chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 19 year old male patient. The nurse reported that on 01-AUG-2012 the patient received the first dose of RECOMBIVAX HB 5/0.5 (lot number, dose and indication were not provided) for prophylaxis (when he was 18 years old), and on 11-JUL-2013, was in the office to receive his second dose of RECOMBIVAX HB (lot number, dose and indication were not provided) for prophylaxis. Concomitant medications were not reported. No adverse symptoms reported. Additional information has been requested.
The charge nurse was called to the scene by the scribe because the patient stated that her vision got blurry and lightheaded. Patient lost consciousness and was caught by one of the nurses. She was lowered to the yoga mat and her feet were placed on top of a chair. When the patient regained consciousness, she stated that she had no allergies, has eaten before getting the vaccine and has no history of fainting or anxiety. She has no medical history that she knows of. After talking to the patient, her vision improved and she stated that she feels better. Patient was transferred to observation and was observed for 30 min.
Pt complained of itchiness on both arms the afternoon of 4/7/2010.  The itchiness progressed to swelling and redness of both deltoids.  Pt was seen in our office today 4/8/2010 at 0815 the redness had improved.
Pharmacy District Manager:  Patient had what was presumed to be a seizure. No epinephrine or any medication was administered on site. Paramedics and Fire Dept was called. She did come to within a couple minutes but was unaware of where she was. She was transported to  Hospital. (head school nurse) confirmed with me that she was released from the hospital later that same afternoon.
Patient received the shot complained of a burning and then within about a 1 or 2 minutes his eyes rolled back in his head turned extremely white and fainted. Blood pressure was taken reported at 68 and blood sugar was at 78. Ambulance was called and taken to Hospital. IV fluids was started in the ambulance.
therapeutic response decreased; last dose was given in a different location, and was given earlier than the recommended 6-month schedule; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 41-year-old male patient who received HBV (Engerix B) (batch number 5397F, expiry date 6th February 2021) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 5397F, expiry date 6th February 2021) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included human immunodeficiency virus test positive.   On 10th February 2020, the patient received the 1st dose of Engerix B. On 17th March 2020, the patient received the 2nd dose of Engerix B. On 14th June 2020, the patient received the 3rd dose of Engerix B. In June 2020, not applicable after receiving Engerix B and Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased and drug dose administration interval too short were unknown.  Additional details were provided as follows: The reporter stated that, the patient was HIV positive. The patient received all 3 dose of Engerix B and had low titer, which led to therapeutic response decreased. The patient received 3rd dose of Engerix B earlier than the recommended schedule, which led to shortening of vaccination schedule. No other information was provided. The reporter consented to follow up.
Parent went into child's room at bedtime and found her on the floor, mouth open and couldn't talk. Client also had trouble breathing. Parent stated she went to school and had no trouble the following morning.
2 hours after receiving the flu vaccine, this employee states she developed 1 hive on her hand then her "throat started to close."  She started to feel dizzy and "felt funny".  She states she took a Zyrtec "one full pill" and then about 2 hours after the Zyrtec, it resolved. She did not have to seek medical treatment but is going to review with her primary physician.
After my baby received the vaccines, he got fever at 100.94F at Feb 25 ,2020, 2:00AM. I gave him the infant Tylenol oral suspension. Then he temperature back to normal after he received the 1.25ml does.  At Received the vaccine 48 hours , my baby feet weak and lost appetite . cried a lot than usual. At two days later after 48 hours period time, my baby feel uncomfortable, cried lots ,lost appetite.
MODERNA: Redness, but no pain at injection site or arm day of vaccine. Chills by 2300 that night. Next morning woke up at 0600 entire arm very sore then, achy muscles and bones, headache front of forehead and half dollar size redness at injection site and hot to the touch. Took two extra strength Tylenol 3/19/2021 for headache and other symptoms.   Felt much better by the next day.
