chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 29 September 2011 from a nurse. A 5-year-old female patient with no reported medical history had received on 26 September 2011 the following intramuscular vaccinations: left thigh injection of DAPTACEL (lot number C3718AA), right thigh injection of IPOL (lot number G106-8), nasal FLUMIST (manufacturer MedImmune, lot number 501098P), right thigh MMR vaccine (manufacturer Merck, lot number 0599AA), and left thigh Varicella vaccine (manufacturer Merck, lot number 0713AA). The following day after receiving the vaccinations, the patient was found to have an area of redness on the left thigh. It was not reported whether the redness was at the DAPTACEL or Varicella site. The patient was evaluated in an urgent care facility (emergency room) where the area was measured at 4 cm in diameter. The patient was seen for follow-up the following day and the area was still reddened but was also raised, warm to touch and had some itchiness. At that time the area measured 7 3/4 cm x 5 1/2 cm in diameter. The physician prescribed BENADRYL cream and cool compresses. At the time of this report the patient had not recovered. Follow-up information was received from a health care professional on 12 March 2012. The patient had no illness at the time of vaccination. The patient's outcome remained not recovered. Documents held by sender: None.
Diarrhea x 3 weeks  Headache 2 weeks Fever chills x 3 days
Underdose/received a little more than half a first dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 2BR9G, expiry date 09-JUL-2024) for prophylaxis.   On 18-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 18-JUL-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: Underdose/received a little more than half a first dose of Shingrix). The outcome of the accidental underdose was unknown.   Additional Information: GSK receipt date: 18-JUL-2023 The reporter was the HCP (pharmacist). The patient received a little more than half a first dose of Shingrix. The syringe malfunctioned and the remainder of the dose leaked out. Nothing else was reported.  PQC was ruled out. The vaccine Administration Facility was the same as Primary Reporter. Consented to follow up.
Patient is stating that she broke out in severe hives 5 days after receiving the vaccine all over her body
Patient was ok immediately after vaccine, but experienced sweating and paleness about 15- 20 minutes later.
I woke up out of deep sleep at 1AM with a horrible headache,  nose was really really stuffy.  I had a lot of fatigue and couldn't walk for 3 days.  My resting heartrate was constantly between 150 and 175.
This spontaneous report was received from a female consumer of unknown age (reporting of herself) with allergy to Erythromycin IV and codeine. The patient's current condition included endometriosis. In approximately February 2011 (reported as 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot #, exp date, dose not reported, subcutaneous route in the arm). Concomitant therapy was not reported. In approximately February 2011 the patient developed a hard lump at the injection site. She stated that she developed a hard lump that persisted for three years and felt like it's sitting on a bed of nerves. The patient stated that the lump felt deep and was not in the superficial layers. An unspecified allergist told her that it was a hematoma. She stated that within the last year she had an injury with her left shoulder, on the same arm as the injection site reaction. The patient stated that she used a CPA chair for physical therapy to prepare for a shoulder surgery on the left arm, and when she did her range of motion exercised with the CPA chair, the lump swell and was painful. The patient also reported that she had been seen by an unspecified plastic surgeon to have the lump removed. She stated that the plastic surgeon performed a Magnetic Resonance Imaging (MRI) and determined that the lump was not a hematoma, although the plastic surgeon could not state what the lump was composed of. The patient said that the plastic surgeon told her I'll need to sit down with the my medical books for this one. She stated that in the past she had an injection of "Erythromycin IV" before surgery and that the injection site looked like a huge red birth mark. The patient's outcome for the adverse events was reported as not recovered. Upon internal review, the surgery was considered an other important medical event. Additional information is not expected.
Broken leg; missed second dose of vaccination; Fell down; A spontaneous report was received from a daughter, concerning her 90- year-old, female mother who received Moderna's COVID-19 vaccine (mRNA-1273) experienced fell down, broken leg/ limb fracture and missed second dose of vaccination.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On 25 Jan 2021,  patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.  Approximately on 15 Feb 2021 or after 3 weeks of receiving mRNA-1273, the patient fell down; broken leg was reported and patient was  in the hospital and rehab now. Daughter wanted to learn if it is late for her to have the second dose of vaccine (missed second dose of vaccination).  No Treatment information was provided.  Action taken with mRNA-1273 in response to events were not reported.  The outcome of the events of fall, broken leg and missed second dose of vaccination was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Delayed injection site rash, swelling, hardness, itching since 3/4/21
8 1/2 cm x 9 cm erythema - tender Rt back upper arm.
