chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Psychological and Speech.  Speech became progressively worse over the months.  Tried to explain all this to the doctor at her 2 yr. old appt. in December of 2014 and was made to feel like I was being paranoid. I had to practically beg for a referral to see a specialist. I stated that she had REVERTED! She is currently in Speech Therapy, with a moderate to severe diagnoses.  We attend therapy twice a week.
Inflammatory pulmonary condition; This case was reported by a physician via call center representative and described the occurrence of lung inflammation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced lung inflammation (serious criteria hospitalization). On an unknown date, the outcome of the lung inflammation was unknown.   It was unknown if the reporter considered the lung inflammation to be related to Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient developed an inflammatory pulmonary condition and the patient was necessitating hospitalization. The patient was admitted to the hospital and was discharged with apparent resolution of their condition. This case has been linked with case US2019AMR207405, reported by the same reporter.
Mouth turned to the left side; Body aches; Abdominal pain; Trembling really strong; Extreme sweat; Pain in the left leg; Headache; Fever of 101°F; Chills; This spontaneous case was reported by a nurse and describes the occurrence of DYSKINESIA (Mouth turned to the left side), PAIN (Body aches), ABDOMINAL PAIN (Abdominal pain), TREMOR (Trembling really strong) and HYPERHIDROSIS (Extreme sweat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma and Hypertension. Concurrent medical conditions included Anxiety, Blood pressure high, Allergic reaction to food, Allergic reaction to drug and Penicillin allergy.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 20-Feb-2021, the patient experienced DYSKINESIA (Mouth turned to the left side), PAIN (Body aches), ABDOMINAL PAIN (Abdominal pain), TREMOR (Trembling really strong), HYPERHIDROSIS (Extreme sweat), PAIN IN EXTREMITY (Pain in the left leg), HEADACHE (Headache), PYREXIA (Fever of 101°F) and CHILLS (Chills).   On 25-Feb-2021, PAIN (Body aches), ABDOMINAL PAIN (Abdominal pain), TREMOR (Trembling really strong), HYPERHIDROSIS (Extreme sweat), PYREXIA (Fever of 101°F) and CHILLS (Chills) had resolved. At the time of the report, DYSKINESIA (Mouth turned to the left side), PAIN IN EXTREMITY (Pain in the left leg) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 101 (High) High.    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.   It is reported that patient is currently consuming High blood pressure and Anxiety medication.   This case was linked to MOD-2021-026852 (Patient Link).
Inappropriate schedule of vaccine administered; Pain in right side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in right side) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, the patient experienced PAIN (Pain in right side). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at an unspecified dose and frequency. At the time of the report, PAIN (Pain in right side) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Had shingrix vaccine in the morning yesterday.  Was feeling fine before the shot with no complaints. Increased fatigue noted at bedtime last night with anorexia and nausea, no vomiting.   Headache started overnight last night.  Some blurring of vision intermittently noted overnight but vision has normalized this AM.  + photophobia overnight, better this AM.  + diaphoresis noted overnight.  + chills.  No cough, some throat pain noted overnight but better today.  Took tylenol before bed and again this AM 500mg x 1.  No fevers measured.  Drinking water well.   Diffuse aching noted of L arm where shot was given, but this discomfort is also improving.  No vomiting.  Some loose stools overnight without blood.  No dysuria.
(L) UE KINRIX inj. site 3 cm x 4 cm erythema and edema, mildly tender.
STARTED SLIGHT COUGH ON 11/11/2011 IN THE AFTERNOON - AND COUGH BECAME MORE FREQUENT 2 TO 3 DAYS LATER.  COUGH WAS WORSE ON 11/18/2011 AND DECIDED TO COME IN AND BE SEEN ON 11/21/2011.  STATES HAD SORENESS IN THROAT FOR FIRST 2-3 DAYS.
Client received vaccine on 5/23/22 and called on 5/24/22 to report redness and swelling in her left arm down to the elbow.  This nurse encouraged the client to contact PCP to follow up with symptoms or go to urgent care/ER.
8 hours after injection, flu-like symptoms started and worsened over the next 24 hours. Flu-like symptoms disappeared between 24-30 hours after the injection. 48 hours after injection, I noticed a red area around the injection site, about 3" wide and 5" long. Area was hard and hot to the touch. I went to urgent care and they couldn't figure out what it was, so they sent me home with a line drawn around the red area, telling me to come back if the redness went outside of the line and they would prescribe antibiotics. The redness never increased and dissipated within a couple of days. By 96 hours after the injection, the redness was pretty much gone.
