chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix inadvertently administrated to 9 month old; Kinrix: inadvertently administrated instead of dtap and polio; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that medical assist inadvertently administered one shot of Kinrix to the patient instead of dtap and polio, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter asked what was recommended going forward. The reporter consented to follow up.
Patient experienced sore at the injection site and fatigue for 1 day, no fever, no chill, no headache
CHIEF COMPLAINT Patient is a 77 y.o. male who presents after being found down.    HISTORY OF PRESENT ILLNESS Patient is a 77-year-old male with past medical history significant for hypertension, hyperlipidemia, diabetes mellitus type 2 who suffered a fall resulting in a prolonged period down before being brought to the ED on 09/29/2021.   Patient reports that he was using a weed whacker in the front lawn when he unexpectedly fell.  Patient was unable to get up secondary to weakness and pain.  Patient believes that he was down for approximately 8 hours before being found by son and brought to the emergency department.  At presentation, patient reported profound pain in his leg.  No evidence of fracture on lower extremity or pelvis x-ray.  CT head unremarkable.   Patient states that he has been falling more frequently over the past 6 months; approximately 2 times per month.  However, he states that he fell 3 times in the 24 hour period prior to presentation.  Patient denies loss of consciousness or presyncope.  He states he merely loses his balance prior to each fall.  This typically occurs with extended periods of exertion, such as walking long distances.  Patient describes himself as healthy but deconditioned due to limited exercise over the course of the past year as result of COVID related restrictions.
This was the #1 dose of the SHINGRIX vaccine for Shingles, administered by the RN at Community Internal Medicine. The shot was given to me at apx 12:30pm. I felt fine and no pain until apx 7pm when my left arm was noticeably sore (no other symptoms.) I woke up in the middle of the night, about 1:00 not feeling well (cold, achy). At apx 4:00am, I began having chills, was sore and had a headache. (My husband got winter PJs for me to wear and I used a blanket, duvet, and the bread spread on top of me to get warm.) I stayed in bed until about 8:00am when the chills had lessened somewhat and took and NSAID-Meloxicam hoping it would help my headache, slight fever, and aching. (When I took my temperature it was just over 99; my normal body temperature is 97.6.).  The following is my complete list of symptoms as of 8:00am this morning: Arm soreness, Chills, Aches, Low grade fever, Headache, Slight nausea, Fatigue.
34 y/o male given anthrax vaccine prior to deployment. Presents at clinic, 48 hrs after with Redness, Swelling, Pruritis, Pain, Warm to touch to right arm. On exam redness/induration is 15cm x 12cm on Right upper Arm and is warm to touch. No systemic issues. Will treat with Ice Pack, Motrin 800mg, and Benadryl per conversation with Dr (Allery/Imunizations) at Medical Center. Manufacturer (Bioport Corporation).
shingles; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (unknown demographics) who had shingles (herpes zoster) when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date (several years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in the unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious shingles (herpes zoster) (unknown latency, intensity: mild) following the administration of INFLUENZA VACCINE.  She did not think that first shot protects people forever. Her plan was to get 2 new shots which would probably prevent her from getting shingles at all.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 09-JUL-2016, the patient  was vaccinated with ZOSTAVAX (strength 19400 PFU, lot # L046295, exp date 17-FEB-2017) subcutaneously. During administration, the vaccine "leaked back out of the injection site" and went down the patient's arm, resulting in topical exposure and administration of a partial dose. No adverse effect was reported. No product quality complaint was filed. Additional information has been requested.
Missed the 2nd dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine) in a male patient of an unknown age 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 PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
SOB, Dyspnea. Febrile, Tachycardia, Hypotensive 38.1C HR 92, SPO2 93% on 5L NC, 97/52 BP,  Resp 24.
Swelling and induration at site starting day after injection (4/13/10). Pt came in on 4/15/10 for check and at that time induration was 30 mm round and redness was 70x50 mm round.  Minimal pain.  Pt cites had occurred before when she received a SQ injctn from pediatrician many years ago and forgot to mention it before this injection was given.
One week after receiving first inoculation I am experiencing some swelling, rash, aching  and itching. at the injection site.  I will take some Benadryl to relieve symptoms.
Itching; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H524, expiry date 22nd October 2021) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th September 2019, less than a day after receiving Shingrix, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed an itchy red area around the infection site the evening the product was administrated. The reporter stated that after about 11 days, the patient came in and the itching and redness were improving and have been improving everyday. The reporter consented to follow up.
