chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient thinks the pharmacist took it out to soon and she didn't get her full dose of FLUZONE with no adverse event; Initial information was received on 17-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (under reference 00774819).  This case involves an unknown age female patient who thought that the pharmacist took the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] out to soon and she did not get her full dose (underdose).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via an unknown route in the arm (not specified) for prophylactic vaccination.  It was a case of vaccine underdose (same day latency).  It was reported "pharmacist stated that she administered an FLUZONE HD to a person with a little bit more fat tissue in her arm and it dripped back out a little bit and the patient thinks the pharmacist took it out to soon and she didn't get her full dose of FLUZONE and patient wants a second dose. Pharmacist wants to know does the patient need a second shot or not and if so what is the the time frame in between the 2 vaccines the patient can receive another dose? Pharmacist states that she gave a flu shot last week and her arm is quite large and some of the medicine came back out and she thinks she needs another flu shot. What do I need to do?"  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Swelling centered at site of injection. Tender, lacy, bloody-red - warm to touch, central hive formulation.
at 10:57 pt. c/o mild tingling of the lips and tongue, itching of the left upper and lower extremities. Noted flushing on the face and neck. pt. denies any respiratory distress. 25mg Benadryl given via IM on the right deltoid. Rechecked pt. after 5 mins; stated feeling better. pt. stayed for additional 30 mins. after Benadryl was given. pt. symptoms were relieved; left under own power; driven home by partner.
stomach aches and diarrhea; stomach aches and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach aches and diarrhea) and DIARRHOEA (stomach aches and diarrhea) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach aches and diarrhea) and DIARRHOEA (stomach aches and diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (stomach aches and diarrhea) and DIARRHOEA (stomach aches and diarrhea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Patient developed rash reported in early am hours of 7/7/07. Patient seem 7/7/07 diagnosed with hives vs erythema multiforme. Patient received diagnosis of hives after phone calls from patient's mother stating rash would resolved then return. Treated with Atarax 7/10/07. Rotateq given 7/2/07 diarrhea, also noted.
Injection site itching, redness (almost circular), bump, hot to touch; Injection site itching, redness (almost circular), bump, hot to touch; Injection site itching, redness (almost circular), bump, hot to touch; Injection site itching, redness (almost circular), bump, hot to touch; This is a spontaneous report from a contactable 37-year-old female Other Health Professional reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medication was not reported. Historic vaccine includes bnt162b2 (BNT162B2, Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 7Jan2021 for covid-19 immunisation. The patient experienced injection site itching, redness (almost circular), bump, hot to touch on 31Jan2021. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138885 mother/baby case
Patient complained of loose bowel movements and stomach pain shortly after vaccination. Patient reported 2 loose bowel movements but reported no more and that her stomach pain had resolved upon second phone call over an hour after intiial contact. Advised patient to monitor bowel movements and to discuss with her PCP. I also spoke with a nurse in her PCP's office to let them know and they said they'd pass it along
Discomfort - Near Injection Site; Itchiness - Near Injection site; Tingling Sensation - Near Injection Site; A spontaneous report was received from other health care professional concerning a 69- year -female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced some discomfort (vaccination site discomfort), itchiness(vaccination site pruritus), and a tingling sensation (vaccination site par aesthesia) near the injection site. The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 15-jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  He reported that his wife received the first dose of the Moderna COVID-19 Vaccine on 15JAN2021 in her Right upper arm. Patient husband reported that her symptoms began the same day on 15JAN2021. These symptoms include some discomfort, itchiness, and a tingling sensation near the injection site.   No laboratory data was provided.  No treatment drugs were provided.  Action taken with mRNA-1273 in response to the events some discomfort (vaccination site discomfort), itchiness (vaccination site pruritus), and a tingling sensation (vaccination site par aesthesia) near the injection site was unknown.   On an unknown date, the outcome of the events some discomfort (vaccination site discomfort), itchiness (vaccination site pruritus), and a tingling sensation (vaccination site par aesthesia) near the injection site was unknown.
BRUISING; PETECHIAE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no history of known allergies and drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced bruising. On 06-APR-2021, the patient experienced petechiae. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising, and petechiae. This report was non-serious.
24 hours after injection developed a welp.  Within 48 hours arm swelled up to size of "grapefruit" per patient.  See at UTC 72 hours after and given medrol dose pack.  Seen back at on 7/27/09 in our clinic.  Site is slightly warm, hard area under skin ~9 X 5 cm and itchy.  Taking benadryl also.
L upper arm just below axillae has warmth, redness, & edema on side & back of arm.
On 7/7/11 pt had a dose of PENTACEL given IM to his left arm (deltoid). He presented with 14cm x 14cm warm swollen local allergic reaction around the site of the vaccination. He was afebrile and not in significant pain.
Focal reaction with redness (2 inches diameter), pruritus and mild induration. Recommended: ice packs/cool compresses, hydrocortisone 1% bid x 4 days, Benadryl 258mg po Q 6 for pruritus.
Rash 150-200 widespread papules, macules, vesicles, DX Varicella 03/07/2006, vaccine given 05/09/2005, TX Symptomatic.
