chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had the Tdap and meningococcal in his LA and HPV in his RA. His right arm did fine. By evening, his left bicep was swollen and red around the injection site. By the next morning, it was even larger and he had fluid building under his armpit. It continued to worsen throughout the day and by the evening the red portion covered all of his bicep and below and the swelling underneath the arm felt like a fluid filled balloon and almost made his armpit indistinguishable. I finally called our family physician on his cell that evening (he is a friend) and told him what was going on.  I was already icing it regularly and giving him ibuprofen.  He said that was really all I could do. I asked him if I should let the Health Department know the next day and he said that I could, but that they probably wouldn't do anything about it. My concern was for the next time he has to have this vaccine (in 10 years) - I wanted the reaction documented because I won't be with him when he receives it as an adult.  On 1/2/14, I took him to the HD and let someone look at it - the injection site also looked sunken by then (similar to old small-pox types spots).  She said this is "normal" and "occurs 50% of the time" with Tdap and that it is often bad in teens and adults.  I knew this wasn't entirely true, because his 2 older brothers didn't have this reaction.  Also, the hand-out did not have underarm swelling as an adverse effect or any reaction being 50% likely. She dismissed it as no big deal, but did say that his reaction was maybe a little worse than most.  I will never allow 2 injections to be given in the same extremity again.  Also, if this is common, someone should tell the parent to expect this reaction and definitely start icing and ibuprofen ahead of time.  Either he had an atypical reaction and someone should have documented it - neither Dr. or other person at the Health Department made any notes of his reaction - or the paperwork needs to be redone to make a parent aware that this is normal and they should go ahead and start icing and ibuprofen as soon as they get home.  I do have pictures of what his arm looked like on 1/1/13.  Today (1/4/13) the swelling has gone down a lot, but it isn't entirely gone. After looking at the next page, just to be clear: Left arm: Tdap & Meningoccal Right arm:  HPV (I have no way of knowing the manufacturers since they didn't even take my concern seriously.  I just picked a manufacturer on the one and picked something so it would let me submit.  You should really correct this issue as a parent has no way of knowing this information.)
PHARMACY LEFT PFIZER VIALS IN THE FREEZER FOR LONGER THAN 2 WEEKS AT THE TEMPERATURE (-25 AND -15 DEGREES C). WE GAVE DONES OUT OF THESE VIALS, RENDERING THEM POSSIBLY LESS EFFECTIVE
Pt had injection site reaction on the left arm after administration of the above vaccines. Pt went to doctor and received antibiotic treatment but was not filled at our pharmacy. Pt complained about redness, swelling, and fever in the arm were vaccines were given.
This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 21-SEP-2016, the patients received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Pt describes feeling sick, run down afternoon of 12/11/13, later evening fever, chills, body ache, pain/ache worst in back. Pt sick 12/12/13, 12/13/13, 12/14/13, 12/15/13.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
-small raw bump (red with a white ring)  in the back of my throat on the right side by the back of my tongue, hurts to swallow.
The patient came in for a 3rd Pfizer dose (booster dose). I accidentally administered a Janssen Covid 19 vaccine instead of pfizer.
56 days after the first dose/He received the first dose on 10Jun2021 and the second dose on 05Aug2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (56 days after the first dose/He received the first dose on 10Jun2021 and the second dose on 05Aug2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (56 days after the first dose/He received the first dose on 10Jun2021 and the second dose on 05Aug2021). On 05-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (56 days after the first dose/He received the first dose on 10Jun2021 and the second dose on 05Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment drug provided   Reporter did not allow further contact
Hospitalized on 10/20/21. Released on 10/22/21. Readmitted on 10/26/21. Patient had pneumonia, cough, shortness  of breath, and difficulty in breathing.
