chrisvoncsefalvay/vaers-outcomes huggingface dataset:
accidentally gave an 18 month old ADACEL instead of DAPTACEL today with no adverse event; accidentally gave an 18 month old ADACEL instead of DAPTACEL today with no adverse event; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious case received (reference number: US-SANOFI-00356979) via a physician.  This case involves a 19-month-old female patient for whom it was reported that a nurse accidentally gave an 18 month old DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] today with no adverse event (Wrong product administered and Product administered to patient of inappropriate age).  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included hepatitis A vaccine.  On an unknown date, a nurse accidentally gave an 18 month old DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE that day with no adverse event (Wrong product administered and Product administered to patient of inappropriate age). lot number not reported via an unknown route for prophylactic vaccination.  Final diagnosis was Not Applicable accidentally gave an 18 month old adacel instead of daptacel today with no adverse event and Not Applicable accidentally gave an 18 month old adacel instead of daptacel today with no adverse event.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was not applicable for the events at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   There will be no information available on the batch number for this case.
Sleepy but she just slept that off; The swelling went down; Heaviness in the chest but it went away; Her left arm (injection site) was sore; She got tired; This is a spontaneous report from a contactable consumer or other non hcp.   A 76-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was healthy before vaccination. On unknown date the patient stated that she had no significant effect except that she was tired and sleepy but she just slept that off. Patient also stated that she experienced heaviness in the chest but it went away. The next day, her left arm (injection site) was sore but she massaged it like a regular vaccine and a couple of days later, the swelling went down. The outcome of event was unknown for sleepy, swelling and for left arm (injection site) sore and heaviness in the chest was recovered on unknown date 2021.
Rash on the injection arm; A spontaneous report was received from a Consumer concerning a 25-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash on the injection arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced Rash on the injection arm.  Treatment details included OTC Cream.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, rash on the injection arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Develop hives on 12/14/2003 was seen in the clinic on 12/15/2003.  Exam showed urticaria on face, arms, chest, back and legs. Lungs were clear no sign of any respiratory component.  Family history positive for food allergy (mom had food allergies.  The patient had never had any reaction to foods.  No new foods in the last 48hrs befor her urticaria started. Patient started on prednisone 40mg PO BID for 5 days.  Has recovered.
Nine days post vax, the pt experienced seizures and fever. Upon medical review, the pt's conditions were considered important medical report.
shortly vaccine given patient felt anxious with sense of heart racing. exam revealed normal vital signs and examination of injection site normal. she had not eaten or had fluids in prior 5 hours, and she was placed in a reclining chair and given apple juice and crackers.  she felt better within several minutes and exam remained normal. she was observed for and additional 30 minutes and remained symptom free.
Info has been received from a consumer, the pt's grandmother, concerning her grandson (age not provided) who on an unspecified date, was vaccinated with a dose of MMRII (lot unknown). Subsequently, the pt developed an extreme sore throat and possible infection after being vaccinated. The pt sought unspecified medical attention. The outcome was not reported. There was no product quality complaint involved. No further info is available.
Diarrhea; Chills; Fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) in a female patient of an unknown age 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 DIARRHOEA (Diarrhea), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Patient experiencing a local reaction at the injection site consisting of a red, swollen hard knot that lasted about 3 days.
04/08/2021- I almost passed out after walking to the pharmacy exit right after getting the vaccine, I did not pass out but only because someone caught me before I fell. The middle of the night I had fever, aches, headaches, leg pain. The next morning, I had a hard time moving my legs to get out of bed. I passed out upon getting out of bed, I was still seated. That day I continued with achiness, fever, headache, fever lasted 48 hours. 04/11/2021 fever broke, that morning when I woke, my legs were cold and numb and I could barely move them, my arms were also cold and tingly, feet were covered in pins and needles feelings, the next day I had random pins and needles throughout whole body, concentrating in my groin and anus, I also had a lot of cramping in ovaries and uterus, still had tingling, coldness and tightness in legs and arms, primarily in calves. I also started experiencing lot of anxiety due to hearing news the vaccine went on pause. Between then and now (4 months), my symptoms have gotten somewhat better but I still have calf tightness, tingling, pins and needles, all shooting from hip to tips of toes. When I go for walks, my hands swell even if it is not warm out, even more so than they ever have. I also want to note that I am very petite weighing around 98 pounds. I also have a family history of auto immune diseases.
