chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT REPORTED SWELLING AT INJECTION SITE AND PAIN AND SWELLING FROM SHOULDER TO ELBOW THAT LASTED ABOUT A WEEK. ALSO HAD CHILLS AND FEVER THAT LASTED ABOUT A WEEK AS WELL AS A RASH FROM SHOULDER TO ELBOW THAT LASTED ABOUT A MONTH.
Patient administered Moderna booster dose (0.25mL) instead of second dose of pediatric Pfizer. Patient showed no immediate signs or symptoms of adverse event and left with parent. (Error noticed a few minutes later. Parent contacted).
Numbness and tingling in arm that hasn't resolved after two days. Injection was given on 11/10/21.
Blistering at site of injection. Site appeared to have peeled where blister erupted. No itching, but burning at site. Also complaints of flu-like symptoms, cough, and body aches. No treatment administered.
No adverse event; Lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Lower than authorized dose of Moderna bivalent vaccine administered to patients).    No concomitant medications were provided. It was reported that 18 elderly patients received 0.25 mL dose instead of 0.5 mL dose The patients have not reported any adverse reactions at this time.  No treatment medication was provided. This case contains information for the 7th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666063, US-MODERNATX, INC.-MOD-2022-666248, US-MODERNATX, INC.-MOD-2022-666249, US-MODERNATX, INC.-MOD-2022-666250, US-MODERNATX, INC.-MOD-2022-666251, US-MODERNATX, INC.-MOD-2022-666252, US-MODERNATX, INC.-MOD-2022-666283, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666286, US-MODERNATX, INC.-MOD-2022-666290, US-MODERNATX, INC.-MOD-2022-666295, US-MODERNATX, INC.-MOD-2022-666278, US-MODERNATX, INC.-MOD-2022-666279, US-MODERNATX, INC.-MOD-2022-666282, US-MODERNATX, INC.-MOD-2022-666280 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666063:Patient 1 US-MODERNATX, INC.-MOD-2022-666248:Patient 2 US-MODERNATX, INC.-MOD-2022-666249:Patient 3 US-MODERNATX, INC.-MOD-2022-666250:Patient 4 US-MODERNATX, INC.-MOD-2022-666251:Patient 5 US-MODERNATX, INC.-MOD-2022-666252:Patient 6 US-MODERNATX, INC.-MOD-2022-666283:Patient 8 US-MODERNATX, INC.-MOD-2022-666284:Patient 9 US-MODERNATX, INC.-MOD-2022-666286:Patient 10 US-MODERNATX, INC.-MOD-2022-666290:Patient 11 US-MODERNATX, INC.-MOD-2022-666295:Patient 12 US-MODERNATX, INC.-MOD-2022-666278:Patient 14 US-MODERNATX, INC.-MOD-2022-666279:Patient 15 US-MODERNATX, INC.-MOD-2022-666282:Patient 18 US-MODERNATX, INC.-MOD-2022-666280:Patient 16
Starting on 1/2/2021 patient started experiencing intermittent tremors of upper /lower extremities that have been impacting on his mobility including transfers, ADLs and eating. Staff has now given the resident cups with lids to decrease spilling with meals. Provider was updated on resident's condition on 1/5/2021. On  interview on 1/6/2021 resident stated he  was feeling better, less tremor. Still felt unstable with transfers. Was able to eat and drink normally  1/6 and 1/7/2021. On exam on 1/6/2021 no tremor seen with rest or movement. In update from nursing staff 1/7/2021 no tremor noted, back to baseline. Had been on Losartan K 25 mg daily which was d/c'd 1/6/2021
No reaction occurred.  The patient received the dose 8 days prior to the 4 weeks.
Patient went to ER on 4/29/12 for rash all over his body and was treated with Benadryl and steroid. Patient states did not take steroid meds. Follow up with PCM on 4/30/12. Returned to duty but restricted from flying duties. Had active orders for Zantac & prednisone.
Pt. experienced continued soreness. To date he is experiencing muscle weakness and pain. Limited ability to lift weights using this arm.
Soldier received his second anthrax injection day after he had a hard lump under his skin with erythema. Instructed him to see the doctor here.
