chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Turned pale; Light-headed/ Dizzy; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown) via an unspecified route of administration on 27Aug2019 at a single dose for immunization because the patient will be leaving for college in two weeks. The patient has no medical history and concomitant medications. On 27Aug2019, the patient went to see her doctor in the morning, she had not eaten any foods. The patient then received the first dose of meningococcal group b rlp2086. The patient became pale, light headed and dizzy after receiving the vaccine. The patient was kept at the office for a little while, she was then going to get something to eat. The patient recovered from became pale, light headed and dizzy on 27Aug2019.  The following information on the batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 26Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovered" (05Jan2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I had a rebound of COVID 2 days after testing; Positive, notes: I had a rebound of COVID 2 days after testing. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain in my shoulder; Numbness in my arm; feel like tingling sensation moving to my arm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) first dose (Lot Number: EW0217) administered in arm left (left shoulder as reported) on 05Jun2021 as dose1, single and second dose (Lot Number: EW0191) administered in right arm (right shoulder as reported) on 26Jun2021 at 11:00 A.M, as dose 2 single both via an unspecified route of administration for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No prior vaccinations (Within 4 weeks). Patient stated, "I have like pain in my shoulder and numbness in my arm in Jun2021" Patient further stated, "So I basically taken the Pfizer vaccine Saturday afternoon and I really started feeling it Sunday morning but I didn't pay any attention to it because I felt the pain as when I got my first shot in my left arm so I didn't take any medication, but when I woke up in the morning I was like oh you know my arm, I can't feel it, it was really numb and it really feel like a tingling sensation moving to my arm in Jun2021. I just need a second opinion, because I called my doctor they told me to go to ER. I am kind of having same reaction in my right arm that I did have in my left arm it felt numb like if I like slept on it wrong or something and blood was trying to circulate through it. I got feel like any pain but it was really numb, I was just trying to figure is this like any side effect or I should go to ER like emergency room." No treatment received for events. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
9 days after injection developed red, itchy, warm rash inferior to injection site. Resolved on it's own within 2 days
Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction ABNORMAL LAB BACK PAIN
Redness, warms, confluent swelling from site in left deltoid extending all the way to neck  and upper chest causing neck stiffness starting approx. 12 hours after vaccine and lasting 72 hours before improving.  Given ibuprofen and Benadryl.
The patient reports feeling nausea and unwell that evening lasting for about 12 hours.  Her arm also swelled and red patch the size of a half dollar developed.  This lasted about one week before resolving.  She self treated with tylenol.
covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 46 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jan2022, outcome "recovering" and all described as "covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Jan2022) positive, notes: Other. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown Prior to vaccination, if the patient was diagnosed with COVID-19 and Since the vaccination, the patient had been tested for COVID-19. It was reported that daughter sick 20Jan and then dx (diagnosed) with covid 22Jan, she woke up sick 27Jan2022 and tested home Ag positive with mild symptoms. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
COVID-19 Treatment; COVID-19 Treatment; Temporary soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 as dose number unknown, single (Lot number: GJ3270) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gluten Allergy" (unspecified if ongoing); "Pollen Allergy" (unspecified if ongoing); "Allergy to Statins" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09May2023, outcome "recovered" (10May2023), described as "Temporary soreness at injection site"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of vaccination site pain.
I have had excessive eye blinking in my left eye.(blepharospasm). I saw a neurologist 1 week ago and will be having an MRI brain without contrast
This spontaneous report was received from a nurse (patient's mother) refers to a male patient of unknown age. Information regarding patient's medical history, concurrent condition and concomitant therapy was not provided. On 30-DEC-2015, the patient was inadvertently vaccinated with the fourth dose of GARDASIL (extra dose administered). Patient's mother stated that the patient was inadvertently vaccinated with 4 doses of GARDASIL. The first dose was administered on 11-JUL-2013, second dose on 05-JUN-2014, third dose on 08-JUL-2015 and fourth dose on 30-DEC-2015. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician via company representative refers to an adult male patient of mid 50's. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (dosing details were not reported). No concomitant therapies were reported. On an unknown date, after receiving a dose of ZOSTAVAX vial the patient experienced shingles. The patient sought medical attention, patient was seen by the physician approximately in February 2016 (reported as on an unspecified date last week). The outcome of shingles was unknown. The reporter did not assess the causality between suspect therapy and the adverse event. Additional information is not expected as the reporter did not wish further contact.
