chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We have several vials of Moderna Covid-19 vaccine that have expired. We've given quite a few doses.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have several vials of Moderna Covid-19 vaccine that have expired. We've given quite a few doses.) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A, 039B21A, 03M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022 at 9:36 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have several vials of Moderna Covid-19 vaccine that have expired. We've given quite a few doses.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have several vials of Moderna Covid-19 vaccine that have expired. We've given quite a few doses.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that several vials of Moderna Covid-19 vaccine that have been expired since December 2021. Few doses were administered to patients. Expired vaccine lot numbers were reported as 044B21A (Exp date: 06-Dec-2021 and 017C21A (19-Dec-2021). Patient received full dose 1,2, and 3.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: The follow up received contains no new information. On 14-Apr-2022: The follow up received contains no new information. updated contact information (Email ID) On 03-May-2022: Significant follow up received contains Patient demographic details added (gender, DOB, ethnicity, race), suspect product details added, start date of event added.
PATIENT IS DESCRIBING TROUBLE MOVING HER ARM AND ALOT OF SORENESS.  SAYS IT FEELS LIKE BROKEN GLASS INSIDE HER SHOULDER
Initial misuse report received from a non-healthcare professional (consumer) on 24 October 2013 and the case was received on 21 March 2014. A female patient (date of birth was not reported) had received second dose of FLUZONE (batch number, route and site of administration was not reported) on 18 October 2013. The patient had received first dose of FLUZONE on 01 October 2013. It was reported that the 2 doses should be administered one month apart. No adverse event was reported. List of documents held by sender: none.
I had Moderna COVID-19 Vaccine on Wednesday February 3 at 11:30 AM . After the vaccine I went home and had virtually no pain. Around 10PM that night I felt some pain in the toes on my left foot. When I looked, I noticed that my toes were red and appeared slightly swollen.   My big toe was the worst. It was sensitive to the touch and very red. I also felt a short intermittent sharp pain that would last a second or two. It would happen every 3-4 minutes. The next day the redness was gone on all but my big toe.  As I write this today Saturday February 6 at at 11 AM. My big toe is still sore, but does appear a bit better.   I have had gout once in the past. So, gout or Covid ?   The people at were great.
Shingles.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Postnatal depression (excl psychosis).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HERPES ZOSTER (Shingles.). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is scheduled to take her second dose on 30-Apr-2021 and she wanted to know whether she can take it or not as she was having shingles.
Full body macular papular rash that began within 24 hours s/p dose #2 and lasted for ~ 7 days. Not reported to be pruritic, no urticaria.
24NOV97 pt recv vax & c/o itching, red wheals over body & swelling, redness of lt arm around 7PM 24NOV97;MOC gave pt DPH;itching, wheals disappeared by next morning however had swollen, red area for about 2 days;MOC did not seek med care;
Just under a week after receiving the first vaccination dose,  the injection site on 02/02/2021 became red, raised, sore, swollen, tender, much moreso than the expected initial response to the vaccine of slight redness and tenderness which I experienced the day after the vaccination. This significant discomfort was accompanied by swollen and tender lymph nodes in my right arm and axilla. It was difficult to wear a bra, move my arm about, sleep on my right side, or conduct my day's work.  The discomfort was helped by taking Tylenol. By 02/08/2021 all symptoms had subsided except for the swollen lymph nodes which took a few days longer to resolve.
Headaches, cramps in the feet, itching on trunk and arms, and loss of weight
Body aches - used a heating pad sometimes and also took Celebrex to help with the pain. I also had chills and I took a lot of baths. I rested a lot. Kind of light headed and had nausea - resting and trying to be horizontal. I have had a lot of fluids and ginger. I had had the first POTS episode recently - the doctor had said I could take - Promethazine if I needed it but I haven't taken that yet.  I have been shaky and I've tried to have electrolytes and salt and tried to keep my blood sugar up. I am kind of recovered. I'm still having the nausea and the light-headedness. I did have some chills and aches today but they are more minor; getting better.
Patient was unable to catch breath following second IZ (was given VZV, then PCV13), she was observed turning blue in the face, her eyes rolled back, she arched her back and contracted her arms, was very stiff and unresponsive for approximately 15 seconds. She started crying and returned to normal consciousness and color within 2 minutes. Probably breath-holding spell.
Case number PHEH2012US020829 is an initial spontaneous report received from a physician on 11 Oct 2012. This case refers to a 17-year-old male patient. He was vaccinated only with the MenCYW-135 liquid conjugate component of MENVEO (batch number: M11050)  intramuscularly on 04 Oct 2012. He did not receive MenA lyophilized conjugate component of MENVEO. No adverse event was reported following this drug administration error. No other information was available.
pt recv Td on 15SEP97 on 21SEP97 states rt arm became warm to touch, reddened & swollen w/discomfort running up neck;
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were inadvertently administered doses of M-M-R II (lot number K024035 and expiration date 26-NOV-2016, lot number K024825 and expiration date 02-DEC-2016, dose and route of administration were not reported) that had been improperly stored. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Reaction; This case was reported by a pharmacist and described the occurrence of adverse reaction in a 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   The reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows The age at vaccination not provided. The patient was sustained a reaction to the shingrix vaccine resuiting ln medical treatment.
