chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered Moderna Covid-19 vaccines beyond the 30 day use by date; administered Moderna Covid-19 vaccines beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 016B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021 at 10:31 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021 at 10:14 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022 at 1:46 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022 at 1:46 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The vial was initially stored in the refrigerator on 19-Jan-2022. It was reported that, the vial did not undergo any temperature excursions.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up contains no new information.
The patient came in several days after she had received her vaccine with a swollen red arm.  She was instructed to consult with her prescriber.
This spontaneous report was received from a current 64 year old registered nurse who is also the patient with no pertinent medical history or concurrent conditions. Drug reactions/allergies included penicillin and sulfa allergy. On an unknown date, in the late 1980's or early 1990's, the patient received the complete three doses of hepatitis b vaccine (recombinant) (manufacturer unknown), (Lot # not provided) 10 microgram one dose, intramuscularly for prevention of hepatitis. Co-suspect therapy and concomitant medications were not provided. The patient received the complete 3 doses of hepatitis b vaccine (recombinant) (manufacturer unknown), and in 2010, the hospital had drawn up titers for all hospital employees and her titers for Hepatitis B were low, so she was revaccinated with another dose of hepatitis b vaccine (recombinant) (manufacturer unknown). Nurse's titers were later drawn up and again showed that she had low titers so she completed dosing schedule with two more doses of hepatitis b vaccine (recombinant) (manufacturer unknown). A couple of months later, nurse's titers were drawn up and still showed inadequate protection. The patient's sought medical attention in hospital at employee health. The patient's outcome was not provided. Additional information has been hospital.
Stabbing knee pain when I tried to walk - resolved next day on its own Socks and shoes felt tight - on going  small fiber neuropathy  Toes numb - on going small fiber neuropathy  Fingers numb - on going. Small fiber neuropathy  Bi lateral mid to lower back and abdominal pain - ongoing  myofacial pain
sore arm; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
VIOLENTLY ILL; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced violently ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from violently ill. This report was non-serious.
Bells palsy; A spontaneous report was received from a consumer, concerning a 70-year-old, male who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy/ facial paralysis.  The patient's medical history was not provided. Concomitant product was not provided.   On 01 Feb 2021, approximately 31 days prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (batch number: 012M20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  On 03 Mar 2021, post vaccination, the patient experienced Bell's Palsy.    Treatment included prednisone 20 mg once daily and valacyclovir 1g TID 7 days.  The outcome of the event, Bell's Palsy was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
19JAN99 unable to attend school;10SEP98 began feeling ill;11SEP T105, diff breathing, resp distress (rushed to hosp);  spitting up lots of mucous;severe h/a;coughing/choking sounds;exhaustion,sinus infect;hair falling out;Annual follow-up dated 02/21/01 stated that the pt was bedridden for 10 months following the vaccine with a fever, sensitive to light, difficulty breathing, wheezing, asthma, hair loss, menstruation ceased, extreme exhaustion. She is beginning to recover.
PATIENT EXPERIENCED SYNCOPE IN POST VACCINATION WAITING AREA. ELEVATED FEET WITH ANOTHER CHAIR, GAVE A WATER, AND A WATER PAPER TOWEL TO COOL OFF WITH. AFTER THE RECOMMENDED 15 MINUTE WAIT TIME WAS UP, PATIENT WAS FEELING BETTER AND LEFT WITH NO ISSUES.
A non-serious spontaneous report of administration to individual over 49 years of age was received from a registered nurse concerning an 81-year-old male subsequent to administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 11-Sep-2009, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. On 20-Oct-2009, it was confirmed that the patient did not experience any adverse events.
Has not recieved second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not recieved second dose yet) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041D21A or 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not recieved second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not recieved second dose yet) had resolved.            Concomitant product use was not provided.   Treatment information was not provided.
Pt received adult dose instead of pediatric dose. Pt father entered 12 years as age so nurse gave adult dose. No side effects after 2 days. Pt is fine.
pt recv vax & devel thrombocytopenia;no further info was available @ the date of this report;
No adverse event; Half volume dose administered instead of full volume dose of monovalent Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Half volume dose administered instead of full volume dose of monovalent Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in a 6-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. On 07-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Half volume dose administered instead of full volume dose of monovalent Moderna COVID-19 Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Half volume dose administered instead of full volume dose of monovalent Moderna COVID-19 Vaccine) 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 ACCIDENTAL UNDERDOSE (Half volume dose administered instead of full volume dose of monovalent Moderna COVID-19 Vaccine).    No concomitant medications were reported. It was stated that, on 7Nov2022 a 6 year old patient received half of a dose (25 mcg) instead of full dose (50 mcg) of the monovalent Moderna COVID-19 Vaccine. Caller informed that patient did not report any adverse event so far. No treatment medications were reported.   Reporter did not allow further contact
03/18/21 @ 1008: After covid -19 vaccination, pt suddenly reported having tingling lips, dizziness, flushed face, nausea, palor. Assisted pt to laying position on floor. Applied cold wash cloth to forehead, turned on fan. Vitals: 110/69, 52, 18, 99% spO2 on RA.  After laying, pt then reported symptom improvement.  03/18/21 @ 1015: Assisted pt back to sitting position in chair. Pt remained stable and feeling well. Vitals: 126/80, 723, 16, 97% spO2 on RA. Pt remained in clinic until 1023 then was discharged to home with driver in stable condition. 03/22/21 @ 1100: Called pt for follow-up. Pt reported he had another episode on the way home in vehicle, same symptoms as in clinic following vaccination.  Driver took pt to nearest medical facility where they did 3 EKG's which should pt was in a second degree heart block and known vitals reported by pt was 102/60, and HR of 50's.  Pt then went to another facility for further evaluation @ 1500. EKG performed then was normal and vitals were stable. Pt was set up for 24 hour heart monitor the next day, 03/19/21-03/20/21. Pt has not found out those results as of this conversation. Pt reports not having any further episodes and feels good today.
