chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 Doses administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient. It was reported that vials were taken out of freezer on 27Oct2021. Vials were thawed and administered on the same day and vials were stored properly, no temperature excursions involved.   This case was linked to MOD-2021-380857, MOD-2021-380858 (Patient Link).
This spontaneous report was received from a pharmacist refers to a 45 year old patient of unknown gender. The patient had previous administration of PREVNAR 13. On 03-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # M033086 and expiration date 05-MAY-2018) 0.5 ml, unknown route. No concomitant medication were reported. On 03-OCT-2016 (reported as within 24 hours of receiving PNEUMOVAX 23) the patient experienced warmth, redness and swelling below the injection site. The patient sought medical attention by calling the pharmacy on unspecified dates. The pharmacist reported that the patient was advised a treatment of pain killers and call their physician if symptoms get worse. The outcome of the events reported as unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed. This case is cross linked with the MARRS# (same reporter link) 1610USA005734. Additional information has been requested.
Nausea; have really bad runny nose; have really bad stuffy nose; I had a fever; I got flush rash, itchy rash kind of all over my body; I got flush rash, itchy rash kind of all over my body; Headache; This is a spontaneous report from a contactable Nurse (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient stated that she got the first round of COVID vaccine the day prior the report and she was told to report her symptoms. She had a fever and got flush rash, itchy rash kind of all over her body and a headache on 18Dec2020. She took Tylenol Benadryl, it had helped with symptoms. At the time of the report morning she woke up with headache and she had really bad runny nose and stuffy nose and nausea on 19Dec2020. The outcome of the events was unknown.  Information on lot/batch number has been requested.
difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation.  Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
When inputting information into the immunization information system  it was noted the individual received a first dose of Pfizer on 1/26/21 lot number EL3249. HD was not aware of this occurrence until the 1st dose of Moderna.
20 hours after my first injection my entire body broke out into a rash. My skin was warm to the touch and itched. The rash lasted about 8 hours
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Dec2022 as dose 5 (booster), single (Lot number: GJ6743) at the age of 24 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cyclic neutropenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Tested negative after finishing; Positive, notes: Tested recently and the results were positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid started on 10Feb2023 and stopped on 15Feb2023.  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.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or before 08 September 2006, the subject received a dose of Infanrix at an unspecified site of injection (dose number and lot number not provided). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 08 September 2006, the subject experienced "a large localized reaction"  at the injection site of Infanrix. The outcome of the event was not reported.
The day after the vaccine, pt experienced typical side effects of fatigue and fever that was controlled by Tylenol. The fatigue was extreme and has continued to present day. Also, she has inability to focus and concentrate. She is nauseated daily intermittently.  The main complication was in post vaccination day 5, she felt worse than before. Vertigo, nausea, extreme fatigue and inability to perform ADLs and spent most of the day in bed. Approximately 1 am the next morning she woke me, cold, clammy and pale collapsing on the side of the bed with a feeling of impending doom after having diarrhea saying ?something is really wrong.? She went back to the toilet, but had a syncopal episode from standing where she fell straight and flat on her back with no attempt to break her fall. She hit her head on the marble floor and shoe molding. She was unresponsive for 10-20 seconds with no palpable pulse or visible respiratory effort before becoming arousable. She was groggy, but oriented to person and place. She was amnestic for the event. She had an approximately 6 inch full thickness laceration to her posterior scalp that required staples. I took her BP- 85/56, pulse 50, respirations were normal. Ambulance called. Mild hypotension that responded to fluid bolus. CT of head was negative and other than non-specific leukocytosis, labs were normal (CBC, CMP, TFTs, Mg and PO4).
6/23 PEDVAX and INFANRIX given. 6/24 doctors visit - urticaria. 6/25 - 6/27 Hospitalized urticaria with angioedema - serum sickness.
