chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got doses out of the box of expired tenivac single-dose syringes with no reported adverse event; Initial information  received on 15-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 43 years old male patient who got dose out of the box of expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] single-dose syringes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jul-2022, the patient received 0.5 mL dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult single-dose syringes (lot U5856AA, expiry date: 26-Jan-2020) via intramuscular route in the left deltoid for immunization.  On 25-Jul-2022, the patient got dose out of the box of expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult single-dose syringes with no reported adverse event (expired product administered).  It was reported, "would like to verify an expiration date on a box of TENIVAC SINGLE-DOSE SYRINGES that was confusing. Pharmacist states that the expiration date is 26Jan20. Pharmacist asking about the follow-up and if someone should get another dose if they were to get an expired dose of the vaccine. Pharmacist states that four people got doses out of the box of expired TENIVAC SINGLE-DOSE SYRINGES".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Periorbital swelling, nausea.  Treatment:  benadryl, zofran.   Taken to ED
Within minutes of vaccination, patient reported that her arm felt a warm sensation that extended across her chest.  10:20 Stated her chest felt tight.  Feeling lightheaded.  Denied any tingling sensations of the mouth and throat.  Lungs Clear to auscultation, no facial swelling noted.   BP: 69/112.  P: 119.  O2Sat: 99%.  R: 20.   Pt did not eat this morning.  States she is on Keto diet.   Pt.  became jittery,  Juice provided.   BP rechecked: 10:35 BP 140/115, P: 77.  R-20.  O2Sat%:  99%. Lungs CTA bilat.   Continued observation, BP: 158/104. 11:05 C/ O  increasing pain in both arms and chest.  Pain in abdomen.  Increased anxiety,  Fainted momentarily.  Placed supine. Crying stated she was feeling "weird" , tingling hands, ears, increased pain.  Lips tingling, face flushed.   BP: 183/102.  R: 20.  O2Sat: 99.   Became chilled.   EMS activated.   11:12 Patient transported via ambulance to Hospital.  Husband notified of transport by  NP.
Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Severe, Additional Details: Patient recieved Moderna Covid vaccine and was waiting for the 15 mins, friend came over to tell me that he friend was shaking, when I went over to the patient she was unresponsive. After about 15-20 seconds she was reponsive, after further discussion with the patient she said this has happened before when she gave blood, she said she was extremely nervous and thinks that is what caused the reaction BP was 90/60 at first after it was back to normal at 120/80. She did not want to call Emergency.
Headache- 36 hours - took Excedrin. Metallic taste- 12 hours. Flushed- 12 hours.
Pt is a 51 yo f who presented to pharmacy to receive both the pneumococcal and influenza vaccines. Pt then experienced some swelling in one of her arms, but the pharmacy was unable to verify which arm. Pt received Influenza vaccine in left deltoid and the Pneumovax vaccine in the right deltoid.
nose blood that wont stop; fever; pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (nose blood that wont stop), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection site) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included Back pain (the patient stopped taking aspirin 1 year ago, when HCP changed patient to Mobic for back pain.). Previously administered products included for Product used for unknown indication: Aspirin (Aspirin). Concomitant products included MELOXICAM (MOBIC) for Back pain.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection site). On 15-Apr-2021, the patient experienced EPISTAXIS (nose blood that wont stop). The patient was treated with OXYMETAZOLINE (AFRIN [OXYMETAZOLINE]) (nasal) on 16-Apr-2021 for Bleeding, at an unspecified dose and frequency. On 15-Apr-2021, PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, EPISTAXIS (nose blood that wont stop) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that consulted ER at 2am-4am 16APRIL2021 Treatment Afrin spray up nose which stopped bleeding. Following discharge, at 7 am bleeding restarted.
The day following the 2nd vaccination dose, I had zero symptoms other than a slightly sore injection site.  Around hour 30 following the vaccination I began to feel warm, and I got up to brush my teeth and cool off in the bathroom.  As I was brushing my teeth, I started experiencing an increasing ringing noise in both my ears that I thought was strange and somewhat alarming, but I didn't feel any signs of dizziness or dysphoria.  The next thing I remember is waking up the bathroom floor with my husband standing over me.  Apparently I experienced a complete lose of consciousness and feel to the floor, hitting my chin on the bathroom vanity as I feel and splitting my chin open, which I have zero recollection of.  My husband states that when he found me, that my eyes were open, but I was staring blankly at him with a glazed over look and my whole body was limp and diaphoretic.  I came too in about 30 seconds after he found me, but I was very confused, not making a lot of sense, and felt very disoriented and weak.  It took about 20 mins for my fever to break, and to have the strength and power to get up and walk to bed.  We changed all my clothes because I had soaked through them, and he got me into bed after cleaning/bandaging up my chin.  I then slept solidly until noon the next day, which is very unlike me, but since then I have felt relatively fine with no other experiences of fever/chills/disorientation, just some continued mild fatigue off and on.  After discussing with my nursing colleagues, they all had similar experiences around hour 24-30 post 2nd vaccine with fevers, chills, restless sleep, or just general malaise, but no one experienced a complete loose of consciousness, so I reached out to my PCP yesterday, and she confirmed today that I should report this to VAERS.  I have never experienced any form of loss of consciousness/fainting/black-out/syncope prior to this, which is another reason I thought it was important for me to report this.
