chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 44-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, there was no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they needed to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was also reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
Arm soreness; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PAIN IN EXTREMITY (Arm soreness) in a 45-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Prior Use). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for Vitamin C supplementation.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Jul-2021. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved and PAIN IN EXTREMITY (Arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2020, Pregnancy test: positive (Positive) Positive. On 12-Jan-2021, Prenatal screening test: normal (normal) Normal. On 12-Jan-2021, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported. Patient was 15 weeks 3 days pregnant at the time of vaccination.  The patient's last menstrual period was mentions as 2 years ago. The date of pregnancy test positive was mentioned as 10-Nov-2020.   The patient previous 3 pregnancy with live full term  birth.
I started having severe abdominal pain that lasted for hours. After 45 minutes I had diarrhea and felt somewhat better but still had stomach pains. Having Celiac Sprue I was not certain of the ingredients in the vaccine as I know I did not get contaminated during the day. I can only attribute it to the H1N1 shot I received yesterday afternoon.
Narrative: 3/9-dose 1 Pfizer vaccine 3/30- dose 2 Pfizer vaccine 7/26- loss of taste/smell, sore throat 7/26- Covid+ 8/2- pt also reports chills, cough, fever, myalgias, rhinorrhea, andausea
Caller wanted to know if the vaccine would cause a strange odor in her nose/I have an odd odor that I continue to smell in my nose; This is a spontaneous report from a contactable consumer (patient). This 76-years-old female patient received the first dose of BNT162B2 (the covid 19 vaccine Batch/lot number: EL3249) on 18Jan2021 at single dose for covid-19 immunization. Medical history was Diabetic, High Blood pressure, Pain, Heart burn. On 04Jan2020, patient stated became quite ill and that was before COVID was made public. So I thought I had flu but I was sick about for two and a half weeks that I did not get out of bed, could barely move. I couldn't eat, I lose a lot of weight, I lost my sense of smell and taste. I think now I may have COVID. I am getting a smell that is very unusual and it's hard to describe, it's kind of a pungent kind of a smell. I can't really describe it, correct and is there any remedy for it After that I took a COVID test in March and in March it was negative. Then I took another one in August and it was negative. Concomitant drug included Metformin for Diabetic, Lisinopril for High Blood pressure, Tramadol for pain. Patient had a strange odor in her nose from 19Jan2021/20Jan2021, continue to smell in her nose. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
10 days p/vax c/o rash, painful joints, swelling neck glands;
right arm injection for Moderna booster.  noticed mild tingling in right hand, specifically thumb, pointer, and middle fingers. lasted for 24 hrs from morning after injection on the 7th, through morning of the 8th.
pt recv vax & exp chickenpox rash w/approx 30 to 30 lesions;1wk later pt recovered;
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates in 2014, unspecified number of patients were vaccinated with a dose of VAQTA (lot number, Expiry Date, dose, route were not reported), that was improperly stored in April 2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female with no relevant medical history or allergies who on approximately 17-JUN-2010 ("3 weeks ago") was vaccinated with a third 0.5 ml dose of GARDASIL (lot number, injection site and route not reported). There was no concomitant medication. The patient reported that she was pregnant at the time she was given her third dose of GARDASIL shot. Laboratory test included home pregnancy test (result not reported). No adverse event reported. Unspecified medical attention was sought. At time of this report, the patient was 3 or 4 months pregnant. Follow-up information has been received from a physician concerning the patient. The patient's pregnancy ended in spontaneous abortion from information reported by patient's mother. Date of spontaneous abortion was unknown. The physician was not able to verify if patient's fetus had a viable heart rate because she had no record of prenatal care from any physician. The physician stated that the patient was a "poor historian". No other information was known. In addition, the physician also reported that the patient had a subsequent pregnancy and voluntarily terminated this pregnancy approximately 6 months ago (captured in WAES # 1106USA01354). Upon internal review, spontaneous abortion was considered to be an other important medical event. No further information is available.
