found not to have converted;
PATIENT DESCRIBED EXPERIENCING A LUMP IN THROAT AND DIFFICULTY SWALLOWING, WHEEZING, AND RED EYES,SEVERAL HOURS (ABOUT 6 HOURS) AFTER RECEIVING VACCINE. ALSO SAID SHE HAS A LOT OF FOOD ALLERGIES BUT DOES EAT EGGS WITHOUT REACTING. SHE TOOK 2 DOSES OF 2 BENADRYL 25MG AND THAT WORKED TO RELIEVE THE SYMPTOMS
- Our daughters first two DTaP vaccines were Pentacel. Following a move, our new provider did not carry, and would not obtain, Pentacel to continue the vaccine series.  - We informed our provider of the manufacturer/ACIP recommendation against switching vaccine manufacturers mid-series whereverpossible and where the vaccine history is known. We had our daughters vaccine record with us at the appointment, complete with vaccine brand and lot numbers.  - In spite of the our concerns, our provider insisted that there was no risk whatsoever to switching manufacturers.  - We were unaware that there are three brands of Glaxo DTaP vaccines, and our provider elected to administer Kinrix as the third dose. We later found out that Kinrix is contraindicated as the 3rd/4th dose, and is only licensed as the 5th dose, according to the manufacturer's FDA insert. - On the day of the injection, our daughter had a red lump/bruising at the injection site and wouldn't put weight on her leg.  - 6 days after the injection, she developed a 4.5" diameter rash, with the red lump/bruising remaining in the center. The school nurse called us out of concern when she noticed the rash at school. We later found out that the rash is a rare (delayed) Type 3 hypersensitivity reaction. We called the doctor's office immediately when we saw the reaction, but no one was willing to see her, and instead told us to giver her benadryl and take her to urgent care if necessary. We documented the timeline, took photographs, and filed one with her provider for inclusion in her medical record.
HIVES starting 32 Horus vaccines, unclear if related, took Benadryl,
soreness at injection sites; Fever; Body aches; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included BIVALENT COVID-19 BOOSTER VACCINE for prophylaxis.   On 19-MAY-2023, the patient received Shingrix and BIVALENT COVID-19 BOOSTER VACCINE. On 19-MAY-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at injection sites), fever (Verbatim: Fever) and general body pain (Verbatim: Body aches). On 22-MAY-2023, the outcome of the injection site pain, fever and general body pain were resolved (duration 3 days).   It was unknown if the reporter considered the injection site pain, fever and general body pain to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 27-May-2023 This case was self reported by the patient. This report was submitted submitted by public reporting reference. This report was submitted via the online direct entry reporting system. The patient received Shingrix and Covid Bivalent vaccines manufacturer unspecified other products and dates for other products various routine medicine Started unspecified date and was ongoing. The patient experienced fever, soreness at injection sites, body aches. The symptoms was not treated. The patient did not gave permission to contact. It was unknown if the reporter considered the events to be related to bivalent covid-19 booster vaccine.
Client complained of a headache and it being hard to breathe. Mother told EMT that client has a history of anxiety. EMT did not get DOB, but did get age of child. First dose of Peds Pfizer given today. Client felt better and was able to leave after being in observation area for 30 minutes. Benadryl was offered but mother of child declined. Client was very anxious mom expressed while child was being vaccinated.
Vomiting; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), FATIGUE (fatigue) and HEADACHE (headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced VOMITING (Vomiting), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, VOMITING (Vomiting), FATIGUE (fatigue) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol provided as a Treatment medication.
Raised red rash on neck and face on the side of injection.  Itching over entire body.
High Fever, Chills, Body aches, Very sore arm. Fever lasted about 12 hours.
Pt developed swelling, erythema and warmth at the site of injection. Reported fever to 104F (orally) with increased diameter of left arm of 1" more than right arm.
Information has been received from a physician and a 76 year old female retired registered nurse with chronic obstructive pulmonary disease and drug hypersensitivity to codeine and aspirin who on 27-Feb-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 659324/1835U) SQ in her left deltoid.  Concomitant therapy included MAXZIDE, SPIRIVA, ADVAIR, vitamins (unspecified) and LIPITOR.  On an unspecified date the LIPITOR was discontinued for liver function abnormal.  On 11-SEP-2008 the patient developed shingles (nonspecified rash on left leg, possible shingles).  The rash developed around the knee.  The patient was examined by the physician on 12-SEP-2008 and was prescribed FAMVIR and MEDROL dose pack.  The patient was seen by the physician on 16-SEP-2008, it was documented that the patient's rash had decreased.  The patient had a follow-up visit schedule for 19-DEC-2008.  Follow-up information was received from an office manager.  The patient was not exposed to chickenpox.  The patient did not have a direct fluorescent antibody drawn and the patient did not have a specimen collected for PCR.  It was reported that the patient did not have a biopsy.  It was reported that the patient's rash decreased after four days.  Subsequently, the patient recovered from the shingles.  The outcome of liver function abnormal was not reported.  Additional information is not expected.