chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had 2 Twinrix doses, missed 3rd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (received 1st dose on unknown date) and Twinrix adult (received 2nd dose on unknown date).   On an unknown date, the patient did not receive the 3rd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's comment: The patient self-reported this case. The patient had 2 doses of Twinrix vaccine in the correct time and the 3rd dose was missed at 6 months.  The patient enquired if she could get the 3rd dose now.  The lot and expiration dates were not provided.  The date of vaccination were unknown reporter disconnected abruptly. No additional information could be collected for adverse event. The consent for follow up was not provided. Additional supportive information: Till the time of reporting, the patient did not receive 3rd dose of Twinrix adult, which led to incomplete course of vaccination.
L HAND DORSAL ASPECT WITH TINGLING AFTER 10 MIN. Resolved in 5 minutes.
Nurse reviewed record to see what infant need for vaccines for this appt. She needed Dtap, IPV, Rota, PCV13, Hib. She gave KINRIX (Dtap-IPV), Rota, PCV-13 and Hib. Nurse should of given PEDIARIX, Hib, PCV13 and Rota. No adverse reaction occurred.
w/in 24 hr of vax lt deltoid was red & swollen (size of a silver dollar); A few other red swollen areas occurred below the largest reddened area; no swelling occurred below the elbow; mom started APAP p/the vax; t99.8;mom contacted MD
MEDICATION ERROR Patient received Pfizer (EW0173) as a second dose in the covid vaccine series. Patient was monitored for 40 minutes with no adverse effects.
I have had a swollen injection site with a raised rash around the  injection area (approximately 2in) since the injection. I thought it would go away but it has been almost 2 weeks.
Information has been received from a physician concerning a female (NOS) who on approximately 07-Dec-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Immediately after receiving the injection on approximately 07-Dec-2006 the patient developed hives in the same arm where she received the injection. The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the hives.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), RASH (Rash), INJECTION SITE ERYTHEMA (Red circle around injection site) and MYALGIA (Soreness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (Itching), RASH (Rash), INJECTION SITE ERYTHEMA (Red circle around injection site) and MYALGIA (Soreness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 11-Feb-2021, PRURITUS (Itching) and RASH (Rash) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red circle around injection site) and MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Telephone call from mom 3/18/04 in PM- Child woke up and with red, swollen areas on legs  & 102 temp (R). Mom gave Tylenol with relief- After lunch Pt acted dizzy & lethargic- Temp 103 (R)- "Just not acting right". Advised to take pt to ER for evaluation by doctor. 3/04 Note: Follow-up with mom- Spoke to child's doctor (Peds) advised to give Tylenol for 24 hours & call doctor back if no improvement. Doctor states normal reaction- mom to call health department back if any problems- no return call.
I had nausea, vomiting, chills, fever (up to 103F) before taking a fever reducer, body aches, fatigue, I couldn't stand for very long with out feeling nauseous. My left arm still hurts more than the rest of my body but I still have some body aches too. The chills started around 7:30 on the 10th and while I still have pain from body aches it now feels like a really hard workout from the gym. I was able to break my fever for good by the 12th and regain my appetite.