Received flu vaccine in office and developed 104 fever in late evening. Went to Emergency Room and after exam was told fever due to flu vaccine.
Rash; mild swelling of the throat; non-anaphylactic allergy reactions; This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported same events for two patients. This is 2nd of two reports.   A patient of unspecified age and gender received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, propylene glycol via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On 17Dec2020 at 2:50 pm, PharmD, Clinical Pharmacy Manager, shared with the reporter that two employees had non-anaphylactic allergy reactions to the Pfizer BioNTech COVID-19 vaccine, this patient is one of them. She reported rash and mild swelling of the throat. They suspect it was a reaction to propylene glycol and will be doing skin testing. The action taken in response to the event for propylene glycol was unknown. The outcome of events was unknown.   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) : US-PFIZER INC-2020501256 same reporter/drug/event, different patient
Difficulty breathing starting at approximately 1254, upon EMS arrival she was unresponsive, absent pulse and absent breath sounds. Blood glucose 390. CPR initiated. initially in asystole then 1 episode of a shockable rhythm and was defibrillated at 150 joules, but then returned to asystole. Transferred to hospital. During transport received 5 rounds of epinephrine and supraglottic airway in place with ETCO2 at 25 and chest compression administered via LUCAS device. 1L of NS given during transport and sodium bicarb. Arrived at hospital unresponsive time 45-50 minutes.
Diarrhea a few days following injection; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and migraines. The patient had unspecified known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included golimumab (SIMPONI), erenumab (AIMOVIG) and thyroid (as reported) (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 14Apr2021, the patient experienced diarrhea a few days following injection x 4 weeks. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with unspecified supplements antidiarrheal medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea a few days following injection was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Covid rebound, non symptomatic; Covid rebound, non symptomatic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0161), in right arm, on 10Dec2021 as dose 3 (booster), single (Lot number: FJ16111), in left arm and on 28May2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing); "Neurological" (unspecified if ongoing); "Musc" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT; LIOTHYRONINE; TRIPLE MAGNESIUM COMPLEX. The following information was reported: VACCINATION FAILURE (medically significant), 1 year 6 months 18 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "Covid rebound, non symptomatic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19: paxlovid from 03Oct2022 to 08Oct2022.  No follow-up attempts are possible. No further information is expected.
He had ringing in the ear that is tinnitus; This is a spontaneous report from a contactable pharmacist.A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient had ringing in the ear that was tinnitus. The outcome of event was unknown. . This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
PATIENT PRESENTS WITH RASH IN ABDOMEN, GENITAL AREA, RED PATCHES WITH EDEMA, ERYTHEMA AND GENERALIZED PRURITUS. EVALUATED BY DR. IN THE ER. WAS ORDERED TO TAKE BENADRYL AND SOLUCORTEC.
he also got COVID; he also got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient in his 70's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "has high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "he also got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter stated her husband and she developed Covid and they were just getting over it. She also reported that her husband was also vaccinated with Pfizer Covid 19 vaccines (dates not provided) and he also got Covid and was recovering. Patient took Paxlovid as soon as they tested positive and had symptoms. Patient took Paxlovid and it helped.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300228656 same reporter/product, different patient / event.;
On 10/20/2022, I noticed four bumps in a ring shape on my lower back above the left buttock. I used a hydrocortisone cream that day. The next few days, I started to feel a little tired and not myself. I felt like I might be fighting something or under the weather. At some point, my left groin lymph node became swollen and was visibly larger than the other side. Around that area and into my upper leg, my skin felt tender to the touch. By 10/23/2022, I was starting to become more concerned, so I emailed my doctor with a description of my symptoms and a photo of the ring of bumps. Yesterday, they responded saying that it sounded like early shingles. They prescribed an antiviral which I began taking yesterday. Since then, I have now developed 5 separate rashes and I have felt malaise, headache, chills, fatigue, tender skin, and I still have swelling in the groin area.
At 10PM day of vaccination, started feeling weakness. Weakness became fever and mild headache around 11PM.  Low grade fever and weakness and intense fatigue persisted into the next day, April 30th. Low grade fever still ongoing at time of this writing.  Headache has mostly resolved, along with regaining some strength.
joint & muscular pain-severe began w/in a wk of vax;numbness of limbs;swelling of liver-elevated bilirubin-abd pain & short term memory loss, h/a, rash & some itching;
muscle twitching at night; This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCLE TWITCHING (muscle twitching at night) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (muscle twitching at night). At the time of the report, MUSCLE TWITCHING (muscle twitching at night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.