04/26/06 am right arm site of injection warm to touch, pain, swollen at site of injection, 1/2 inch induration, unable to move arm. 4/26/06 pm body aches, nausea, dizzy, fever, diarrhea, headache. Pt also started oral Typhoid vaccination on 4/24/06 (1 dose).
After the first shot felt fine, just a sore arm. Second shot was not feeling the best very low energy. One January 19, 2022 I was at work sitting at my desk and I felt as if I was having a heart attack. My chest felt constricted, shortness of breath and my heart was pounding out of my chest. Pain was shooting from my chest directly to my back. Today, February 21,2022, I still have agonizing pain in my chest and upper middle back, shortness or breath, and pounding heart beats. I am a division 1 athlete and walking 30 feet takes my breath away. I have only ever felt my heart pound like this during conditioning practices.
Chills; Fever; Soreness in the body; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, lot number and expiry date were unknown), via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has experienced chills, fever, and soreness in the body in Apr2021. She would like to know if this side effects have been reported. The events were reported as non-serious. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
6"x 4" erythematous, warm area spreading from site of previous vaccines given on left thigh
This spontaneous report was received from a registered nurse and refers to a currently 7 years old male patient. The patient's concurrent conditions included elevated liver enzymes, developmental delay, attention deficit disorder (ADD), retinal disorder and proteinuria. It was also reported that the patient had allergy to sulfonamides (Sulfa (unspecified)) and atomoxetine hydrochloride (STRATTERA). On an unknown dates, the patient received hepatitis B vaccine series (manufacturer unknown) (exact doses, units, frequency, route of administration, lot numbers and expiration dates were not provided) for prophylaxis. Concomitant therapies included clonidine. On an unknown date, it was found that the patient had hepatitis B titre that was nonreactive. Lab diagnostic studies performed included hepatitis A, B and C panel. The patient sought medical attention (unspecified). The outcome of the event was unknown. The relatedness between the event and vaccination with hepatitis B vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Caller refers having a home test and testing positive. Her last Pfizer COVID-19 booster vaccine was administered on Dec 2021; Caller refers having a home test and testing positive. Her last Pfizer COVID-19 booster vaccine was administered on Dec 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown (booster), single for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NEBIVOLOL; HYDROCHLOROTHIAZIDE;TRIAMTERENE; ROSUVASTATIN; SYNTHROID; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller refers having a home test and testing positive. Her last Pfizer COVID-19 booster vaccine was administered on Dec 2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Clinical information: The patient referred being on nebivolol, triamterene hydrochlorothiazide, rosuvastatin, Synthroid and Aspirin and was asking if these medications would interfere with Paxlovid.
Local reddness, edema, erythema,& discomfort extending from injection site to elbow.  Started 24 hours after injection.  Currently day three.  Edema improving and no longer itching.  Treated with Ibuprofen & Benadryl prn.  Distal NV intact.
5 1/2cm X 4 1/2cm area of redness, induration and bruising and increased warmth.
Urinary retention.  Then she developed weakness in right leg on 10/19/2011. Weakness in leg resolved. Still having urinary retention without explanation.  On 12/7/2011 had suprapubic put in.
Patient c\o neck pain and being lightheaded s\p dose #1 of Pfizer vaccine. Patient's first recorded B\P at 1735 on 9/30/2021 s\p vaccination was 130/75. At time patient was sent out by EMS VS 81- 20- 205/109- 99% RA. Called patient X3 and left VM. Unable to get a hold of this patient to find out specifics of incident and what hospital said to her.
Hx of anxiety. Became anxious, legs shaking and felt like her throat was closing immediately after getting the vaccine. Pulse ox originally 91% on RA but improved to 95% on 2L. Patient fully recovered after 30 minutes with no medications.