FELT OFF; FEVER; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included sulfa allergy, and concurrent conditions included nonsmoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine sodium for drug use for unknown indication, linaclotide, melatonin, and zolpidem tartrate. On 14-MAR-2021, the subject experienced felt off. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt off, and fever on 14-MAR-2021. This report was non-serious.
A non-serious, spontaneous report of hives all over her body was received from a nurse, a 41 year-old female subsequent to FluMist. The patient's past medical history includes hives of unknown etiology and trips to the emergency room for IV treatment. Concomitant medications or therapies are unknown. The patient received FluMist , nasal on 04-Nov-2008 for flu vaccination. On the evening of 04-Nov-2009 the patient experienced hives all over her body. The patient went to the emergency room for treatment and received an unknown IV. The patient was not admitted. No additional reactions or descriptions of the reaction were reported of available. The patient recovered from the same night and did not consider the event a "big deal".
Client was inadvertently given Pfizer booster vaccine and was supposed to get a Moderna booster vaccine
Ataxia and rash day 7 after MMR and VZV administration. No treatment. Resolved after 2 days.
Pt noted pain, redness, hardness, warmth, swelling & soreness @ the inject site approx 11 days p/Td; did not return to ER as instructed for eval;
Patient was administered expired Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Pharmacist reported that she administered expired vaccine to three patients on 10-AUG-2021 and  later it was discarded. She mentioned that punctured vial was left out all the day on 09-AUG-2021 for about 12 hours at room temperature.
15 year old female syncope s/p Pfizer first dose Covid19 vaccination at 1300 . Pt was with both parents  Assisted fall to ground  Approximate LOC of 10 seconds No injuries  Laid down supine with legs elevated.  After about three minutes pt placed in W/C and placed in cot in supine position.  Initial VS 99/56 71 12 98% O2 sat on RA   Ate a bag of potato chips and drink one bottle of water (118 mL)   Ambulated to BR by self, steady gait, maew, nad, a+o x3.  Given instructions to patient and parents to increase salt intake and water intake and to lay down immediately if dizziness returns. Repeat VS at 1320 97/64 67 16 99% on RA  Pt is asymptomatic at this time.  DCd home with parents and to f/u as needed with pcp and to inform staff of syncope for 2nd vaccination,
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Patient name. Patient phone number Rx number. Reporter given batch/lot number and date (09-17-2021). No treatment medications was reported.
c/o redness and swelling in the arm she got the injection with a "line going down into armpit."  Described as "very tender and hurts if I reach for something."
No adverse effects reported for either vaccine; first GARDASIL 9 vaccine on 12/20/2017 at the age of 15 / the second GARDASIL 9 vaccine was given on 4/22/2019; This spontaneous report as received from a pharmacist refers to a currently 16-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 20-DEC-2017, the patient, at the age of 15, was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On 22-APR-2019, the patient, at the age of 16, was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot number R024264, expiration date 29-OCT-2019 (dose and route of administration were not provided) for prophylaxis. No adverse effects were reported for either vaccine.
Erythema, swelling, and pain occurring immediately after vaccine given. Pt experienced rapid increase in swelling and erythema 48 hours after vaccine given. Pt admitted and treated for cellulitis-swelling so intense that compaitment syndrome was considered. MRI performed. Clinical improvement within 48 hours of hospitalization. Symptoms essentially resolved. 10/09/02 Per review of medical records injection site reaction was diagnosis. Told to avoid Hep A vaccine in future.  The folow-up states "9/3/02 symptoms reported were in the L arm, site of Hep A vaccination."
Left arm/shoulder pain for 18 days. Inability to use left arm. Pain into (L) breast - first reaction from flu inject such as this in many years receiving flu shots.
I had been talking to my doctor, pulmonologist about my breathing, I was having a hard time catching a full breath. I was wondering if it had anything to do with my C-pap machine as it was one that was part of the recall. My pulmonologist had me do the chamber breathing test to determine if I was getting enough oxygen in my lungs. They said I was getting oxygen into my lungs, but the oxygen is not transferring to my red blood cells properly. I will be going for a CT scan of my lungs for my pulmonologist to get a better look at my lungs to determine if the C-pap machine could have damaged my lungs or if this is long haul COVID-19 symptoms.