she woke up with a swollen lip; This is a spontaneous report from a contactable consumer (Patient herself). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 Immunization. The patient got her second dose about 3 weeks ago, yesterday she woke up with a swollen lip, that looks like it's ballooning on the left side. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Admitted to hospital on 11/5/2021 with community acquired pneumonia, COPD exacerbation, benign essential htn, on 11/5/2021.  On 11/7 developed acute STEMI, likely RV infarct at ~8am.  Code STEMI, transferred to hospital for emergent cardiac cath, possible PCI.  Noted to have cardiogenic shock, respiratory failure, Acute mycodardial infarct, lactic acidosis, which was deemed non-survivable.  Expired at 1:25 pm on 11/7/2021
61 year old male received undiluted COVID19 Pediatric Bivalent 5-11 year old vaccine
receive Covid-19 vaccine #2 January 26th 10:00 at employee health. I developed symptoms of fever (100.5-100.7), sweats, chills, headache, body aches during the night. Symptoms continued at this level for 24 hours. My daughter's school required me to get a PCR test in order for her to attend school in person. I had a PCR test Jan 27, that was negative. Fever came down, sweats and chills improved by the night of the 27th. Headache continued. I had loss of power in my muscles, without "muscle aches". My muscles felt extremely fatigued climbing one flight of stairs or carrying a basket of laundry. I stay home from work and used sick time, 10 hour shift Friday January 29. I continued to have a sense of loss of power in my large muscles, especially my legs. I fell on the ice Sunday January 24 and hit my head. I think lack of strength contributed to the fall. I had a headache before the fall from the Covid vaccine. I had a bad headache Sunday after hitting my head. Headache lasted a week. My symptoms, headache and muscle weakness went away by Sunday February 7th.
Symptoms began on Wednesday the day after the shot was administered. I had swelling, severe pain, redness, chills, body aches, the area around the shot about a 4 inch diameter was hard.  I went back to the doctors office and they told me to heat, take ibuprofen and prescribed me 875 mg pills of amoxicillin.
Confusion, dizziness, inability to call out for help, followed by period of unresponsiveness with loss of bladder control, unable to determine exact time frame- probably not more than 30-45 min before able to recover sufficiently to access support, difficulty thinking clearly and unable to manage self-care without assistance for several hours; assisted to bed and slept through the night without further incident
Patient reports muscle spasms at the site of the injection and headaches. She says she was hospitalized for 2 days after vaccination. She also reported an itchy rash and nausea.
Inflammation of injection site with erythema onset 24 h post injection. Pt treating with BENADRYL and cold compress.
stressed me out; My pressure was up when I was dating this man who stressed me out/ I stopped dating him and my blood pressure has been just fine; This is a spontaneous report from a contactable consumer.   This 72-year-old female consumer (patient) reported for herself that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced her pressure was up when she was dating that man who stressed her out. She stopped dating him and her blood pressure has been just fine. She got both doses of the Pfizer covid vaccine. Then in June, on 06Jun2021, she was in a car crash, her jeep got onto fire and her vaccination card burned up in the crash, need to get a replacement card. Will be 73 years old next month and was very healthy for her age. She takes 2 pills. One of them is a 1/2 of a blood pressure pill. Her pressure was up when she was dating that man who stressed her out. Stopped dating him and blood pressure has been just fine with that 1/2 pill. Do not even take the potassium pill and when her blood was checked, her potassium was just fine. Not getting that booster shot. Have 2 girlfriends who got that booster shot. One of them died 2 days after getting that booster and the other one was in the hospital right now. To be honest, their health was terrible. Hated to talk to them because it was depressing. They had blindness and serious cancers, like breast and liver cancer. Just did not even want to hear about it. Outcome was unknown for stressed me out and was resolving for the other event.  Follow-up (03Oct2021): This is a follow-up spontaneous report from a contactable consumer. This 72-year-old female consumer (patient) reported for herself.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
On the morning of the 10th day after vaccine I woke up with a 1.5inch ring of redness around my injection site. No pain or itchiness.   I am pregnant with second child. Due July 21,2021. No adverse events with pregnancy known at this time.
Chills, fever, huge headaches, muscle pain, joints pain, difficult in breathing, heavy chest,  nausea, frequent urinations,  random pinching sensation on my arms.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 10Aug2023 ,stop date: 15Aug2023).   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300280047 Same reporter/patient, different drug/event;
Client was given expired dose of hep B in error. Vaccine exp 11-13-11, after 30 min. No adverse s/s observed or voiced.