Date of Admission: 10/11/2022   Date of Discharge: 10/14/2022   Admission Diagnosis: Community acquired pneumonia, unspecified laterality [J18.9]     Hospital Principal Problem (Discharge Diagnoses): AKI (acute kidney injury) (CMS/HCC)   All Hospital Problems (Other Diagnoses): Active Hospital Problems   Diagnosis o Principal Problem: AKI (acute kidney injury) (CMS/HCC) o COVID-19 o Leukocytosis o Elevated troponin o Type 2 diabetes mellitus without complication, without long-term current use of insulin (CMS/HCC) o Essential hypertension
I experienced intense itching within a 6-inch area below the injection site for 5-6 days
Headache, systemic muscle tightness, full body pain, lymph node pain torso/neck/head (similar to insect stings). I am on my fifth day after vaccination and symptoms wax and wane throughout day.
FLUSHING IN THE FACE; RASH ACROSS NECK, EARS, LEFT CHEST; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included removal of lymph nodes, covid-19 infection, and hives, and concurrent conditions included breast cancer, latex allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with lidocaine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 201a21a, expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced flushing in the face. On 25-MAY-2021, the subject experienced rash across neck, ears, left chest. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from rash across neck, ears, left chest, and flushing in the face. This report was non-serious.
Pain and swelling at the site of injection and fever. She went to the doctor and was prescribed antibiotic.
By 3pm on the same day that i recieved the vaccine i had very bad muscle aches in my starting in my neck and back. When i woke up on the morning of 02/04/2021 I had severe muscle aches all over, headache, loss  of appetite and bad chills. No high temperature was noted. Duration of the event was 3 days.
unable to eat or drink much or take medications, too weak to do anything, vomiting, fevers, myalgias, cough and SOB.
a little rash on the arm; This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is the second of the two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a little rash on the arm on an unspecified date. The patient recovered from the little rash on the arm, which went away, on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s): PFIZER INC-2021252201 Same reporter, suspect drug, similar event; different patient
Patient was walking in store outside of clinic after vaccine and felt nauseous and fainted. Father caught patient so no injury occurred. Patient appeared pale and not cognitively aware of surroundings. After several minutes patient stated she could walk and was assisted to waiting area where she had been advised previously to remain for 15 minutes. Patient has a history of nervous maneurisms with vaccines and fainting with covid vaccines. After some time patient felt somewhat better and pt father and mother stated they were taking her home. Pt walked away with flinching and tics continuing but appeared more stable walking. Advised father to take pt to ER if symptoms persist or become worse and father agreed. Whole incident lasted approximately 30 minutes after vaccine was given.
About 7 days after receiving VARIVAX left Deltoid Pt developed erythematous papular left Deltoid which have persisted about 1 week with minor local exanthem. No fever - No warmth. Rx PROVENTIL.
Patient fainted and experienced minor jerking motions for about 10 seconds immediately following MENACTRA vaccination.  She then regained consciousness and stopped jerking.  Patient felt dizzy afterward.  After resting for 10-15 minutes, patient felt ok to go home with mother.
I have leg cramps and stiff calves after about a month of the vaccination. I initially had body ache which lasted only 1 day after the vaccination however I continue to experience leg cramps. I have no previous history of leg cramps.
PATINET WAS GIVEN PFIZER FOR 5-11 YEAR OLDS INSTEAD OF THE OVER 12 PFIZER DOSE
Temperature up to 102, sensitive skin, achy joints, achy muscles, lack of energy/tired
Concurrent medical conditions included Blood pressure abnormal and Thyroid disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MALAISE (Didn't feel good), HEADACHE (headache), VACCINATION SITE PAIN (pain in my arm of injection), FATIGUE (tiredness) and LYMPHADENOPATHY (Swelling of lymph nodes under arm of injection (left arm)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Didn't feel good), HEADACHE (headache), VACCINATION SITE PAIN (pain in my arm of injection), FATIGUE (tiredness) and LYMPHADENOPATHY (Swelling of lymph nodes under arm of injection (left arm)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also reported were Blood pressure medicine, Thyroid medicine.
Fever; Headache; Tiredness; Abdominal pain; Nausea; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the left arm on 06Oct2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was unspecified. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 07Oct2021 at 16:00, the patient experienced fever, headache, tiredness, abdominal pain and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, headache, tiredness, abdominal pain and nausea was resolved on an unknown date in Oct2021.
VAQTA that had undergone temperature excursion was administered to a patient; No additional AE reported; This spontaneous report was received from a healthcare worker referring to a currently 8-year-old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies was not provided.   On an unspecified date, the patient was vaccinated with an improperly stored dose of Hepatitis A vaccine, inactivated (VAQTA) as prophylaxis (dose, route of administration, and vaccine scheme were not reported; lot number U026782 is an invalid lot for Hepatitis A vaccine, inactivated (VAQTA) as confirmed by Lot Verification team; expiration date reported as 28-OCT-2022).  It was reported that the vaccine was exposed to a temperature excursion of 49.6 degrees Fahrenheit during a time frame of 32 minutes (product storage error).  There was no previous temperature excursion, and no additional adverse event was reported (no adverse event).
