chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-403721 (Patient Link).
Case number PHEH2015US002129, is an initial spontaneous report received from a nurse on 28 JAN 2015. This report refers to a male patient of unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M14069) intramuscularly on 21 JAN 2015. It was reported that MENVEO was stored at temperature of -0.8 degree C and 2 degree C on an doff for one to six hours. It was also reported that MENVEO was not frozen during this temperature excursion based on visual inspection. No adverse events reported after the maladministration (incorrect storage of drug).
Patient became light-headed and nauseous. She tried to sit down and then had to take a seat and put her feet up in order to not throw-up. The symptoms lasted about 15 minutes in the pharmacy. She said she was feeling a little better about 10 minutes after vaccination. The patient left after about 20 minutes and I am not sure when she fully recovered.
The day following his Moderna vaccination, the pt became profoundly week with difficulty standing on his own and frequent falls.  He also experienced sever malaise
Moderna COVID-19 EUA Starting approximately 10 hours after injection, I began having injection site pain and significant chills.  Throughout the night, I developed a fever, headache, and body aches, and the chills increased.  All of these symptoms persisted through the next two days, along with extreme fatigue and some dizziness.   Day three saw marked improvement in symptoms, with only the headache remaining.
MMR given on 4-3-03. Fever w/no illness 101-103* started 4-10 ( early afternoon) thru 4-12 (evening). THEN fever broke and body was covered starting in neck and behind ears with bumps that looked like a rash. Continued to spread over trunk and back and then down legs.  Lasted 48 hours. Seen by MD at clinic, he stated that it "could be reaction to MMR" or that it "could be Roseolla" although time frame indicates that it is a reaction to MMR vaccine.  After 4-14 no other symptoms and return to normal. Apparently the Roseolla virus and MMR reactions are similar and difficult to specifically diagnose given that had the MMR vaccine the week prior.
Incorrect dose given. Contents of entire vial of Moderna Covid-19 Vaccine  2023-2024 for 6 months to 11 years was administered instead of 0.25ml. Once error was identified patient's parents were contacted.
1.5 day after vaccine my mouth didn't open then by 2nd day couldn't blink my eyes, and sharp pain in heck.
Red area at site, oval in shape about 2 inches long and 1.5 inches wide with several darker red circles inside the oval. It itches intermittently. It has lasted 4 days and on the 4th day the itching has almost subsided and the redness is still present but a little lighter. No treatment
Low grade fever; Body aches; Chills; Extremely sore arm could not lift arm; Swollen lymph node in armpit of arm of injection site; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 20Sep2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3183) via an unspecified route of administration in the left arm on 30Aug2021 at 17:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 21Sep2021 at 10:00, approximately 18 hours after the second dose, the patient experienced low grade fever, body aches, chills, extremely sore arm that she could not lift the arm and swollen lymph node in armpit of arm of injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, body aches, chills, extremely sore arm could not lift arm and swollen lymph node in armpit of arm of injection site was resolving at the time of this report.
Underdose; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 68-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7k545, expiry date 22-OCT-2024) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced underdose (Verbatim: Underdose) and pharmaceutical product complaint (Verbatim: Product Complaint).  The outcome of the underdose and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt date: 31-AUG-2023 Pharmacist reported that a colleague had administered Arexvy to two patients and after the patients had left the pharmacy, the reporter noticed that retained white powder in the antigen vial.  The powder was described as partially pill-like and partially like powdered sugar.  They did not know which of two patients received the underdose.  The reporter reviewed the reconstitution instructions and received the following information prior to transferring the call to the medical information department for further instruction. The reporter stated that all operations were performed appropriately before defect was discovered. The defect was discovered after administration. The mixing was performed gently. The vial was held upside-down while being withdrawn. The product was administered. The health care professional was experienced in vaccine administration. The antigen component was the component in question. The health care professional was not able to email a picture. No liquid, only powder was left in the affected vial/s. Yes, the stopper was pierced in the circular area dedicated to perforation.  It was unknown if air was injected into vial. The reporter would call GSK back with wholesaler information for credit when they locate this information. The reporter consented to follow up. This is 1 of 2 linked report, reported by same reporter. The patient received Arexvy and later it was noticed that retained white powder in the antigen vial, which led to underdose.; Sender's Comments:  US-GSK-US2023119231:Same reporter
Dizzyness, headache for 4 days now.  Eversince 2nd shot.. it happened like 4 times now.. i never had that happen to me..
Pfizer vaccine was administered outside of hospital - reported by patient  I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/10/2021 ASTHMA, UNSPECIFIED I82.411 ACUTE DVT OF RIGHT FEMORAL VEIN 7/10/2021 ASTHMA, UNSPECIFIED
Seizures lasting 1-2 min w/ limpness, circumoral cyanosis, eye rolling, post ictal state of 10-15 min 4 times in 16 hrs.  Given meds.
Right leg with redness, swelling, and tenderness surrounding vaccine site. Fever and lethargy, difficulty walking. Blood work, strep screen, flu screen, urinalysis obtained.