Developed a rash near my eye after a couple of days rash moved to my face and neck. After the second shot rash covered face, neck and face and eyes would be swollen
Approximately 1-2 minutes after administered injection, employee stated not feeling well.  stated a little nauseated, and light headed, and diaphoretic.  stated left wrist felt strange.  Later stated felt odd sensation down arm after receiving the vaccine.  Asked for some water.  Denied any shortness of breath.  Vital signs 103/67, re-checked was 108/69.  Pulse 77.  Pulse oximeter was 100%.   States ate a little early today, but no lunch yet.  Had coffee today as well.   A few minutes after this, employee stated feeling better, but not 100%.  Stated nausea subsided.  Still maybe light headed.  Escorted employee to Dr. office in Employee Health.   Was evaluated by physician.  Blood pressure 149/106 in right arm.  Pulse 76.  Stated felt cold.  Temperature was 36.8.  Re-checked blood pressure in left arm and was 150/96  Re Stayed with employee until 1430 when Dr. Felt employee was  safe to drive home.
red mark at her injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (red mark at her injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medial history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red mark at her injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red mark at her injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Approximately 7-10 days after receiving 4th Covid shot ( second booster) experienced post-menopausal bleeding including clots lasting a half-day.  The bleeding repeated approximately a week later.
pt recv vax 9OCT96 & had hot very very red flush over face & chest;ear ringing & sl weakness in body;flush would last 3hr come & go for 3 days;ear still ringing today;stiff neck today is about 18OCT96;
PATIENT CAME BACK TO PHARMACY ON 9/12/2017 (AROUND 5PM) AND STATED THAT THE AREA WHERE SHE HAD RECEIVED HER PREVNAR INJECTION WAS SWOLLEN AND ITCHY, ESPECIALLY ITCHY THE NIGHT BEFORE (9/11/17). I LOOKED AT HER ARM AND IT DID LOOK SLIGHTLY SWOLLEN AND MAYBE A LITTLE RED. SHE STATE THAT THE INJECTION SITE WAS VERY ITCHY SO I SUGGESTED SHE TAKE DIPHENHYDRAMINE AND CONSULT WITH HER DOCTOR. I ALSO COUNSELED THAT IF HER SYMPTOMS DID NOT GET BETTER OR IF WORSENED, ESPECIALLY IF GENERALIZED SYMPTOMS OCCURED OR DIFFICULTY BREATHING TO GO TO EMERGENCY ROOM RIGHT AWAY. I CALLED HER BACK THE NEXT MORNING AND SHE STATED THAT THE ITCHING WAS GONE, THE SWELLING WAS DOWN, AND THAT EVERYTHING WAS BETTER.
delayed allergic reaction - 1 week and 2 days after receiving vaccine there is red rash at insertion site that is swollen and hot to the touch.  No systemic symptoms.  Prior to today I experienced no adverse or allergic reaction
Staring spell, drooling, collapse, neck stiffness which lasted 15 to 20 minutes before full recovery, but still stuttering.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 02-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 40 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
pt had measle-like rash;28MAR97 fever 104 or greater, coughing, runny nose, possible Koplick's spots;
Loss of use of legs and issues with bowel and bladder. Loss of sensation below the waist with banding and pins and needles sensations.  Diagnosed with Acute Transverse Myelitis.
Woke with severe sciatic pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:00 (at the age of 71 years), as DOSE 1, SINGLE for covid-19 immunisation at Military Facility. Medical history included pacemaker insertion on an unspecified date of 2010 (pacemaker), ongoing back disorder (including any illness at time of vaccination: has always had back problems) from an unspecified date. There were no concomitant medications. Patient received the first dose of the Covid-19 vaccine yesterday afternoon. The patient experienced Sciatica on 11Feb2021. He woke today (on 11Feb2021) with severe sciatic pain on the lower right side of his back and hip. He had always had problems with his back. Is this something that had been reported before. The clinical outcome of the event was unknown at the time of report.  Follow-up attempts completed. No further information expected.
