chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a LPN concerning an approx 28 month old female pt, who on 21Oct03 was vaccinated with a dose of varicella virus vaccine live (lot 643591/0867M). Concomitant vaccine therapy, administered at the same time, included HIB conj hep B vaccine. The nurse reported that five or six days ago (approx 11Mar05) the pt developed herpes zoster. It was noted that the treatment was isolation and diphenhydramine (Benadryl). The pt is not recovered. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/16/2005.  Information has been received from a licensed practical nurse concerning a 28-month-old female patient with no significant history or concurrent conditions, who on 21-OCT-2003 was vaccinated on the "left" with a second dose of VARIVAX (Merck) (Lot # 643591/0867M).  Concomitant vaccine therapy, "administered at the same time", included COMVAX and MMR II (manufacturer unknown).  The nurse reported that "five or six days ago" on 11-MAR-2005) the patient developed herpes zoster on her right leg.  The nurse reported that other than some slight pain and itching, the patient had no other signs or symptoms, she was afeburile and doing well.  Additional information noted that the paitent was seen on 17-MAR-2005 for a "zoster-like illness" on right leg, buttock and groin.  It was noted that hte treatment was isolation and BENADRYL.  There was no lab data collected.  The patient is not recovered.  There was no product quality complaint reported.  Additional information received from the licensed practical nurse reported that the patient recovered on 23-MAR-2005.  It was also noted that a specimen was not submitted to the VZV ID program for PCR analysis because according to the patient's mother, the patient's lesions were already dried/resolved, so obtaining a specimen was not possible.  Unspecified medical attention was sought.  No additional information is expected.
4 days post vax, the pt experienced erysipelas swelling in areas of the whole arm. Presumed non-infectious.
Received Smallpox vaccine in left deltoid on 5/14/02. On 5/21/02, primary response. Returned on 5/23/02 with vesicular lesion (right hand) over 2nd metacarpal; auto-innoculation. On 5/28/02, decreased lesion on right hand with scab formation but no redness.
Angioedema of arm, delayed large local. Treated with oral Prednisone to resolve.
Patient passed out after vaccination for about 5 seconds. Patient was checked by paramedic and was fine.
10 hours after vax severe vomiting, diarrhea, myalgia and fever
Breakthrough case admission after 2 vaccines Pfizer 3/23/21 Lot# EP6955;  Pfizer 4/13/21 Lot# EP6955
Information has been received from a female with sulfa allergy and no other medical history who on approximately 10-Nov-2008, was vaccinated with PNEUMOVAX 23 (661577/1161X). Concomitant therapy included Influenza virus vaccine (unspecified). On "the same day of vaccination", the patient developed burning pain at the injection site which was very tender to the touch. The injection site had 4 inch diameter of redness. The patient also developed chills, fever, shortness of breath and nausea. The patient was bedridden for 3 days and she was given cortisone, histamine and antibiotics. The patient saw physician for medical attention. The patient was recovering. The patient still had some tenderness on the injection site. The patient considered her events to be disabling as she was bedridden for three days. Additional information has been requested.
Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. Pain at the injection site that traveled through my arm to the joints in my wrist.
Information has been received from a consumer concerning her 13 year old daughter with no pertinent medical history and no drug reactions/allergies who was vaccinated with varicella virus vaccine live (Oka/Merck) at age 21 months. There was no concomitant medication reported. On approximately 06-JUN-2007, the patient developed a severe case of chickenpox with over 300 lesions. She did not seek medical attention. As of 20-JUN-2007, she was recovering. No additional information is available.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.  Moderna booster vaccines were administered to patient around 490 to 500 people on the date last Oct 20.2021 to Nov 29, 2021, with lot numbers 006C21A (10-10-2021), 026B21A (09-17-2021),031B21A (9-22-2021).
first Moderna COVID-19 vaccine on 20Dec2020 and the second on 27Jan2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 20Dec2020 and the second on 27Jan2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 939903) for COVID-19 vaccination.     Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), COLECALCIFEROL (VITAMIN D3), PHYTOSTEROLS NOS (CHOLESTOFF ORIGINAL), UBIDECARENONE (COQ-10), ZINC, VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]), MULTIVITAMIN [VITAMINS NOS], ASCORBIC ACID (VITAMIN C ACID), ACETYLSALICYLIC ACID (ASPIRIN 81) and MONTELUKAST for an unknown indication.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 20Dec2020 and the second on 27Jan2021). On 27-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 20Dec2020 and the second on 27Jan2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications were reported.  The additional concomitant products included prostate plus   This case was linked to MOD-2022-470206 (Patient Link).