Suspect vaccination failure/ Had shingles in mid 80's; I still have reoccurring issues with them; for 3 months i could hardly sleep; 3 shingles vaccine shots; pain never stopped for 3 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, difficulty sleeping and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, difficulty sleeping and extra dose administered were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and difficulty sleeping to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The had the shingles in the mid 80's, it was the worst pain the patient ever had . For 3 months the patient could hardly sleep. The patient's physician sent him/her to a pain clinic and they wanted the patient to have a shunt put in his/her spine and inject Morphine directly into his/her nervous system, that was not something that would ever do, the pain was so bad he/she almost did it.  The patient still had reoccurring issues with them even though he/she have had 3 shingles vaccine shots. The patient would did whatever it takes to get the vaccine.  The pain never stopped for 3 months. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
arm and body discomfort at the injection site; arm and body discomfort at the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 86-year-old female patient received bnt162b2 (BNT162B2), on 28Mar2021 as dose 2, single (Lot number: EL926) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: diagnosed many years ago; "hypertension" (unspecified if ongoing), notes: diagnosed many years ago. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1,SINGLE, Batch: EN6203), administration date: 07Mar2021, when the patient was 86-year-old, for COVID-19 immunization, reaction(s): "arm and body discomfort at the injection site", "arm and body discomfort at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "arm and body discomfort at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, vaccination site discomfort.  Additional Information: The caller's mother experienced arm pain at the injection site after the Pfizer covid vaccines and the patient did not seek medical help and only took Tylenol. The caller has the patient's shot information from 2021. The caller had three covid vaccines and the booster. Both the caller's mother and she both had the same shot on same day but the caller's mother is ok except for arm and body discomfort at the injection site and the caller is not concerned about that. For the injection site pain, reporter states it is unknown for the dosages for those vaccines as the dose is not written down and it was probably 0.1 but she would have to find out. Other products were reported as "no". Clarified that the patient and the caller both experienced pain with all of the Pfizer covid vaccines which is normal and the patient's first Pfizer dose was on 07Mar2021 with lot EN6203; the next was on 28Mar2021 with lot that starts with EL926 and the caller can't make out the rest of the information and thinks it says 60 but it is not that legible. The patient experienced the arm pain at the injection site for all her Pfizer Covid vaccines. The patient has been covid negative and has been fine except for that discomfort she thinks at the site and they have been pretty lucky.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353410 same reporter/patient/vaccine/event, different dose;US-PFIZER INC-202300353420 same reporter/patient/vaccine/event, different dose;US-PFIZER INC-202300347242 same reporter/patient/vaccine/event, different dose;
Notified on 2/24/2021  that patient passed away on 2/14/2021.   Other cause of death  - non-covid -19 related
Pt complained of severe headaches, numbness of arm and hands, 24 hrs later, still numbness and tingling in left hand. Pt was very flushed and feverish. Still complaining of sick feeling.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 04-MAY-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Case number PHEH2013US011443 in an initial spontaneous report received from pharmacist on 21 may 2013. This report refers to the patient of unspecified age and gender. Patient's medical history and concomitant medications were not reported. Patient was vaccinated with MENVEO (batch number: A 11082) intramuscularly on unspecified date. According to reporter, the patient received MenCWY liquid conjugate component only without reconstituted with MenA. Reporter noticed that they had one extra MenA vial in refrigerator and at the time of this report, they were investigating which patient received the partial dose of MENVEO. No adverse event was reported following this administration error.
Late entry @ 1025 HeplisaV- B 20 mg IM was given @1106 patient started C/O chilling temp 99.5 @ 1108 treatment ended and patient rinsed back. @1111 was called over by the LPN to assess patient that was chilling and now N/V B/P. I asked the patient how she was feeling and she stated "something isn't right, I don't feel good" I asked her is she was having a had time breathing and she stated "yes a hard time" @ 1113 Diphenhydramine 50 mg IVP  was given followed by Solu medrol 125 mg IVP over 5 minutes. @1125 Patient stated she was feeling better and SOB was going away. Chilling has subsided and Temp 97.5 B/P 247/120 clonodine 0.1mg was given. Had patient remain in her chair until B/P came down. @ 1226 B/P 151/69 patient disconnected and discharged Husband informed. Dr. also informed.
3/26-pain at injection site  Tylenol taken, advised to continue taking Tylenol as directed, if symptoms worsen, recommended to see primary provider 3/29-Patient still has pain at injection site, continues to use Tylenol. Recommended to call primary provider if pain continues or worsen over 2 weeks, she concurred.