This case was reported by a consumer via call center representative and described the occurrence of appetite absent in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 18th June 2018 with no reactions). Concurrent medical conditions included mental disability. On 11th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th December 2018, 1 hr 30 min after receiving SHINGRIX, the patient experienced appetite absent, gagging and gas in stomach. On an unknown date, the patient experienced frequent bowel movements. On an unknown date, the outcome of the appetite absent, gagging and gas in stomach were recovered/resolved and the outcome of the frequent bowel movements was recovering/resolving. It was unknown if the reporter considered the appetite absent, gagging, gas in stomach and frequent bowel movements to be related to SHINGRIX. Additional details were received as follows: This case was received from the patient's brother. About 1.5 to 2 hours after vaccination, the patient did not want to eat dinner. He complained that his stomach was all gas and he was gagging like he was going to throw up. The couple hours after vaccination, the patient had bowel movement and felt better. The patient ate radishes prior to getting the vaccine, so the caller thinks that might have contributed to the problem. It was related to patient.
DIZZY AND LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizzy and lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizzy and lightheadedness was not reported. This report was non-serious.
Malaise; Sore arms; a nurse accidentally administered 2 doses of Pfizer bivalent adult to a 14-year-old patient on each arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 14-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 14 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Date: 26May2021, Site of injection: Left Arm, Route of administration: Intramuscular, Batch/ Lot number: Not available / Provided at time of report completion), administration date: 26May2021, for COVID-19 Immunization; BNT162b2 (Dose: 2nd, Date: 17Jun2021, Site of injection: Left Arm, Route of administration: Intramuscular, Batch/ Lot number: Not available / Provided at time of report completion), administration date: 17Jun2021, for COVID-19 Immunization; BNT162b2 (Dose: 3rd, Date: 21Jan2022, Site of injection: Left Arm, Route of administration: Intramuscular, Batch/ Lot number: Obscured by other product labelling), administration date: 21Jan2022, for COVID-19 Immunization. The following information was reported: MALAISE (non-serious) with onset 22Oct2022, outcome "recovered"; PAIN IN EXTREMITY (non-serious) with onset 22Oct2022, outcome "recovered", described as "Sore arms"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 22Oct2022, outcome "unknown", described as "a nurse accidentally administered 2 doses of Pfizer bivalent adult to a 14-year-old patient on each arm". Therapeutic measures were not taken as a result of malaise, pain in extremity. Additional information: It was reported that, a patient who accidentally administered 2 doses of a Bivalent adult booster to a 14-year-old patient on each arm (Site of injection: Left + Right Arm). She said that it happened on Saturday and it's been 24hrs and she mentioned that there were no side effects reported yet and the patient was still doing ok. They wanted to know what they could advise the parents regarding the situation. Considered the Pfizer product had a causal effect to the adverse event was Yes. Specific relevant test for thromboembolic events with thrombocytopenia was unknown.  Follow-up (09Nov2022): This is a spontaneous follow-up report received from a contactable Pharmacist. This Pharmacist reported in response to HCP letter sent which included that: Updated information included: Reporter information slider #02 updated, Patients information (Patient initial, age at vaccination), Historical vaccine added. Product details (vaccination date, dose number, dose description, batch / lot number, route of administration, anatomical site of injection) added. Vaccine facility information added. New event (Malaise and Sore arms) added
16JUN93 site red, hot itchy, swollen (baseball size( fingers swollen, arm numb & tingling; 17JUN arm red warm swollen; no numbness/tingling; 18JUN resolved no sx;
10/31/2021 - Seizure, Several injuries from falling/hitting head, unable to drive for 3 months.  Seizure lasted approximately 1 minute followed by approximately 1 hour of not being present or aware of my surroundings.