Following administration of Hep B and PCV-13 in (L) thigh pt. developed fever, hematoma and area of erythema (3.5 x 1.5 cm). Self resolved after 2 days.
Pt experienced a fine red rash to entire body except face, hands and feet. Pt doesn't feel well.
PATIENT CAME IN FOR PFIZER BIVALENT SHOT AND WAS ADMINISTERED FLUAD . 2ND FLU SHOT FOR YEAR
Fever 102.9 degrees set in about 10pm, along with entire body  severe muscle and joint pain. in the morning of the 21th, I had an extreme headache and fever/ body ache symptoms remained through the 24th. I have had severe migraines since the day after the shot and only ease slightly with NSAIDS.
Chills, aches, felt hot within 5 hours of Covid vaccine booster on 8/12/22.   No symptoms prior to vaccine and no ill contacts.  8/12 to 8/13: congestion and sore throat and face swollen.  8/14/22: cough.  Felt SOB with chest tightness 8/14/22.  Albuterol: 2x, not helping, last dose 3-4am.  Eyes red, not sleeping.
On 10 Nov 08, pt administered flu vaccine administered in right arm.  Mother states was more painful than usual.  Noted rash/bruise around injection area.  last night noted redness & vein distention in triceps region. - SOB. Assessed by NP Dykstra; allergic reaction; given benadryl
4hrs p/shot, low grade fever then became pale, greenish & somewhat unresponsive; given APAP went to sleep; @ 12 hrs cried inconsolably for 3 hrs then slept & was OK in AM;
Hospitalized with resp distress Jan1 , 2021 COVID-19 positive Severe illness, mechanical ventilation Remains hospitalized Feb 5, 2021
Sinus infection, fatigue, swollen sore throat, difficulty breathing, headache, burning sinuses and tongue
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 10-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection (dosing regimen and lot # unspecified, expiry: 28-AUG-2014). Concomitant therapy was not reported. The pharmacist reported the patient, who remains Anonymous, received an expired dose of PNEUMOVAX 23 on 10-SEP-2014. The pharmacist reported the vaccine had an expiration date of 28-AUG-2014. No adverse reactions were reported. No PQC (product quality complaint) reported. The outcome of patient received expired dose of PNEUMOVAX 23 on 10-SEP-2014 was unknown. Additional information has been requested.
This case was reported by a physician via sales representative and described the occurrence of swelling injection site in a 4-year-old female subject who was vaccinated with KINRIX, (GlaxoSmithKline). In "late" July 2013 the subject received a dose of KINRIX (.5 ml, unknown route, unknown thigh) and experienced vaccine administered at inappropriate site. The preferred site of administration for KINRIX is the deltoid of the upper arm. In "late" July 2013, immediately after vaccination with KINRIX, the subject experienced swelling injection site (described as injection site leg swelling). At the time of reporting the event was resolved. Per the reporter, the event resolved "3 to 4 days later". The physician considered the event was probably related to vaccination with KINRIX.
Fever, Body Aches, Headache,  Dizziness, Shakes
Patient was light headed after returning to her vehicle post vaccination.  Then she started to have heart palpitations.  EMS called an ambulance and put her on a heart monitor.  She showed mild Atrial Fibrillation.  EMS wanted client to go to the ER but she refused.  No other symptoms or treatment that I am aware of.
sick cry for 3 hrs wouldn't stop, t101 fell asleep for several hrs OK when woke up;
Approximately two days post vax the pt experienced pain and burning sensation in her whole left arm, which was sensitive to touch. Her left little finger and the next two fingers were numb. She had back and leg pain and generalized malaise. She had shortness of breath occasionally. She had blurred vision which resolved in November of 1999. The most recent information received reports the condition of the pt is ongoing.
BACK SORE; PAIN IN HIPS DOWN BOTH POSTERIOR LEGS; DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced back sore. On 12-APR-2021, the subject experienced pain in hips down both posterior legs. On 12-APR-2021, the subject experienced did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel good, and was recovering from back sore, and pain in hips down both posterior legs. This report was non-serious.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Medical assistant reported that since 13-NOV-2014 patient have been administered GARDASIL (dose, route and lot numbers were not provided) that underwent a supported temperature excursion. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Arm turned bright red and severe itching warm to touch and red at injection site X 6 days. Itching and redness started 20 min after injection.
My VSAFE check in was answered incorrectly.  I did not have an adverse event from the vaccine.  I had an exposure to COVID 19 the prior week and developed similar symptoms.  However I tested negative on 2 PCR tests and it was determined that I had a sinus infection only.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized for poor oral intake, nausea, vomiting, diarrhea, and pancytopenia three days after vaccination. Administered IV fluids, antiemetics, blood products, and antibiotics and improved. Discharged to home medically stable.
Myalgia  MALAISE Narrative:  EMPLOYEE C/O GENERALIZED MALAISE AND FLU LIKE  SYMPTOMS FOR TWO DAYS POST VACCINATION. ENDORSED  SYMPTOMS RESOLVING THE EVENING OF 1/14/21
Patient 3.2 hours after immunization with H1N1, Flu shot had fever up to (103) deg.