First week of February approximately one week after the shot I started having severe chest pain.  I went to an urgent care hospital.
pt states that about a week and half after getting the covid vax she developed fatigue, vomiting, chills and headache.  On 2/22/2021 pt stated she developed a rash on both thighs and her top lip started to swell.  She went to Urgent Care.  They gave her a steroid injection and prescribed Methylprednisolone. Pt states after going to the doctor the rash has moved from the side of her thighs to the front of the thighs and her belly.  On 2/24/2021 the rash had moved to the folds of  both legs and to the right arm and left hand.  Pt will FU w/PCP.
Patient had presented to pharmacy wanting to get Pfizer vaccine only. Had determined to get vaccinated if Pfizer was available. Patient's information was collected, we wrote a P on the top of consent form which indicated to nurse to give Pfizer and the paperwork was processed as Pfizer. Patient left pharmacy thinking he received Pfizer. He realized approximately 5 days later that Moderna was listed on his immunization card. He and his mom called on 5/2 to discuss with pharmacy staff. Upon investigation into the situation and pulling the consent form and talking with the nurse who immunized him, it was determined that he did in fact get Moderna vaccine. Patient was notified of the error and the error was fixed in the computer so it would be reported correctly, receiving the Moderna vaccine.
Patient reported feeling of warmth in chest 10 minutes after vaccine administration. She then  reported warm sensation and numbness in bilateral hands ~20 minutes after vaccine administration. All   symptoms above resolved within 40 minutes after vaccine administration. She remained well appearing  throughout observation period and had no evidence of airway compromise, facial swelling or vomiting  during 40 minute observation period. Her vitals remained stable throughout:   BP 97/61, HR 68 BP 107/70, HR 60
Arm and joint pain that radiates through the shoulder to neck and arm, swelling, bruising, loss of joint motion, bursitis, adhesive capsulitis, muscle spasms, numb shoulder muscle, bicep tear. Radiating pain from shoulder joint down arm to elbow and hand. Tingling and minor numbness concentrated in pinky and ring finger, but also moving to the rest of the hand at times.
Rash on stomach and thighs; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2021, the patient received the 1st dose of Shingrix. On 15th December 2021, less than a day after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had rash on the same of day of vaccination on stomach.  At the time of reporting, the rash was on stomach and thighs and not resolved yet. The reporter consented to follow up.
This spontaneous pregnancy retrospective report was received from a female patient of unknown age concerning herself. There were no pertinent medical history, concurrent conditions or drug allergies/drug reactions. The patient's concomitant medication included unspecified birth control therapy. It was reported that "around the year, 2013, the patient completed series with the three GARDASIL vaccinations, as routine vaccination (strength, frequency, route of administration, lot # and expiration date were not provided). After the patient completed series with GARDASIL, she gave birth to her daughter and reported that she currently was 3 months postpartum, approximately in March 2018. The last menstrual period was not reported. It was mentioned that after that, she "had two HPV positive tests results". It was reported that "after second HPV positive test result she had a colposcopy (results not provided). The patient did not seek medical attention and there was no treatment given for the adverse event. The outcome of the HPV test positive was unknown at the time of the report. The causal assessment between the aforementioned event and GARDASIL was not reported.
Area of injection right thigh 4cm x 5cm swelling with redness. No fever, Good appetite. Treatment: applied ice.
Coryza, followed by sore throat, spots on throat, fever, then rash on body.
