chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 month old received Fluzone Quadrivalent too early. Instead of waiting 4 weeks she gave it in less than 2 weeks, no AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a Office Staff.  This case involves a 17 months old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] too early in less than 2 weeks instead of waiting 4 weeks (inappropriate schedule of product administration).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ247AA via intramuscular route in the left thigh less than 2 weeks Instead of waiting 4 weeks.  It was a case of inappropriate schedule of product administration.  At the time of this report, no adverse event was reported.   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 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.
Gluteal rash, right side, appeared 10 minutes after vaccine administration. Patient showed no sighs of NVD, difficulty breathing, swelling, or wheezing. No treatment needed, per provider. Patient told to follow up if symptoms worsen.
Initial report received from a healthcare professional on 09 October 2014. A female patient whose medical history was unknown and concomitant medications not reported, had received an intramuscular dose of FLUZONE QUADRIVALENT (batch number UI188AB, expiry date 30 June 2015, dose number not reported), in right deltoid, on 09 October 2014. On 09 October 2014, 3.5 hrs after vaccination, the patient experienced chest tightness which worsened when she stood 5/10. The patient was sent to the emergency room and there was no follow-up at this time. Corrective treatment and laboratory investigations were not reported. The outcome of the event was not reported. List of documents held by sender: none. This case is linked to case# 2014SA140000 (same reporter, same vaccine). Follow-up information received from healthcare provisional on 4 March 2015. No additional information to provide.
Given MMR vaccine on 2/10/15 and since discovered is pregnant.  Seen OB today and is 6 to 8 weeks pregnant.  OB referred patient to high risk doctor.
No other AE; Vaccines were administered following a temperature excursion; This spontaneous report has been received from a vaccine coordinator concerning a 7-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 27-SEP-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number W004501 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and confirmed as 20-APR-2023) (exact dose was not provided) administered orally as prophylaxis. The vaccine administered had been suffered a temperature excursion of 8.6 Celsius (C) degrees for a time frame of 18 minutes, and had also suffered the following previous temperature excursions: 11.5C for 1 hour 6 minutes; 8.8C for 21 minutes; and 9.6C for 6 hours 41 minutes (Product storage error).   No other information was available. No other adverse event (AE) or product quality complaint (PQC) were reported.  This is one of nine reports received from the same reporter; Sender's Comments:  US-009507513-2209USA010872:
Arm soreness; Headache; Weakness; This is a spontaneous report from a contactable other health-care professional. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 10Mar2021 at 13:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy to antibiotic. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm left on 17Feb2021 at 13:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 10Mar2021 at 14:30, the patient experienced arm soreness, headache and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events arm soreness, headache and weakness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
HIGH BLOOD PRESSURE (138/96 MMHG); FACIAL NUMBNESS; ELECTRIC SHOCK LIKE PAIN BEHIND BOTH EARS IN BRAIN; HEAT UP NECK; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included arm numbness, and concurrent conditions included penicillin allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no prior diagnosis of high blood pressure. The patient did not have any history of drug abuse or illicit drug use. The patient was not pregnant at the time of vaccination. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced facial numbness. On 10-APR-2021, the subject experienced electric shock like pain behind both ears in brain. On 10-APR-2021, the subject experienced heat up neck. On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 138/96 mmHg. On 12-MAY-2021, the subject experienced high blood pressure (138/96 mmHg). Laboratory data (dates unspecified) included: CT scan (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine was not applicable. The patient was recovering from facial numbness, electric shock like pain behind both ears in brain, and heat up neck, and had not recovered from high blood pressure (138/96 mmHg). This report was non-serious.
Mild headache, stiff neck, and weakness of both legs, which completely resolved (with no medical treatment) in 2 weeks.
Patient reports awoke with redness at the left & right of injection site. raising over the course of the day. stopped by the office at noon 10/29/2009 and was told to do cool compresses and take Benadryl 25mg 1 or 2 three times a day & use lotrisone topical.
Had a little bit of sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Had a little bit of sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FE3502 and 013L20A) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Arthritis.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Had a little bit of sore arm). At the time of the report, PAIN IN EXTREMITY (Had a little bit of sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. Patient had not had a previous diagnosis of COVID-19.   This case was linked to MOD-2022-554727, MOD-2022-554795, MOD-2022-554802 (Patient Link).
Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to right toe, right jaw lock, and headache on right side 4/10 pain.