Dizziness, weakness in legs, and brain fog. Lasted for 5 days.
Red rashes (hives) from scalp to toes and very itchy and was spreading throughout the body. Swelling of the eyelids. Treatment: 25 mg tablet Diphenhydramine, MEDROL (Pak) 4 mg tablets, SINGULAIR 10 mg tablet, shot to stop the itch.
My temp gradually rose over the course of the day/night after getting the vaccine. By the 12 hour mark I had a 103.9 fever, chills, severe body aches, nausea, weakness, fatigue, and dizziness. Treated with Tylenol and Advil over the next 24 hours. Fever, aches and chills subsided within 48 hours. Weakness and fatigue lasted for 7 days after vaccination, then went away. General dizziness (constantly feels like when you have a cold/ear infection and get up and are dizzy) persists through date of this report (day 12 after vaccination). I feel completely better except for the dizziness.
On Saturday she worked 7am to 4pm but was having trouble concentrating to operate her phone. She also began to have headache dizziness and stomach problems. She did follow up with her doctor office and had high blood pressure. She is currently off work until further notice. Will see neurologist on 3/11/21.
Patient received vaccine and about 20 minutes post-injection began experiencing throat swelling similar to anaphylaxis with peanuts.  Pt. took Zyrtec and felt better 1-2 hours later.  Pt. was transferred to ER for follow-up.
Headache Injection site pain, odontalgia Narrative:  Patient experienced odontalgia without Bells palsy  Other Relevant History:
To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital.
2nd dose 3 years after the 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 5th March 2020, received 1st dose).   On 01-APR-2023, the patient received the 2nd dose of Shingrix. On 01-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose 3 years after the 1st). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 03-Apr-2023. The pharmacy manager stated that a patient who was not immunocompromised received Shingrix second dose almost 3 years apart.  The reporter did not consent to follow-up. The patient received 2nd dose late than recommended schedule, which led to lengthening of vaccination schedule.
He had his booster Moderna vaccine and had no problems.  Went to the hospital for an unrelated thing and that showed a PE.  He was then put into the ER and kept for several hours and put him on blood thinners and discharged him.  He did not have any symptoms or shortness of breath.  He has an appointment today with a vascular specialist and has seen a cardiologist, pulmonary and there seems to be no explanation to the PE, but believes it may be related to the J&J vaccine that he got in March.  He also has an APT with a hematologist coming up as well.    Feels that there should be more information available so that people can find out what is to the speculation to the blood clotting.  He does regret getting the J&J vaccine due to having the PE.
itchiness at injection site about 7 days after 1st does. Red circle on arm for about a week after. Itchiness only lasted briefly but took about another 7 days for red circle to go away on arm
7 day post administration right arm become red, painful and swollen.  Treated with Advil, Zyrtec, and topical hydrocortisone cream.  At time of report the redness is  less, but still present.  The swelling has resolved
pt recvd vax 2FEB94, t101 9MAR94, t102 10MAR94, t103 11MAR93, t105 12MAR94; throughout this period pt was placed periodically in tepid bath & was given Motrin & peds APAP 13MAR94-temp was nl;
First dose: just a little itchy arm day 2. Second dose: 26 hours post dose very tired, sore muscles,chills,headache,insomnia. 42 hours post dose left arm at injection site very red 6inches by 4 inches, hot to touch, painful, itchy
Patient Experienced Temperature between 99.9 - 100 deg. cel., he complained of body aches, tiredness, and being sweaty. Symptoms lasted for 11 hours.
Client is 20 yo female who was vaccinated with Pfizer vaccines in April 2021.  Symptoms started 11/26 - vomiting, nasal congestion, cough, fatigue, myalgia.  PCR + for Covid on 11/30.
Fever, fatigue, headache, back and body aches, cough, congestion , runny nose  Taking  acetaminophen, ibuprofen,  actifed equivalent, NyQuil .
Started having an intermittent shooting /burning pain in R) nipple during sleep. Currently, randomly happens.  Advised to take anti-inflammatory for a few days and call if it continues.
feeling achy bones; feverish; running nose; felt like he had covid; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 55-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 02Apr2021 via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. After the vaccine, from "Sunday" (as reported) he had been feeling achy bones, feverish, running nose. He felt like he had Covid. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna vaccine). No concomitant medication information was provided. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. It was reported that a total of 35 doses were given from 4 vials for approximately 40 patients. The dates of administration of the vaccines was reported as 1-Apr-2022, 5-Apr-2022, 6-Apr2-022, 8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. No treatment medication information was provided.
A patient had the vaccine running down her arm after administration; most of that vaccine came pouring down arm; A spontaneous report was received from a pharmacist, concerning a 28-year-old, female patient, who received Moderna's COVID-19 vaccine and a patient had the vaccine running down her arm after administration/ underdose.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis.  On an unknown date, the pharmacist reported that a patient was administered the vaccine and most of the vaccine came pouring down her arm. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, a patient had the vaccine running down her arm after administration was considered as resolved on 11-Feb-2021.; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact with no associated AEs reported.