BRIEF MOMENT LOST OF CONSCIOUSNESS, BRIEF TONICITY ON THE ARMS AS SHE LOC
71 year old female patient reports after administering third dose of Moderna she feels aggressive pain in chest area and mandibular pain. She was taken to observation area at 4:00pm and vital signs were evaluated: 59 pulse, 150/90 BP, 92 saturation and 167 dxt. The case was consulted with Dr. who indicated to keep patient under observation for 30 minutes At 4:12pm. At 4:44 pm patient is reevaluated and vitals are: 60 pulse, 150/90 BP, and 93% sat. Later patient reports feeling dizzy but reports that it is normal for her.
Shakes; fever; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shakes and fever on an unspecified date with outcome of unknown.    Information on the Lot/batch number has been requested.
He just got more than one dose; While administering the needle and syringe lost the connection; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (While administering the needle and syringe lost the connection) and OFF LABEL USE (He just got more than one dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 038c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (While administering the needle and syringe lost the connection). On 06-Jun-2021, the patient experienced OFF LABEL USE (He just got more than one dose). On 09-May-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (While administering the needle and syringe lost the connection) had resolved. On 06-Jun-2021, OFF LABEL USE (He just got more than one dose) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was no change No concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received. Added the event-Offlabel Use
No adverse reaction notice after administration of extra dose of Varicella vaccine. Patient was observed for 15 minutes post vaccination by RN. Mother of patient does not report any adverse reactions noticed since 12/06/21. Mother of patient was contacted on 12/13/21 by RN.
severe tachycardia; severe muscle tremor; fatigue; what seems to be a skip in my heart beat.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in arm left on 10Mar2021 09:30 AM (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in arm left on 17Feb2021 09:30 AM (at the age of 66-year-old) as dose 1, single for COVID-19 immunization. On 11Mar2021, the patient experienced severe tachycardia, severe muscle tremor, fatigue, what seems to be a skip in my heartbeat. Adverse event: 16 hours post 2nd injection experienced severe tachycardia and severe muscle tremor on and off for several hours during the night. There is no history of this occurring. I am experiencing fatigue and what seems to be a skip in my heartbeat. The patient did not receive treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2015, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Redness, swelling, pain and bruising at the right thigh injection site x3-4days (per parents' report)
experienced sudden onset of tinnitis mostly in my right ear, but both ears were affected.  It sounded like I was hearing a lot of echoing/tinny sound in my ears every time someone was talking; This is a spontaneous report from a contactable pharmacist (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at 5:00PM at single dose in left arm for COVID-19 immunisation at the age of 38-year-old. Lot number was EL3249. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccination. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 at 1:00PM at single dose in left arm for COVID-19 immunisation (lot number was EL1284) at the age of 38-year-old. About 26 hours after 2nd dose of vaccine on 22Jan2021 at 7:00PM, the patient experienced sudden onset of tinnitis mostly in right ear, but both ears were affected.  It sounded like the patient was hearing a lot of echoing/ tinny sound in ears every time someone was talking.  It only lasted a few hours and hearing returned to normal, but the patient had never experienced anything like that before, and it was so close to the vaccine administration, that she had to wonder if there was a correlation. The patient was not treated for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered from the event. Information on the lot/batch number has been requested.
Debilitating migraine; This is a spontaneous report from a contactable consumer (patient).   A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 20Feb2021 10:00 as DOSE 1, SINGLE for covid-19 immunization at the age of 31-year-old. The patient was not pregnant at time of vaccination. Patient denied for any medical history. The patient had no known allergies. Patient denied for any other vaccine in four weeks and denied for any other medications in two weeks. Patient did not had covid prior to vaccination neither tested for covid post the vaccination. The patient's concomitant medications were not reported. On 20Feb2021 at 20:00, the patient experienced debilitating migraine. The patient did not receive any treatment for the event. The reporter considered the event as non-serious. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient inadvertently received vaccine after published expiration date of vaccine. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity needed to protect against covid 19 at date vaccine was administered. Also patient did not call in to advise of adverse event.