Temporary loss of taste started on 3/21 that lasted 12 hours. Fatigue and chest tightness from 3/20-3/23. Occasional nausea
A medical assistant reported that a 55 year old female received an injection of Pnu-Imune 23 on 01/04/01. The following day, she developed an injection site reaction characterized by tenderness, swelling, redness, and warmth. She was treated with Benadryl and applications of moist heat. The patient recovered by 01/09/01. This is 1 of 2 patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 466-440. Follow-up info received from the physician on 05/29/01, indicated that the patient received Pnu-Imune 23 and Fluzone vaccines on  01/04/2001. The patient developed the injection site reaction at the site of Pnu-Imune 23 administration.
Exactly one week after getting the shot, a 2 inch by 1.5 inch red, swollen itchy rash developed at the place I received the shot on my left arm. I found it strange because of the delay in this symptom occurring. Please also note that when I first got the shot, a much smaller, lighter red rash developed at the injection spot, but it went away after a couple of days and wasn't nearly as big, was not as red, and wasn't itchy.  This new rash developed yesterday afternoon (1/20/21) and now after 1 day I still have it. It got a little bigger overnight, but since this morning it appears to have had no change. I feel fine otherwise and do not have rashes anywhere else on my body. Just where I got the shot in my left arm.  Something else to note is that over the course of my life, I have had hives develop-usually always for unknown reasons, so perhaps I am just more prone to getting reactions to things. However, I received the seasonal flu shot Nov 11, 2020 and did not develop a rash from that.
"Covid Arm"   had a red, tender inflamed area approx. 2 inches at injection site left upper arm with an itchy rash appearing approx. 9 days after injection Rash, itching, and redness  lasted about 5 days, and then disappeared. No treatment was taken/needed.
December 29, 2021, I experienced tachycardia.  I had an echo cardiogram monitor for 3 days.  They found nothing wrong with my heart it just has electrical problems. The issue went away.  I had more testing.  This would come and go while I traveled out of the country and back.  I had stress tests and MRIs, and all confirmed that there was nothing physically wrong with my heart.  At the intersection of arrythmia and feeling fine I had another round of tachycardia.  I have experimented with anti-inflammatory and an SSI with success.  When I go back next month, I have a follow-up appointment with my cardiologist.  The doctors believe it is Pericarditis.  I am not being treated for either tachycardia or arrythmia but for now they have subsided.  The doctor I seeis a cardiologist and I also have another one.
migraine headache; Injection site pain; pain in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 60-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for covid-19 immunization.  The following information was reported: MIGRAINE (disability), outcome "unknown", described as "migraine headache"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "Injection site pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm". Therapeutic measures were taken as a result of vaccination site pain.  Clinical information: The reporter is the mother of a patient who experienced pain in her arm and migraine headache after receiving her second shot of the Pfizer COVID-19 vaccine and now totally disabled. The reporter is looking for any solution on how to stop the headaches. The reporter mentioned that her daughter was recommended by a doctor to have surgery to relieve the injection site pain but may cause more problems. The reporter stated that a different doctor did the operation and after the procedure, her daughter had more migraines and the migraine just got worse. The reporter stated that they will be doing a CT-Scan next to see what is going on. Informed the reporter that included in the other reported side effects of the Pfizer BioNTech COVID-19 vaccine are Injection site pain/tenderness, redness and swelling, headache, dizziness and nausea.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
No additional AEs were reported; A physician called to report that a 5 year old patient received a dose of GARDASL 9 today.; This spontaneous report was received from a physician, concerning a 5-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies or reactions were not reported.   On 28-MAR-2022 (reported as "today"), the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (vaccination scheme, route of administration, anatomical location, strength, lot number, and expiration date were not reported) (product administered to patient of inappropriate age). No additional AEs were reported.   The outcome of the event was unknown.
Extremely swollen; Red; Painful thigh; Fever; This case was reported by a consumer and described the occurrence of swelling of legs in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced swelling of legs, redness of legs, pain in thigh and fever. The patient was treated with paracetamol (Tylenol), benadryl (nos) (Benadryl) and antifungals nos (Antifungal). On an unknown date, the outcome of the swelling of legs, redness of legs, pain in thigh and fever were unknown.   It was unknown if the reporter considered the swelling of legs, redness of legs, pain in thigh and fever to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were proided as follows: after vaccination with dose of influenza vaccine, the patient experienced extremely swollen, red and painful thigh and a fever. The patient did not consent to follow up.