V-safe requested I complete VAERS form. I attended my medical school reunion which required proof of booster and negative rapid test to enter. Events on 6/3/22 and 6/4/22. I became symptomatic 6/5/22 at 2 AM with sore throat, headache and cough. My I-Health Rapid Covid test was positive later that day despite having received 4 vaccines (1st 3 were Pfizer). This was my first documented episode of Covid despite being a primary care physician for the past 2 years of the pandemic. Subsequently 21 more people from my medical school reunion class tested positive over the next 5 days - I have dates of all of their last booster shots and many had received 4 shots like me and got Covid for the first time at the reunion.
Diarrhea every time I eat anything; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea every time I eat anything) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea every time I eat anything). At the time of the report, DIARRHOEA (Diarrhea every time I eat anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 81-year-old male patient who received ENGERIX B Adult. On 15th March 2017, the patient received the 2nd dose of ENGERIX B Adult. On 15th March 2017, 1 hr 30 min after receiving ENGERIX B Adult, the patient experienced nausea (serious criteria hospitalization), sweating (serious criteria hospitalization), felt faint (serious criteria hospitalization), balance difficulty (serious criteria hospitalization) and vomiting (serious criteria hospitalization). On an unknown date, the outcome of the nausea, sweating, felt faint, balance difficulty and vomiting were recovered/resolved. It was unknown if the reporter considered the nausea, sweating, felt faint, balance difficulty and vomiting to be related to ENGERIX B Adult. Additional details were provided as follows: The event was previously reported to a doctor. The patient received vaccine at about 1:30 PM. The patient also reported that this injection was 2 days later than normal. It had been 32 days after his 1st injection. In the early evening, the patient felt nauseous, vomited, felt like fainting and sweated profusely. Also, the patient noted he had difficulty balancing. The patient called the rescue squad at about 8 PM and was taken to the hospital. He spent one night and was discharged. The patient provided limited physician information about address and contact information.
pt recvd vax;pt had been v all noc;to md & dx of ear infect;given atbs & shot for v;
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Additional Details: TEN MINUTES POST VACCINE, PATIENT STATED SHE WAS HAVING A HEADACHE, SOME DIZZINESS AND FELT SOME THROAT TIGHTNESS. PATIENT SAID NO TROUBLE BREATHING. GIVEN TWO BENADRYL 25MG AND FELT RELIEF ABOUT 20 MINUTES LATER. PATIENT VITALS STAYED NORMAL THROUGHOUT EPISODE. PATIENT SPOUSE PICKED HER UP ABOUT 35 MINUTES AFTER REACTION.  FOLLOWED UP WITH PATIENT HUSBAND AND PATIENT FEELING GREAT AND NO SYMPTOMS.
7/16/09 pm - Received care from MD's office stating, pt. there with c/o "redness and knot" in right deltoid area - child had school booster at Health Dept on 7/14/09 - Mom states arm became red, swollen and hot to touch on 7/15/09 - States very red on 7/16/09 - States "that's when I came here to the doctor".
2-16-07- broke out in lesions, having itching. She states 4 days after receiving vaccine her arm was swollen, red and had a lot of pain. She did not report it until 2-20-07. Took pictures of lesions and reported them to Doctor. To stay home until lesions crust over.
1. Acute bilateral pulmonary emboli. 2. Extensive left lower extremity deep vein thrombosis. 3. Status post catheter insertion into left lower extremity with  tPA thrombolysis and thrombectomy.   4. Status post venogram and stent placement into left iliac to common femoral artery
PAIN & ITCHING AT ARM AND INJECTION SITE.  DISCOMFORT/PAIN/RASH AT LOWER BICEP AREA.  WARM TO THE TOUCH, INFLAMED. FELT SMALL BUMP AT LOWER BICEP.  NO FEVER.
site of flu vax red & warm;redness measures 4.6cm x 6cm;mild soreness @ site;noticed it all the next morning @ 715AM;c/o itchy inside also;29OCT98 no redness & no warmth;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient passed out after about 7 minutes. Was unconscious for about 2 minutes. had a pulse and was breathing but Paramedics were called but patient recovered and denied further treatment
Approximately 80 hours (3.3 days) following the vaccination, site became noticeably reddened and very warm to the touch, encompassing a 12x9 cm area on the upper arm. Injections was given in the distal deltoid v proximal. Up until this time, site had been significantly sorer than previous vaccinations. Sxs persisting on Day #4 w/o worsening. Pt is a retired surgical nurse who sees no reason for medical intervention.