I received a COVID booster (immunocompromised dosage) on Tuesday morning, March 29 after meeting with my doctor.  I developed flu-like symptoms with the 1st and 2nd COVID vaccines, but the reaction from the booster was a whole order of magnitude greater.  I started experiencing intense pain, not just in the arm that was injected, but throughout my whole body. Moving an inch became torture. I had the worst headache of my life and my eyes felt like there was a knife stabbing them from behind. Similar knife-like pain attacked the rest of my body. This made sleeping for more than a few minutes at a time impossible. The pain, weakness and fatigue were overwhelming. I could only eat a few bites.  I was able to drink lots of water as I usually do. Surprisingly, I could only urinate a few drops and couldn?t defecate at all for five days. The second night was just as bad.  The third I was able to sleep from 10 p.m. until 3 a.m. Symptoms have slowly eased for the next 3 days/nights. My arm had a large red patch wrapping around it from 1.5 inches from above the elbow to my shoulder. Headaches continues continually for 20 days.
Stevens Johnson's synd diffuse erythematous, general fine rash w/T102 3-4hr post vax;gross hematuria 24hr later w/vesicular rash, mucosa gen;no joint pain or swelling ;
Tested Positive for Covid 19  06/24:2022@ 0930 A
8/19/12 - gave pt PNEUMOVAX, HAVRIX & FLUZONE, in evening pt reported arm swelling at site of SQ PNEUMOVAX w/fever and diarrhea. Pt went to ER but did not fill Rx. 8/21 - went to Urgent Care told to take BENADRYL any given Rx for steroid but did not take. 8/22/12 - saw Primary. Given triamcinolone cream.
Golf Ball sized swelling that is red and warm to touch.  Started about 24 hours post immunization.  Slightly painful to touch but does not limit movement / motion of the extremity.
This patient's arm had swelling, red, hot, tender to touch with multiple hives moving up her arm to her neck and across the chest. Tongue felt numb. Took Benadryl and put ice on her arm, the next day it was not noticeable.
mom states child had temp 103 that might & was screaming;temp was treated w/APAP & temp & screaming resolved in AM;advised by PMD to notify PHD of rxn;
NONE: Covid vaccine expired 10-25-2022.  vaccine given. 02/13/2023
developed a few recurrent papules / small papules on her back; This case was reported by a physician via sales rep and described the occurrence of papular rash in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 20th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 24th October 2020, 4 days after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was unknown.   It was unknown if the reporter considered the papular rash to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received either Fluarix or FluLaval on 20th October 2020, and developed a few recurrent papules on 24th October 2020, at the same location where she had a bout of herpes zoster post-Shingrix administration over a year ago. Be advised that the  Herpes zoster event post-Shingrix was previously reported to GSK so that is not a new event to report. Patient stated that the recurrent papules post-influenza vaccination in October 2020 has not been physician diagnosed, just a new event that she was self-aware of as she is able to feel these small papules on her back. Reporter/patient does not know if the flu vaccine is the cause but noted that was the flu vaccine was the only new event. She plans on seeing her physician soon to get a diagnosis. This case has been linked with case US2019AMR193464, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR193464:same patient
I was tired, had a fever, and experienced body aches and chills, which were horrible. I took Norco, a muscle relaxer, and Tylenol. The fever lasted for 32 hours. I have experienced muscle pain since receiving the vaccine that have not gone away, I am drained, and tired all the time. Everything tastes like metal and my sense of smell has not been the same.
72 hours after receiving the shot I had debilitating vertigo and nausea, as well as rapid heartbeat.  I went to the ER and was admitted for 2 days.  I am still currently experiencing dizziness on Friday April 16th 2021.
Red eyes, fatigue, aches, sore throat, dyspnea. Tx: Dexamethasone/BENADRYL.
Fever of 100.8, general exhaustion, body aches, sweating, headache
Reported feeling jittery and nervous, overall just "not feeling right". Hypertension.
headache, muscle pain, joint pain, chills nausea for 24 hours. Still feeling fatigue after 72 hours.
Donor arrived at facility at 3pm. C/C her right arm was sore and tender warm to touch after Tetanus shot on 8/14/07 at 1350pm. She complained she had nausea, sweating last night at about midnight, but resolved by early AM. Advised ice packs on right arm, call if any other problems.