Extreme fatigue and moderate nausea upon waking up the day after the shot. Slept through most of the day (20 hours out of 24 hrs), had trouble staying awake for long. Fatigued the next day but up and awake.
Varicella like rash > 50 umbilicated lesions diffusely on body, scalp. In different stages of healing. Began week (7) days following vaccine. Worsened over following week.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 12-JAN-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L027287, dose and route of administration not provided. No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
menses started a few hours after vaccination. Had not had a menses for 3-4 months prior.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-APR-2018, 05-JUN-2018 and 13-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019; lot# N030175 and expiration date 16-JUN-2019) orally for prophylaxis, respectively. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Achy feeling; Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain and pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain and pain in arm were unknown.   It was unknown if the reporter considered the pain and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-OCT-2022 and 13-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shingles vaccine yesterday this week.  The reporter stated that, just a little achy feeling. The patient only had sore arm.  The patient stated that, his/her father had the shingles shots and suffered really bad. The patient took Tylenol.  The patient further stated that, he/she believed in vaccines. The patient was glad to get the shingles shots. Additional Supportive Information: The follow up would not possible as no contact details were available.
PT had his first dose of Pfizer vaccine at 5pm on 21st. He looked low energy at night. We felt his forehead and he was warmer than usual. However, thermometer did not show he had a fever. He looked much better in the morning on 22nd. We thought that was it.  Only after a week did PT tell us he had more reaction. However, because he was well then, we did not pay too much attention. When we learned of the link between Covid 19 vaccine and Myocarditis, we asked him in detail again. Here are his responses.  He started feeling his throat hurt when he had dinner that around 7pm. It lasted only that night.  He started feeling chest pain around dinner time too. It only hurt when he moved. That chest pain lasted longer and disappeared on the 23rd.  He started feeling there were air bubbles under his skin on the flat part of his left shoulder (above the injection site and below his neck) on the 22nd. He did not see them. He just felt them. When he pressed them with fingers, he felt them popping. This feeling lasted for a total of three days. He could feel the amount of air bubbles become less over the three days.   We have not seen any side effect in the news like his. We are not sure that he should get his second dose. Please someone could advise us, please send us an email. Much appreciated.
Severe pain, could hardly move around, fever of 101.6 , bad headaches, dizzy, nauseous. When I called my doctors office they said to report it as it was my first shot and I had covid back in November into December and was hospitalized. My pain specialist believes I?m still having lingering covid effects before I even got the shot. So my PCP said she believed the shot made the vaccine attack my immune system because I still had antibodies in my system so she was not sure if I should get the second dose
has an autoimmune condition of her skin and a flare up of the condition; has an autoimmune condition of her skin and a flare up of the condition; has an autoimmune condition of her skin and a flare up of the condition; This is a spontaneous report from a contactable consumer (parent).  A 38-year-old (also the age at vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 28Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization.  Medical history included vitamin D deficiency diagnosed last year (2020) and ongoing which her level was 16. She also had ongoing autoimmune skin disorder which she used to having flare up and initially received DUPLICIT (as reported) and tried other antibiotics which nothing seems to work. She also mentioned that got large lymph nodes because of her skin condition (ongoing), had breast cancer and a carcinoid tumor in left lung which she had radiation and chemo a while ago prior to COVID shots.  The patient also had birth control as she doesn't get her period every month, sores in her mouth due to acne medicine and iron deficiency. Concomitant medications included ustekinumab (STELARA) taken for autoimmune skin disorder from an unspecified start date to Aug2021 and unspecified birth control.  The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 07Mar2021 (Batch/Lot number was not reported) at the age of 38-year-old as for COVID-19 immunization. Then, received the 2nd dose on 28Mar2021. A couple weeks after, she had a mild flare up of the condition (has an autoimmune condition of her skin). The flare up that doesn't seem to be going away which her doctor give her steroids because she's not sleeping due to the flare up. Outcome of the events were not recovered.   Information on the lot/batch number has been requested.
Generalized pruritis, maculopapular rash beginning at injection site spreading to both upper arms, forearms, thighs, calves, and chest 995.3, 905A Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter 708.9 L50.9 Uticaria, unspecified Treated with corticosteroid injection, 20mg prednisone 2x daily, Atarax  25 mg every 8 hrs as needed.