chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The indentation is now around the size of a five cent piece that is dark and has been getting deeper in indentation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "They got the first 2 doses 2 weeks apart"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE.), for COVID-19 immunization, reaction(s): "Soreness". The following information was reported: INJECTION SITE INDENTATION (non-serious) with onset 2022, outcome "unknown", described as "The indentation is now around the size of a five cent piece that is dark and has been getting deeper in indentation".  Additional information: Reporter stated that they had both had the series of Pfizer injections where they got the first 2 doses 2 weeks apart and then got the 3rd, 4th and 5th booster, caller stated they had a total of 5 injections. Caller stated after the 3rd dose, both of them experiences soreness that went away after 3 or 4 days. Caller stated after the 4th dose in the 4th month of this year, about 10-14 days after it made his wife's skin got brown and they thought it was bruising. Reporter stated her skin was dark and it started making like an indentation where it kept sinking where the injection site was. Reporter stated the indentation was then around the size of a five cent piece that was dark and had been getting deeper in indentation. Reporter stated it had gotten deeper over the last month. Reporter stated when they went to get their 5th injection, the pharmacist said she had never seen that before.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368860 same reporter and drug, different patient and event;
68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Consumer reports that p/1st immun @ age 2 mos, pt devel diarrhea which lasted 3 wks; p/2nd immun @ 4 mos, devel diarrhea again lasting 3 wks (more severe);
Pt recvd 1/2 dose DTP 25APR91 & devel fever; 20AUG91 pt recvd 2nd 1/2 DPT c/o arm hurting, fever, h/a, laid around a lot; 26AUG91 c/o stomach ache upon arising, "didn't feel good", "shaking", fever, vomited x 1, limpness, sz; poss viral syn
Patient reports fever, lethargy, and light-headedness that effects her ability to walk and perform normal daily activities. These started the morning of 9/5/21. We spoke in the mid afternoon. Several hours later I called her to follow-up and her light-headedness had decreased somewhat.
This is my 5th shot and I had no reaction to. This shot I had nothing. It started like a cold. I had a slight sore throat and runny nose. I developed a cough that was really bad. It became painful and hurt in my abdomen and back. I was given additional medication from my doctor. MUCINEX DM. The congestion and cough were still bad. I went into the doctor yesterday and she prescribed a ZPAK. I actually am feeling better today. I think it's virus that has been going around. I have this cough that I'm treating it with regular cough medicine.
body aches - 1 hour after 6:10 pm vaccination for several hours.  None by the next morning.
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient was 15 years old at the time they received the booster (3rd dose). No reported adverse events.
The patient is a 89 y.o. male with history of CAD, CHF, CKD presented from the urgent care clinic for progressively worse SOA and lower extremity swelling.  His wife tested positive for COVID 4 days prior to admission.  Patient transferred for COVID pneumonia, CHF exacerbation, hypoxemia.   Acute hypoxemic respiratory failure secondary to COVID-pneumonia and CHF exacerbation Covid-19 Virus Infection Date of onset of symptoms: 9/30 Symptoms present on admission: Shortness of breath Date of covid positive test: 10/2 Vaccination status: vaccinated Imaging: CXR mild to moderate interstitial opacities throughout the lungs suggesting interstitial edema Oxygen requirements on admission: 2 L nasal cannula Needed HF, but now on RA at rest and needing 2L on ambulation for discharge Consultants following: Infectious disease Anticipated special isolation end date: 10/10 Started remdesivir and dexamethasone on 10/4 Discharge home on decadron     Acute HFrEF  HTN HLD CAD ECHO in 7/2021 with EF 35%, grade 2 diastolic dysfunction Patient with 1+ bilateral lower extremity edema but no crackles on exam, given insensible losses of respiratory failure 2/2 COVID-pneumonia  Started on IV diuresis with bumex Continue home Coreg, aspirin qOD, amlodipine, atorvastatin, Plavix, lisinopril  Bumex twice daily- discharge home on bumex 1 mg bid, and will resume lisinopril Fluid balance -7 L   CKD 3 Baseline GFR 25?29, stable on admission Cr at 1.79, around baseline Continue to monitor Resume lisinopril on discharge   Thrombocytopenia Platelets of 130  Likely due to infection improvd RLS Continue home Mirapex   BPH Continue home doxazosin   GERD Continue home famotidine
Horribly sick; Diarrhea; Still not feeling particularly well; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Horribly sick), DIARRHOEA (Diarrhea) and MALAISE (Still not feeling particularly well) in an 81-year-old male patient who received mRNA-1273 (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol (patient did not report any historical medical condition, but is on unspecified blood pressure, blood thinner and cholesterol medication.s) and Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and PANTOPRAZOLE for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced ILLNESS (Horribly sick), DIARRHOEA (Diarrhea) and MALAISE (Still not feeling particularly well). At the time of the report, ILLNESS (Horribly sick), DIARRHOEA (Diarrhea) and MALAISE (Still not feeling particularly well) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications taken by the patient include baby aspirin, pantoprazole, Blood Thinner Medication, Cholesterol Medication, Blood Pressure Medication   This case was linked to US-MODERNATX, INC.-MOD-2021-100410 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100410:Wife case
7/27/21: presents to the ED with confusion and generalized weakness. Son states pt has been forgetful, unable to verbalize, and has not been finishing sentences. Chest x-ray was read as:  Mild pulmonary vascular congestion.  admitted. Treated for PE/DVT. Not treated for any disease related to Covid. 8/27/21: discharged Note: previously vaccinated with Moderna COVID-19 vaccine: First Dose: 01/07/21 Lot Number O11J20A; Second Dose: 02/04/21 Lot Number 029K20A
Pt received Covid vaccine at 1725. At about 1730 pt let out a little moan, fell back into the chair and stiffened up. She began to have seizure like activity. Pt?s father caught her as she slid out of the chair. After approximately 5 seconds of seizure like activity pt went limp and slouched over in her father?s lap and was not responding to voices. Pt?s dad placed back into chair and pt then lifted head and was awake. When asked if she was ok she stated yes. Total episode lasted about 10 seconds. Pt was alert and was responding appropriately to questions. Denied and symptoms prior to episode. Denied any further symptoms following episode. Pt stayed in exam room with parents for 30 minutes and left clinic with no further symptoms.