Initial literature report received on 03 Jan 2011: The authors presented 3 cases of lichen planus (LP) occurring after influenza vaccination.  This patient was vaccinated with inactivated INFLUENZA (manufacturer and batch number: unknown) and 2 weeks after vaccination the patient developed lacy white plaques and erosions on both buccal mucosa and later spread.  She had neither dental alloys nor dental fillings.  She had not received any medical treatment for any diseases before the injection.  A test for oral fungal infection was negative.  HBV or HCV infection testing was negative.  A biopsy specimen obtained from the buccal mucosa showed basal cell liquefaction with band-like lymphocytic cell infiltration, consistent with oral LP.  During the follow-up period of 1 year, the eruption had gradually disappeared with topical dexamethasone.  The author commented that subclinical reactivations of varicella zoster virus (though the patient was asymptomatic, the serological evidence does not necessarily exclude the possibility of previous herpes zoster) subsequent to influenza vaccination may be involved in the occurrence of LP in a striking linear pattern.
I63.9 - Cryptogenic stroke (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) N17.9 - Acute kidney failure, unspecified
My bowel perforated on November 22, 2022. I took an ambulance to the hospital. I had an emergency CT scan. It also showed Peritonitis. I had emergency surgery to remove the offending piece of bowel, flush out the area, and install a colostomy bag. They covered the incision, but they left it open. On the 8th day in the hospital, they closed the incision. They discharged me yesterday. They also gave me several medications.
8 hours after vaccine: severe headache, fatigue, muscle aches, joint and bone pain, night sweats, dizzy/ light headed, exhausted to even walk to bathroom and back.  Most symptoms resolved by 60 hours post injection.  Persistent - headache, lightheaded, poor endurance.   *woke up out of sleep extremely restless with all above symptoms 16 hours post injection   *Injection site :  less than 24 hours post injection noticed erythema, swelling , warmth,  raised firm area- larger than silver dollar sized, moderated  pain to touch - persists at 84 hours post injection.  Progressively worsened daily.  Itching began to injection site around 60 hours post injection and continues.
Yesterday had DTaP, MMR, and IPV. Today had fever, 4cm area of erythema, hot to touch, tenderness right arm.
Patient called and stated that she had a reddened injection site with a rash that was hot to the touch. She claimed that she was unable to sleep and had to sleep with an ice pack. She said that she reported it to an MD and saw a few of them for consult.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 07-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sore throat; Diarrhea; Sweats; was shaking bad; Head was killing her; had cold chills; Vomited; Left arm was sore arm where received the injection; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), TREMOR (was shaking bad) and HEADACHE (Head was killing her) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), TREMOR (was shaking bad), HEADACHE (Head was killing her), CHILLS (had cold chills), VOMITING (Vomited) and INJECTION SITE PAIN (Left arm was sore arm where received the injection). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), TREMOR (was shaking bad), CHILLS (had cold chills), VOMITING (Vomited) and INJECTION SITE PAIN (Left arm was sore arm where received the injection) had resolved and HEADACHE (Head was killing her) had not resolved.        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.   Company comment: This case concerns a 43-year-old female who experienced NS events of unexpected tremor, oropharyngeal pain, diarrhea, hyperhidrosis, tremor, and expected injection site pain, headache, chills, vomiting. Event onset occurred the same day as the first dose of mRNA-1273. Treated with paracetamol. Based on 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.   Reporter did not allow further contact; Reporter's Comments: This case concerns a 43-year-old female who experienced NS events of unexpected tremor, oropharyngeal pain, diarrhea, hyperhidrosis, tremor, and expected injection site pain, headache, chills, vomiting. Event onset occurred the same day as the first dose of mRNA-1273. Treated with paracetamol. Based on 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.