chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Received a 0.5ml monovalent dose as a booster lot 057a22a on 21-Dec-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a 0.5ml monovalent dose as a booster lot 057a22a on 21-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057a22a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 21-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Received a 0.5ml monovalent dose as a booster lot 057a22a on 21-Dec-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a 0.5ml monovalent dose as a booster lot 057a22a on 21-Dec-2022) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Received a 0.5ml monovalent dose as a booster lot 057a22a on 21-Dec-2022).    It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were provided. Patient received 4 doses of the Moderna COVID19 vaccine prior to this event. No treatment medication was provided.
Name:  DOB:  Phone: PMH: denies ALL: denies VS: 97%, HR 80, BP 170/104 (immediately after epi, then 148/94 20 minutes later)  Symptoms: No medical history or allergies. This is Dose#2 and had immediate wretching, nausea, with spitting up phlegm and gasping. No oropharyngeal swelling but felt tongue itching, shortness of breath and had left sided wheezing with decreased air entry.  Assessment: In distress, gasping/wretching, left sided wheezing with decreased air entry and normal   Treatment: 0.3mg epinephrine autoinjector50mg IM benadryl x1 albuterol inhaler x 3 puffsPatient felt jittery but clear airway, no SOB, no nausea.EMS was called, assessed by PGFD and recommended ED for observation but the patient refused transport (signed with EMS to refuse transport). She asked to be allowed to rest on site and then go home. Remained on site with in-car observation for 2 hours and resolution of symptoms.Drove herself home.
No adverse event; Moderna 1st dose on 29Jun2022, Moderna 2nd dose on 9Sep2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 29Jun2022, Moderna 2nd dose on 9Sep2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 29Jun2022, Moderna 2nd dose on 9Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 29Jun2022, Moderna 2nd dose on 9Sep2022) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 29Jun2022, Moderna 2nd dose on 9Sep2022).    The patient was not immunocompromised.  No concomitant medication was reported.  On 17-Nov-2022, patient received Flu dose.  Reporter stated that she had a 3 year old that received 1st and 2nd Moderna monovalent. On 22-Dec-2022, patient received 0.2 ml of the Pfizer monovalent as a third dose (Initial booster) with batch no.: FX5095. The nurse explained that the patient should have gotten Moderna bivalent, so the nurse was trying to figure out if she should give the bivalent to the patient again.  No treatment information was provided.
Information has been received from a 31 year old white female with rheumatoid arthritis and codein allergy who on 01/31/2001 was vaccinated IM with a first dose of heb b vaccine recombinant. Concomitant medications included hydroxychloroquine sulfate, and hydrochlorothiazide. On 01/31/2001 the pt experienced fever, started to feel weak and body aches. The pt stated that the symptoms continued "on and off for a couple of weeks." The pt did not get second vaccine because of the experience she had. Follow-up info from a registered nurse indicated that several hours after receiving hep b vaccine recombinant, the pt had severe body aches, low grade fever and weakness. The pt's rheumatoid arthritis symptoms increased dramtically. Subsequently her rheumatoid arthritis had stabilized. No further info is available.
Client was given 5-11 year old Pfizer (orange cap) when she should have been given Pfizer (purple cap) for 12 years and older. Client did not have any reactions while at the clinic during her observation time.
A report has been received from a Physician concerning a 7 year old, male subject, Height: 50.0 inches: Weight: 61.4 pounds, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.5 Millilitres, Once/Single administration. The patient's concurrent disease(s) included asthma and ADHD. Concomitant medications included Salbutamol, cetirizine hydrochloride, clonidine and dexmethylphenidate hydrochloride. FLUMIST QUADRIVALENT started on 19-Nov-2013. It was reported that they had inadvertently gave FLUMIST QUADRIVALENT to a patient with very well controlled asthma on 19-Nov-2013. FLUMIST QUADRIVALENT was discontinued on 19-Nov-2013. The outcome of the event of inadvertently gave FLUMIST QUADRIVALENT to a patient with very well controlled asthma is unknown. The report was considered to be non-serious.
3"-5" hives over entire body that lead into small raised red bumps over entire body that lead to diagnosed eczema on arms, trunk and legs.
Fully Covid-19 vaccinated with Covid-19 positive test and Covid-19 symptoms.  Syncope and Angioedema
Topical rash, red and "splotchy".  Starting within several hours of vaccination, worsening over next 8 hours to 6sq inches and improving by next day to less than 3 sq inches.
Pt and two siblings,  administered a dose of Pfizer 5-11 (Orange Top) that was discovered to be undiluted.  The doses drawn up by RN  who had discovered she was unable to draw more than 3-4 doses from the vial.  Pt and siblings had observation period and no adverse effects were observed or mentioned.  Mother was contacted about the discovery and said her children were experiencing sore arms, severe nausea, and headaches.
