chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 74 year old female patient with chronic obstructive pulmonary disease (COPD), hypertension and hypothyroidism. The patient's medical history included unspecified reaction to CIPRO, unspecified reaction to Macrolide and unspecified reaction to Ketolide. The patient's history drug included CIPRO, Macrolide and Ketolide. On 05-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot # unknown), 0.65 ml, once subcutaneous as recommended. Concomitant therapies included budesonide, SYMBICORT, SYNTHROID, lisinopril (manufacture unknown) and NEXIUM. Pharmacist reported that after a patient received ZOSTAVAX she developed shingles. The patient reported that "3 days after" received ZOSTAVAX, in approximately 08-OCT-2013, she developed a "headache; her head hurt and was sore to the touch". The patient saw her unspecified primary care provider on 11-OCT-2013 who diagnosed her with shingles. The unspecified primary care provider prescribed Acyclovir and Prednisone. The patient reported to the pharmacist that there was "no actual outbreak or visible rash, the shingles was intercranial". The outcome of intercranial shingles was reported as not recovered/not resolved. Additional information has been requested.
Imm. on 3/2/02, Tuesday On Friday, 4/5/02, c/o @ school of stomachache and backache school, Called mom, by time she got there, the child's face was swollen Called dr's office, told to bring right in, On way, he stopped breathing, Called 911, pulled over and gave artificial respirations until ambulance arrived. Transported to hospital, gave Benadryl, Did fine, DC from ER. went to Dr's office, Tested positive for MMR and one day later (4/29/02)for Hepatitis B. Dr called and meds givedn right away. No problems since.
Initiated treatment 48 hours after first symptoms and 12 hours after first initial positive test (at-home then confirmed by doctor).; Initiated treatment 48 hours after first symptoms and 12 hours after first initial positive test (at-home then confirmed by doctor).; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 29Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: FJ1611), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM, start date: 01Jan2021; XYZAL, start date: 01Jan2021. Past drug history included: Sudafed, reaction(s): "Known allergies: Sudafed". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Initiated treatment 48 hours after first symptoms and 12 hours after first initial positive test (at-home then confirmed by doctor)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: First initial positive test (at-home then confirmed by doctor). Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 17Apr2022 to 22Apr2022 (Lot number: FL4517). Initiated treatment 48 hours after first symptoms and 12 hours after first initial positive test (at-home then confirmed by doctor). Felt better within 3-4 days after starting treatment. Only side effect was horrible bitter taste in mouth for 6-8 after taking each dose. Four days after completing treated, COVID symptoms rebounded and came back with nagging cough, low grade fever, headache and congestion.
Expired vaccine used; 11 YO patient received the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 11-year-old patient who received DTPa (Infanrix) (batch number unknown, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were 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: 14-JUN-2022 Reporter's comment:  11 years patient received the infanrix vaccine, which was expired on 28th May 2022 The reporter consented to follow up. Additional supportive information: The patient received infanrix vaccine, which led to Inappropriate age at vaccine administration and expired vaccine used. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093051:Same reporter
Bells Palsy, diagnosed by Medical Center. Treatment: Valacyclovir for 7 days, Prednisone for 12 days.
Pain at injection site, neck pain, left jaw pain and inflammation, painful swollen  lymph nodes around left collar bone , joint pain, fatigue - all began the night of/morning after injection and are still present four days later. Unrelieved with ibuprofen.
This spontaneous report as received from a health professional refers to 3 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K026384, expiry date 15-DEC-2016, dose and route of administration not reported). No adverse symptoms were reported. The temperature excursion for the VARIVAX (Merck) in question could not be evaluated at the time of reporting as the healthcare worker did not know how long the product was stored outside of the proper storage temperature range. Additional information has been requested.
