chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications details were not reported by the reporter.  Patient ID was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, In this report the patient was not Eligible. Breakdown of doses were reported as 51 doses from batch numberAS7140C and 60 doses from Batch number AS7148B.  Treatment details were not reported by the reporter.
RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.
Patient left with mother after injections, mother came back in with child, patient was pale in color and vomited clear mucus(small amount) Child was brought into a exam room laid on the exam table with a cool compress on forehead. Patient did not completely faint and was conscious the whole time. Patient was given water as well as a lolly pop. Patient was monitored by the physician and the medical assistant. Blood pressure and pause stayed in nml range. Patient was aloud to leave after 30 minutes. His color returned to normal and patient was verbal and coherent when he left the office as well.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received the expired FLUMIST on 01-DEC-2011. The patient received a repeat dose. There was no adverse event associated with the medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The patient had no late occurring adverse events.
I had a heavy rash above my cheeks; My eyes turned black and blue; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient's eyes turned black and blue and patient had a heavy rash above the cheeks after vaccination on an unspecified date.The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Intense headache, alternating chills and sweating, nausea, vomiting, muscle pain in both shoulders, along spine, and between ribs. These symptoms occurred primarily between 9 p.m. on day of vaccination and 9 a.m. the following day.  Headache diminished, but continued for about 12 hours until about 9 p.m. on the 20th.  Vomiting stopped by 9 a.m. on 12/20, but appetite did not return for approximately 48 hours.   Felt weak and lethargic for about 48 hours.
Rash appeared on trunk 7/20/21. Care chat with provider diagnosed as shingles.  Provider recommended reporting just in case there was a connection.
PATIENT STATED SHE IS GETTING BUMPS ALL OVER HER BODY.
No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) 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 EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Red burning eyes, back pain couldn't breath, fast heart rate, fever, was in hospital got shot at 2:00pm symptoms started at 5:30 pm and got horrible by the hour.
PT presented covid card with 8-20-21 for first shot, didn't have a 2nd shot listed, and our access to the database was offline at the time. We gave the shot and found out after billing the insurance that it was "too soon". We then discovered the 2nd shot on 9-11-21 after investigating..
EL9264 (the lot number could be this). Started noticing a little shortness of breath a few days before the 2nd vaccine. I had the second vaccine on 2/22/2021, same place as before and the lot number is EL9266. I believe it was March 1st, when I felt so tired, I had to sit down and get some rest. Unusual. I called my primary. I had checked my oxygen saturation, it was low, I was out of breath very easily. I went to ER and they admitted me to hospital. After I went home, by Monday, I went again to hospital ER and they admitted me again. They did a nebulizer treatment when I was in the hospital. They sent me home and told me to get a nebulizer. I still felt shortness of breath, I took them. I used an inhaler when I was a patient and they sent me home with one, too. I couldn't do the inhaler and nebulizer together because that would be too much. I had to use one or the other to treat the shortness of breath. Eventually, I no longer had the shortness of breath anymore. About a week after I got out of the hospital the second time, is when I noticed that I was not having as much shortness of breath. Catherization into my wrist up to my heart. An artery was blocked to my heart, but it was not needed to do a stent because they said that artery was insignificant. Atorvastatin is changed from 20 to 40mg now. And then the inhaler, albuterol, was prescribed for me to take home (was used in hospital, too). They thought I had pneumonia when I was in the hospital so they put me on antibiotics in the hospital as a precaution.
About five hours after injection, started sweating with chills. About ten hours after injection, when tried to go to sleep, felt like someone shot me with adreneline, and couldn't sleep the night.   Severe muscle aches,  Eighteen hours after injection, I was able to get a restful sleep (had to miss work for the morning). I still feel achy 24 hours after the injection, but the adrenelin feeling has passed.
This spontaneous report as received from unspecified health professional via company representative refers to a unknown number of patients of unknown age and gender. Unspecified number of patients medical history and other drug allergic reactions were not reported. On an unknown date the unspecified number of patients were vaccinated with ZOSTAVAX vial (strength, dose number, dose, units, lot number and expiry date unknown). No concomitant medications were reported. Unspecified health professional reported that most of the patients receiving ZOSTAVAX have no injection site reactions but once in a while there was one on an unknown date. On an unknown date the unspecified number of patients experienced injection site reactions. The outcome of injection site reactions was unknown. The reporter did not provide causality of injection site reactions to ZOSTAVAX. No further information provided. Additional information has been requested.
