chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose in 2018, now following up to get second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by registered pharmacist. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. On the day of reporting, the patient was following up to get the 2nd dose. However, it could not be confirmed if the patient received the second dose or not. The patient was present at the pharmacy. The reporter called for medical guidance concerning restarting the series or not and it was suggested that it was not necessary to restart, but that she should get the second dose as soon as possible.  Then, the call was transferred to Medical Information for further education for the reporter, as he was not completely comfortable with the suggested response. The reporter consented to follow up.
Fever/cough/congestion/chills/body aches x 24 hours.
Patient perceived reaction-patient thought they were bleeding significantly and had swelling on their arm. Patient had stopped bleeding almost immediately and there was no visible abnormality on their arm. watched patient for 15 minutes and re-examined and arm again had no abnormalities.
Vague arm soreness and itchiness but then 1 week after vaccination with second Pfizer covid vaccine urine turned dark orange, approx 2 weeks after vaccination started noticing jaundice
Expired on 07/31/2018 dose of MEMNVEO given om 08/0182018. Dose was repeated on the same day.
symptoms, severe pain in arm where injection was administered. Very fatigued and sore all over. Symptoms were gone by next day
tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.            No concomitant medications and treatment was provided.
This spontaneous report as received from a registered nurse refers to a currently 20 year old female patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported). Other suspect therapies included (Oka/Merck) VARIVAX (dose, route and lot # not reported) and RECOMBIVAX HB (dose, route and lot # not reported) both given on an unspecified date. On an unknown date, the patient had a blood test and results showed low titers for measles, mumps, rubella, varicella and hepatitis B. At the time of the report, the patient's outcome was unknown. Additional information is not expected as the reporter did not wish further contact.
This case was reported by a pharmacist via call center representative and described the occurrence of ulcer in a 64-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 7th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, 2 days after receiving SHINGRIX, the patient experienced ulcer, breast ulceration and nasal ulcer. In March 2018, the outcome of the ulcer, breast ulceration and nasal ulcer were recovered/resolved. The reporter considered the ulcer, breast ulceration and nasal ulcer to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. On 7th March 2018, at 4:20 pm, the patient received the SHINGRIX vaccine. The pharmacist reported that the patient experienced sores on one breast and in her left ear and nostril after receiving the SHINGRIX vaccine. The patient reported the sores started with 2 to 3 days after the vaccination and they resolved in one week.
Time of vaccination 10:30 am. Within 5 minutes of shot, while sitting down became weak and disoriented. This lasted about 15 -20 minutes. Cautiously proceeded through day as seemingly almost normal.  At 10:30 pm........suddenly I felt seriously achy throughout my body, skin crawling and not wanting to move an inch. Nurseline said drink water, take temp(normal) and an Ibroprfin. Sleeping was very tough. Better today....the day after but still feel sore, tired and weak.
5 hours post vaccine came down with fevers, aches, pains similar to vial infection.  With in a week visited he primary for abnormal vaginal bleeding.  Date of that was 03/22/2021, patient has continued to have several office visits and emergency room visits  from June-October.  In July , 07/28/2021 was seen for massive vaginal bleeding where she was referred to OBGYN 08/31/201 pre op 09/13 total lap hysterectomy (almost 6 months to the day of 2nd vaccine)  With in a week had post op complications had drains placed.  Hospital stay was 09/20-09/25.  A week after that had ED visit for leg pain which then which was dx DVTs and patient placed on blood thinners.  September 2021.  October 3, 2021 presented to emergency room for vaginal bleeds and was admit to hospital
Woke early, then fell asleep again once up for the day (unusual). Didn't eat anything that day aside from nonstop breastfeeding (very unusual). Fell asleep again 2 hours before scheduled nap time (unusual). Very red injection site. Instead of one red spot on that leg, there were two. Slowly began forming two giant lumps under skin. They are swollen and hard to the touch. I emailed his doctor and received no response. Lethargic, crabby, loss of appetite, fever of 101.
pt recvd 1 dose of Engerix-B & 2 wks later elevated SGOT & SGPT observed which persist;
HAVE NOT HAD A MIGRAINE AGAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced have not had a migraine again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of have not had a migraine again was not reported. This report was non-serious.
after administration they wrote out the expiration date, but it was smudged therefore he couldn't read the month. caller reporting it was 2023 but month unknown with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age male patient and the reporter reported after administration they wrote out the expiration date, but it was smudged therefore he couldn't read the month. caller reporting it was 2023 but month unknown with no reported adverse event after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Immunization and after administration they wrote out the expiration date, but it was smudged therefore he couldn't read the month. caller reporting it was 2023 but month unknown with no reported adverse event (expired product administered) (latency: same day).      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 the 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.