Headache started at 4am the next morning, not relieved by any medication; aleve, excedrin migraine, or tylenol. Finally, imitrex taken at 7pm with mild relief. Felt tired all day. Arm sore.
Given DTaP #5, IPV #4 in L arm. Seen in ER 3 days later w/ swelling of L arm and face itch L eye lids. (+) SOB/wheezing (according to parent). Given Benadryl 5x5 resolved in 24-48 hrs. Made appt/referral to allergist.
all over outbreak on body and face of painful acne for over one week now, hsv1 had since birth but not active for years became painful and active on face for over one week now, extreme fatigue for 2 days following injection
Pt received #1 dose of Hep B vaccine on 06/08/02. Also receiving 10 day course of Tetracycline. Pt previously received 10 day course of Doxycycline without adverse effect. On 06/09/02, pt complained of rash and tightness in throat. Benadryl 50mg IM given. medical client called due to increase dyspnea. Pt on floor face down lips cyanotic. Epinephrine 1:1000, 1ml given with modest effect. Pt then reported to ER. Given 2 liters of normal saline and monitored. Cardiac monitor, pulse, okay, chest X-ray, EKG done. Benadryl 25 mg prn itching q 6-8.
2 days later after her first dose, she was diagnosed as COVID19 positive; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had her first shot of the PFIZER-BIONTECH COVID-19 VACCINE on 01April2021. Two days later after her first dose she was diagnosed as COVID19 positive. She was scheduled for her 2nd dose supposedly, April 22 2021 however she was getting conflicting information as to when should she get her 2nd dose. Some says to wait out 90 days and some would tell her to just proceed in getting the 2nd dose. She also had completed her isolation period and had shown no symptoms for over a week. She wanted to confirm as to how long would she have to wait to have the 2nd dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
fatigue; Headache; fever; chills; This is a spontaneous report from a contactable consumer  An adult 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 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Unknown if Covid prior vaccination. Unknown if Covid tested post vaccination. The patient experienced fatigue on 10Mar2021, headache on 10Mar2021, fever on 10Mar2021, chills on 10Mar2021. No treatment received. The outcome was recovered.    No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Disorientation, vomiting, diarrhea, sense of impending doom. Lasted for several hours.
Fatigued; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE INJECTION (ZOSTER VACCINE RECOMBINANT, ADJUVANTED, NON-LIVE).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine and 2 months later received a booster dose. The patient reported fatigue for a day and that was all. Consent to follow up was not possible as no contact details were available.
The adverse event  was 10/1 patient was given 0.3ml of UNDILUTED PFIZER.        PLEASE NOTE:   WE HAVE SPOKEN WITH PATIENT AND SHE IS FINE!  We are contacting Dr and so is patient.
Swollen, red and itchy inflamed area around injection site; painful and hot to the touch with raised blister-like appearance; area is approximately 3 inches around.  Dr.  prescribed course of antibiotics (Penicillin) and antihistamine for 7 days.
fever over 102,  chills, pounding headache,  body aches,  chest tightness, could not move my left arm for two days.
Started with cough; Sore throat; Headaches; Body aches,muscles were difficult to move; joints and muscles were difficult to move; skin a little tight everywhere; first day a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT DISCOMFORT (joints and muscles were difficult to move), SKIN TIGHTNESS (skin a little tight everywhere), OROPHARYNGEAL PAIN (Sore throat), COUGH (Started with cough) and MYALGIA (Body aches,muscles were difficult to move) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (hasn't been bad last year with the use of the mask.), Allergy (hasn't been bad last year with the use of the mask.) and Chronic bronchitis (has been good for two years). Concomitant products included CETIRIZINE for Allergy, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2021, the patient experienced VACCINATION SITE PAIN (first day a little sore). On 15-Nov-2021, the patient experienced VACCINATION SITE JOINT DISCOMFORT (joints and muscles were difficult to move), SKIN TIGHTNESS (skin a little tight everywhere) and MYALGIA (Body aches,muscles were difficult to move). On 17-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headaches). On 19-Nov-2021, the patient experienced COUGH (Started with cough). On 17-Nov-2021, VACCINATION SITE JOINT DISCOMFORT (joints and muscles were difficult to move), SKIN TIGHTNESS (skin a little tight everywhere) and MYALGIA (Body aches,muscles were difficult to move) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), COUGH (Started with cough), VACCINATION SITE PAIN (first day a little sore) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was also a teacher with severe disabilities. She usually took a medication for Bronchitis, 6 doses, and she was good to go afterwards. Patient has inhaler but hasn't used it for two years.  Patient drank too much water with potassium and electrolytes and felt better. Patient reached out to her doctor  and was waiting for doctor to call back.   This case was linked to MOD-2021-392250, MOD-2021-392451 (Patient Link).; Sender's Comments: Non-serious case.