Severe headache, light sensitivity-nausea-full body aches-intensely sore left arm
My neuropathy consists of pins and needles in my feet and heat going down the back of my legs. On the first day of the reaction, there was a significant increase in both pins and needles and heat. Also, started to experience restless leg syndrome which I had never had before. The next day I suffered from nausea. The next night the pins and needles and heat was even greater and the restless leg syndrome continued. Eventually, I had what felt like a hot flash and I thought I was all sweaty. My wife felt my shirt and body and said I was not sweaty. Immediately, after the hot flash, the restless leg syndrome disappeared and the pins and needles feelings were greatly reduced.  I have never experienced anything like the hot flash, before.
Irregular (extra) and heavy periods; Irregular (extra) and heavy periods; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in arm left on 22Apr2021 13:00 (at the age of 44-year-old) at dose 2, single for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing. Patient had no Known allergies. Patient did not have covid prior vaccination. Patient has not tested for covid post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); lamotrigine (LAMICTAL); sertraline hydrochloride (ZOLOFT); lithium (LITHIUM), all the drugs taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 25Mar2021 13:00 (at the age of 44-year-old) at dose 1, single for covid-19 immunisation. On 23Apr2021 the patient experienced irregular (extra) and heavy periods. Patient did not receive treatment for the adverse events. Outcome of the events was not resolved.   Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.
This case was reported by a pharmacist and described the occurrence of injection site pruritus in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 12 October 2012 at 19:30 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 12 October 2012, at 20:00, 30 minutes after vaccination with FLUARIX, the subject experienced injection site pruritus, difficulty breathing, pruritus of chest, chest tightness, swollen lips and throat tightness. During routine flu vaccination, subject received FLUARIX at 19:30. At 20:00, she started to "feel left arm itching, chest itching, tightness in chest, swollen lips and tight throat". She went home and symptoms got "worse". The subject "went to the emergency department at another hospital". The subject was hospitalised and the pharmacist considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with steroid, "breathing treatment", and ADRENALINE. At the time of reporting the injection site pruritus, pruritus of chest, and difficulty breathing were reported as resolved. The outcome of the chest tightness, swollen lips and tight throat were unknown. "The above information was all that was available."
I experienced a breakthrough case of COVID-19 with a stuffy nose, head congestion, fever, sneezing, headaches.
Symptoms of stuffy nose and fatigue started 15 minutes after shot, dizziness and fatigue worsened through the day, stuffy nose lasted 5 hours then ceased. Nausea and headache started two and a half hours after stuffy nose ceased.
Patient received Moderna Booster instead of Monovalent Moderna as 1st dose vaccine.
I was due for my annual mammogram in 2022.  I had an ultrasound and diagnostic and a biopsy and it came back positive for breast cancer in my left breast.  I had surgery in May 17, 2023 and I am on a treatment with Tamoxifen for 5 years.
muscle ache; soreness st the injection site; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 21st December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and chills. On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the injection site pain, chills and muscle pain were unknown.   It was unknown if the reporter considered the injection site pain, chills and muscle pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The patient received 2nd dose of Shingix and had number of the side effects included chills, muscle ache, soreness at the injection site. The patient wanted to know how long these symptoms were expected to last. Shingrix package insert information was provided to patient and was advised to refer back to his/her physician or pharmacist for treatment options for these side effects.
small blood clot when tried to donate blood 2.5 weeks after shot, preventing me from finishing donation
pain in her hips; vaccination site was tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in her hips) and VACCINATION SITE PAIN (vaccination site was tender) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (pain in her hips) and VACCINATION SITE PAIN (vaccination site was tender). At the time of the report, PAIN (pain in her hips) and VACCINATION SITE PAIN (vaccination site was tender) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication reported.   No treatment medication reported.