A 4 month old patient received a dose of FLUZONE QUADRIVALENT/no AE; A 4 month old patient received a dose of FLUZONE QUADRIVALENT/no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse (other health care professional) via agency (Reference number- 00334499) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 4 months old male patient who received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [prefilled syringe, lot number and expiry date not reported] via intramuscular route in the right thigh for prophylactic vaccination (product administered to patient of inappropriate age and overdose).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL).  It was a case of overdose and actual medication error due to inappropriate age at vaccine administration. It was also case of overdose [Latency: at the same time of vaccination].   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Hives from head to toe / Hives as very itchy and uncomfortable; Hives as very itchy and uncomfortable; Hives as very itchy and uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than a month after receiving Shingrix, the patient experienced generalized urticaria, pruritus and discomfort. The patient was treated with prednisone (Prednisone (Oral)) and fexofenadine hydrochloride (Allegra). On an unknown date, the outcome of the generalized urticaria, pruritus and discomfort were unknown.   It was unknown if the reporter considered the generalized urticaria, pruritus and discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that after vacination, at the end of September 2019, had hives from head to toe. The patient stated that, the hives were very itchy and uncomfortable and that it came and went but continued to come back. The patient seen by the physician and prescribed oral prednisone and Allegra but they did not help the hives. The reporter did not consent to follow up.
Original Due Date: 11/4/2021.  Miscarriage discovered 4/5/2021 and suspected to have occurred around 3/20/2021 (baby measured 7weeks,1 day on ultrasound).  There were no indications of miscarriage before the ultrasound 4/5/201.  Neither me, the  patient, nor my doctor believe the miscarriage was a result of the vaccine but as it occurred a few weeks after I received the second dose in the series I felt it should be reported.   I was approximately 4 weeks pregnant at the time of my second dose.
Red swelling right underneath the injection site. Increased temperature on swelling site. Tender to pressure. No treatment given. Swelling and redness reduced after 2-3 days.
Approx 8 hrs p/recvd Recombivax in lt deltoid, pt had red rash on lt upper torso & lt upper arm; it faded p/ a day & no tx was necessary;
His 2nd dose was given on 4/2021. He had decided to skip the 3rd dose due to side effects he was reading; No additional AE; This spontaneous report as received from a consumer, referring to 43-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On unknown day in April 2021, the patient was vaccinated with his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. He had decided to skip the third dose due to side effects he was reading (Intentional misuse in product use duration). Customer provided limited information. No additional adverse event (AE) reported. No product quality complaint (PQC) reported.
Transverse myelitis, numbness chest, feet, legs, arms chills, night sweats.
Patient received J&J vaccine on 03/05/2021  (Lot # 1805031)  Patient returned without reporting prior receipt of J & J vaccine and then received a full course of Moderna vaccine as follows:  04/01/2021:  Lot#031B21A  right arm 04/29/2021:  Lot#025C21A left arm  No adverse events noted as a result of multiple vaccines.
Patient reports feeling nauseated approx 2-3 hrs after flu vaccine. Vomited from 3AM 9/3 - 6AM. Also complained of headache. Self resolved no further vomiting or nausea; headaches continued.
This spontaneous report was received from a certified nursing assistant referring to a multiple unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of (Merck) PROQUAD (lot #, dose, route of administration and frequency were not reported). No adverse effects reported. Concomitant medications were unspecified. This is one of several reports from the same source. Additional information has been requested.
Pt got flu vaccine 2/7 in office ;  seen in office 2/13 and dx with clinical  L sided Bells Palsy
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Nurse stated clients many had been vaccinated with improperly stored ROTATEQ (lot number not reported). No adverse effects reported. This is one of two reports from the same reporter source. Additional information is not expected.
(1) severe injection site pain that did not stop. (2) shingles that started on the face and spread to the mouth, throat, left eye and inside the nose.
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 24-May-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information does not provided by the reporter. No treatment information is provided by the reporter.