Redness to be expected was present after the vaccine was given, per mom. Around 10am today (8/30), while changing pt diaper, mom noticed the redness has spread to cover the top of left thigh, per mom.
Patient is a 47 y.o. female with a history of diabetes, hypertension, TIA who presented from home on 9/2/2023 with COVID-19 pneumonia.  She also developed steroid-induced hyperglycemia requiring non-DKA insulin drip.  Patient was treated with remdesivir, Decadron, and IV Lasix.  Patient was initially on heated high flow nasal cannula at 75% / 30 L, and she was weaned to 2 L nasal cannula oxygen.  Patient completed remdesivir course in the hospital.  Patient will continue with Decadron as an outpatient to complete a 10-day course.  She will be discharged with home oxygen, and this can be weaned as an outpatient.  For her diabetes, she will be discharged with Lantus 40 units twice daily along with her Humalog 18 units 3 times daily.  Once her Decadron has been completed, she can decrease her Lantus to home dose 6 units daily and Humalog 18 units 3 times daily.  She will get home health care for outpatient PT/OT.          Assessment and Plan COVID-19 Pneumonia - Presented with: dyspnea, cough, but resolved - Positive COVID-19: 8/31/23 - Vaccination status: vaccinated with 2 doses, no boosters - CTPE on admission showed no PE, B/L GG opacities and consolidative opacities- edema vs PNA; B/L pleural effusions - Oxygen status: Discharged with 2 liters  - Decadron: Yes. Expected end date 9/11 - Remdesivir: Completed 5-day course in the hospital  Acute Hypoxemic Respiratory Failure -Secondary to COVID-19 and CHF -Resolved -Patient will go home with 2 L of oxygen, and this can be weaned as an outpatient.   Acute heart failure with preserved ejection fraction -Secondary to above -Echocardiogram 9/5/2023 demonstrated ejection fraction 69% with normal right ventricular systolic function. -Resolved with IV diuretics -Patient will be discharged with Lasix 40 mg p.o. daily.     Hyponatremia-- >resolved - Secondary to volume overload and COVID - Resolved   IDDM2 With Hyperglycemia - Hba1c 9% - Home regimen lantus 60 units, novolog 18 units TID plus sliding scale. In process of switching Ozempic to Mounjaro - Noncompliance with dietary indiscretion and overeating due to depression and recent stroke -During hospitalization, patient was treated with insulin drip -Switch to basal bolus insulin regimen on 9/3/2023  -Patiently discharged with Lantus to 4 units twice daily, and continue with Humalog 18 units 3 times daily -Once Decadron course completed, patient can resume her home insulin dosages. Chronic Microcytic Anemia - Partly related to menstruation - No signs active bleeding. Iron studies with low Fe but normal ferritin and low normal TIBC   H/o- MoyaMoya disease CVA with left-sided weakness - s/p STA-MCA bypass in 2020 -Follows with health stroke chronic -Continue with ASA; - hold statin given recent use of paxlovid outpatient    Morbid obesity - BMI 49 - lifestyle modification for weight loss imperative - Can be switched to Mounjaro as an outpatient   Seizure Disorder - Continue with lamotrigine
SLE; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 27Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient suffered from systemic lupus erythematosus (SLE) and has had both Pfizer COVID-19 vaccines but did not have the usual side effects from any of the doses. The patient did not develop a fever nor any flu-like symptoms which were commonly reported. The patient wanted to find out if the patient developed any amount of immunity. The patient was willing to participate in a clinical trial if there was one in the local area for patients with autoimmune disorders. The outcome of the event was unknown.   Information about lot/batch number has been requested.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 83 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
This case was reported by a physician via a sales representative and described the occurrence of injection site erythema in over 20 subjects of unspecified age and gender who were vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On an unspecified date, the subjects received an unspecified dose of Pediarix (unknown). The physician estimated that there were over 20 subjects who experienced local injection site erythema and induration on unspecified dates, after an unspecified time after vaccination with Pediarix. At the time of reporting, the outcome of the events was unspecified . Follow-up received on 22 June 2006 indicated that the office would not follow-up and did not provided the outcome.