pt recv vax 19JUL96, & still contracted disease 27JAN97;
Information has been received from a 62 year old female with no pertinent medical history and an adverse drug reaction history with statin drugs who on 13-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (no lot number was provided). Suspect drug therapy included ezetimibe (+) simvastatin (MSD), tablet every other day (dose and indication not reported). Other concomitant drug therapy included raloxifene hydrochloride (EVISTA). In November 2007 "a couple of days ago," the patient experienced a headache. The patient did not seek medical attention. No labs or diagnostic studies were performed. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
Vaccine was administered 6 days after vial expiration date. Parent notified by provider. Provider chosen not to revaccinate. Parent agreed, child doing well.
Dizziness; Cough; Running nose; Fast heart beat; Stuffy nose; Weakness; Tiredness; Headache; Muscle pain/ muscle aches; Fever; Nausea; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6198, NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 10Mar2021 (at the age of 72-years-old) in left arm as a single dose for covid-19 immunization. Medical history included blood cholesterol abnormal and anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol abnormal, start and stop date were not reported; clopidogrel bisulfate (PLAVIX) taken for anticoagulant therapy, start and stop date were not reported. She stated that she takes both the pills by mouth, once a day. The patient reported that she received the vaccine, and the events did not start until 2-3 days and later she had different things at different time. The patient experienced tiredness, headache, on one night she had muscle pain (real bad), fever, nausea, swollen lymph node, fast heartbeat, dizziness, weakness, cough, stuffy nose, runny nose in Mar2021. The patient underwent lab tests and procedures which included heart rate: fast in Mar2021. The patient was schedule for second dose on 31Mar2021. Investigation assessment was not reported. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
The vaccine got leaked on the patient arm during administration/ leakage was between the needle attachment to the syringe, no Ae; The patient did not receive the full dose of the vaccine, no AE; The vaccine got leaked on the patient arm during administration, no AE; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 36 years old female patient who had received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] [0.5 ml, lot number: UJ509AA and expiry date: 10-MAR-2021] on 7-DEC-2020 via intramuscular route in the left arm for prophylactic vaccination that got leaked on the patient arm during administration and did not receive the full dose of the vaccine as the syringe- needle wasn't screwed on correctly or tight enough (Syringe issue) (underdose) (exposure via skin contact).   Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  This was an actual medication error due to vaccine underdose and exposure via skin contact [latency was same day].  This was also a case of syringe leak.  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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 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.
Immediate severe pain in testicles both times; severe rash; breakouts on genitals, leg, hand (all on right side of body)
Ten days  after receiving Pfizer booster discovered two benign cysts in left breast that had not been present before booster.
PATIENT HAD NAUSEA , DIZZINESS , EXTREME ANXIET ANDF DIAPHORETIC  AFTER 15 MINUTES OF ADMINISTRATION . WE CALLED  PARAMEDICS  . NO TREATMENT WAS GIVEN ANF PT. GOT BETTER AFTER 25 MINUTES AND LEFT STORE WITH HER BROTHER . PT. CALLED 4 HOURS LATER AND INFORMED US  THAT SHE WAS WELL
Swollen bottom lip (left side only); This is a spontaneous report from a contactable consumer. A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04Jun2021 16:30 (Batch/Lot Number: EW0178) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient received first dose of vaccine BNT162B2 on 14May2021 (at 15 years) for COVID-19 immunization (product=COVID 19, brand=Pfizer, lot number=EW0182, administration time=16:00 PM, dose number=1, vaccine location=Left arm). Concomitant medications included tretinoin (ALTRENO) taken for an unspecified indication, start and stop date were not reported. On 05Jun2021 21:45, the patient experienced swollen bottom lip (left side only). Therapeutic measures were taken as a result of swollen bottom lip (left side only) AE treatment: Benadryl (after call to dr). The outcome of the event was unknown. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  Batch/lot number already provided
Heavy flow of my period with blob of blood; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy flow of my period with blob of blood) 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 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 HEAVY MENSTRUAL BLEEDING (Heavy flow of my period with blob of blood). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy flow of my period with blob of blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported. for mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessment.
Sore lymph nodes underarm left arm Very sore and swollen lymph nodes above the left collarbone
Two weeks after my vaccination  04/20/2021- I had pain in my right hip, knee, chin and I had x-rays and they were negative. I started physical therapy on 04/29/2021.  I was unable to walk any more. I was walking 28  miles a week , and I had to completely stop  walking for exercise because the pain was too much. On 05/10/2021 Right leg and knee would give out on me. On 05/24/2021 I fell lifting something, the right leg couldn't handle me lifting the weight and I fell. I was still doing PT to strengthen the leg but it wasn't helping. On 06/28/2021 I fell again, the right leg just went out again. I continued PT up until 07/06/2021, We temporarily stopped. I had no pain or weakness in my right hip, knee, or chin prior to the vaccination. The pain is still ongoing.