Covid19 breakthrough.  1st vaccine received on 01/16/2021.  98 y/o PMHx Afib, CAD with CABG/Prosthetic Heart Valve, Pacemaker, HTN, HLD, CHF, Pulmonary Emboli, Aortic Aneursym presented from HCF after testing positive for Covid 19 on 01/27/2022 for c/o increasing generalized weakness and loss of appetite.  Room air sat 85% initially, CXR no acute and pt afebrile.  Pt started on low dose steroids.
Started blowing large blood clots out of my nose, particularly on my left side. At first I believed this to be simple sinusitis, but it has continued and increased in severity to the point that I have been screaming in pain. I sought urgent care after getting mass swelling behind my left ear in the mastoid area all the way up to my temporal lobe/skull, and blowing a large, red blood clot out of my nose.
headache  -  dizziness  -  soreness at shot location  -  abdominal pain
Received first Covid shot April 6 (same location as the data entered for this one, Pfizer Lot EW0153).   April 10 had uncontrollable muscle spasms in both legs for 5 minutes. Did not seek treatment.  Received second Covid shot April 27.   April 30 had muscle spasms increasing throughout day and anxiety. Did not seek treatment.  Anxiety increased through May 5 when I went to the hospital around 2AM due to muscle spasms, muscle pain, anxiety. In hospital I experienced over 1 hour of constant full body muscle spasms/seizures where all my muscles would tense up uncontrollably over and over. This eventually subsided and I was released. Diagnosis absent any other cause was anxiety.  From May 5 through ~June 11, experienced frequent random muscle spasms and tics mostly in left leg but also encompassing abdominal, lower back, chest and rib pain. Experienced feeling of left arm heaviness through July 3. Arm pain in shot area recurred since the time of the second shot at least six separate times (last July 3).  Was stared on Gabapentin for nerve pain, muscle spasms, anxiety, which eased symptoms. As of July 10 feeling mostly normal, no longer experiencing muscle spasms with any frequency.
Patient states she has a red circle about  the size of an egg under the deltoid muscle where the vaccine was given. She states it is slightly warm and sore. Began the day after vaccination. Recommended patient monitor size of redness on arm, apply ice, and follow up with us tomorrow. Will recommend doctor's visit/ follow up if redness or other side effects worsen.
MIGRAINE; CHILLS; FEVER; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, and batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced migraine, chills, and fever.  (Dose number in series: 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, chills, and fever. This report was non-serious. This case, involving the same patient is linked to 20211249027 (Dose number in series: 2).
Headache, Rash, UrticariaPruritus, Diarrhea, sore neck Narrative:
Scalp/chest/arms/legs some vesicles, some papules. Some papules with degree of puss.
storage error; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concomitant medications and concurrent conditions was not provided. On 08-DEC-2020, the patient was vaccinated with improperly stored dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). 0.5 ml,  lot # 1637648 with expiration date of 19-JUN-2022 for prophylaxis.  The vaccine experimented temperature of excursión of 14.7 degrees Celsius for 19 hours and 14 minutes. There were no previous temperature excursión. Digital data logger was involved.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Redness, itchiness, pain and indurated area at injection site about 3 in x 3 in, nasal congestion, malaise, fatigue, low grade fever, headache. ( No problem other than mild pain at injection site with 1st dose) Tylenol, ice pack at injection site, Claritin. Injection site pain and redness area slightly improved but still having other symptoms after 2 days.
When awoke 24 hours after injections, had hills, diarrhea, and vomiting x 5-6. Returned to school 01/05/2003 and felt fine.
Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PAIN (Soreness). On 13-Jan-2021, PAIN (Soreness) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medications of the patient were provided. No concomitant medications were provided.  Patient stated that on 8FEB2021 she was riding her bike when she was hit by a car she experienced whip lash and bruising from the accident
Patient called to let us know she had a large, red, swollen aread at injection site for 3 days.  Also had itching at site.
Worsening unilateral arm pain, with some numbness, tingling, and weakened grip strength of same arm.
chills; cough; shortness of breath; body aching; loss of taste; lots of nasal congestion and mucus; lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 16-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15May2021, one of her children experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever, then she presented the symptoms 4 days after receiving the vaccine and her other son presented it a week later. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021. Treatment medication included antibiotics for the events. Outcome of the reported events are unknown at this point of time.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651028 Same reporter/drug/event, different patient.;US-PFIZER INC-2021650327 Same reporter/drug/event, different patient.
