chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse and refers to unspecified number of unknown age and gender. The reporter stated that since 06-JUL-2014 those patients were administered VARIVAX (dose, units, route of administration, anatomical location, lot number were not reported) which was not stored properly. No adverse effects were noted. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a medical assistant concerning a female (age unknown) who on unknown dates was vaccinated (route unknown) with a first and second dose of GARDASIL (Lot # 's unknown). Subsequently, unspecified dates, the patient experienced mild pain at injection site after 1st dose and severe pain at injection site after 2nd dose. Subsequently, on an unknown date, the patient recovered. Unspecified medical attention was sought at the time of the vaccination. The physician gave the patient TYLENOL in the office after the second dose. No product quality control was involved. No further information is available.
The patient received expired dose beyind expiratory date 13OCT2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 13OCT2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 13OCT2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 13OCT2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 01-Mar-2022. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Bright red rash on her torso; patch; chills; sweating; nausea; fever; Pain in her joints / pain which radiated up to her neck and down her shoulder; pain; pain in her joints, back; pain in her joints, back, feet and hands; pain which radiated up to her neck; intense pain around the injection site; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included FLU VACCINE with an associated reaction of fatigue (Annual flu shots,case US2020AMR224679) and Zostavax.   On 6th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, less than a day after receiving Shingrix, the patient experienced pain. On 7th November 2020, the patient experienced chills, sweating, nausea, fever and joint pain. On 8th November 2020, the patient experienced red rash and patchy rash. In November 2020, the patient experienced back pain, foot pain, neck pain and injection site pain. On an unknown date, the outcome of the red rash was not recovered/not resolved and the outcome of the chills, sweating, nausea, fever, joint pain and pain were recovered/resolved and the outcome of the back pain, foot pain, neck pain, injection site pain and patchy rash were unknown.   The reporter considered the red rash, chills, sweating, nausea, fever, joint pain, pain, back pain, foot pain, neck pain, injection site pain and patchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the 1st dose of Shingrix.  Late that night she experienced intense pain around the injection site. She woke up in the middle of the night due to the pain which radiated up to her neck and down her shoulder. She also had pain in her joints, back, feet and hands. She woke up with nausea, sweating and chills. By yesterday she felt fine except she had a bright red rash on her torso which she said isn't unusual for her. The patches were about four in in diameter. The areas were not raised. They were worse this morning but she says they will go away based on her history. During the call she mentioned she gets the flu shot and experiences some tiredness afterwards but she could not provide any additional information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222199:same reporter
Decreased sensation in hands and feet, parathesias, chest tightness and SOB the next morning at 0600
-At 1050 pt sat up and felt nauseated, dizzy and vomited x3. Taken back to exam bed and patient had still felt dizzy. Denied SOB and development of any other symptom. Blood glucose taken at 1056, 1057 patient had lost consciousness and experienced body spasms that lasted 5 seconds. Following those 5 seconds pt could not recall events. Pt alert and oriented, stable and back at baseline after episode of syncope. No other adverse events noted
15 MIN AFTER VAX, HUGE WELT OCCURRED BEHIND LEFT EAR TO MIDNECK. SEEN IN ER. NO TREATMENT NECESSARY.  EVENT RESOLEVED 45 MIN LATER.
experiencing low-grade fever.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored. The male patient received first dose of bnt162b2 (BNT162B2), unknown on 09Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low-grade fever on an unspecified date. It was reported as " had the vaccine yesterday and i had like a really low-grade fever and I was wondering if it was okay to just take some Tylenol for the fever". The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
No additional AE; HCP called to report the first doses of MMRII and VARIVAX were administered at too close of an interval.; This spontaneous report was received from a pharmacist referring to 41-year old female patient. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 07-JUL-2023, the patient was vaccinated with first dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (0.5 mL, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 22-JUL-2023, the patient was vaccinated with first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL, lot #X000532 was valid, expiration date 04-JAN-2025, route of administration and anatomical location were not provided) for prophylaxis (Inappropriate schedule of vaccine administered).  The patient reported no side effects. No additional information reported. No additional adverse event (AE) or product quality complaint (PQC) (No adverse event).
severe pain and swelling in entire deltoid, redness lasting through today, which is 4 days
missed the second dose by 4 years; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 4 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The patient was the reporter. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient enquired that he/she had missed the deadline for the second dose by 4 years, so could he/she still take it
Swelling, pain, itching same day as administration. It continues to itch on day 5. Patient has used pain pill to control pain and hydrocortosone and alcohol topically to aid itching.
Shivering, chills, extreme headache, dizziness, motion sickness, fever, extreme sweating.