Breakthrough case admission after three vaccines Moderna 3/3/21 Lot# 040A21A;  Moderna 3/31/21 Lot# 026B21A;  Moderna 10/25/21 Lot# 076C21A
Itchy mouth, throat and numbness of tongue.  No treatment given and the sensation stopped after 15 minutes.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A patient (age and gender unknown) received PREVENAR-13 on an unknown date. On an unknown date, the patient developed burning sensation after vaccination.
high fever noticed 18JAN @ 430PM;temp of 104+ R;contacted MD treated fever w/APAP & Motrin;had ashen color;fever nl 10PM 18JAN;19AJN 7AM fever of 100 R;no fever 19JAN PM
chest pressure; shortness of breath; Dizziness; Rapid heartbeat; headache; nausea; extreme dizziness; hives; rapid heartbeat; chest pressure; shortness of breath; sweating; throat tightness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness), URTICARIA (hives), PALPITATIONS (rapid heartbeat), the first episode of CHEST DISCOMFORT (chest pressure) and the first episode of DYSPNOEA (shortness of breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (extreme dizziness), URTICARIA (hives), PALPITATIONS (rapid heartbeat), the first episode of CHEST DISCOMFORT (chest pressure), the first episode of DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweating), THROAT TIGHTNESS (throat tightness), HEADACHE (headache) and NAUSEA (nausea). On 11-Mar-2021, the patient experienced the second episode of CHEST DISCOMFORT (chest pressure), the second episode of DYSPNOEA (shortness of breath), DIZZINESS (Dizziness) and PALPITATIONS (Rapid heartbeat). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. On 10-Mar-2021, DIZZINESS (extreme dizziness), PALPITATIONS (rapid heartbeat), HYPERHIDROSIS (sweating), THROAT TIGHTNESS (throat tightness), HEADACHE (headache) and NAUSEA (nausea) had resolved. On 11-Mar-2021, last episode of CHEST DISCOMFORT (chest pressure), the last episode of DYSPNOEA (shortness of breath), DIZZINESS (Dizziness) and PALPITATIONS (Rapid heartbeat) had resolved. At the time of the report, URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Red, warm to touch, increase temp to 100. Swelling and redness to elbow.
This spontaneous report was received from a physician via company employee, regarding a 11 year old female patient. The patient's medical history included an unspecified "immune disorder" and the historical or concomitant medications were unknown by the reporter. On an unspecified date (reported as "a couple of weeks ago") the patient was administered GARDASIL 9 on her left arm for prevention of Human Papilloma Virus (HPV); the product Lot # was reported as A013698 and expiration date as 19-DEC-2019. The patient was also administered with an influenza virus vaccine (reported as "unspecified flu vaccine") in her left arm and unspecified meningococcal and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid vaccines in her right arm. Upon receiving the GARDASIL 9, the patient complained about the pain. It was reported that an unspecified Medical Assistant and the patient's father "thought she was standing up, but she was not and she passed out and fell to the floor". The patient woke up once her father picked her up. The patient did not sought medical attention for the events. The recovery status from pain by the time of the reporting and the association between the events and GARDASIL 9 were unknown.
gen sz-brief; pt had one prev sz w/fever age 2 1/2mo, EEG negative;dx as febrile sz;-no problems p/prev vax;
Pt rec'd vaccine. ~1 hour after, pt began noticing redness and itching to R arm, then became more diffuse, to chest and L arm. Redness was nonblanchable. Pt returned to clinic and 50mg IM benadryl was given by supervisor at ~1400. Now (~1420), redness has almost completely resolved. No SOB, chest tightness, wheezing.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N034554, expiration date 05-DEC-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted about 3 mins after shot administered. blood pressure was low. came to in less than 1 minute. once patient was alert took blood pressure was low so laid patient down with legs elevated and blood pressure returned to normal. patient waited over 40 mins after event in pharmacy then walked around to make sure she was feeling ok then left pharmacy once symptoms resolved
FULL BODY CHICKEN POCK LIKE BUMPS EVERYWHERE 1 DAY AFTER SHOT
3-4 hr onset fatigue. for 3 days confined to bed from fatigue.  Has slowly remitted. - Now - 8 weeks after second shot still daily fatigue, pedal edema with activity. Nap required daily. Occasional episodes of sleep disruption. 2-4 days severe arthritis flare with rheumatoid joints swelling as well as mild swelling in OA joints: fingers, wrists, elbows, neck, back, hips, knees and ankles. deformity of dips, not previously present.  Now, 8 weeks later, swelling resolved but arthritis still worse than prior to 2nd immunization. Severe bruising in R upper arm. 8 weeks later still have brown discoloration over6 inch area - INR increased to 5.4 3-4 hour mild headache lasted 2 days reoccurred 2 or 3 times over the week
Expired vaccine was given. Vaccine had been expired for four days.  Moderna has been notified and we are waiting for a response from them as to what the next steps are.  Update: Moderna informed today; "The vaccine administered on May 24, 2022 from lot number 033K21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
Left thigh redness, swelling, tender, painfull, unable to apply weight or walk. Seen in ED on 4/27/12 admitted for Cellulitis and antibiotic treatment.