Vaccinee rec'd a 1st Engerix-B dose(deltoid on 30AUG90; Eight days post vax had onset of flu-like sx which lasted 24 to 48 hrs then recurred on 12SEP90;
I had my shot at 3:45 pm on friday, the 26th of March.  at around 6:30 I started to feel nauseous and started to get body aches.  Lot of congestion and a runny nose.  I also got a stomach ache later in the evening.  by the time I went to bed around 10 pm I hurt all over and was very sick to my stomach.  I felt like if someone touched my skin my bones and muscles would all shattered.  I did not sleep much that night and woke up on Saturday, the 27th with the same symptoms but not quite as bad.  I still had nausea and a stomach ache and was very tired and drained.  I did start to get diarrheic around 3:30, 4:00.  I still hurt and have diarrheic and am very tired today, which is Tuesday, the 30th of March at 5:15 pm.
Swelling right deltoid, pain radiating with range of motion to neck. Pain relieve with Motrin. Now pain has continued for five weeks, swelling has decreased.
Severe flare of Sjogren's syndrome - auto-immune disease. Excessive dryness requiring an increase in medication  (pilocarpine, hydroxychloroquine) and OTC symptom relief products. Now almost 10 months later, symptoms have not subsided. Consequently, I am hesitant to get a booster shot.
Headache, Arthralgia,  Fatigue,injection pain and swelling Narrative:
Fatigue, Headache, Joint pain, Lasted about 48 hours, I took Tylenol.
Pt. states that after receiving the 2nd dose of Shingrix 02/13/2021, started experiencing symptoms 10/27/2021 of a Shingles outbreak across the chest and towards the back. Under treatment of Primary for Shingles.
Global Transient Amnesia - sudden onset of memory loss and inability to form short term memory.  No other medical problems. Lasted about six hours
When administrating pediatric covid vaccine, the original vaccine vial wasn't diluted before drawn, and administered. PATIENT HAD HIGHER DOSE THAN NORMAL
This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. The patient had no relevant medical history, drug history or laboratory test results. On 12-APR-2017, the patient was vaccinated with PROQUAD rHA, 0.5milliliter (ml) in a single dose, intramuscularly (lot#M026879, expiration date: 27-NOV-2017) (anatomical location was not reported) for prophylaxis. On the same date, the patient was vaccinated with M-M-R II rHA, (lot# M008588, expiration date: 16-FEB-2018) (dose, route of administration and anatomical location were not provided) for prophylaxis. On 12-APR-2017, a sterile diluent (manufacturer unknown) solution for injection (lot# reported as M04921 identified to be not valid and M014921, expiration date: 30-NOV-2018) (dose and anatomical location were not provided) was used to dilute both of the aforementioned vaccines and administered together with the respective vaccines. Concomitant therapies included hepatitis A virus vaccine (unspecified) (GlaxoSmithKline) administered on 12-APR-2017 and fluticasone nasal spray. On 12-APR-2017, the patient was given PROQUAD as an intramuscular injection, however the reporter stated that she should have VARIVAX. When this immunization occurred the patient was also given M-M-R II and hepatitis A virus vaccine (unspecified) (GlaxoSmithKline). No issues or adverse events were reported. At the time of the report, it was unknown whether PROQUAD or M-M-R II will be administered in the future. The outcome of accidentally administering PROQUAD was unknown. Additional information has been requested.
16 year old received the first Moderna vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the first Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history reported. ).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the first Moderna vaccine). On 28-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the first Moderna vaccine) had resolved.        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.   This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.
was sore for day's; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 09-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shingle vaccine a few days ago and it was sore for days and still kind of sore got it. The reporter stated that, Tuesday, so he/she was hoping that, he/she did not get shingles because people who had it said it was real painful. Additional Supportive Information: The follow up would not possible as no contact details were available.
< 24 hours after injection developed significant arm swelling, fever 103 degrees and pain.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 36-month-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 06-Dec-2010. The patient received the expired FLUMIST on 08-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. The reporter informed that on 01-DEC-2017, the patient was inadvertently administered a dose of expired ROTATEQ orally, for prophylaxis, lot# M007311 and expiration date 30-NOV-2017 (strength, dose and frequency were not reported). No adverse effects were reported.
Could not walk; Stomach was hurting so bad; Arm was hurting; Itching; Expired vaccine administered to patient/Vaccine was out of the refrigerator by days; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Could not walk), ABDOMINAL PAIN UPPER (Stomach was hurting so bad), PAIN IN EXTREMITY (Arm was hurting), PRURITUS (Itching) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Vaccine was out of the refrigerator by days) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The Medical history information was not provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Could not walk), ABDOMINAL PAIN UPPER (Stomach was hurting so bad), PAIN IN EXTREMITY (Arm was hurting), PRURITUS (Itching) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Vaccine was out of the refrigerator by days). At the time of the report, GAIT INABILITY (Could not walk), ABDOMINAL PAIN UPPER (Stomach was hurting so bad), PAIN IN EXTREMITY (Arm was hurting), PRURITUS (Itching) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Vaccine was out of the refrigerator by days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was received by patient.