Pt still has significant arm pain at injection site. Pt was in for follow-up and mentioned her concern.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
I started experiencing moderate cramping from my bra strap down through my lower back (basically the central part of my torso) and those have gotten worse since then. The cramping is more centered towards my back than my belly. I then started experiencing breakthrough bleeding/spotting that's lasted a week and a day now. And the cramping and bleeding is getting more severe. Its definitely breakthrough bleeding because I track my period and it's not time for me to have it now. I haven't been sleeping well but that's pretty normal when I'm on my period. I spoke to my Dr. on Friday she said the spotting can last up to 2 months.
I contracted COVID. It started with a mild headache that continued for 3 days before the congestion started. I was exposed and took a home test on the 3rd day, and it showed negative, but the next day my PCR test at a pharmacy and in 2 days the results came in and was negative, however a day after I took another home test and it was positive. The congestion continued and got worse and with a positive result I went to urgent care and was prescribed PAXLOVID. By the next day the congestion was backing off and by the 3rd day I was feeling almost normal again. After the treatment I felt fine and have had no rebound.
Swelling at the injection site; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site) and PAIN (Soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site) and PAIN (Soreness). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
after first vaccine: increased ocular migraines - no treatment.  after second vaccine: 101.5 fever - took 2 ibuprofen; slept 15 hours; moderately sore are 5 days.
Following the vaccine: Within 8 hours: headache, body aches, pain at injection location Within 15 hours:  headache, body aches, fever, chills, pain at injection location These subsided to a lack of energy 30 hours after vaccination and a rash on vaccination arm.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:54 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 41.58 years. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. Product moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit up saliva, and noted a new headache, and asked her daughter to sleep with her that night considering she was feeling poorly. She was restless all night, and then at ~5am her L arm began to twitch; she was still alert at this time but didn't realize her arm was moving. Shortly after this she lost consciousness, her eyes rolled back in her head, and she developed a frank GTC seizure. Her daughter called an ambulance, and by the time she was on the way to the hospital, she was awake and alert again. At the hospital, she was initially talking and able to answer most questions appropriately. She was noted to be afebrile, hemodynamically stable, without an O2 requirement, though with tachycardia to the 110s.  She was found to have a leukocytosis to ~16, thrombocytosis to ~550, and LDH elevated in the 600s. Over the following day, her mental status declined and she became agitated and disoriented to place/time. CT chest revealed b/l multifocal pneumonia, for which she was started on pip-tazo. She underwent MRI brain (DWI sequence only) which did not reveal any obvious CVA. LP was performed on 1/29 at ~10PM; as far as we can tell, she had only received pip-tazo for antibiotics at this point. CSF studies revealed 220 WBCs (14% PMNs, 76% lymphs, 10% monos), 14 RBCs, Glu 59, Prot 145; GS 2+ WBCs, no orgs; india ink stain negative; Cx pending at time of transfer. Given concern for bacterial or viral meningoencephalitis she was transitioned to vancomycin/ceftriaxone/acyclovir. Patient was then transferred to another Hospital for further management. Micro was all negative or pending at the time of transfer. Shortly after admission to hospital she was intubated. Spine MRI was notable for longitudinally extensive transverse myelitis. All infectious workup has been negative with just two more pending studies for tuberculosis; autoantibody panel pending. She is now able to follow commands with eyes and mouth, but has not been able to move her arms or legs.  We do not have high suspicion that this syndrome is related to the vaccine, given that progressive neurological symptoms started the week before vaccine, but thought it prudent to report given the time course.
No adverse effects were reported.; a 50 years old patien received a dose of GARDASIL 9 recently; This spontaneous report has been received from a pharmacist refers to a 50-year-old patient of unknown gender. The patient´s concurrent conditions, medical history and concomitant medications was not reported.   On an unspecified day in July 2019, the patient was recently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, dose, route of administration, anatomical location of vaccine were not reported) for prophylaxis. No adverse effects reported.
Swollen red bump at injection site. The bump went down roughly 5 days after shot. It reappeared 8 days after shot but was not as raised. It is itchy and stiff.
patients received expired FLUZONE QIV NP with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional via Agency (under the reference 00814567).  This case involves a 18 years old female patient who received expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.   On 14-Oct-2021, the patient received a dose of suspect FLUZONE QIV (0.5 ml, lot UT7108MA and expiration date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14-OCT-2021 to 15-OCT-2021 that expired on 30-JUN-2021.Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  At time of reporting, 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.