Patient presented to the pharmacy on 4/2/21 to ask about side effects she was experiencing from her 2nd dose of Moderna COVID-19 vaccine. She stated that she received her second dose on 3/29/21, and at this time was still having side effects. When asked what side effects she was experiencing, she showed me her arm which had a large red area (approximately the size of a baseball) that appeared to wrap around her arm. She said this area was painful, itchy, and warm as well. She said she experience this since the day of getting her second dose, but her symptoms had improved slightly since. I recommended she follow up with her primary care provider as soon as possible, which she said she had an appointment for the following day. She asked if she could do anything regarding the pain, redness, and itchiness and I told her it would be okay in the meantime (until her follow up with her primary care provider) to use over the counter pain relievers for some pain relief, and diphenhydramine topical cream for relief of the itching and redness.   I tried to follow up with the patient today to check in and see if there had been any improvement since yesterday (especially since new information came to light - see below), but she was unavailable for contact. Prior to submitting this report, I took a look at the patient medication profile at our pharmacy and discovered her COVID-19 first dose was on 3/22/21, and she received her second dose on 3/29/21 (21 days earlier than she should have received it). At this time my district pharmacy manager and patient care services manager have been made aware of this incident, and am awaiting guidance from them once they make contact with Moderna regarding the early administered dose.
May 3, 2021, received a call from healthcare provider where the vaccine was given by healthcare provider. COVID 19 Prescreening Form Completed and Vaccine given 4/23/2021. Patient waited 15 minutes post vaccination no reaction.  Her family also received a vaccine. Daughter and Son-In Law. Received a call that patient had died on 5/2/2021. Presented to healthcare facility for chest pain according to healthcare provider.
Case number PHEH2015US021448 is an initial spontaneous report received from a nurse on 20 Oct 2015. This report refers to a 47 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1413101) at a dose of 0.5 ml, intramuscularly on 13 Oct 2015. No adverse event was reported following this medication error.
Sore throat; Sinuses are draining; Coughing; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Sinuses are draining), COUGH (Coughing) and PYREXIA (Slight fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Sinuses are draining), COUGH (Coughing) and PYREXIA (Slight fever). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Sinuses are draining), COUGH (Coughing) and PYREXIA (Slight fever) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 32-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
6 hours post vaccination pt developed rash on lower extremeties and lower abdomen. "small red like dots" all over legs were described. Rash subsided over the next 7 days
patient received J&J vaccine during the day on 6/16. reports to ED on 6/18 for evaluation of Nausea and vomiting. She reported feeling ill on same day as vaccination with one vomiting episode same day, also reports generalize malaise and body aches. 3 additional non bloody non bilious vomiting episodes 6/17 with inability to keep anything down with constant nausea. found to have acute emphysematous cystitis and admitted at observation to our hospital. Diagnosed with worsening AKI due to dehydration.
I received the flu and pneumonia shots. The day of the shot my arm with the injection was very sore to the point I could barely move it. The following day I was experiencing chills, soreness, body aches and just had a "blah" kind of feeling. The second day, I had some soreness and lots of redness near the injection spots.
WOKE UP AT 0700 THIS AM WITH BODY ACHES, NAUSEA/VOMITING, CHILLS, DIZZINESS, WEAK, TEMP 102.  ADMITTED 1/21/2021 INPATIENT. IV NS @ 100ML/HOUR, ZOFRAN 4MG IV, LOVENOX 40MG, SOLUMEDROL 125MG IV.
Pt is a 29 yo who was given Moderna vaccine at 09:03 AM.    11:30 AM: Adverse effect symptoms : Itching all over the body, dizziness, itchy throat.   12:10PM: Benadryl 50mg IM given   12:25PM: V/S: B/P= 143/109, T=93.9,  Pulse =92, RR= 24, Spo2=99%.    12: 30PM:  Emergency Medical called  01:30PM . V/S: B/P=140/89, T97.1, Pulse=88, RR=24--Pt verbalized the itching stopped including itching throat, no more dizziness.  Pt walked out of facility with no assistance.
Achy/ soreness; hips and shoulder hurt; 100 degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy/ soreness), ARTHRALGIA (hips and shoulder hurt) and PYREXIA (100 degree temperature) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achy/ soreness), ARTHRALGIA (hips and shoulder hurt) and PYREXIA (100 degree temperature). At the time of the report, MYALGIA (Achy/ soreness), ARTHRALGIA (hips and shoulder hurt) and PYREXIA (100 degree temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) High.         Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-163637 (Patient Link).
received / first dose / on Nov 9, 2020 / does the dose received today count as the 2nd dose?; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th November 2020).   On 9th August 2021, the patient received the 2nd dose of Shingrix. On 9th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter stated that, the patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. The reporter follow up via an email. This case was linked with case US2021168420, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168420:Same reporter