Information has been received from a physician concerning a 19 year old female who on 16-APR-2007 was vaccinated with Gardasil (Lot #657005/0314U).  On 16-APR-2007 the patient experienced a cough, headache and itchy throat for two weeks after vaccination.  The patient saw her primary care physician who diagnosed her with allergies and possible bronchitis.  The patient was treated with loratadine (CLARITIN) and amoxicillin.  Medical attention was sought.  The patient's outcome was not reported.  Additional information has been requested.
Headache,  muscle aches in back arms neck.    Sore and slightly swollen at injection site.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported).  There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 had two temperature excursions; one of 24 hours and other one of 32 hours. The lowest recorded temperature of 34 F (1.111111111 Celsius) and the highest recorded temperature of 48 F (8.888888889 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Chest pain; pressure; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program COVAX US Support. A patient of unspecified age and gender received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported) 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.The patient experienced chest pain and  pressure ( on an unspecified date.The outcome of the event was unknown.Pharmacist was calling because a patient had adverse reaction to Covid vaccine and he is calling to see if the patient should take 2nd dose. Relayed PMI information.Cold transferred to PSCC due to long hold times and faxing AE.  Follow-up (18Feb2021): This is a follow-up spontaneous report received from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a patient that No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient.The pharmacist called to COVAX US support for patient 2nd dose clarification.  Information on the lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Moderna vaccine (HDC80777-0273-98) lot 039D21A & GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna = no need to repeat the dose.
Information has been received from a physician via a field employee referring to a female patient of unknown age. The patient's pertinent medical history and drug reactions were not reported. On unknown dates, the patient was vaccinated with an unspecified number of doses of GARDASIL (dose, route and lot# were not reported). On an unknown date, the patient was experiencing chronic headaches. On an unknown date, magnetic resonance imaging (MRI) was performed (no result was reported). The outcome of the event was reported as not recovered at the time of reporting. The causality was not reported. This is one of several cases from the same reporter. Additional information has been requested.
On Dec 22, 2021 I took my booster shot at approximately 4 pm. On Dec 23, 2021 by 11:15 am, I got fever chills. Later that day I took ibuprofen. By next day fever chills subsided. This was followed by weakness throughout week. On Jan 2, 2022 by 9:30 pm (approximately), the hives/body rashes started to appear all over body. It was itching badly, so I took a quick cold shower and applied Aquaphor cream. On Jan 3, 2022, I got the Benadryl and started the dosage. So after 1st dose, hives and rashes were gone. I felt comfortable but again hives/rashes erupted as was getting close to 5-6 hour mark after the 1st Benadryl tab dosage. So I continued to take the Benadryl tab every time between 5-7 hours after the previous Benadryl dosage.
This case was reported by a nurse via sales rep and described the occurrence of erythema in a adult female patient who received FLUARIX QUADRIVALENT (batch number 345AX, expiry date 30th June 2018). On an unknown date, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown. The reporter considered the erythema and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that one of their nurses at a different location received this lot and expiration date and also reported significant redness and swelling. There were no initials, date of birth and date of vaccination available at the time of reporting. This case has been linked with case US2017GSK166153, reported by the same reporter for same events.
Stomach cramps, vomiting, diarrhea, fever. Diarrhea for 7 days. Vomiting for 1 days. Stomach cramps for 3 days. Fever for 2 days.
7/28/03: Mom phoned community health office today at 10:15. States "her child has had a fever since Weds 07/23 ranging from 99.8-103.0" Mom is using Tylenol and Motrin for fever reducer. Child received varicella and MMR vaccine on 7/14/03. On Sat PM 07/26 Mom noticed a rash. Child was fussy and hot to touch. The rash started on shoulders and progressed to head/scalp, ears, trunk area, genital area, buttocks, arms and toes. Currently it is not on her thighs to ankles. The rash only seems to itch child on her head area. Mom has been using benadryl and calamine lotion for itching. The areas have no scabs or pustules. To the touch Mom states "the rash doesn't feel bumpy but like normal skin." On 07/27 in PM, Mom took child to ER. Dr in ER told Mom "I'm in a hurry, I have one pt dying of a heart attack and another one coming in." Dr told Mom it was chickenpox and discharged her from ER. Mom concerned because child continues to have fever, rash and lowered appetite and continues to be fussy. Child has also had a cold after given shot for approx one week. Encouraged Mom to call clinic. Mom has appointment at 1330 today. 7/28/03 spoke with mother of child. States "Dr says it is a viral infection not related to vaccination on 7/14/03." They can't quite pinpoint what the cause is but labs were drawn and her platelets were decreased. She has a prescription for Zyrtec 1/2 tsp daily. No other questions or concerns. Mom is to continue to watch child.
Severe rash on hands. Target type lesions. Very itchy. Few on feet. Possibly on eye as well.
Dose 1 caused arthritic and neuropathy pain in hands.  Dose 2 increased the symptoms in 2 days.  Was told by the administrator at the pharmacy that it could bring back rheumatoid arthritis.  PCP office confirmed patients are reporting neuropathy.
