chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client in clinic with complaints of right arm pain since receiving her seasonal flu vaccine on 10-29-09 during the flu clinic. States she experienced severe pain immediately after receiving vaccine and had decreased mobility; continuing until present time; denies local reaction at site of edema or redness. Lot number unavailable for specific client due to multiple lot numbers used on 10-29-09 mass flu clinic.  All client forms were sent out of state for data entry and have not been returned at this time.
POC alleges that the resident was eating days before but, on 3/24/2021 he did not want to eat in the afternoon, he took a Pediasure around 4 pm, at 6 pm, caregivers on their rounds found him  foaming at the mouth. It was heard with phlegm. They refer him to the hospital, they take a chest plate and indicate that everything was fine. Dies by aspiration, due to cardiac respiratory arrest.
Red blotches on hip & red blotches high on the inside of both legs. Burn at night & some during the day when I sit.
Patient was given vaccine on 03/25/21. On 04/01/21 patient found in yard and brought to ER, then transferred via air to ER. Patient had concussion due to fall, pneumothorax, and PEA episode. Chest tube placed in the ER, Comfort cares then administered per family request with patient passing that day.
This spontaneous report as received from a pharmacy technician concerning a currently 18 month old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 25-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Patient passed out in car on the way home approx 30 min after receiving vaccine. He was a passenger and almost home. Pulled into the driveway and he said he did not feel go and needed to lie down. Started down the driveway and passed out.  Fell on the right side of his face. 911 was called. BP was low and he was awake when they arrived. He ended up with a broken jaw and broken teeth on both sides of his mouth. He is going to have surgery to repair the jaw and teeth this week. He also had stitches under his chin.
Client administered on 10-15-2010, Influenza, PPD and Pneumonia. Fever 103 all day Saturday, took IBU to reduce fever. Returned to clinic on 10-18-2010, client has cellulitis of upper & middle left arm and lips have several fever blister. No elevation of temp today. Eval by FNP and ordered Cephalexin 500 mg 1 TID.
he had just a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: FK5127) at the age of 8 years as dose 1, single and administered in arm left, administration date 15Dec2021 (Lot number: FL0007) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "he had just a sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from an Office Manager referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and expiration date were not provided. On an unknown date, the patients were vaccinated with ZOSTAVAX (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patients experienced  redness (injection site erythema) and soreness (injection site pain) at the injection site, after being vaccinated with ZOSTAVAX. The reporter stated, that no rash or blisters were developed by the patients. At the time of the report, the outcome of injection site erythema and injection site pain was unknown.  Additionally, the reporter did not provide for causality between the adverse events and vaccination with ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013025:
Developed stuffy nose and cough on 12/2/99 and given Robitussin cough/cold syrup. On 12/4/99, awoke with hives around eyes and was given Benadryl and hives went away. Went to ER on 12/4/99, MD did not say if he thought it was a reaction to vaccines or not. Had hives 12/5/99, also. On 12/6/99, had worse hives on arms, legs "all over". Back to ER again on 12/7/99 and MD said hives bothering mom more than child. Hives and cold symptoms ceased on 12/9/99. No further problems per mom.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 23-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
ARM ITCHING, IN THE ARM OF INJECTION SITE; PAIN IN ARM OF INJECTION, CANNOT SLEEP ON THAT ARM; ARM NUMBNESS AT THE INJECTION; SHOCKING FEELING TO ARMS BILATERALLY; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced injection site pain. On 12-APR-2021, the subject experienced arm numbness at the injection. On 12-APR-2021, the subject experienced shocking feeling to arms bilaterally. On an unspecified date, the subject experienced arm itching, in the arm of injection site, and pain in arm of injection, cannot sleep on that arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, arm numbness at the injection, arm itching, in the arm of injection site, pain in arm of injection, cannot sleep on that arm, and shocking feeling to arms bilaterally. This report was non-serious.
Frequent and sometimes persistent dizziness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 10:15 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 sertraline (MANUFACTURER UNKNOWN), hydroxyzine (MANUFACTURER UNKNOWN) and Birth control pill; all for unknown indication from an unknown date and unknown if ongoing. On 22Apr2021 at 10:00, the patient experienced frequent and sometimes persistent dizziness. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.Therapeutic measures were not taken as a result of the event. The clinical outcome of the event dizziness was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
A 10-weeks-old female patient had received an intramuscular (IM) injection of PENTACEL (lot number and site of administration not reported) on 16 January 2012. On an unspecified date after the vaccine, the patient was constipated for six days. She also developed increased lethargy and was advice by the physician to take her to the emergency room (ER). No further informational was available at the time of this report. The patient outcome was reported as unknown. Documents held by sender: none.
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with hepatitis B vaccine for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received an injection of hepatitis B vaccine on 4/6/96. He also received hepatitis B vaccine, diphtheria and tetanus toxoids and pertussis vaccine, diphtheria and tetanus toxoids and acellular pertussis vaccine, haemophilus influenzae type B conjugate vaccine, oral poliomyelitis virus vaccine, MMR, and varicella virus vaccine. The subject's attorney alleged that as a result of mercury in thimerosal-adulterated infant injection s that the subject received as an infant, he now suffers, and in the future will continue to suffer from the toxic neurological effects of mercury poisoning. The attorney alleged that the subject will be hindered and prevented from pursuing a normal course of employment.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "ITP (remission)" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "Splenectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Toridol, reaction(s): "Known Allergies: Toridol." The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: COVID-19 treatment. Therapeutic measures 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.
Weakness on lower extremity and progressing numbness in bilaterally extending upwards into nipple and loss of sensation to.