Shortness of breath, occasional heavy breathing, increases resting heart rate. Started to notice it more frequently Monday 1/18/21 and only lasted a couple days. Got tested on Wednesday 1/20/21 and received positive result.
Regional LAD (anterior cervical, supraclavicular, axillary and inguinal (all L side); mild pleuritic CP.
Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of breath from simply walking around swelling of the glands and consul in the neck and throat
Flu shot. 10-11 days later GBS. Hospitalized for 3 months. Total paralysis-only could move eyes many complications since.
Fever between 99.5 and 101, chills, shuvering, body aches, headache.
Patient came in for her 2nd dose of the Moderna vaccine 11/5/21 which should have been 0.5ml, we accidentally gave her a booster dose which is 0.25ml. Patient was contacted the same day to be notified of the error and returned today 11/8/21 for the other 0.25ml.
Last shot was 4/12/21. On 5/1/21 I was rushed to emergency with acute appendicitis and it was removed 5/2/21. Released home 5/3/21     Horrible experience at 70 years old! Still suffering!
On 7/28/14 in the evening, client c/o of joint aches. On 7/29 c/o nausea, itching all over body, difficulty breathing, and muscle twitching. 7/30 body aches worsening, lethargic, headache, dizziness. Called MD and was told to go to ER. CBC and Liver profile drawn and all normal.
I felt very weak, painful joints, hypotensive, dizzy, cold and clammy and an overwhelming sense of not feeling well, like my immune system was being attacked. I called the employee clinic and reported it to RN and she said to see my primary. I took Motrin, Vit. C and drank lots of fluids and felt better in a few days except my Rt Knee remained inflamed. Reported to my Dr on Dec. 4 when my rt Knee symptoms persisted and a MRI shows an inflammatory process of my rt knee, unable to walk properly, constant rt knee pain and unable to work I took home.
12/04/10 pt had child at hospital. Child was in NICU. Parents traveled back & forth. TDAP given 12/11/10 by OB nurse. Pt stated arm sore for a few days. On 12/14/10, pt noticed hard, painful lump where "injection was given. Pt in for W/C on 01/3/11 and showed RN lump. RN encouraged pt to see PCP. Pt saw doctor on 01/04/11. She sent her for ultrasound on 01/05/11. Per pt. doctor decided pt had a hematoma in the injection location. Injection of TDAP given in (L) arm on outer aspect about 1 1/2 inches up from elbow. Pt given no treatment and told "lump would go away with time".
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 13-AUG-2015, the patent was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 52-year-old male patient who received SHINGRIX for prophylaxis. On 23rd November 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 23rd November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, fever, general body pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, fever and general body pain were recovering/resolving and the outcome of the injection site erythema and injection site pain were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, fever and general body pain to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left arm, subcutaneously, which led to intramuscular formulation administered by other route. The patient experienced swelling, redness and pain at the injection site, fever and body aches. The swelling was down at the time of reporting, but the site was red and sore. It was stated that, the pain was migrating down to his elbow. The reporter gave consent to follow up.
This spontaneous report was received from a licensed practical nurse referring to a 6 months old patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. 12-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M006112 with an expiration date of 16-NOV-2017, orally, (volume/dose reported as 2), for prophylaxis (dose was not reported). The vaccine was exposed to temperature of 49 Fahrenheit for 32 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. The vaccine was purchased with private pay insurance. This is one of several reports received from the same reporter. Additional information is not expected because all information required has been received. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA004377: US-009507513-1612USA006675: US-009507513-1612USA006674: US-009507513-1612USA006673: US-009507513-1610USA003097: US-009507513-1612USA006672.
Pt recv vax on 10/30/97; on same day pt exp fever (102F), dec appetite, dizzy, vomiting & diarrhea; pt imp in 2 days
After 15 minutes of observation Pt. went to car, en route to car pt. started feeling throat tighten and felt trouble breathing.  Pt. was escorted to the back where she was monitored for an additional fifteen minutes.  Pt. stated that she was feeling better.  Pt. left the facility with no further incident and was speaking in full clear sentences without any obvious difficulty.
pt recvd vax & 4 days later exp a rash that was measles-like in appearance & that started out on the abdo & spread to the buttock, legs & arms; w/in 48 hrs began to exp pruritus; Atarax & aveeno baths; 18JUL93 rash had completely faded;
severe reaction to the vaccine had a anaphylactic shock had 2 more the next day; This is a spontaneous report received from a contactable consumer. A 17-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history includes diabetic (reported as Takes diabetic med humaran). It was reported that the patient experienced severe reaction to the vaccine had an anaphylactic shock had 2 more the next day. It was added that very sedated fighting it so he dont die. The outcome of the event was unknown.   Information on the lot/batch number has been requested.