Dizziness, Headache, Arthralgia, Fever, Tachycardia, Chills Narrative:
Patient is a 93 y.o. male patient of a local MD with history of prostate cancer, bladder cancer, HTN presented to a local Medical Center with weakness, cough and found to have COVID 19 resp failure, hypoxia and possible acute CVA.   Acute hypoxic respiratory failure In setting of COVID-19 Requiring 2L NC on admission CTPA negative for PE No dvt on dopplers Antitussive/mucolytic, prn albuterol, mobilize, IS On 2-3L NC, wean as tolerated; may need some more time to wean as SNF Pulmonary followed    Covid-19 Virus Infection Date of onset of symptoms: 12/26 Symptoms present on admission: cough, weakness, poor appetite Date of covid positive test: 12/28 Vaccination status: vaccinated Imaging: CT chest no infiltrate Oxygen requirements on admission: 2L Current oxygen requirements: 2L Medical therapy: remdesivir completed continue dexamethasone Consultants following: pulm Anticipated special isolation end date: 1/6   Subacute right thalmic stroke Symptoms:  confusion, slight L arm weakness Etiology: likely small vessel disease Imaging:  ? CTH age indeterminant infarct R thalamus ? CTA H/N showed hronic right-ICA occlusion at the level of skull base with distal reconstitution at the cavernous segment Asa statin continued Neurology signed off PT/OT/SLP   Afib with RVR Spontaneously converted to NSR Started on low dose lopressor CHADS2VASC 5 TTE unremarkable Will need eliquis but has significant hematuria with bladder CA Acute metabolic encephalopathy Cognitive decline Aox1 on arrival, family reports suspicion of early dementia not diagnosed, worse confusion in recent days PTA Due to COVID +/- CVA contribution Delirium precautions; Otherwise as above Alert to self Add trazadone for sleep at night   Gross Hematuria Bladder mass History of bladder Ca Incidentally noted bladder mass on CT CAP, prevously noted on CT 2021 UA large blood, prior UA 2019 same Follows with an outside urologist "Dr." and has consistently expressed he does not want this treated further Monitor for gross hematuria with addition of antiplatelet, urology consult if needed
Day after vaccine, had 3 minutes of severe vertigo,  and for several hours felt like I had a virus. Within a few weeks I often felt very ill, as if I had a virus. But symptoms would come and go. By May 2018 I had developed tingling in all extremeties and head, and continued to feel very ill often. After many tests and several doctors (primary care, a new primary care, vascular, neurology (2 different neurologists), provider at Neurology diagnosed me July 17, 2019 after reviewing all MRIs, blood work, et al. His diagnosis is that my symptoms are caused by the Shingrix vaccine, that the nerve damage creating the tingling sensations are not permanent but will take another 18-24 months to clear. I have now gone 85 days without feeling ill as if I have a virus. The tingling is constant, but has reduced since May of 2018.
2ND DAY AFTER SHOT WAS GIVEN DEVELOPED REDNESS & SWELLING ON THE INJECTION SITE AND PAIN AS WELL. A WEEEK AFTER THE SHOT-REDNESS & SWELLING IS STILL NOTICEABLE WITHITCHINESS & HARD ON THE INJECTION SITE NO PAIN.
Received Covid Booster/Moderna on 12/09/2021 in the morning, after 5 hours, the patient developed headache 8/10, from the frontal lobe back to the occiput. No prior history of headaches/migraines. The headache has been pressure like since for "24/7", not relieved by tylenol or ibuprofen.
congestion; cough; shortness of breath; sore muscles; fatigue; intestinal trauma; sharp pain when he raise his arm above his shoulder from the injection site; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER 8733, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 29Mar2021 (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. The patient has no relevant medical history and no known allergies. The patient has no concomitant medications as the patient didn't received any other medications in two weeks. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number: EN 6205, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 08Mar2021 at 11:45 (at the age of 68-years-old) for COVID-19 immunisation and experienced events which included shortness of breath, congestion and slight cough, chills, sore muscles, fatigued, intestinal trauma, and raise his arm above his shoulder a sharp pain strikes down his upper arm from injection site to now. On an unspecified date, the patient experienced congestion, cough, shortness of breath, sore muscles, fatigue, intestinal trauma, sharp pain when he raise his arm above his shoulder from the injection site. It was further reported that on the 3rd day the patient was feeling a lot better, and symptoms are not as severe except the injection site in his left arm. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event sharp pain when he raise his arm above his shoulder from the injection site was not recovered while the outcome of all the other events was recovering.   No follow-up attempts are possible. No further information is expected.