Very sore throat, headache, eustachian tube pain, swollen lymph nodes (base of throat, collarbone area, possible armpit),  all on side where vaccine was given. Had sore arm the day of, but stretching the muscle helped.
Polio vial was still in refrigerator and dose was drawn up with no issue, appeared to be the last dose, full 0.5 cc drawn.  Dose was administered to pt.  When documenting administered dose within EHR, it showed that all 10 doses had been given and this would have been the 11th dose.  Email was sent Health Program Immunization Program, Public Health who reached out to epidemiologist.  Advised this event be reported to VAERS.  Pt tolerated vaccine well and has adverse reactions.
vaccine Not removed From Freezer  at 2wk Mark - at 3 wks and administered consult w manuf Notified Pt offer Repeat dose  Repeated 1/31/22
Patient complained of itching and redness at injection site. On exam had moderate erythema and mild inflammation measuring 4-5cm.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:05 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 76.50  Concomitant products were not provided.  On 07-Jan-2021 vials were moved to clinic. On 05-Jan-2021 the vaccines were moved to fridge. On 07-Jan-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 34 and at 10 AM temperature was 34  The vaccine beyond use date was reported as 27-Jan-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
On 1/6/21, 91 yo M amb to ER with c/c of allergic reaction to COVID x 1 day. Pt receive COVID vaccine Moderna Jan 3, 2021. Pt c/o fever, n/v, lower back pain, SOB, dark colored urine. Jaundice noted to bilat sclera and generalized skin. Patient hospitalized and discharged on 1/17/21. Admitting diagnosis was pneumonia, hepatitis, acute repiratory failure with hypoxia and acture renal failure. Patient was treated for sepsis due to acute cholangitis and completed 10 day course of IV zosyn
pt recvd vax 4OCT95 & 10OCT95 pt exp inc hematomas, bruising & petechiae on body;a bleeding time test result on 9OCT95 was 18mins;PT & PTT testing performed the same day were nl;sed rate 25 11OCT95
After the vaccination, I had a sore arm and a slight fever. I woke up on January 4, 2023, with a sore throat and a 100-degree fever. I had a little bit of diarrhea. Certain foods tasted different. I also had aches, weakness, and a headache. I've also experienced a wave of dizziness a few times. I've also had a stuffy nose and blow my nose frequently. On January 5, 2023, I had a telehealth appointment with my doctor for a different issue. I mentioned I was sick and asked if I should test for COVID-19 at home. She said yes. I took a COVID-19 test at home. The result was positive. I sent her a message after receiving my results to get advice on how to proceed. She told me to quarantine for five days. She said to wear a mask after five days if I left the house.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Bell's Palsy-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: All muscles in limbs stiffened up within 10minutes. Lips turned blue. Patient reported rapid heart rated. Touble moving mouth, and couldn't talk. Jaw Stiffened and locked in place.
Immediately when the vaccine was administered my left arm went completely numb, while waiting my face and right arm went numb.  I was given Benadryl at the site.  When returning home I experienced nausea, vomiting, stomach pain, diarrhea, and muscle twitching in my right arm.  I took Claritin for the facial and arm numbness, which helped.  I?m not sure the long term course or time frame as it hasn?t gone away yet.
Patient presented to the ED and was subsequently hospitalized on 1/23/21, 3/26/21, and 4/19/21. She did receive a second dose of vaccine on 2/17/21.
30 yo M with h/o vasovagal events with lab draws was vaccinated with his first Pfizer Covid-19 vaccine (Lot# ER8729) in the left deltoid at 1202 4/12.  Prior to vaccination, patient had had nothing to eat or drink. Pt became syncopal when moving from the vaccination chair to the observation area.  When he fell, he hit his head.  After the fall, pt remained on the floor and was placed in Trendelenburg position.  BP - 105/63; P-40 to 51.  Patient reports having a low heartrate.  Patient 15 minutes patient attempted to sit up but was dizzy and laid back down.  After 5 to 10 minutes, patient was able to sit up and eat some crackers and drink juice and water.  After 15 minutes, pt was moved to recliner.  Provider noted a bruise above his right eye. About 15 minutes later the pt vomited and started coughing. Provider called EMS and patient was transferred to ED.  During ED visit, reaction assessed and thought to be vasovagal reaction.
On 1/2/2021, about 45-60 mins after receiving the vaccine, I had mild right sided throat swelling.  It didn't seem to progress so I wasn't concerned.  I also developed the typical immune response (headache and sore arm) later in the evening on 1/2/2021.  On 1/3/2021, I woke up with a cough, chest tightness, wheezing, and mild shortness of breath.  These symptoms continued on 1/4/2021, however, the symptoms were improved when I woke up on 1/5/2021.  On 1/7/2021, I received an allergy infection.  Within 24 hours I re-developed a cough, chest tightness, wheezing, and shortness of breath (all vitals were stable).  Since I had no improvement in symptoms, I consulted with a physician and was placed on antibiotics and advised to continue with albuterol inhaler.  I'm now slowly improving with my symptoms.  I reviewed this information with my allergist and they have advised me to not get the second Moderna vaccine, in case if what I experienced was some form of a mild-moderate allergic reaction.  I personally feel it is also quite possible that I could have had onset of an upper respiratory infection just after receiving the Moderna vaccine, and this may possibly not have been an allergic reaction.  Since this was not the normal course, I felt it should be reported regardless.
Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol.  During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis.
Patient complaint of shortness of breath and dizziness after receiving Covid 19 2nd dose.  Felt as if her throat was constricting. Vital signs assessed and WNL. Patient stated symptoms were subsiding a few minutes after noticing and decreasing in severity. Patient was monitored for 45 minutes and displayed no signs of distress with vital signs remaining normal.