chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant Medication use information was not provided by reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  Treatment Medication use information was not provided by reporter.  This case contains information for the 73rd of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
developed irritability, paleness & poss myoclonic; very pale on exam in ER;adm for IV fluids & observation
The client had severe joint pain starting two weeks after being vaccinated and continuing today.  The client states her knees and especially her hips hurt. The client looked this condition up on the internet and found reactive arthritis. The client is taking an over the counter anti-inflammatory which reduces the pain.
DTaP and Flu vaccinations administed on 10/21.  Fever of 102-102 through the night, 9:00 a.m. 10/22 Stopped Breathing, turned blue, eyes rolled back, seisure.  Recesitation given within first minute.  Baby stopped breathing again for 2 minutes, revived by emergency staff, pale, unresponsive, seisures continued.  Pt 19 months old revived by Emergency Response Team.   Observed by Hospital Emergency Staff and later that night brought to Hospital where again observed for high fever. It is now the third day after the shot recieved, 10/24 baby is very pale, diarear, I am so scared additional seasures will occur and cause brain damage, I am in search of Doctors to watch her for the next 30 days.  Pt held her head today and said boo boo.  Please help us. Medical Records received on 1/3/2005 states pt experienced otitis media and was irritable.
Ringing in Ears which has continued and is ongoing as of today's date 12/13/2015.  Fever and flu like symptoms occurred and last for 48 hours.
Pt received PPV23 in his right arm on 08/17/09 at 2:40 p.m. On 08/18/09, pt was complaining of redness, pain, and swelling to right arm where vaccine was administered. Pt denies fever, chills, SOB, or chest pain. Pt was diagnosed with cellulitis on 08/19/09 and started treatment on 08/20/09. Pt is on Keflex 250 mg, four times a day, for 10 days.
after 8 day a erithema in the are appears.. warm palation and endure .. feeling ok within normal limits At 9 day disapear.. took Benadril cream and started Cefalexin ( antibiotioc) At 11 day a rash ocurred on site .. elevates puritis  and redness.. call Dr and staret Decadron / chang antibiotic  to Azitromax.. wird sensation of the tongue .. sweeling.. enlarged papilae.. tngling sensation around face snd lips.. .. feeling ok within normal limits
Body aches; Occasional chills; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for COVID-19 immunisation. On unspecified date, the patient experienced body aches and occasional chills. Reporter stated that on behalf of her mother who received her 2nd dose of the vaccine 1 month ago and since then she had body aches and occasional chills. Reporter questioned if this was normal and why the symptoms would linger on for so long. Patient had seen a doctor and reporter stated that they did blood work and a bunch of test and they had not found out why. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Tested positive for COVID-19 on 25Aug2022; Tested positive for COVID-19 on 25Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). An 8-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 1, single (Lot number: FK5618) and on 03Dec2021 as dose 2, single (Lot number: FK5618) at the age of 7 years for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Aug2022, outcome "not recovered" and all described as "Tested positive for COVID-19 on 25Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: No covid prior vaccination, No other vaccine in four weeks.  No follow up attempts are possible, Information about lot/batch number cannot be requested. No further information is expected.
This is a spontaneous report from a contactable pharmacist. A 79-year-old female patient of an unspecified ethnicity received PREVNAR 13, (lot number and expiration date unknown) via an unspecified route of administration on 12Apr2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2018, the patient stated that she had redness on the application site, with swelling and itchiness. The patient also stated that the red area has the diameter of her palm and has gotten itchier these past few days. The reporter was querying to see if there was any information regarding what to do with this local reaction. The patient has not recovered from the itchiness while the outcome of the events was unknown. The following information on the batch number has been requested.
Pt. received vaccine on 7/30/20.  She stated she did not sleep well that evening.  She stated that on the following day (7/1/20) she had a 100.4 fever, which I'd previously advised would be possible. On 8/1/20, after going out for lunch with friends, she stated she did not feel well after eating and subsequently went back to a friends house at which time she passed out (she stated she was assisted to the floor by friends).  She mentioned that she able to get back up moments later.  Pt. unaware if this would have been related to vaccine administration, but wanted to report accordingly.