Client in HD for vaccinations administered TDAP and Hep A in LD and HPV and MENACTRA in RD. Immediately after administration of HPV (last vaccine) client c/o feeling dizzy and then passed out. Her legs and arms constricted for about 30 seconds the client started coming back around. Father was positioned behind client and supported her head and upper body while I attempted to elevate head, provide cool cloths and request assistance from staff. Client was provided a coke and gradually resumed her pre shot color. After the incident which lasted about 15 minutes, the family advised us that this occurrence has happened once when she gave blood once when she had her ears pierced and once when she had her navel pierced.
Admin dose 6/14/13 in PM. Pt reported fever (< 101 degrees F) on 6/15 and 6/16/13 with injection site pain. Remained in bed all day 6/15 with lethargy. Returned to normal on Tues 6/8/13. Still some arm soreness.
Within 12 hours of the injection experienced pain, hard painful lump at injection site.  It was also warm to the touch.  Ten days after the injection there was a red circle at the injection site.
earache; sore throat; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration, administered in left arm on 27Jan2021 at 11:00 (at the age of 65 years old) as a single dose for COVID-19 immunisation. The patient family history was none. The patient medical history and concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19 with SARS-CoV-2 test and unknown results on unknown date. On 27Jan2021 the patient experienced sore throat reported as last night, is fairly mild. Is now in her ear. Earache: Mild earache, noticed this morning.  The patient wanted to know could that be a symptom of the vaccine, hasn't been tested for COVID throughout the pandemic. Knows earache and sore throat are a symptom of COVID but has no reason to think she has COVID. Asked if she can still get tested for COVID if she had the vaccine. Her appointment for her second vaccination was scheduled for eight weeks from the first. The patient asked if the vaccine could interfere with or cause a false positive on a Covid test. The outcome of the event earache was not recovered while Sore throat was unknown.  Follow-up attempts are completed. No further information is expected.
The patient presents with COVID positive. ED Nurse states pt is from Care Center and was tested for COVID on 8/9/2021 and had an X-ray that showed COVID pneumonia but it wasn't confirmed. Nurse states pt was sent so COVID pneumonia can be r/o and pt can get medically cleared back to facility. She states the pt is 93% on room air, and pt has no complaints at this time. HPI limited to pt's history of dementia.  The course/duration of symptoms is constant.  The degree at present is none.  Risk factors consist of hypertension, diabetes mellitus and age. Patient was still admitted at time the form was submitted.
received HAVRIX instead PEDIARIX; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 10-month-old female patient who received HAV (Havrix pediatric) (batch number 4CY9H, expiry date 28th April 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th April 2022, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 7th April 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The patient received dose Havrix instead of the intended Pediarix. The patient spoke per PI (Package insert) and content.  The reporter provided outside phone number for GSK Medical Information given for future reference and warm transfer provided. The reporter consented to follow-up. Additional supportive information: The patient received dose Havrix instead of the intended Pediarix, which led to Wrong vaccine administered. The vaccine administration facility was the same as primary reporter.
Patient claimed that she had a reaction with a red circle/rash on arm that kept getting bigger. It started after she got the shot on 10/5/18 within an hour. She said it was bright red on her whole upper arm. She contacted a nurse and her doctors office. They told her to take BENADRYL or use hydrocortisone cream and call the pharmacy. The patient did not contact the pharmacy where she got the shot until 10/11/18. At that point the rash was already clear.
shipment was to be delivered on 10Oct2019 and was not received until 14Oct2019,no AE; shipment was to be delivered on 10Oct2019 and was not received until 14Oct2019,no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from Nurse.  This case is linked with 2019SA287366 and 2019SA287333 (same reporter)  This case involves a 75 years old female patient who was vaccinated with 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ283AB, expiry date: 29-May-2020), via intramuscular route in the left arm on 14-Oct-2019  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an case of incorrect product storage and Product shipment delay due to product was to be delivered on 10Oct2019 and was not received until 14Oct2019.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
She developed hives.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to anything gel based such as the gel cap vitamins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "hives". Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 Immunization; Bnt162b2 (Dose 2, single), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "She developed hives.".  Additional Information: Patient was instructed by the pharmacist to call Pfizer medical information contact number to ask about one of the ingredients in the COVID-19 vaccine that's currently out, whether this vaccine contains anything gel-based or whether the glycoprotein is gel-based. Patient that she is allergic to anything gel based such as the gel cap vitamins, Tylenol liquid gel which causes her to develop hives. Patient confirmed that she previously received 3 Pfizer COVID vaccines and opt not to receive the fourth because of what happened to her. Patient confirmed that after the third shot of the COVID vaccine, she developed hives. Upon providing response, patient mentioned that the pharmacist told her that Glycoproteins are gel-based.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.