I got shingles after both my first and second dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at 63-year-old vaccination age for the first dose via an unspecified route of administration in the left arm on 13Jan2021 18:30 (unknown lot number and expiration date) at a single dose and at 63-year-old vaccination age for the second dose via an unspecified route of administration in the left arm on 03Feb2021 (unknown lot number and expiration date) at a single dose for covid-19 immunisation. The patient's medical history was none. The patient has no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccine in four weeks and did not have other medication in two weeks. The patient received vaccine in the hospital. On 20Jan2021, the patient had shingles after both the first and the second dose of the vaccine. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment which included valacyclovir (VALTREX) medication and antiviral cream. The patient has been COVID tested (nasal swab) post vaccination with unknown results on an unspecified date. The outcome of the event was not recovered.  Information on the Lot/Batch number has been requested.
Patient stated she felt like something was in her throat as they were parking immediately after her vaccine was administered.  She was able to talk and breathe without difficulty, she just felt like her throat was closing. EMS checked her out and found her BP to be 193/109. Patient stated she was claustrophobic and the ambulance was causing anxiety.  Patient moved to personal vehicle and monitoring equipment brought to patient's car.  BP checked after she was feeling less claustrophobic .  Repeat BP 181/113 (sitting).  Patient complains of feeling "jittery".  Patient refused EMS transport and said she would be going to the ER (to have her BP/symptoms checked out).
2Dec96 Pt recv 1st dose vax. 16Jan98 Pt exp chickenpox. # of vesicles not more than 50.
After receiving the PNEUMOVAX 23 vaccine on 8/22/18, a few hours after she received it around 1400, the injection site to her left deltoid swelled to the size of a tennis ball and she had soreness to the site. She denies any numbness or tingling down arm, denies fever, discoloration, or any other symptoms. She was told by a friend who is a doctor to take benadryl and she said today (8/24/18) the swelling has gone down a lot, but she still has soreness to the site. Patient is currently away from home.
Pt states he took 2 doses. He experienced headache, fatigue, light-headedness and "prickly feeling" "all over". He noted redness on his back. No rash or shortness of breath.
Distal half of index finger became very very sore on the second day after the shot. No outside damage or injure is detected. It appears slightly red around the nail bed.
Systemic: Allergic: Itch Generalized-Mild, Additional Details: mild itching, benadryl was given and patient was completely fine after 30minutes
Dizziness; This is a spontaneous report from a contactable Physician via Pfizer sales representative.   A 17-year-old male patient, getting school form completed, received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration at single dose on an unspecified date for immunisation.   The patient medical history was not reported.  No concomitant medication at the time of the event, he was not taking any other medications.  The patient experienced dizziness on an unspecified date after the administration of the vaccine.  The outcome of the event was unknown.
Case fully vaccinated with Moderna . Last dose on 4/1/2021. Tested positive for COVID on 9/21/2021. Admitted Medical Center on 09/21/2021. Expired on 9/30/2021 while still hospitalized.
Patient was visibly nervous/anxious about the vaccination. Patient had reported syncope from a previous vaccination on their consent/screening form. Vaccine was administered as prescribed and patient initially appeared fine but lost consciousness approximately 15 to 20 seconds after. The patient's mother, who was present as her legal guardian, helped me cushion the the patient to ensure she did not fall and injure herself. Patient regained consciousness in 10 to 15 seconds but then passed out again. I was then able to elevate the patient's legs and she regained consciousness. Provided patient with chilled bottled water and allowed her to rest in the vaccination booth for 15 minutes. I stayed with the patient during that time and observed her. Afterwards she said she was feeling better and the color in her face was returning. She felt comfortable standing up and moved to a different seat in front of the pharmacy where she waited another 15 minutes. I observed her from the bench during that time.  When the patient and her mother felt comfortable they left the pharmacy together.
Information has been received from an unknown reporter referring to a 8 year old male patient. The patient's medical history and concurrent conditions were not reported. On 30-JUN-2016, at 15:54, the patient was vaccinated with an expired dose of M-M-R II (rHA, lot # K008625, expiration date 16-JUN-2016), 1st dose, subcutaneously in the left deltoid. He was also vaccinated, on the same date, at 14:30 with the 1st dose of BOOSTRIX, in the left deltoid, intramuscularly. No adverse effects were reported. This is one of four cases from the same reporter source, (linked to MARRS # 1607USA000647, 1609USA005772, and 1609USA005773). Additional information is expected.