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 Department of Public Health, VAERS, Immunization Registry 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 53rd 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
Patient 2 (PT2) inadvertently received an age-inappropriate vaccine dose due to mistaken identity on behalf of the patient's mother and sister. EMT, alongside Patient Registrar (PR), confirmed the identity of (PT1) when screening with the mother and (PT1). After vaccinating PT2, PT1 stated they were suppose to receive a vaccine as well and EMT asked PT2 her name, questioned who was PT1 then since they confirmed that PT1 was indeed her name. PT2 stated that it was her sister. EMT asked for PT2 DOB where she discovered was 10 years old and not 14. EMT reached out for guidance immediately. Dr. spoke with the mother of the patient and had translate via teleconference. Dr. informed the mother that, due to mistaken identity, PT2 had inadvertently received an age-inappropriate vaccine dose. In accordance with CDC guidelines, and previous guidelines, advice was given for PT2 to be monitored regularly for any adverse reactions that may occur in the next 21 days, and that a second dose should be an age appropriate pediatric dose. PT2 was asymptotic at the time of the call.
This spontaneous report as received from a other health professional refers to multiple unspecified patients of unknown age. On 27-JUL-2017, the patients were vaccinated with VARIVAX for prophylaxis.  Concomitant therapies included sterile diluent (STERILE DILUENT). On 27-JUL-2017, the patients experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.   Sender's Comments: US-009507513-1709USA001606: US-009507513-1709USA001607:
Splotchy red and swollen at site of injection, approximately 2in x 1in. Tylenol given for pain. Injection administration technique questionable, RN injected too low, possibly missing the deltoid. Reported this information to our primary care provider's office.
On April 30th, I developed severe hives that has continued from then to now. I had fatigue and body aches. I went urgent care.  They tested me for Covid-19, which came back negative.  I went my doctor a week later. He gave me a prescription for steroids.
This spontaneous report was received from a pharmacist and a female patient of unknown age regarding the patient herself. Her concurrent conditions, concomitant medications, medical history and past drugs, drug allergies/reactions were not reported. On 08-FEB-2018, the patient was vaccinated with expired dose of GARDASIL 9 (dose not reported) (intramuscularly, lot # M007764, expiry date: 30-JAN-2018) for prophylaxis (Expired product administered). No adverse effects were reported. The patient was told on 05-FEB-2018 (reported as "1 week ago") that she would need to be re-vaccinated. On 12-FEB-2018, the patient was informed by the pharmacist that it was ok and she "would not have to be re-vaccinated." The patient wanted a second opinion and enquired whether or not she would need to be re-vaccinated. The patient was referred back to her primary care physician (PCP).
No adverse event; one dose of an improperly stored vaccine; This spontaneous report was received from an office manager refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant therapies and drug reactions/allergies were unknown. On 06-NOV-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (therapy type: digital data logger) at a dose 0.5 milliliter per one (route of administration and anatomical location unknown) (lot # S009943 and expiration date:26-JUL-2020) for prophylaxis (product storage error). No adverse effects reported for the patient. The administered dose of the vaccine experienced a temperature excursion of 58.5 degree Fahrenheit for 10 minutes, as recorded by a data logger. The vaccines had no previous temperature excursion. The reporter reported a possible malfunction of the data logger but does not know if the data logger malfunctioned or not.
Fever overnight with headache, lower back pain, dizziness and pain in area of injection site of both upper arms.
This spontaneous report as received from a physician refers to a 15 year old patient. On 06-JUL-2017 the patient was vaccinated with GARDASIL dose 2 for prophylaxis. On 06-JUL-2017 the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL. Additional information is not expected.