3RD DOSE COVID VACCINE GIVEN 11/16/21, PFIZER #FH8027; pt admitted to hospital as a transfer from a local Hospital for periprosthetic femur fx requiring surgical intervention; was transferred for surgery and medical clearance; 8/19/22 pt had a positive COVID test; 8/22/22 surgical intervention; pt experienced post-op hypotension; became unresponsive requiring medical intubation and mechanical ventilation; given PRBCs and Albumin bolus, Levophed, ABX; experienced cardiac arrest 3 x with ROSC with each arrest; pt asystole with ROSC unable to be achieved; pt passed away in the hospital
Almost immediate soreness and some swelling in right arm muscle where injection occurred.  The next morning, extreme fatigue and low grade fever, chills, and aches.  By evening, 102 degree fever.  Next morning, no fever but still extreme fatigue.  Took Advil/Tylenol since injection to help relieve symptoms.  Arm still sore but not as bad.
No injury. While completing  Waste Log at the end of shift.  Clinical lead noticed a discrepancy between 0.2mL  and 0.3mL Pfizer doses. CL suspects a 0.2mL dose was administered to patient. The patient should have received the 0.3mL dose based on her age of 12 years.  documentation indicated a 0.3mL dose was administered to a patient, however, the discrepancy in wasted doses led to this suspicion.   Clinical Consultant contacted, staff advised no additional clinical actions required at this time, based on (website name withheld).
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 22-JAN-2018, the patient was inadvertently vaccinated with an expired dose of PROQUAD (rHa), lot number: M032497 (expiration date: 02-JAN-2018), for prophylaxis (strength, route and dosage schedule were not reported). No adverse effects were reported.
DRUG USE FOR UNAPPROVED POPULATION; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 29-MAY-2021, the patient experienced drug use for unapproved population. On 29-MAY-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug use for unapproved population and off label use was not reported. This report was non-serious.
Over 2-3 weeks increasing pain and swelling of several finger joints  and left middle flexor tendon pain. I've only had some mild to moderate chronic osteoarthritis the past 5 years never acute likes this;  Also left medial knee pain feels like bursitis.  No recent injury never had before.
itching over arm and face; hot over arm and face; red over arm and face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching over arm and face), FEELING HOT (hot over arm and face) and ERYTHEMA (red over arm and face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (itching over arm and face), FEELING HOT (hot over arm and face) and ERYTHEMA (red over arm and face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (itching over arm and face), FEELING HOT (hot over arm and face) and ERYTHEMA (red over arm and face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: Upon internal review on 07 Jun 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (confirmed Lot#L016427 and Expiry date 13-APR-2017; Lot#L018501 and Expiry date 22-JUN-2017; Lot#L025738 and Expiry date 04-AUG-2017; Lot#L019298 and Expiry date 22-JUN-2017; Lot#L016427 ane Expiry date 13-APR-2017; Lot#L014417 and Expiry date 13-APR-2017; Lot#K022265 and Expiry date 22-OCT-2016; Lot#K008334 and Expiry date 09-JUN-2016). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant concerning a 69 year old female with a penicillin, codeine and DARVOCET allergy who on 21-OCT-2006 was vaccinated with one dose of Pneumovax 23 (Lot # 651401/0619F).  Concomitant therapy included MAXZIDE.  "Within 24 hours  of vaccination", the patient experienced swelling of the arm which was vaccinated.  The patient sought unspecified medical attention.  The patient was treated with ATARAX.  At the time of this report, the patient was recovering.  The physician requested a lot check of Pneumovax 23 (Lot # 651401/0619F).  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Several weeks after he received the booster dose, he developed CMV retinitis in his eye on the same side.  He does not have any apparent immunodeficiency and his HIV testing is negative.
Nausea; Fatigue; Irrirability; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0198 and expiration date: not reported), via intramuscular, on upper Left arm, on 25Jun2021 at 09:00 (at the age of 27-year-old), as DOSE 2, SINGLE for covid-19 immunization at pharmacy/drugstore. The patient had no medical history. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, solution for injection; lot number:EW0187and expiration date: not reported) via intramuscular, on upper Left arm, on 04Jun2021 at 13:00  (at the age of 27-year-old) as DOSE 1, SINGLE for covid-19 immunization at pharmacy/drugstore and experienced Confusion, Blurry Vision  and Dizziness. On 25Jun2021 at 10:30 also reported as 1.5 hrs. after given 2nd dose the patient experienced nausea, fatigue and, irritability which took 36hrs to go away. The outcome of the events was recovered on 26Jun2021 at 22:30.
Within hours of receiving the second dose of the Moderna vaccine, I noticed shingles forming on my torso.