Vaccine given 20days after first dose. (8 days too soon) Adverse symptoms are unknown at this time and effectiveness of vaccine unknown
While the patient was receiving their vaccine, the luer lock on the syringe malfunctioned. The vaccine began to leak from the syringe and the patient did not receive a full dose. The medical director advised to give a second dose if the patient was comfortable with it. the patient was comfortable with it and was monitored for thirty minutes after receiving the vaccine.
PT WOKE UP THE NEXT NEXT DAY C/O BODY ACHES, INJECTION SITE WAS LARGE, RED, WARM TO TOUCH, AND BLACK.  PT ALSO C/O NAUSEA, LOSS OF APPETITE, WHOLE ARM WAS SWOLLEN.PT TOOK TYLENOL & MOTRIN.  SEEN AT ER MONDAY AM, REFERRED TO GENERAL SURGEON TO HAVE ARM DRAINED.
Since the second day of vaccination I feel a constant cramp sensation in my hands and feet, it does not go away.
Before puncture and I know after puncture it's only good for 12 hours.; Before puncture and I know after puncture it's only good for 12 hours./total time of storage from the time of dilution to the time of administration was 53 hours; sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. Other Case identifier(s): US-PFIZER INC-202101690247 (Pfizer).  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Nov2021 14:00 (Lot number: FK5618, Expiration Date: 27Jan2022) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cold" (unspecified if ongoing), notes: Weeks of vaccination; "Fever" (unspecified if ongoing), notes: Weeks of vaccination. There were no concomitant medications. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 26Nov2021 14:00, outcome "unknown", described as "Before puncture and I know after puncture it's only good for 12 hours."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 26Nov2021 14:00, outcome "unknown", described as "Before puncture and I know after puncture it's only good for 12 hours./total time of storage from the time of dilution to the time of administration was 53 hours"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No fever, no other side effects recorded from the twins. The reporter stated that the vial of the vaccine was diluted and kept in the fridge between 37.2° to 40°F and from the total time of storage from the time of dilution to the time of administration was 53 hours. It was unknown if prior vaccination (within 4 weeks). Specific Relevant Test Thromboembouc Events with thrombocytopenia: Antibody test to platelet factor IV, result: unknown. No Autopsy information. Pediatric vaccine was mixed on 24Nov2021 at 9 am and was not salvaged by closing pharmacist end of Day. Pharmacy was closed on thanksgiving. On 26Nov2021 at 2 pm, the pharmacist drew out 1 dose from the expired diluted vaccine kept in the fridge since 9 am 24Nov2021 and gave it to the patient. On 29Nov2021 at around 8:20 am, patient's parent was contacted, and where they informed that patient experienced sore arm and no fever or other side effects reported. The reporter stated that the date of second dose, Its from the 21 days from 26Nov so its around 17Dec2021'.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101676457 same reporter/product/event, diff patients
pt denied poss of pregnancy on 16MAR93 when vax given; pt was cautioned to avoid pregnancy for @ least 3 months; pregnancy test pos 20PAR94;
Pt. received PCV13, High Dose Flu, and Tdap on 10/11/16. He reports on 10/13 or 10/14 he developed a generalized  rash on trunk and legs. Papular, "mildly itchy", pt. denies any vesicles, blisters or weeping of rash. He went to a dermatologist and was told it could be vaccine related.
Hyporesponsive hypotonic event. 102 degree fever, taken by EMS to hospital, transferred to another hospital. No tonic clonic movement.
Onset redness, warmth, induration at site of VARICELLA injection. Evaluated by P.C.P. 4/18/16 and given oral antibiotics and topical steroid cream. Father states area size of hen egg.
Information has been received from a nurse concerning a female patient (age not reported) who unspecified dates was vaccinated with a first and second dose of Gardasil. The patient felt faint after receiving the first dose of Gardasil. The patient sought unspecified medical attention. The patient did not end up fainting and recovered the same day. The patient did not have this experience after receiving her second dose of Gardasil. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. No concomitant medications were reported. The pharmacist reported that on 04-AUG-2012, an unspecified patient received a dose of ZOSTAVAX that expired on 03-JUL-2012 (dose, route and lot # not reported). He did not know if the patient experienced any adverse effects. Additional information has been requested.
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 47-year-old female 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 15-Nov-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 15-Nov-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.).    It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that 113 Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses was as follows 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.  Treatment information was not provided.
Client and family waiting for 15 minutes after vaccine per policy. Client told mother he was hot and wanted water. Client noted to be very pale, advised to lay down, and assisted to ground. No loss of consciousness noted. Client given snacks and drink, color improved, went home with parent.
female calling regarding Cough. was diagnosed with COVID on January 26th. increasing shortness of breath over the last few days with new onset chest tightness this morning. Chest tightness non-radiating, described as a band around her lower chest. Associated productive cough, with clear coloured sputum, 3lb weight gain, low grade fevers and chills over last few days.
caught coven; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (caught coven/What percentage of fully vaccinated individuals get covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (caught coven/What percentage of fully vaccinated individuals get covid).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
extreme nausea; heavy chest; Vasovagal reaction; extreme dizziness; This is a spontaneous report from a contactable pharmacist. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received other vaccines within 4 weeks before vaccination. The patient experienced extreme nausea, heavy chest, vasovagal reaction and extreme dizziness without being able to recover for 30 minutes (laying down for 30min not able to stand without extreme dizziness and heavy chest)  to continue normal activities of work on 14Jan2021, 4 hours after the vaccination. The adverse events resulted to none. The outcome of events was recovered on 14Jan2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
On Friday July 16,Patient was wrongly administered 0.5ml of Pfizer Vaccine Intramuscular instead of 0.3ml by the  Management was informed ,Incident report filed and patients are being notified by medical staff.