6 weeks after 2nd vaccination I had a mammogram. Mammogram revealed a enlarged lymph node in left armpit  and ultrasound recommended for next day. Ultrasound completed on 5/28/21 and confirmed enlarged node and further recommendation for biopsy. Biopsy completed on 6/2/21 with result of benign.  Node was titanium tagged for future reference.
No additional adverse events reported.; Product confusion involving administration of VARIVAX mixed with liquid diluent of ROTARIX; Product confusion involving administration of VARIVAX mixed with liquid diluent of ROTARIX; nurse mix and administer a dose of VARlVAX with the prefilled oral applicator of liquid diluent for ROTARlX; these two products were mixed, the nurse administered the ROTATRlX diluent applicator (with VARlVAX) into a 2 month old's mouth and administered orally as directed by the ROTATRlX instructions; Inappropriate age at vaccine administration; This spontaneous report was received from a pharmacist who refers to a 9-week-old (also reported as a 2-month-old) patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided. On 13-SEP-2021, the nurse accidentally took virus vaccine live (oka/merck) (VARIVAX) (vial, 0.5 ml, lot # T041686, expiry date 10-DEC-2022) thinking it was the rotavirus vaccine live oral 1v (ROTARIX) and mixed it with the appropriate liquid diluent (0.1ml ) that should have been mixed with the rotavirus vaccine live oral 1v (ROTARIX). Once these two products were mixed, the nurse administered for prophylaxis the rotavirus vaccine live oral 1v (ROTARIX) diluent applicator (with virus vaccine live (oka/merck) (VARIVAX)) into patient's mouth (orally) as directed by the rotavirus vaccine live oral 1v (ROTARIX) instructions. Formulation, concentration, dose number, frequency for all suspect therapies was not provided. The lot # and expiry date for rotavirus vaccine live oral 1v (ROTARIX) and the diluent were not reported. No additional adverse event was reported. No product quality complaint (PQC) was involved.
Once patient moved to observation area, she stated she was not feeling well. Had pressure on back of neck/head. Had trouble breathing with mask, so we advised her to take it off for the moment. Her breathing improved. Patient stated that she had diabetes and had eaten about 2 hours before: checked blood glucose and was 130.  Her hands were icy cold, she was clammy and sweaty. Provided damp towels and ice pack on back of neck. Took blood pressure: 146/102. Stayed with patient until EMS arrived.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE HYPOXIA
w/in 48hrs pt started a scratchy sore throat w/in 3 days it was a bad cold that lasted 10 more days;worked x/1 afternoon
had a small cough; This is a spontaneous report from a sponsored program support via a contactable consumer (Patient) who reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she received first shot of the COVID 19 vaccine, had a small cough (on an unspecified date) and wanted to know if she should still take second COVID tomorrow (unspecified date). The patient underwent lab test and procedure which included COVID-19: negative on an unspecified date. Outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a fever and chills for about 12 hours after the vaccine. In March and until July,  I don?t know when the hot flashes started, but I would all of a sudden get a flushing feeling like I would get really hot. I felt that internal hotness like a hot flash. It would come and then it would go away. They were very random. I could not predict when they would happen, but I might have one or two a week. There was no rhyme or reason to them. The only reason I thought of them was because I haven?t had them in a very long time. I just put two and two together, and I?m not sure if they?re even related. But they started happening right after the second shot of the vaccine.
Received booster on 12/20/21 around 3 pm.  On. 12/21 around 3 am, Starting having muscular pains over entire body that lasted about 24 hours with relief of advil dual action OTC medication. On  12/24/21,  4th day following vaccination, developed acting pain in both legs. On 12/25/21, legs begin to swell, mainly the right leg as pain continues in both legs. 12/26/21 completed an Urgent Care medical center.  Covering PA  dx that it is  the body reaction of dealing with the vaccine. Offered injection of ibuprofen or OTC ibuprofen. I made choice to use OTC advil.  Swelling in right leg has continued and pain is relieved with Advil. 12/28/21.  Swelling in right leg slightly visible, reduced a little.