worse symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (worse symptoms) in a male 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 ADVERSE EVENT (worse symptoms). At the time of the report, ADVERSE EVENT (worse symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
warmth going throuh her body, hot flashes; burning sensation in throat; Diarrhoea; dry cough; shortness of breath; weak stomach; not able to eat; Nausea; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warmth going throuh her body, hot flashes), COUGH (dry cough), DYSPNOEA (shortness of breath), ABDOMINAL DISCOMFORT (weak stomach) and EATING DISORDER (not able to eat) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced NAUSEA (Nausea), HEADACHE (headache) and MYALGIA (sore arm). On 07-Apr-2021, the patient experienced COUGH (dry cough), DYSPNOEA (shortness of breath), ABDOMINAL DISCOMFORT (weak stomach) and EATING DISORDER (not able to eat). On an unknown date, the patient experienced FEELING HOT (warmth going throuh her body, hot flashes), THROAT IRRITATION (burning sensation in throat) and DIARRHOEA (Diarrhoea). At the time of the report, FEELING HOT (warmth going throuh her body, hot flashes), COUGH (dry cough), DYSPNOEA (shortness of breath), ABDOMINAL DISCOMFORT (weak stomach), EATING DISORDER (not able to eat), THROAT IRRITATION (burning sensation in throat), DIARRHOEA (Diarrhoea), NAUSEA (Nausea), HEADACHE (headache) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The concurrent condition, medical history and concomitant medications was not reported. On unknown dates the patient were vaccinated with improperly stored doses of PROQUAD, (lot# L050909, expiration date 14-JUN-2017, dose and route were unknown). The vaccine was stored at 14 degree centigrade for 4 hours (data logger: yes). There were no previous temperature excursions. No adverse effects were reported. This is one of two reports received from the same source.
Pt received first COVID vaccine on 1/23 and on 2/12 developed persistent periorbital headache and on 2/14 developed OS ptosis and diagnosed w/CN3 palsy
Received vaccination @ 11:19 am 11:32 am noted red blotchiness on (L) neck by observer, pt denied SOB itchiness, lightedheadeness, nausea given Claritin 10mg tab orally observation extended to 30 min blotchiness resolved, no further symptoms
Dizziness, Headache, Myalgia, chills, injection site/left arm pain and swelling Narrative:
I have longstanding epilepsy but have not had a grand mal seizure in many years until the night I received my second Covid vaccination.
PNEUMOVAX 23 administered IM on 2/5/18. Pt called 2/7/18 stating she had a cellulitis. Pt is a physician. Shot was a pre-filled syringe.
hard time getting to sleep; lower back soreness; neck soreness; shoulder soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time getting to sleep), BACK PAIN (lower back soreness), NECK PAIN (neck soreness), ARTHRALGIA (shoulder soreness) and HEADACHE (headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE, COLECALCIFEROL (VITAMIN D3), MAGNESIUM and PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced INSOMNIA (hard time getting to sleep), BACK PAIN (lower back soreness), NECK PAIN (neck soreness), ARTHRALGIA (shoulder soreness) and HEADACHE (headache). At the time of the report, INSOMNIA (hard time getting to sleep), BACK PAIN (lower back soreness), NECK PAIN (neck soreness), ARTHRALGIA (shoulder soreness) and HEADACHE (headache) outcome was unknown.            No laboratory details were  provided.  No treatment medications were reported.
Information has been received from a nurse concerning a female "less than 65 years" who on 10-OCT-2006 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included influenza virus vaccine (unspecified). On 12-OCT-2006 the patient experienced extreme pain, redness and swelling at the injection site, she was unable to use arm or hold pen, had a fever of 102 F, developed a rash on upper trunk and arms with some hives and nausea. On 13-OCT-2006 the patient experienced pain radiating down right leg following the sciatic nerve. The patient was treated with TYLENOL. At the time of the report, the patient had not recovered. Additional information has been requested.
15 minutes post vax pt developed a localized welt, red, raised area 22 X 25 mm. Monitored in clinic for 30 minutes and noticed a decrease in redness. Instructed parents to monitor and give Benadryl if worse
Patient began feeling numbness is their hands and feet after injection roughly 2 hours after the injection. No other adverse events had occurred.
Sudden onset of intense headache. He came to me (his mother) cold, trembling, and glassy eyed. I thought he was going to collapse.
I started noticing a ringing in my ears after the vaccination. I believe it first started the next morning. I mainly notice it at night when I'm wearing ear plugs. It's continued for a week now, so I thought I should report it.
Severe Headache, general not feeling well, tired, very sore arm Ibuprofen helped
diarrhea about every 30 minutes; rash on legs; circles over tongue, looks shinny, looks like no taste buds there; This is a spontaneous report was received from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on 19May2021 as 1st dose, single dose for COVID-19 immunisation. The patient's medical history included COVID in Dec2020 and remembered had no taste then. The patient's concomitant medications were not reported. On 19May2021, the patient experienced diarrhoea about every 30 minutes since then and experienced a rash on legs, which was getting better. The patient also had circles over tongue, looks shiny, looks like no taste buds there, but did have taste. The patient was recovering from the event rash on legs and outcome of rest of the events was unknown.   Information on the lot/batch number has been requested.