No additional adverse events; Patient was administered an improperly stored PROQUAD; This spontaneous report was received form a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 03-DEC-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis, lot #S008572, expiration date on 16-SEP-2020 (dose, frequency, anatomical location and route of administration were not reported) which was improperly stored. The vaccine underwent temperatures from -14 degrees Celsius (°C) to 10 °C (-12.2°C) for 30 minutes, which was not called by the digital data logger with a supported outcome. There were no previous temperature excursions reported.
Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022; Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016j21-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient received second booster dose. Date of refrigeration was 01-Apr-2022. It was reported that vial had not undergone any temperature excursions. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Non-significant Follow-up appended- I narrative updated. On 25-Apr-2022: Follow-up  No New Information received On 27-Apr-2022: Follow up received contains reporters details and I narrative with information regarding the 6 patient was updated. On 27-Apr-2022: Report type changed from invalid to spontaneous. Added patient demographics and suspect product dose number. Updated I narrative.
bad dreams; tightness around my head like there was a band around my head/Pressure like a band was around his head; was going to the bathroom a lot and had a lot of loose stools/digestive track issues with 6 loose stools; felt shaky all day long; woke up feeling lousy/Woke up early and did not feel good; Shivering; This is a spontaneous report from a contactable other HCP (patient). A male patient of an unspecified age (Age: 75) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #EJ1685 (or possibly S instead of a 5)) on unknown date in Jan2021 at single dose for COVID-19 immunisation. Medical history included he did have high blood pressure most of the time and it is under control with medications. The patient's concomitant medications were not reported.  He received the first one on Saturday where he is a volunteer worker. He received it at noon on last Saturday and did not have any effects he could tell. They watched him for a while and dismissed after half an hour and was the fine rest of that day. He was fine on Sunday and Monday, but on Tuesday, he woke up early at 4am and just did not feel good. He was having a bad dream, could not get back to sleep. He had a tightness around his head like there was a band around his head. His head felt pressure like a band was around his head. It was not really a headache. He does have high blood pressure most of the time and it is under control with medications. However, yesterday, along with the pressure in his head, he also had digestive track issues which he described as 6 loose stools in the day. He was going to the bathroom a lot and had a lot of loose stools. He was not running fever and it was colder in the night and day but he was dressed appropriately. He felt shaky all day long. He was shivering all day long, but had no fever. He woke up feeling lousy. He went to bed early and slept really well and was better. He would like to know if this sounds like a delayed reaction. The outcome was unknown.    Information on the lot/batch number has been requested.
10  hours after injection; began to get a headache. Which was when I went to lay down early for bed. Strong chills and sweats. Dizziness and chills for most of the night. Began feeling better in the morning and back to normal by Monday.
'I'm so terrible, since 2 days ago I've had body aches, muscular pains and I'm in bed right now; early menstrual period that lasted for 15 days.; early menstrual period that lasted for 15 days.; 'I'm so terrible, since 2 days ago I've had body aches, muscular pains and I'm in bed right now; she had some fevers; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as (age at vaccination 46-year-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported that, since 2 days ago she had body aches, muscular pains. Caller reported that after receiving her first vaccine dose she had some fevers, nausea, vomiting and early menstrual period that lasted for 15 days. Caller reported that she has never experienced this before and reported she went to the emergency room twice (not admitted to the hospital) where she reports being told that this was a normal side effect from the vaccine. Caller reports that she has heard many reports of women experiencing heavy or changed periods after getting the vaccine and she wanted to make sure it was normal and that it was not going to cause any permanent long-term damage. The clinical outcome of the events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
awakened 1430 pt very pale, hands cold to touch, stiffened in seat & had dusky color to mouth, glazed eyes-diff to arouse;
Migraine x 4 days, nausea off and on x 3 days, itching arms and stomach x 2 hours, fatigue x 2days
About 5 hours post vaccines were given, became very floppy, Marginally responsive with eyes rolling. No Obvious seizure activity-refused to eat normally. No fever. No obvious illness. lasting 3 hours.
All food smells and taste horribly. It smells and taste like dirty kitchen. The best way I can describe it is a mixture of chlorine, metal and moldy fold. I've also been experiencing nauseous and diarrhea. This all began an hour and a half after receiving the vaccination and has continued since.