I received the 1st dose of the Moderna vaccine on 9-1-21 and my arm was sore for 4 days and then everything was fine.  On 9-8-21  I woke up and my arm was itchy and then on 9-9-21 I had a warm ,red, itchy rash appear from the injection site of the needle to about 3-4 inches down my upper arm.  I used cortizone for the itching which has helped some but the redness is still visible on my arm today 9-12-21. No pain.
Left shoulder soreness started 10/2 at 1600; left breast pain & large lump noted 10/2 at 2100 and left upper quadrant and neck achiness noted 10/3 0600AM
my eyes are swollen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (my eyes are swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (my eyes are swollen). At the time of the report, EYE SWELLING (my eyes are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Dx with varicella. Visit date for generalized papular vesicular rash to Medical Center was 22 days after vv1. Rash onset unknown. The character of symptoms is not redness and not oozing. Mom picked him up from dad's on 5/13 and the child had the rash.
Tachycardia-160 for about 10-20 minutes about 10-15 after injection, HR 120-130 for about 1 hour, clamminess, shaky, dizziness
Both hands became itchy and red. It was an internal reaction. No rash on skin. Later that day rash showed up on skin near wrist but quickly disappeared. Rash also appeared on right side of neck but quickly disappeared. Left ear is itchy inside. Used Benadryl and it seems to have helped. But it does come back. Seems worse when I use hands or stand up. This was on my second shot. First shot I only had mild flu symptoms.
Client noted soreness to (L) arm the day after injection lasting the entire next week, from elbow to shoulder - soreness with ROM to upper arm. On 1/11/16 noted soreness to (L) wrist. Condition is improving - no tenderness or redness reported to injection site at any time.
3/22/2021 Urgent care visit: vomiting, nausea, no appitite, diareah.  3/27/2021 ER visit same symptoms  4/1/2021-4/5/2021 Hospitalization. Endoscopy, bloodwork, MRI, and severe allergic reaction to iodine. Doctor was unable to find an answer to my symptoms . For the next few weeks I had lost over 10 pounds and still had the same symptoms except no diareah. On 4/30 - 5/1/2021 I was hospitalized again for surgery. Doctor found a few lesions and repaired a hernia but still could not find an exact reason for my symptoms. I have been out of work for over a month. #21 will not allow information input 7 days toal hosptial stay at Medical Center
Pt had red swelling over entire upper arm.  She took Benadryl and Motrin and it subsided.  Still had a hard red spot about 2 inches in diameter when she showed me on 3/25/08.
pt passed out, yet remained sitting, we helped get him to the floor to lie him down, he was very pale and profusely sweating. He stated he had not eaten or drank anything and had worked outside as well. Took his BP which was 105/63, placed an ice pack on his back of his neck and forehead.  He remained awake during all of this and was alert.  Quickly regained. Had paramedics come as well to double check status.
Information has been received from a consumer concerning her husband who in 1970 was vaccinated with MMR vaccine. Subsequently the pt experienced an unspecified adverse event and was hospitalized. Additional info has been requested.
Gravida 4 para 3.    Became dizzy, tired and complaining of eye weakness.  Was taken to the emergency room, and it was noted the patient was hypotensive - 100/55.  Benadryl was administered, and the patient was discharged.
Why does Prevnar 13 burn at a higher rate than other vaccines?/Prevnar 13 burns when it is administered at a higher incidence rate compared with other childhood vaccines.; This is a spontaneous report from two contactable physicians received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter inquired as to why did pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) burn at a higher rate than other vaccines. It was reported that pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) burnt when it was administered at a higher incidence rate compared with other childhood vaccines. The event took place after use of product. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Inflamed tonsils; Anxiety; Sore arms; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR INFLAMMATION (Inflamed tonsils), ANXIETY (Anxiety) and MYALGIA (Sore arms) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No reported medical history reported.  The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced TONSILLAR INFLAMMATION (Inflamed tonsils), ANXIETY (Anxiety) and MYALGIA (Sore arms). At the time of the report, TONSILLAR INFLAMMATION (Inflamed tonsils), ANXIETY (Anxiety) and MYALGIA (Sore arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Brain Fog; Abdominal pains; Shoulder Pains, Upper Respiratory discomfort
Patient came in for R arm being completely swollen and warm to the touch.  Patient stated the swelling began the night of the administration and continued to swell. Patient was not complaining of any pain or loss of movement. No fever. He is otherwise well.
she said that she lost her mind set for 1/2 hour. Muscle ache. Couldn't control the bladder. Diarrhea She said that she had Seizure. Pain in her eye