Scattered eryth mac/pap with suggestion of visicelar component in scalp around neck upper back shoulder. Chest, thighs.
Patient started experiencing severe vaginal bleeding the night after receiving the second COVID Pfizer vaccine. There is heavy flow bleeding throughout the day and slower in the morning and night.
Patient reported swollen and painful lymph nodes in the left armpit area and left side of chest area.
No adverse event; HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     Patient had no known relevant medical history, allergy,concomitant diseases and risk factor.     On 07-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant information was reported. Suspect product dosage text was reported as unknown. The 2.5ml vial was thawed directly from the freezer each time they needed to administer a dose. The vial did not underwent temperature excursions. No treatment information was provided. This case is reported for patient 6 out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729345 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729345:Same reporter
Mild arm soreness; This is a spontaneous report from a contactable physician. A 34-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, intramuscularly on 22Dec2020 14:00 (at the age of 34-years-old) as a single dose in the  left arm  for COVID-19 immunization. Medical history included allergies to medications, food, or other products: shellfish from an unknown date and unknown if ongoing.  Concomitant medication included clomifene citrate (CLOMID), folic acid (FOLATE).  The most recent COVID-19 vaccine was administered in the hospital. It was unknown if the patient was pregnant at the time of vaccination.  On 23Dec2020, the patient experienced mild arm soreness.  The event mild arm soreness did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the event. Outcome of the event mild arm soreness was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Became very tired, dizzy, and muscle aches. Sight of injection was very sore, swollen and increase red area on arm.  Took Motrin and sent to bed and slept all night and the next day.  Slight temperature the next day and continued feeling of tiredness and muscle aching.
He had hives and a few red pox. The hives changed location several times, going from torso to back, some on his arms and legs. They were completely gone by 9/14/02-about 22 days. Pt never ran a fever nor did he seem bothered but I was very worried because it was not on the sheet as a possible reaction.
24 hrs. after vaccine was given pt states had fever 4" x 6" hot red welt & chills.
headache, nausea, chills, weak. severe body aches lasted for 6 days.
Upon visiting with the patient for the 2nd dose of Moderna about 4 weeks later, the patient's arm around where they received their 1st dose of Moderna was still discolored. The patient did not seem to be too concerned as they were present to receive 2nd dose of Moderna. The 2nd dose was given in the opposite arm.
This is a spontaneous report from a contactable nurse practitioner reporting on behalf of her mother. A 75-years-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on 30Apr2015. Medical history included diabetic and hypertension. Concomitant medication included glipizide 2.5mg once a day in the morning with a meal, topiramate 50mg at bedtime, amlodipine 50mg at bedtime, chlorthalidone 25mg, take 1/2 tablet once a day, LIPITOR once a day, aspirin 81mg daily, alendronate once a week to prevent osteoporosis. On 01May2015, the patient became very confused that required hospitalization from 01May2015 to 02May2015 with outcome of unknown. On 30Apr2015, the patient developed redness with outcome of recovering, tenderness with outcome of recovering, joint pain with outcome of not recovered, blood glucose elevated on an unspecified date with outcome of unknown, left arm deltoid where it's puffy almost looks like a nasty blister with outcome of not recovered. Also, she experienced blood pressure elevated on 01May2015 with outcome of recovering. Reporter added that she noted on 06May2015 that her mother had a blister that was oozing located approximately one half inch distal to her elbow on the lateral side. She mentioned that this was not near the injection site for the PREVNAR 13 but was on the same arm. She stated that she washed it with antibacterial soap and used Neosporin, with outcome of unknown. The patient underwent lab tests and procedures which included Blood glucose (fasting) Low: High; Date: 06May2015 Results: 129; Blood glucose (non-fasting) Low: High; Date: 06May2015 Results: 157; Blood glucose; Date: 02May2015 Results: 259; Blood glucose; Date: 01May2015 Results: 159 or 179; CT Scan; Date: May2015 Results: Normal; EKG; Date: May2015 Results: Normal; Blood work; Date: May2015 Results: Normal. The nurse described the clinical course as follows: After receiving PREVNAR 13 injection patient started to experience adverse events. On Friday 01May2015 patient became very confused and was taken to the emergency room. Confusion came first on Friday and noticed blood glucose was elevated, either 159 or 179. Friday morning it was within normal range 70-75. Normal range for patient is 70-75 range, in the 70s. Every so often 79. In the hospital BG was 259. Discharged from hospital and blood glucose was still elevated. Upper 100s, which is high for her. Also concerned with how area looks. Left arm deltoid, where it is puffy looks like a blister. Nurse who administered saying it is not the injection site. The puffiness is 2 inches below injection site and it is the diameter of a dime looks like a nasty blister.