Very sore at injection site immediately after shot. Left arm was very sore 3/31/21 through 4/2/21. Patient was very fatigued on 3/31/21. Menstrual cycle began as expected on 4/6/21 and is much heavier than normal, with unusual and painful cramping. Low fever (100F) and fatigue, along with heavier than normal bleeding continued 4/7/21.
Patient recieved the HPV, MEN B, and mcv4 in that specific order. One minute after receiving all vaccines, patient stated she felt nauseous and then started falling back onto the table. Patient was sitting down so when she started leaning back her mom and I both laid her down. After 30 seconds patient became conscious again and stated she just felt shaky. Patient was given water and was told to sit down for a while. While she was sitting down, a set of vitals were taken on her. BP- 105/64, HR  went from 47 to 57 to 61, O2 98%. VSS. Patient was then kept in the lobby for 15 extra minutes to make sure she was not going to have any other adverse reactions. After the 15 minutes, she felt fine and she left to go home with her mom.
Flu like symptoms; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The reporter stated that the patient experienced flu like symptoms after vaccination.
3/5/21, 3/6/21  and still is exhibiting side effects - Fire and burning sensation all throughout my body, shooting pains down my left arm of where I got the vaccine, body chills, low-grade fever, nausea, vomiting, diarrhea, and dizziness, confusion, lightheadedness, and blacked out. Fell and hit my head and got a concussion.
Rhabdomyolysis and acute renal failure on dialysis. (Had flu shot (Mfr Unk) on 11/26/01.
2:10 fainted after vaccination and bumped head on floor. Monitored for 50 minutes. Sent home with mom to monitor s/s concussion. BP 94/60, P 72
Patient is fully vaccinated.  Presented to ED 11/28/2021.  COVID + on 11/28/2021. Chief complaint is fatigue. 87-year-old female presents to the emergency Department for fatigue. Patient was in a car accident earlier in the year which has worsened her chronic low back pain. Patient states that she sometimes feels burning pain on the lateral aspect of her right leg. This symptom flared up in the middle of last week and has now resolved. However for the last 3 days she has experienced worsening fatigue.  Positive for Hypomagnesemia.  Leukopenia.  Chest x-ray stable.Magnesium 1.5 and was replaced. Patient lives alone but states that she has her daughter living close by, who she could call should she need anything. Patient states that she feels safe and comfortable to go home.Patient told to return to ED for any worsening symptoms. Discharged home.
Patient 3 years and 6 month old inadvertently received a dose; It was the 3 dose of the TDAP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: Nurse reported that the patient inadvertently received a dose of Kinrix at the age of 3 years 6 months. It was the 3rd dose of the TDAP series. The reporter consented to follow up. Healthcare professional wanted to remain anonymous but gave consent to follow up. Additional supportive information: The patient inadvertently received a dose of Kinrix at the age of 3 years 6 months, which led to inappropriate age at vaccine administration which was the 3rd dose of the TDAP series, which led to inappropriate schedule of vaccine administered.
This spontaneous report was received from a medical assistant, regarding a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, or drug allergies were not reported. On 18-APR-2017, the patient was inadvertently vaccinated with the first dose of an expired M-M-R II injection (dose and route were not reported) (lot number: L012480; expiration date: 10-APR-2017) for prophylaxis, which was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were unknown by the reporter). According to the reporter, the M-M-R II that was administered to the patient had a prior temperature excursion in the range of 9 degrees Celsius (C) to 25 C for a cumulative time of 1 hour in 2016. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 72 year old female patient without known drug allergies. On 31-OCT-2014 the patient was vaccinated with ZOSTAVAX, 0.5 ml, subcutaneous, lot # reported as K009773, expiration date reported as 09-OCT-2015. There were no concomitant medications. On 31-OCT-2014 the injection site appeared red and swollen but did not appear to be shingles. There were no laboratory diagnostics studies performed. Patient sought medical attention on unknown date. The outcome of the events was not recovered/not resolved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT WAS NOT ELIGIBLE TO GET THE BIVALENT BOOSTER BECAUSE IT HAS NOT BEEN 2 MONTHS SINCE THEIR LAST COVID VACCINE. ADDITIONALLY, PATIENT REVEIVED THEIR LAST COVID VACCINE (PFIZER BOOSTER DOSE #2, TOTAL DOSES = 4) ON 8/6/22 ALTHOUGH THEY WERE NOT ELIGIBLE FOR THIS VACCINE (NOT 65 Y/O OR OLDER AND NOT IMMUNOCOMP)
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted immediately after receiving vaccine, seemed slightly disoriented initially upon waking up, felt nauseous, but symptoms rapidly improved after drinking water and eating crackers and remaining seated. Patient called mom to pick him up so that he was not at risk driving home alone.
10:30 Immunizations administered at 2:30 that afternoon. Mom states that she started crying inconsolably and holding her breath. Right leg was then red and swollen at injection site, with whelps on ankles, abdomen and forehead. Took to MD, he stated she was just having a reaction to immunization. Gave Benadryl. Next day ran fever 103 degrees until six pm, 99 degrees temp 3rd day. 4th day ok