22 days p/vax pt devel severe hives covering entire body;swollen joints;no fever;face/neck swelling;black/blue areas behind knees,diff walking;w/in 5-6hrs mom states was unrecognizable;took to ER;blood work pending-r/o serum rxn;r/o RA
Headache, stiff neck, muscle and joint pain, low fever-99.7 F, light-headed, and slight nausea
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated improperly stored RECOMBIVAX HB (lot # L038018 with expiration date 13-SEP-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of minimum (Min) -0.5 degrees centigrade for 3 hours 39 minutes and maximum (Max) 15.9 degrees centigrade for 16 minutes on 28-SEP-2016; Min 0.8 degrees centigrade for 5 hours 19 minutes on 29-SEP-2016; Min 0.7 degrees centigrade for 5 hours 37 minutes on 30-SEP-2016 and Min 1 degrees centigrade for 2 hours 26 minutes on 01-OCT-2016. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient here for immunization for school.  Grandmother here with patient. During the immunization risk assessment, patient reports "I have history of seizures that started in April and has seizures very 2-3 weeks. I am taking seizure medication that the doctor double up on and it has helped a lot." Denies any other problems in agreement with grandmother.  Needs meningococcal ACWY.  Meningococcal vaccine information statement given to grandmother with risks discussed.  Meningococcal vaccine given in right deltoid.  Patient tolerated well. Awake, alert and tolerated well.  Patient escorted to discharge desk at which point she became weak and was transferred to chair.  Patient talking but reporting "feeling weird". Patient warm and clammy. 1600:  BP  95/55 pulse 69 Resp 18.  Patient sitting in chair with head resting on back of chair Patient sipping sprite. RN at chair side.  1615: 101/62 pulse 60 Resp 18 Patient awake and alert with color returning to lips and face. 1625 Patient sitting up in chair BP 110/65 pulse 56 resp 18. Patient states she feels able to ambulate to car with minimal assistance escorted by nurse and placed in vehicle sitting up in seat.  Awake and alert.  Grandmother at side.  RN Supervisor notified. Grandmother and patient comfortable leaving clinic.   Will follow up with patient. -------RN  Notified that grandmother and patient are back in parking lot. Grandmother states patient is not feeling good again. BP 105/55 Pulse 65 O2Sat 100% Resp 18. Patient looked weak, slumped, oriented x 3, diaphoretic, and talking. 1641: EMS called. BP 1645: 98/59 pulse 68, pulse ox 100% continuous monitor per Nurse. P: EMS arrival 1645.  EMS to assess and determine further need.  Accompanied by RNs.  EMS monitored and spoke with legal guardian by phone.  Mother declined transport by EMS. Mother Chooses to meet patient by private vehicle.  Patient transferred to vehicle by EMS ambulating, alert and oriented x 3. Care released to grandmother.  Will follow up with patient. ----RN
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) in a 36-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
Patient came to me 11/19 about 5:00pm stating  that he feels like he as been having a reaction to the vaccine. He states he started getting a headache the next day after administration and it keeps getting worse. I asked him if he was taking anything for the reaction. He said he was taking some over the counter phenylephrine. I told him he needed to be doing an antihistamine and some Advil if able to tolerate those medications. He said he was also feeling very congested following administration. He was not willing to do the Advil or antihistamine and walked off.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L006384, expiry date: 25-FEB-2017; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Four gran mal seizures, severe rash, fever, diarrhea and breathing difficulty. Diagnosed with autistic behavior. The annual follow up states severe autism, retardation, gastrointestinal disease, seizures, immunoglobulin disorder, mercury poisoning.
Arm red and swollen, eyes became blood shot and watery. Throat became sore and felt as if it were starting to close off. Noted a cough. At approx. 8:30pm went to Emergency room and was treated. Now has to have epi pen on hand at all times, per Dr. orders. No adverse reactions to flu shot in past. No allergy to eggs.
Patient had urticarial rash 1 week after GARDASIL vaccine 8/9/14; Rash 8/16/14. Mom had pictures on phone. Rash resolved at office visit 8-19-14. 15 year old female presents with c/ rash started 8/16 under arms trunk LE UE; very itchy; mom took pictures - c/w urticaria-hives on back and thighs; had GARDASIL vaccine 1 week prior to rash; no recent illness, no new foods, lotions or other known exposures; mom concerned b/c she read online other reports (from patients/families) of hives 1 week or more following GARDASIL vaccine.
Order was for INFANRIX. KINRIX was given to pt. instead. Age of patient at time of event: 3 years.