Notes received from Medical Center. Patient was recently discharged from the hospital to a skilled living facility brought into ED because of hypoglycemia.  Per EMS, the patient's roommate at the facility noticed that the patient was not acting right.  Per note the staff at the skilled living facility checked the patient's blood sugar and it was low.  They called EMS and on EMS arrival blood sugar was 27.  EMS gave D10.  At that time patient was minimally responsive but woke up very quickly according to EMS. EMS did note patient to have transient hypotension and hypoxia.  Per report the patient denied any fever, vomiting, diarrhea, pain. Patient had dialysis and stated she does not make urine. CT of chest noted bibasilar atelectasis without other focal consolidation and shows not frank infiltrate, shows evidence of fibrosis and edema. Per Note the patient met the criteria for sepsis. PCR positive for COVID 19:  New leukocytosis with elevated LFT's and pro calcitonin and lactate. Cr shows mixed interstitial opacities. Patient was not hypoxic during exam. But received a dose of dexamethasone in ED. Received a dose of vancomycin and cefepime in ED. Labs were ordered to trend. Note stated inflammatory markers were elevated mostly from COVID. Patient was admitted to the medical floor. Patient denied any complains and stated she was feeling better. Per 2nd note, the patient's lactic acid was high due to persistent hypoglycemia, chronic renal failure, and hypoxemia.  Due to renal failure, the patient was not a great candidate to receive IV fluids. The patient was given gentle fluids. Patient was also given multiple doses of amp of dextrose 50. Per note, the patient went into respiratory failure and patient and family declined any heroic efforts or intubation. Note stated Patient was a DNR and Do not intubate. Per note, patient died comfortable on 7/31/2022 at 22:37. Health Department does not have any further information on this patient.
I had pain in my left calf and foot. Had multiple blood clots in my left leg in my artery. Had an emergency surgery to remove them.
66 years old patient administered regular flu vaccine in error, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66 year old female patient who was vaccinated with a dose of INFLUENZA VACCINE lot number not reported via unknown route in unknown administration site instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on an unspecified date.  The patient's past vaccination(s) included Fluzone HD (reported that patient was taking Fluzone for two years). The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Hypogammaglobulinaemia.   It is an actual medication error case due to wrong vaccine administered.  At the time of reporting the patient did not had any adverse event.  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.  Information on the batch number was requested.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 07-DEC-2012, the patient was vaccinated with (route not provided) GARDASIL (lotnumber and expiry date not provided). On 07-DEC-2012, the patient received the first dose of GARDASIL on 12/07/2012 that expired on 10/18/2012. The patient is not experiencing any known symptoms. The outcome of received the first dose of GARDASIL on 12/07/2012 that expired on 10/18/2012 and the patient is not experiencing any known symptoms is unknown. The reporter considered received the first dose of GARDASIL on 12/07/2012 that on 10/18/2012 and the patient is not experiencing any known symptoms to be not related to GARDASIL. Additional information has been requested.
Headache, fever, constipation, fatigue, upset stomach, lack of appetite, muscle aches/pains, dizziness, loss of equilibrium
10 days after shot, both upper arms were hot, had haves and were itchy, remarkably so 14 days after shot significant loss of Range of Motion of left arm burning/ripping/tearing sensation in glenohumeral joint of the shoulder constant referred pain in area of shot/front of left upper arm 27 days after shot, noticed a hard wide lump in area of shot on left arm (does not hurt) 6 weeks to the day after shot diagnosed with adhesive capsulitis/frozen shoulder, on left 2 days after that kidney stone, hospital stay
Golf ball size swollen lymph node under left arm.  Painful on the first night that it affected sleeping (throbbing pain).   One week later and still swollen to about half the size of golf ball and sore when touched or stretching arm.  This occurred on the 2nd shot.  Did not have this reaction with the first shot.
Entire arm hurts, trouble moving it, taking ADVIL and it helps. Patient experienced burning feeling overnight.
no additional adverse event; Nurse reports patient was accidently administered both VARIVAX and PROQUAD on Aug 24, 2022. No further information provided. This agent therefore marked other fields as Not Applicable since no further information was provided at the time of the call.; was accidently administered both VARIVAX and PROQUAD; This spontaneous report was received from a nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 24-AUG-2022, the patient was accidentally vaccinated with both varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W003819, expiration date: 02-FEB-2024 (strength, and route of administration were not provided); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, lot #W002784, expiration date: 24-JUL-2023 (strength, and route of administration were not provided), both administered for prophylaxis (inappropriate schedule of vaccine administered) (extra dose administered). No additional adverse events were reported.
pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria medically significant and life threatening). The patient was treated with HEPARIN for Pulmonary embolism, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism) outcome was unknown.            No treatment information provided.  Comment company: 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.; Sender'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.