Large reddened area on right thigh about 4x4 inches on 1/9/07 submitted photograph taken by mother of patient. Pt not seen by MD not brought to office.
"Got Sick"; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("Got Sick") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 011DZ1A) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis. Concurrent medical conditions included Allergy NOS and Hay fever.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS ("Got Sick") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ILLNESS ("Got Sick") had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided.  No concomitant medications were reported     This case was linked to MOD-2021-228482 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant Follow up received on 12-Jul-2021. Recovered adverse events reported.
sore throat/had soup and "felt like her throat was on fire"; trouble with voice; experiencing congestion; blowing nose; soreness at left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat/had soup and "felt like her throat was on fire"), DYSPHONIA (trouble with voice), NASAL CONGESTION (experiencing congestion), NASAL DISCOMFORT (blowing nose) and VACCINATION SITE PAIN (soreness at left arm injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and LISINOPRIL for an unknown indication.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat/had soup and "felt like her throat was on fire"), DYSPHONIA (trouble with voice), NASAL CONGESTION (experiencing congestion), NASAL DISCOMFORT (blowing nose) and VACCINATION SITE PAIN (soreness at left arm injection site). At the time of the report, OROPHARYNGEAL PAIN (sore throat/had soup and "felt like her throat was on fire"), DYSPHONIA (trouble with voice), NASAL CONGESTION (experiencing congestion), NASAL DISCOMFORT (blowing nose) and VACCINATION SITE PAIN (soreness at left arm injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included allergy pills.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Outcome updated to recovered.
Please note that this 7 year old boy had covid and had recovered approximately a month to 6 weeks prior to being vaccinated. Three days after the vaccine, in the same arm in which he was vaccinated he had what appeared to be a blood clot. He was sitting watching a video, when he suddenly grabbed his forearm, screamed and began to cry from extremely sharp pain.  When i looked at his arm,  there was a vein that was solid blue and very swollen (thick) - very pronounced in his arm.   Very blue and very pronounced.  After the application of the cold, it shrank somewhat and the pain subsided.   It continued to shrink throughout the afternoon and evening, and had disappeared completely by morning. I had never seen anything like it before on a 7 year old boy. The pediatrician who saw him a few hours after the attack, also said he had never seen anything like it in his career and assumed it was somehow associated with the fact that he had had both covid and the vaccine. The phenomenon has not returned thus far. He has not had a second vaccine.
Patient then had a titer draw for entry to college and the titer resulted nonimmune; because of this nonimmune titer a booster of VARIVAX was given 26MAR2021.; This spontaneous report was received from a medical assistant, referring to a 21-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were reported as no. The patient concomitant medication included ethinyl estradiol, levonorgestrel (LESSINA).  On unknown dates, at the age of 1 and 9-year-old, the patient received the first and second dose, respectively of varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulations, concentrations, routes of administration, anatomical sites of vaccination, lot numbers and expiration dates were not reported).  On an unknown date, the patient had a titer drawn for entry to college and titer resulted nonimmune (antibody test negative), because of this nonimmune titer on 26-MAR-2021 was given a booster (1 dose) of varicella virus vaccine live (oka/merck) (VARIVAX), 1 DS x 10 vials, administered via subcutaneous, as prophylaxis (concentration and anatomical site of vaccination were not provided; lot number S024362, which has been verified to be valid, expiration date reported and validated as 06-AUG-2021) (extra dose administered). Concomitant therapy included sterile diluent (MERCK STERILE DILUENT), administered 1 dose (lot number T004402, which has been verified to be valid, expiration date reported and validated as 19-SEP-2022).   The patient sought medical attention. No treatment was given for the adverse event.   The outcome and the causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) with the event antibody test negative was not provided.
The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA w038118   4/6/2024 Temperature : 50F Time f; The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA w038118   4/6/2024 Temperature : 50F Time f; Information has been received from a health care professional, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-AUG-2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, lot #W038118, expiration date: 06-APR-2024, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse events were reported.  The vaccine had a temperature excursion of 50 Fahrenheit degrees (F) during 3 hours. It was confirmed that no previous temperature excursions occurred.