Sharp left knee pain within a couple of hours and right knee pain the following day.; Left arm pain; swelling at incision site; Headache, exhaustion with first hour.; exhaustion with first hour; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old non pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 27Mar2021 at 12:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anaphylaxis several times, hives, patient was treated for mast cell activation syndrome symptoms, parvovirus infection, lyme disease, joint pain, melanoma, osteoporosis and small nodules on lungs which were watched and diagnosed as benign. The patient was allergic to birch, stone fruits, (i.e plums, cherries), eng, plaintain, peanuts, mould, dust, cats, dogs, grass, trees, ragweed, cockroach, mugwort plant, histamine and had chemical sensitivities to perfume, cologne, lotions, bleach, polyurethane, wood stains, could be anything. Concomitant medications included beclometasone dipropionate (QVAR) 80, salbutamol (ALBUTEROL), montelukast (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), famotidine PEPCID for unknown indications from an unknown date received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 13:45, the patient experienced left arm pain and swelling at injection site, headache, exhaustion with first hour, sharp left knee pain upon standing within a couple of hours that lasted at least a week. On 28Mar2021, patient experienced right knee pain the following day. Therapeutic measures were taken as the result of adverse events, which included treatment with tylenol 8 every 8 hours for a week to lessen all symptoms. The patient reported that arm pain went away and headache was not as bad but left knee pain was still there. The clinical outcome of the events painful left arm was recovered on an unknown date in 2021, the outcome of vaccination site swelling, headache, exhaustion and knee pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected
I received the first Vaccine 1/9/21. I developed hives/rash over areas of my body which began after to first vaccine and became much more severe after the second dose which I received 1/30/21 (Pfizer BioNTech EL9262). I saw a doctor in 2/11/21, then saw an allergist and had extensive testing which did not show a cause for the rash and urticaria. I had  biopsy done 3/25/20. The result stated  "Urticarial Hypersensitivity Reaction" most likely secondary to the COVID vaccine.  I am still suffering from severe urticaria which has not been helped by prednisone or topical steroids.
Patient didn't receive second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient didn't receive second dose) 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 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient didn't receive second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient didn't receive second dose) outcome was unknown.        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.   The concomitant medications were not reported ? The treatment information was not provided.
Both arms and shoulder froze after shots. Pt doesn't have full function of arms/shoulders. Experience pain and discomfort.
Red face with itching and tightness. Also had nausea, muscle aches, headaches and chest heaviness.  Treatment per doctor was benadryl 50 mg by mouth. Needed to take med twice more. Still with face redness that is improving
4/19/18 at 9pm: extremely painful left arm; 4/20/18 at 5:30am: woke up with extremely painful tangerine-sized lump in left armpit; 4/21/18 at 6am: woke up with extremely painful and swollen gland in neck on left side and sore throat on left side; also rash and swelling at injection site. 4/22/18: rash continued to grow to approximately 1.5? wide by 3? tall; 4/29/18: evidence of rash still present but is fading.
I got flu shot 10/17/2018 around 11:30am at work during a wellness on site event. After shot, wound was bleeding, thought was okay. After received shot felt pain in left arm where shot was taken-normal. That night took Tylenol and felt pain the next day had to take Tylenol  the whole day. The night I couldn't sleep, woke up with pain in middle of night. Friday, I felt severe pain on and off on my left side shoulder/arm/chest area and couldn't breathe with pain and at this point Tylenol was helping only a little. Again at night couldn't sleep and had pain. Saturday had the worse pain. It was my left side chest to shoulder area, pain was constant, any bump in car hurt, couldn't really speak or breathe and Tylenol did not work. So went to a Urgent Care facility. Did an EKG to make sure it was not my heart. Give me Naproxen. Had alittle bit of pain then and got actual icy hot to rub on -helped too. By Sunday had soreness but hardly any pain. Went to work on Monday with some soreness but no pain.