Mom reports itching on 08/17/2005 on 08/18/2005 mom brought patient in with erythema and swelling 3 x 5". Dr put patient on antibiotics for possible cellulitis.
A non-serious spontaneous report of mild congestion has been received from consumer concerning a 42-year-old male patient, subsequent to receiving FLUMIST and H1N1. The patient's medical history and concomitant medications were not reported. On 13-Oct-2009, the patient received H1N1 and on 23-Oct-2009, the patient received FLUMIST. On 24-Oct-2009, the patient experienced mild congestion. The reporter stated that the event of mild congestion resolved on 25-Oct-2009.
Started with arm pain about half an hour after shot similar to first shot but more immediate. Later around 5pm I started to experience full body aches akin to the flu. Then I had chills and a mild fever of 100 and a headache. This lasted through the night. I slept until 11am today the 11th and awoke with only a headache. Then around 8pm I began experiencing menstrual cramps and breast tenderness despite my cycle (bleeding) ending 5 days ago. I usually do not experience menstrual cramps. This has been happening for the last 2 hours. It?s now 10pm
mom reported pt had a rash around shot site;denied any other problems;advised that should take child to ER;mom did;stated no meds or treatment;
The day of vaccine, vaccine sight became hard, red, swollen, hot to touch and very very sore. I am unable to lift arm. I am still have these side effect (red, hot to touch, hard, very sore, and swollen) today (3/5). The day after the vaccine I became very tired, achey, not feeling well with a low grade fever. I plan on calling doctor on Monday if still have bad arm vaccine sight.
He developed hematuria about 24 hours after vaccination, it resolved after a few days. He has had three episodes of hematuria after this, all coinciding with respiratory illnesses, all resolving without treatment.
Patient called saying that she still has rash, redness, and it feels hot to touch at the site of injection
metastasis/metastasized to her liver, stage 4; allergic reaction; hard of hearing; trouble breathing; throat closed; hives; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received second dose of pneumococcal 13-val conj vac (dipht crm197 protein) via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included breast cancer from 1999, double mastectomy. Historical Vaccine included first dose of Pneumococcal 13-Val Conj Vac received on an unspecified date for immunisation. The patient's concomitant medications were not reported. The patient will be starting palbociclib (IBRANCE) for breast cancer that has metastasized to her liver, stage 4. She first had it in 1999; had double mastectomy 15 years later and now, 5 years later, there is metastasis. She stated that she had an allergic reaction after her "second pneumonia shot/vaccine" (name and manufacturer of product unknown) but was told that the second one was different from the first pneumonia shot (the second one had a few more different ingredients from first one). She stated that within 15 minutes of getting the second shot, her throat closed and she had trouble breathing. She took diphenhydramine (she can't take regular Benadryl due to food coloring), put ice on her throat, and chewed on ice chips and the reaction subsided within 15 minutes. She also reported she did have an underlying issue with hives, that she could get hives randomly. She was also hard of hearing. The outcome of events was unknown.  Information on the batch number has been requested.
Information has been received from a Doctor of Pharmacy concerning a 45 year old female with no known allergies who on Oct 10 2004 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649693/0486P). On Oct 10 2004, the patient was concomitantly vaccinated in the right arm with a dose of influenza virus vaccine. Subsequently, in October 2004, the patient developed a fever, hives and severe muscle pain. The patient sought unspecified medical attention. At the time of this report, the patients hives had decreased. The Doctor of Pharmacy also reported another patient who had similar reaction post vaccination with pneumococcal 23v polysaccharide vaccine  (lot # 649693/0486P) (WAES0411USA01558). Additional information has been requeste.
pt recvd vax; n; v; muscle weakness w/ significant elevated CPK & LDH enzymes; on 20nov93 returned to work & enzyme levels returning to nl;
hyporesponsive, hypotonia started @ 46-48hr p/vax;cont for 36hr;
1/16/21: A few hours after vaccine administration, experienced severe pain in R arm.   Pain worsened over time, and nearly 10/10 even with light touch.  Intense pain lasted about 24 hours, and pain resolved within 36 hours.    1/17/21: Fatigue lasting about 24 hours.   1/24/21: Itchiness, swelling, and redness at vaccination site.  Itchiness has continued until today, and redness went from being uniform to now being a large red, bumpy circle around the vaccination  admin site.   1/24/21: Excessive sweating at night while sleeping, hot flashes lasting throughout the night.  1/25/21: Some chills & feeling very cold throughout the day.