About 4-6 weeks after 2nd dose, noticed small lump in right breast. Had it checked at HCF and it was benign--the NP suggested it may have been caused by Covid-19 vaccine (I had also had a bi-lateral mammogram performed about 2-3 weeks before noticing lump and it was normal).
1 hr p/vax pt woke up from nap in severe pain & swelling cried from 6PM til 1030; would not eat or drink anything; began vomiting about MN; began running fever 103-104 p/nap; consulted MD-friend 12AUG94 advised contact clinic;
Approximately 3 minutes after vaccine administered patient reported dizziness, lightheadedness, nausea. Vomited x1, felt better x 2 minutes then reported she felt dizzy and lightheaded again. Vomited x 2. Patient appeared pale. O2 99%, HR 71, BP 85/30. Alert and oriented. Speaking clearly. 911 called, taken to hospital by EMS.
Information has been received from a Registered nurse concerning to multiple unspecified patients (age and genders not reported). No medical history, concomitant medications nor concurrent conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored dosages of PNEUMOVAX 23 (Lot number R012497, exp. date 08-JAN-2020; Lot number R012976, exp. 25-JAN-2020) for prophylaxis and M-M-R II (Lot number N032752, exp. date 20-NOV-2019 and lot number N025898, exp. date 19-SEP-2019) (rHA both lot numbers) for prophylaxis. All lots of M-M-R II were reconstituted with properly stored diluent (lot number N029877, exp. date 18-MAY-2020 and lot number M041689, exp. date 29-JUN-2019). No adverse effects were reported. Excursion information: PNEUMOVAX 23 (Lot R12976 and lot R012497); Temperature: at or above 32°F up to 35°F; Time frame: 36 minutes. Previous temperature excursion: Yes, 47°F to 77°F for 37 minutes. Was call made of "data logger": Yes. M-M-R II (Lot N025898 and lot N032752); Temperature: -58°F and +46°F; Time frame: 36 minutes. Previous temperature excursion: Yes, 47°F to 77°F for 37 minutes. Was call made of "data logger": Yes.
Tinnitus - ringing in ears.  Persistent.  Not present prior to vaccines. Started soon after the 1st vaccine (not sure of exact date of onset) .  I have listed info for both doses - first given on 2/8/2021, second on 3/5/2021
Developed severe itch in extremities.  Later developed to hives covering torso area.  Has not gone away for 2 months.  Having difficulty sleeping due to itching.
Med error - COVID-Moderna given to wrong patient.  A dose was given to patient already fully covid vaccinated - therefore receiving a 3rd dose of Moderna.  No side effects were seen. Temperature normal.
Circular redness around site; Minimal swelling; Chills; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Circular redness around site) and VACCINATION SITE SWELLING (Minimal swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Circular redness around site) and VACCINATION SITE SWELLING (Minimal swelling). On 04-Apr-2021, CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Circular redness around site) and VACCINATION SITE SWELLING (Minimal swelling) outcome was unknown.            No relevant concomitant product use was reported.  No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-068557 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068557:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30,75 hours and in 59.4 F for 4,5 hours) doses of ROTATEQ (orally, lot # M006111 with expiration date 18-NOV-2017 or lot # M019707 with expiration date 25-OCT-2017; dose was not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Follow up information has been received on 13-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative updated. Sender's Comments: US-009507513-1610USA011275: US-009507513-1611USA001104: US-009507513-1611USA001102: US-009507513-1611USA001103: MERCK 1611USA001105:Mfr number.
This spontaneous report was received from an unspecified reporter and refers to a 2 patients of unknown age and gender. On 23-JUN-2016, the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency, route of administration and indication were not reported lot # L014401 with expiration date improperly stored 23-OCT-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
MENQUADFI underwent temperature excursion was administered to patient with no reported adverse event; Menquadfi reached a low temperature of 32.9F with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 13 years old patient of unknown gender who was administered the Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] that underwent temperature excursion and reached a low temperature of 32.9 F with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus vaccine Toxoid (TDAP) for Immunisation.  On 15-May-2023, the patient received an unknown dose (series 1) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7576AB and expiry: 28-Feb-2025 via intramuscular route in the left arm for immunization.  On an unknown date, it was reported that Meningococcal A-C-Y-W135 (T CONJ) vaccine reached a low temperature of 32.9 F with no reported adverse event (product storage error) (unknown latency).   On 15-May-2023, the patient was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine that underwent temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).   No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.   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 guidelines. 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.
The patient did not request or require this vaccine.  The vaccine was not ordered at time of administration.