Sharp and burning pain in left hip, buttock, and thigh followed by similar pain in left arm. Experiencing radiating pain, pins and needles, and muscle weakness in both left leg and left arm which are simultaneous. I also have mild pain in left ear. I took Ibuprofen for about a week but had to finally go to Urgent Care. After blood test and X-ray results came back normal, I was prescribed Gabapentin and was referred to a neurologist. I had an MRI on 03/25/2021 and waiting for the results.
since receiving the shot to which my workplace gave me a full dose booster of the Moderna vaccine , within 2 hours of the vaccine i was a bit dizzy, exhausted and had a headache, Within 12 hours I had a 101. temp, severe joint pain, body aches, headaches, exhaustion ( fatigue)  nausea, chills.  this continued for 3 days.  After the 3rd day I was still experiencing a low grade temperature,  headaches , fatigue. this continued for at least a week or more.  At this time i continue to have fatigue that does interfere with my normal activities, headaches, chills with an on and off low grade temp of about 99.5.  this includes chills and sweating.  These symptoms occur throughout the day and into the night.  With this continued fatigue, headaches and low grade fevers, I am wondering if there is a direct correlation to the full dose booster given to me.   If this continues, i will be following up with my primary physician.
My arm was sore for a couple of days. How should the second shot be; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (My arm was sore for a couple of days. How should the second shot be) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    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 MYALGIA (My arm was sore for a couple of days. How should the second shot be). At the time of the report, MYALGIA (My arm was sore for a couple of days. How should the second shot be) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication information was not provided.
Patient was seen at pharmacy Clinic 9 days post 1st Moderna vaccine for sudden development of erythematous macular 5cmx6cm round rash on right deltoid at injection site.  Patient reported slight tenderness at the site. Diagnosed as likely a delayed hypersensitivity reaction and recommended treatment with cool compresses and analgesics if needed. She also had some axillary swelling and tenderness on the same side of the injection site. I called patient back the next day and she reported the rash resolved within hours of the visit.
Patient was instructed to remain in waiting area for 15 min after receiving his 2nd Pfizer shot. He chose to leave without waiting , he left the waiting area but shortly turned around and told the front desk he felt dizzy and then fainted on the floor, face first, causing a forehead laceration. Pt was sweating and was nauseated, when he woke up. He was oriented, BP was 100/60, FSBS 88, given bottle of water. 911 was called due to facial laceration, hitting his head from standing position and blacking out. Pt left on his own with the squad to go to the ER for evaluation.
Both times my face developed blisters on the Monday following the vaccine. The first time I even had them in the corner of my right eye along the lash line and eyebrow.  2nd time I have developed them on my right cheek and they are starting on my lips. 1st time I tried to report to my Dr., asking if the vaccine could cause it they kept brushing over my question and simply told me to take Benadryl before. This time they saw me and gave me a steroid shot and steroid pack.
Client received flu vaccination on 11/20/13. Left deltoid was swollen and red starting Thursday morning. Care at home caused no relief and client sought treatment from urgent care on 11/22/13. Client given cephalexin 500mg TID x 10 days for cellulitis.
Information has been received from a physician concerning an 8 year old male with no pertinent medical history or drug allergies who on 31-MAR-2008 was vaccinated with the second dose of VARIVAX (Merck). Concomitant drug therapy included albuterol. On 01-APR-2008 the patient developed a hot, red ring around the injection site. The patient sought unspecified medical attention. No labs or diagnostic studies were performed. The outcome was unknown. Therapy with VARIVAX (Merck) was discontinued. The date of the first dose was unspecified. There was no product quality complaint. Follow-up information from a licensed practical nurse indicated that the 8 year old male who on 31-MAR-2008 at approximately 10:00 was vaccinated with his second dose of VARIVAX (Merck) (lot# 659943/1800U) in the right arm. There was no illness at the time of vaccination. On 01-APR-2008 in the morning, the patient developed a 3 x 2 cm area at the right arm with tiny blistered and redness to the elbow and shoulder. No swelling or hear was noted. The patient sought medical attention through a physician office visit. The patient was treated with BENADRYL. Subsequently the patient recovered. Additional information is not expected.