This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling around neck on day dose was given) and PHARYNGEAL SWELLING (Able to palpate swelling around right side of the throat today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced SWELLING (Swelling around neck on day dose was given). On 17-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Able to palpate swelling around right side of the throat today). At the time of the report, SWELLING (Swelling around neck on day dose was given) and PHARYNGEAL SWELLING (Able to palpate swelling around right side of the throat today) had not resolved. No concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
information has been received from a health professional concerning a 4 and 10/12 year old female, with no medical history and no known drug allergies, who on 6/13/2001 was vaccinated in the right arm with a subcutaneous first dose of varicella virus vaccine live (lot 638495/1904K). There was no concomitant medication. There was no illness at the time of vaccination. It was reported that the patient developed shingles on her right arm, which was the same arm used for injection of varicella virus vaccine live. The patient was seen at the ER on Tuesday, 4/5/2005, and she is being treated with acyclovir and acetaminophen Tylenol with codeine. There were no laboratory or diagnostic tests. No product quality complaint was involved. Follow up information from a health professional indicated that on 4/7/2005 the patient developed shingles, varicella and a red rash on her right arm with multiple vesicles from fingers to her elbows. The patients status was reported as recovered. Shingles was considered to be other important medical event by the reporter (OMIC). Additional information is not expected.
Chicken pox diagnosed 12/17/2001. Treated with Zovirax 400 mg QID for 5-7 days.
At 9 pm on June 14th, 8 hours after vaccine, patient began getting extremely itchy hives all over stomach, left arm, right arm, neck, breasts, and back.
right arm, red to dark brown imprint where injection was done; red to dark brown imprint where injection was done; induration as where the band aide was; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported, NDC number: Unknown), via an unspecified route of administration, administered in Right Arm on 30Mar2021 (at the age of 27-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that on 06Apr2021, dark brown induration as where the band aide was. 3 days before on 06Apr2021 at 9:30, patient noticed a red mark at the injection site of his right arm. The area was now changing to dark brown with an imprint where the band aid was. It was not sticky from the residue, it was an imprint in the shape of the band aid. It was not going away. Patient noticed this marking on 06Apr2021 on his right arm. Patient was concerned, would it go away or be a permanent mark his arm. No history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. Events were not required a visit to Emergency Room nor Physician Office. No prior vaccinations (within 4 weeks). No other products. No Investigation Assessment and Relevant Tests. Therapeutic measures were taken as a result of the events included band aid. The outcome of the events 'red to dark brown imprint where injection was done' was not recovered, outcome of the other event was unknown. Seriousness for events 'right arm, red to dark brown imprint where injection was done' was reported as unspecified by reporter.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
got my first dose but not a full dose / did not get a full dose of the #1 shot; felt something running down my arm / wiped my wet arm with my hand; This case was reported by a consumer via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered and exposure via skin contact were unknown.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient received first dose of Shingrix but not a full dose the top was not tight and during administration the vaccine came running down patient's arm, which led to incomplete dose administered and exposure via skin contact. The patient wiped his/her wet arm with hand and his/her hand was wet. The patient enquired if he/she can get the small shot to get the full dose. The patient also enquired if he/she can get larger 2nd dose to make up the lost vaccine. The patient said he/she only wanted the protection against shingles and did not want to get shingles.
5 mins after HPV vaccine was administered pt felt light headed and stated having difficulty breathing. Had pt sit for 15 mins.
A physician reported the occurrence of a positive test for Hep B surface antigen following vaccination with Hep B vaccine recombinant (Engerix-B). The subject's medical history included hemodialysis. Concurrent medical conditions or concomitant medications were not specified. On an unspecified date, the subject received an injection of Engerix-B. At an unspecified date post-vaccination, the subject tested positive for Hep B surface antigen. Comment: The reporter indicated that two subjects experienced this event. However, they are not presently identifiable.
Shingles, first outbreak. Chicken pox at 3 years old. Rash appeared Monday night, approx 1"x2" at top of left buttocks. Soreness in left leg and fatigue followed over next 3 days
approximately 8 days after the shot, early symptoms of "Frozen Shoulder" began - has progressively got worse, EXTREME PAIN, sleepless nights, loss of range of motion
Swelling of injection sight area  red rash about 2 inches round and swelling about same.  I did take a picture of it.
Patient experienced "tingling feeling throughout body, like a wave" 13 minutes into monitoring after vaccination.  *Patient stated she has HBP and had not taken her medication for 3 days  * 3:30pm BP taken by RN, L arm 260/140, Pulse- 100, Resp- 18  *3:34pm BP taken by RN, R arm 232/138, Pulse- 80, Resp- 16  *Dr. in at 3:38pm  *BP taken by RN with different cuff. L arm 228/122 R arm 218/118  *AUSC, Heart & Lungs  *Denies H/A, SOB, Chest Pain  *Dr. offered to call ambulance. Pt refused and stated she was going to see her personal MD, today. (at that moment)  *Pt escorted to her vehicle by Dr.   RPh 1/31/22 4:45pm
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L018500, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
The pt experienced 14 bite like papules on trunk and extremitites. A few appear vesicular. Suspected chicken pox, failed vaccine.