Local symptoms: Pain-discomfort, General symptoms: fatigue, sweating. Narrative:
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 13-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
TDaP given 6/5/17 patient C/O pain left arm on 6/12/17. Patient seen by provided on 6/13/17 Referral to neurology. Rx Prednisone 40 mg PO x5 days 7/6 in 1 wk.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of GARDASIL 9 (lot # M009362, expiration date: 13-JUN-2018) (dose and route of administration were not provided). The vaccine was exposed to a temperature of 53.6 Fahrenheit degrees for 1.5 hours and to a temperature of 55.2 Fahrenheit degrees for 1 hour and 45 minutes. No previous temperature excursions were reported. The reporter stated that the temperature was back in ranges. There was no information provided if data logger was used. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Cellulitis at injection site , redness, warmth at site of injection Placed on antibiotics 11/19/19
died in his sleep 3 days after taking the Pfizer covid vaccine; This is a spontaneous report from a contactable consumer. A 13-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced died in his sleep, 3 days after taking Pfizer COVID vaccine on 16Jun2021. This is coincidental, this is not causative. Cause of death was unknown. No investigation assessment. The patient died on 16Jun2021. The county health department confirmed the investigation and the autopsy was being performed. The information is being sent the CDC to see if there is a correlation. The reporter mentions that we all know a lot of 13-year-old falling over for that.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cause of death was unknown
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of OUT OF SPECIFICATION PRODUCT USE (Vaccine administered after temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced OUT OF SPECIFICATION PRODUCT USE (Vaccine administered after temperature excursion). On 02-Apr-2021, OUT OF SPECIFICATION PRODUCT USE (Vaccine administered after temperature excursion) had resolved.        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.   Concomitant product use was not provided by the reporter.   Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C.  No treatment information was provided.   This case was linked to MOD-2021-066725, MOD-2021-066824, MOD-2021-066807 (Patient Link).
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 29-APR-2010, patient received improperly stored VARIVAX dose 2, from batch/lot # 665413/1128Y (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
US Army NG SGT who noticed a single 4mm vesicular lesion on her left forearm one day following receipt of ANTHRAX (AVA#4), influenza, & typhoid vaccines on 12/18/2008.  No other skin lesions or systemic symptoms reported; non-medical derm photos were sent by pt & did not appear bullous or urticarial (reviewed by VHC Medical Director);  by 12/30/2008, pt reported resolution of vesicle, however a single lesion remained, slightly larger in size and pruritic.  Pt sent a f/u derm photo in which there was a single lesion which appeared flat, erythematous, irregular in shape with a well demarcated slightly raised border.  Pt was advised to f/u with PCM a/o derm for diagnosis and treatment.  To date, unknown whether further f/u a/o diagnosis obtained.  Symptoms:  Lesions, Vesicle.
Awful rash and itching over entire body starting on day 7. Unable to sleep or even wear much clothing.
Narrative: COVID infections following completion of COVID vaccine series 04/17/21 COVID vaccine dose #1 05/23/21 COVID vaccine dose #2 07/21/21 Pt reports no symptoms but has had exposure to COVID positive wife; COVID POSITIVE 07/22/21 Pt reports chills, cough, fatigue, headache, fever, muscle pain; rx given for acetaminophen, DM/guaifenesin; adamantly denies receiving COVID vaccine despite records indicating vaccination - nurse contacted for assistance and requested correction for HIMS 07/23/21 Pt reports cough is improving: reports subjective fever and runny nose 07/24/21 Pt reports muscle pain, subjective fever 07/25/21 Pt reports other than feeling fatigue, he feels great and all other symptoms have resolved 07/26/21 Pt is improving and is to remain isolated until 7/30
Information has been received from a healthcare worker (Medical assistant) concerning multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ 9lot # L027726 with expire date 10-MAY-2017) (dose and dose number not reported) orally. The improper conditions of storage was 9 degree centigrade for 2 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Chills, cough, headache, severe body ache, nausea, chest pain, fatigue for several days
Swollen lymph node; Headache; Nausea; Feeling unwell; Dizziness; Weakness; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had headache, nausea, feeling unwell, swollen lymph node, dizziness and weakness. Reporter (Husband) stated that he had a question regarding the, regarding the side effects she (wife) is having from her first dose (COVID 19 Vaccine). Primarily a headache but also some nausea and feeling unwell, and swollen lymph node. She also had some dizziness and weakness which is continuing. Question was, with those side effects, we have heard that the side effects are even worst with the second dose and we are wondering about the safety of her getting a second dose or not. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.