States fatigue, itching around face, neck, scalp, shoulders, ears.  Flushing of face, also apparent.  Started itching again left arm toward back.
Signs and symptoms developed 2 hours, post vax. The pt had a temperature of 101F, generalized tremors and shaking. Questionable seizures. The shaking and tremors lasted 5 minutes, then his eyes rolled back, the infant was lethargic and limp with shallow breathing. The mother called 911. The paramedics monitored the infant. The pt received Tylenol alternating with Motrin. The mother called the doctor and was told that if the signs and symptoms continue or persist to call 911 again and go to ER. No further RX necessary.
sore arm; chills; nausea; vomiting; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 01-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown and CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 06-Apr-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient got shingles after receiving 2 doses of Shingrix and wanted to know if there was a place to get this information reported. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
On the morning following the Moderna Covid Booster Vaccination, my palms and upper lip became very itchy. The next morning, my right eyebrow was puffy and swollen, and hives appeared on my chest and neck. The hives appear and disappear randomly on my body. When they appear, the hives are itchy, feverish, and burning. They last about thirty minutes to forty-five minutes wherever they appear. After that time, they disappear from that spot on my body and appear somewhere else on my body. This happens day and night and has been going on since the morning after having received the booster shot.
Redness, warmth, and swelling at injection site. Patient had similar histamine reaction to first shot of SHINGRIX as well.
She received vaccine March 26, 2021. A day after receiving vaccine, she reported feeling a hypersensitivity on skin. It started in lower back as a scratcy feeling of her shirt. It has since spread to her entire body. It is a scratcy feeling, and it feels like she can crawl out of her skin. It is very irritating. If she puts pressure on skin, it does not cause the the effect. It is not a pain.  She reported no rash so far.  She reports still feeling this way on Monday, March 29, 2021. She decided to call and ask about it. I told her to monitor for rash or worsening of symptoms.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 06-MAR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Myalgia & NauseaVomiting Narrative: dose 2- Nausea Headache Body aches fatigue
Mom c/o that when she received the varicella vaccine the child's left eye, cheeks, and arm swelled up. Allergic.
High fever (103.1) + Fever reducing medicine (Acetaminophen)  Chills, Lethargy, Severe Headache (treated with Ibuprofen), Blurred vision, loss of appetite on Day 2, increased thirst, sore throat, minimal pain to injection site
A bivalent Moderna booster indicated for patients aged 6-11 years was inadvertently given to this patient.
Skin 6 x 7 cm area of erythema and mild edema on extensor surface of right upper arm surrounding injected site.
rash on his upper arms (both); This is a spontaneous report from a contactable consumer (Reported for himself). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3246), dose 1 via an unspecified route of administration, administered in arm left on 11Jan2021 (age at vaccine 70-years-old) as dose 1, single for covid-19 immunisation at Senior Living Facility. Medical history included cardiac disorder (heart disease), diabetes mellitus and hypertension (High blood pressure); all from an unknown date and unknown if ongoing. Concomitant medications, the patient received within two weeks of vaccination: Yes. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Relevant past drug history was not reported. The patient has no reported allergies. On an unspecified date in 2021, the patient experienced rash on his upper arms (both). The case assessed as non-serious. No treatment was given for the events. The second dose was scheduled on 02Feb2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
I got sick from it; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got sick from it) 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 ILLNESS (I got sick from it). At the time of the report, ILLNESS (I got sick from it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
This spontaneous report was received from a pharmacist via a company representative concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection, by subcutaneous route (strength, dose, lot number and expiration date were not reported) for prevention of shingles. The pharmacist reported that the patient was getting the shingles virus (herpes zoster) after receiving the ZOSTAVAX on an unknown date. No symptoms were reported. At the time of the report, the outcome of the event was not reported. The causality assessment between the event and the ZOSTAVAX was not reported. Additional information is not expected as the reporter did not consent for follow attempts.
At onset of monthly menstrual cycle, my PMS was much more severe than normal, and included severe pelvic pain, severe breast pain, migraine headache lasting three days, back pain, fatigue, nausea, and heavy menstrual bleeding. I have an IUD and I normally only experience spotting for 2-3 days during my cycle, so heavy bleeding is not normal for me.
33 yr old patient was administered ANTHRAX, Hep B, seasonal flu, H1N1, Tdap and Typhoid on 2/23/10. On 2/26/10 at approx. 01:00 am patient started having diarrhea, vomiting, lightheadedness and shortness of breath.