PAIN, SWELLING, HYPEREMIA, HYPERTHERMIA AT LT ARM, ELBOW AND FOREARM. FEVER.
Adverse was vaginal bleeding the required an overnight observation stay with montoring. Had Blood count, transvasginal ultra sound done, and CDC.
Contracted COVID; Contracted COVID; This is a spontaneous report from a contactable consumer via Pfizer Colleague. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8736) via an unspecified route of administration on 17May2021 as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown If patient had covid prior to vaccination. It was unknown if patient received other vaccine in four weeks. On 03Aug2021, patient experienced contracted COVID. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient had COVID tested Rapid PCR post vaccination via, nasal swab on 03Aug2021. It was unknown if patient received treatment. Seriousness was reported as no. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.  .
twitching in different places (arms, face, thighs..) at first and then a trembling or twitching all over but inside my body . Also had sudden unexplained very high blood pressure readings and went to the cardiologist.  The highest reading was 235 over 110. Got on blood pressure meds.
awoke w/swelling hand, wrists/ankle joint; painful, no redness, some ache in neck; no lymph nor rash;
I received my booster too soon/ I got my booster 4 months after 2 vaccine / booster given too early; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my booster too soon/ I got my booster 4 months after 2 vaccine / booster given too early) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my booster too soon/ I got my booster 4 months after 2 vaccine / booster given too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my booster too soon/ I got my booster 4 months after 2 vaccine / booster given too early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported No treatment medication reported
Case number PHHY2015US039675, is an initial literature case report received on 26 Mar 2015. The author in the article discussed about pregnancy and severe influenza infection in the 2013/2014 influenza season. This report refers to a 21-year-old female pregnant patient. The patient's current conditions included controlled asthma. The patient's obstetric history included gravida 2 and para 1. No concomitant medication was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that the patient was vaccinated during pregnancy at least two weeks before the onset of symptoms. The patient was evaluated in an outpatient setting for respiratory symptoms and received outpatient care before hospitalization. Five days after the onset of the symptoms the patient received antiviral treatment. On an unknown date (after vaccination) at 21 weeks of gestation, the patient experienced pneumonia, acute respiratory distress syndrome and asthma exacerbation. The patient was hospitalized and was placed on mechanical ventilation. Patient's laboratory results confirmed positive for influenza A infection by polymerase chain reaction (PCR) but the non PCR laboratory result (rapid influenza diagnostic test or direct fluorescent antibody) was negative. The patient had no microbiologic evidence of a bacterial co-infection. The patient was in the hospital for 24 days and later the patient was discharged to home. The final outcome of the events was not reported. Seriousness of the event "confirmation of influenza A infection by PCR (vaccination failure)" was upgraded based on NVS-IME list. The author stated that influenza remains a significant cause of morbidity and mortality in pregnant and postpartum women. Although vaccination was not 100 percent effective given the higler risk of influenza complications among pregnant and postpartum women, it was incumbent that health care providers and obstetricians provide education and counseling to every pregnant woman about its benefits for both mother and neonate. The author concluded that most of the pregnant women in the current literature case series had previously given birth; suggesting the possibility that other small children in the household could also be a source of transmission. Because influenza vaccination was universally recommended, strategies for reducing transmission in pregnant and postpartum women should include vaccination of the entire household unit; likewise, early initiation of antiviral treatment in infected household members who may have close contact with pregnant and postpartum women should be considered.
Received vaccine 09/10/2018 started with fever on 9/18/18 then rash, red bumps on 9/20/18. Received ZOVIRAX medication prescription in office 9/18/18. Patient recovering.
Information has been received from a health professional who was informed by a physician's office concerning a 14 year old patient who on unknown dates was vaccinated with a dose of PEDVAXHIB (OMPC) instead of a dose of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. No further information is available.
Patient experienced tinnitus on the same day as the PREVNAR-13 vaccine was administered. She did not have this symptom earlier. In time, she also started experiencing hearing loss and is now requiring hearing aids for it.
Patient stated about 4 hours after the injection her whole arm was red, swollen, and warm to the touch. Patient also stated she felt somewhat confused. She went to the ER the following day. She states they did not give her anything for it.