Large hematoma formed 6 days after injection, lots of redness, swelling, itchiness. Looks raised and exophytic, approximately 10mm in diameter.
48h post vaccination: Headache now, pain rated as a 5 Took 1000mg of tylenol an hour ago, pain has not decreased Nausea only after eating Client had severe headache for 7 days after first covid vaccine dose.
Pallor, unresponsive, hypotonic for 5-10 minutes. Occurred 2 minutes after injections. Follow up: note child did not die.  Nurse follow up on 08/19/04 states: "Vasovagal reflex."
After 1st vaccine, I experienced fatigue and chills the morning afterwards. I also had a rash appear on my L deltoid a few days later that lasted about 4-5 days.   After the 2nd vaccine (1/19) on 2/11 I stood up out of bed, lost vision and fell over. Throughout the past 8 months I have had multiple instances of my vision going black and falling over when standing up. I have dizziness, decreased concentration, decreased memory, and fatigue. My blood pressure has also been very low. I was worked up by cardiology and was diagnosed with Neurogenic orthostatic hypotension. I have been treated with increased water intake, increased salt intake, compression stockings and Midodrine 10mg x 3 per day.
Never felt so sick in my life; Can't sleep; Can't shower; Feel horrible/everything is off; Can't walk; Hit me hard; Shook for 3 hours; 103 fever; Severe chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Never felt so sick in my life), SLEEP DISORDER (Can't sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't shower), FEELING ABNORMAL (Feel horrible/everything is off) and GAIT INABILITY (Can't walk) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B and 012F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced MALAISE (Never felt so sick in my life), SLEEP DISORDER (Can't sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't shower), FEELING ABNORMAL (Feel horrible/everything is off), GAIT INABILITY (Can't walk), VACCINATION COMPLICATION (Hit me hard), TREMOR (Shook for 3 hours), PYREXIA (103 fever) and CHILLS (Severe chills). On 09-Dec-2021, TREMOR (Shook for 3 hours), PYREXIA (103 fever) and CHILLS (Severe chills) had resolved. At the time of the report, MALAISE (Never felt so sick in my life), SLEEP DISORDER (Can't sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't shower), FEELING ABNORMAL (Feel horrible/everything is off), GAIT INABILITY (Can't walk) and VACCINATION COMPLICATION (Hit me hard) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2021, Body temperature: 103 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided. No treatment medication was provided.   This case was linked to MOD-2021-408501 (Patient Link).
Patient received DTaP right thigh intra-muscular on 07/01/2003.  Mother called office said patient had redness, hard knot, warm to touch and instructed to present to office on 07/02/2003.  Was seen and given Keflex.
Pt had 7 cm x 7 cm red raised area (L) upper arm at injection site. There was a 8 cm x 6 cm red raised area underside of (L) upper arm.
I had extremely sharp pain and loss of grip in my right arm. It comes and goes. It is about 6 inches from my elbows in my arm that is in extreme pain. I went to the emergency room and they told me that it will go away. I went to urgent care as well and they told me to take ibuprofen. That I must have hit it and I do not recall hitting my arm on anything. I wake up in extreme pain. I have not been able to get an appointment with a provider to have it checked out.
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unknown age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unknown route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included heart valve replacement (she has had heart surgery). The patient's concomitant medications not reported. On an unknown date, patient experienced itchiness on her stomach, something under her stomach running (caller described this sensation as tingling) and allergy. The outcome of the events reported: unknown. Information about lot/batch number requested. Follow-up attempts completed. No further information expected.
Covid19 breakthrough.  1st vaccine received on 04/08/2021.  68 y/o with PMH AFIB, COPD, HTN, HLD, OSA, Seizure, pituitary tumor, Cardiac ablation, IVC filter presents with c/o nasal congestion, cough, fever and sore throat x1 day.  PCP advised ER visit for concern of Covid symptoms and pt currently has active MAC infection.  Bibasilar atelectasis per CXR. Room air sat 98%.  On IV ABX.
Chills, high fever of 101 to 102; body and joint aches; headache; lasted about 24 hours. Treated with Advil.
She had a NSTEMI  heart attack on 4/11/2021  and was hospitalized .
6 x 8cm erythematous induration right upper arm at site of immunization.
reddened areas about 3mm diameter and scabbed in the center; on Left hip/abdomen, left wrist and forearm, navel area and right hip/abdomen. Appear as flea bites. Reports no edema of throat but intense desire to clench teeth-onset about 3 or 4 days after injection. No unusual appearance of injection site-Right deltoid. Donor called 5/20/04 and spoke with LPN PA. Stated she is okay. No symptoms remained other than rash which appears somewhat improved.