- NO inflamtion @ sight or swellg @ sight (-) Fevers (+) Histy of vertigo (BPV) Feels vertigo @ night in bed. Not sure related  to vaccine but wanted to report it
Death Narrative:  Death on 12/27/20. 1st dose 10 days before serious event. Patient was admitted for hospice care at the facility with bladder cancer with mets to liver, lung, and bone. There are no indications that death was related to the vaccine.
Patient got a shot on 7/2/2018 in the evening around 3:30-4pm. On 7/3/2018 around 9-10 am, he start having a low fever (his body very warm but the temperature isn't touch 98-99 yet. Around 3-4 pm, he got fussy and a little cranky. I use cloth with warm water to wipe his body such as armpit to make sure his temperature isn't go high. At 6pm, I checked his temperature under armpit, it is around 99.9. I was nursing him and he just had seizure right in my arm. I called 911 and we went to the hospital. After that, I gave him ibuprofen as the doctor said. However, he still have fever. So On 7/5/2018, I went to hospital again and this time diagnosis as Left acute otitis media.
Fever   Narrative: Per supervisor report: "called out this AM [3/17] at 0517 for  Authorized Absence, secondary to the COVID vaccine she received on  Monday, March 15, 2021. Her stated symptom fever 101.    Other Relevant History:
The pharmacist went to administer the second dose of my COVID pzifer vaccine. She pulled the needle out of my right arm when instantly I felt dripping down my arm. I told her immediately and she wiped my arm off. She stated that I would be fine it was a lot though more than just a drop. I voiced my concern about proper dosage. While sitting for my 15 minutes I looked on the CDC website and it says as long as I got half the vaccine I don?t need to repeat. I voiced my concerns again and she said I would be fine she was sure I got half of the vaccine but if I?d like she would give me another dose in my other arm. I refused as she said I got more then half the shot but I personally disagree. If she really thought I was vaccinated properly why even offer me another dose? She wasn?t sure herself.
1 day after injection of DTaP and MMR in right arm, she developed red lump on right upper arm. This has continued to swell on second day. Erythema has spread to 10x11cm area of right upper arm.
2/24/2023 I woke up not feeling very well. I had a slight sore throat and cough. I was feeling tired, not energetic at all. Normally, I am energetic. I did a home COVID test and it was positive. On 2/25/23 I went to the walk-in clinic and was prescribed Paxlovid. I began taking it that day. I never got really sick, did not have a lot of symptoms. I immediately began feeling better. I did not sleep very well for two nights but felt less sick. On 2/26/23 I felt better. My head was a little stuffy and I had a little bit of a cough. By 2/28/23 I went back to work. I feel like I have recovered. However, I am a little congested again and am not sure if it is from the COVID or if it is a cold.
fever, restlessness, abdominal pain, limb pain all resolved within 24 hours
weak as a baby kitten/It is got me weak; It is got me weak and I cant do anything; chills; extreme body aches; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 (at the age of 80-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the Pfizer covid vaccine 2 weeks ago, was experiencing, chills, extreme body aches (2021), and weak as a baby kitten (Sep2021). Patient wanted to know what to do about the side effects, and how long will they last. Patient stated, it had been 1 week ago today It had got me weak, and I cannot do anything (Sep2021), I sure wish it would leave me. The events were assessed as non-serious. The clinical outcome of events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient experienced her left cheek was swollen and red also hot. she stated her lips was numb and tingly
Shots given at 11:30 am on 10/26/2006. At 2:00am on 10/27/06 she awoke with a fever of 104.2F. Given Tylenol and cold bath to reduce to 102.1F.
This spontaneous report as received from a pharmacist refers to an approximately 50 year old female patient with an allergy to codeine and morphine who on 31-JUL-2013 was vaccinated with a dose of ZOSTAVAX (Lot No. H024045, exp. 14-FEB-2014) vial 19400 PFU subcutaneous. The patient reported to be on "a few" concomitant medications. It was reported that on an unknown date the patient visited the pharmacy due she developed an injection site section 4 inches in diameter that was red, itchy and patient described it as "felt like I've been stung by a bee". No lab diagnostic tests were performed. The pharmacist recommended BENADRYL and ice. Developed an injection site section 4 inches in diameter that was itching. At the time of the report the patient was recovering from the events.  Relationship between the reported events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Hospitalization within 6 weeks of COVID vaccination. Hospitalization on 10/29/2021 for gastric ulcer with hemorrhage, acute blood loss anemia.
3JUL93 abdo pain; 7JUL93 diarrhea (severe) 4 days; treatment w/Levicin on 9JUL; 7JUL93 tingling in lt foot; 8JUL near total numbness in lt foot from ankle down;