Initial report received on 24 February 2014 from a healthcare provider via another manufacturer. A 5 month old patient, date of birth and sex not reported was immunized with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) and HAEMOPHILUS TYPE B (HIB) VACCINE, manufacturer unknown on an unreported date. Within a few months, date not reported, the patient experienced haemophilus influenza type b meningitis and possible vaccination failure. The patient has a history of being a twin born prematurely at 29 weeks gestation with intraventricular hemorrhage. The patient also has a history of gastroesophageal reflux disease. The patient received a 1st dose of PENTACEL and 2nd dose of Hib vaccine, (dates, route and site of administration) not reported. Concomitant medications include Zantac, dose and route not reported. Within a few months of vaccination in 2013, date not reported, the patient experienced haemophilus influenza type b meningitis and possible vaccination failure. Relevant test results included a CSF culture that was HIB positive by latex agglutination and haemophilus test positive in 2013. The patient was hospitalized, dates not reported. The patient outcome was not recovered (events were improved). No further details were available at the time of this report. Documents held by sender: None Addendum on 29 Jan 2018: Upon second medical examination of case at time of internal review the following has been modified in this case: Suspect product code changed to HAEMOPHILUS TYPE B (HIB) VACCINE from HAEMOPHILUS INFLUENZAE. Sender's Comments: PENTACEL as any vaccine, may not protect 100% of vaccinated individuals. In the reported case, the child likely received only one dose of PENTACEL and one dose of HIB, manufacturer unknown. It does not appear that the child was fully immunized at the time of the event. Additional information such as the full vaccination history, medical history, laboratory results confirming the diagnosis of Hib infection is needed to further assess the case.
got a headache and neck ache on same side as shot , started right after, headache lasted 14 days and then lingering , neck ache still there and feels like it went up into my head like brain fog  arm hurt really bad for 3 days   WILL NOT GET 2ND DOSE
Patient called on 04/12/22.  She said she had a terrible time this last few weeks because she had an allergic reaction to the vaccine in her mouth. She said she had some swelling inside her mouth and she couldn't eat. She said her mouth was burning, around her lips, mouth. She said she is getting better now. She just wanted us to let us know.
Shot was given in left deltoid but upon needle insertion I could feel that I was not in the muscle. Was still able to inject vaccine. After removing the needle the patient straightened his posture and I could tell that the injection was too high and more in the shoulder area. Patient said that he felt okay and no pain but then returned 3 hours later complaining of shoulder pain and limited range of motion. I instructed him to ice the area 20 minutes on and 20 minutes off and to take Ibuprofen. Area was not swollen. Upon follow up later that evening he said he was having a hard time laying on that side and was more comfortable sleeping in a recliner. He said he was still having pain the following morning and was going to go to an urgent care for further testing.
Pt developed bilateral arthralgias of all joints in hands and wrists approximately 3 weeks after second Anthrax immunization. Symptoms resolved in 3 weeks. After third dose, pt had whole body arthralgias lasting approximately for 3 weeks. Pt had no relief with ASA/Tylenol.
Pt fainted about 5 mins after getting vaccines. He states that he has done it in the pass when giving blood. He states he has been having freq fainting episodes lately. Pt placed on back in floor with both leg elevated. Pt was able to situp within 30 seconds, bp checked freq and was wnl at all times. Pt stated ok to leave after 5 mins of sitting in chair. BP was 130/76. no s/s of complication at that time. Pt states will us know at next visit that he has a hx of fainting. Instructed to see pcp regarding freq fainting.
#1. Tired. Sore arm. Headache. Increased heart rate  #2.  Aches. Low grade fever 100.4. Body aches headache x 24 hrs. Increased irregular  heart rate
Developed swelling, pain and difficulty moving left arm. Also has itching all over.  Ice applied and instructed to use on site.  Sent to Urgent Care center for f/u and treatment.
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.   No Medical History information was reported.  On 20-Mar-2021 at 2:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:44 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 50.00 years  Concomitant products were not provided.  On 09-Mar-2021, the vaccine with batch number 031A21A was moved to fridge. On 20-Mar-2021, 19 vials were moved to the clinic. On the same day between 09 AM to 10 AM, vials underwent temperature excursion with temperature of 34 and 37 degrees Fahrenheit respectively. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 08-Apr-2021.   It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
Initially redness of the eye lids within several minutes of the injection. Both eyelids and upper lip (slightly) were swollen  were as well by the next morning.
"COVID arm"  About 7 days after receiving the vaccine, I developed an approximately 2 inch diameter slightly raised, itchy, tender red "rash" at the injection site.  Prior to this, I had only experienced minor fatigue and overall bodyaches the day after the shot.
Developed 8 food allergies after taking varicella vaccine.  Had eczema and rash beginning the day of the vaccine. Later developed allergies to 8 very common food and food ingredients - effects include vomiting, irritability, rash, itching.
Narrative: Patient tested positive for Covid-19 and was hospitalized despite full vaccination of Pfizer dose 1,2, and 3 (booster).