On April 22, 2021 I had lab work done in relation to abdominal pain that I was having. The lab work showed my platelet count was high at 490,000 when the normal count is 130,000-400,000. It also showed that my red blood cells was high at 5.37M-UL when the normal range is 3.80-5.20M-UL. The doctors treated me for diverticulitis and gave me antibiotics for it.  I have been fine since taking the medicine and haven't had any more abdominal pain.
On the next day of the vaccine on 1/9/2021 in the morning I started having fevers & chills this lasted 1 day. On 01/12/2021 I started feeling a sore throat & a running nose & this symptoms continue.
no adverse event. moderna confirmed 216K22A was viable until 2/21/23 despite beyond use date of 1/22/3
Lump inside upper arm where shot was administered. Pain in joints and additional lumps showing up at several other areas, neck, wrist, and shoulder.
Information has been received from a pt's mother concerning an approximately 24 month old female with no past medical history and no known allergies who on 04/23/1997, was vaccianted with the first dose of hep b vaccine recombinant. About 6-9 months later, the pt received the second dose of hep b vaccine recombinant. By the time the pt was 15 months old in approximately July of 1998, the pt received the third dose of hep b vaccine. Concomitant therapy included etanercept. In approximately April 1999, about 9 months after the last dose, the pt was diagnosed with juvenile rheumatoid arthritis. the pt's mother felt that the hep b vaccine recombinant is the cause of the rheumatoid arthritis because there is a history of it in the family and she thinks that there is something in the hep b vaccine recombinant that triggered it in her daughter. Additional info has been requested.
It started with my joints popping then pain in the muscles and joints.  It advanced into pain and arthritis in my hands, knees, neck and shoulders.  I am in a lot of pain and it is hard to sleep.  It seems to be getting worse.
The patient was inadvertently administered an expired dose of vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a Nurse via Global Medical Information (GMI) (Reference number- 00509255) and transmitted to Sanofi on 08-Mar-2021.  This case involves an 11 year old male patient who was inadvertently administered a 0.5 ml first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6521AA, expiry date: 26-Jan-2021) via unknown route in the right deltoid on 17-Feb-2021 for prophylactic vaccination (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no concomitant vaccines.   It was a case of an actual medication error due to Expired vaccine used (latency same day).  The reporter had a question on the expiration date for Menactra as it was given to a patient past the expiration date  At the time of report, no adverse event was reported.  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.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M040271 with the expiration date of 30-APR-2018, for prophylaxis. The administered doses of ROTATEQ underwent a temperature excursion between 9 and 25 Celsius degrees (average 10.8 Celsius degrees) for 20 minutes. Digital Data Logger was involved. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-00957513-1705USA005160:
Woke up at 11 pm with severe joint and muscle pains. Left arm extremely sore. As evening progressed, chills, body aches, nausea and extreme fatigue. It?s now 2:11 pm on 10/09/2021 and I feel like I?ve got the flu - extreme fatigue, aches and joint pain.
On 04-12-2021 at night, I noticed blood in my urine. I saw my PCP on 04-13-2021. On 04-14-2021, I again had blood in my urine. I called my urologist and was seen on 04-14-2021. My blood platelets were extremely low. I was then referred to see a hematologist who sent me to the hospital. I was admitted at Hospital where they performed lab work, MRI's and CT scans. I stayed two days at the hospital. The hematologist who saw me said I have thrombocytopenia. Other tests were also performed and they checked me for stroke and I did not have a stroke. I am concerned due to my thrombocytopenia, if I get cut, I will bleed a lot and this is interfering with my job and to carry out my daily functions.   I am still not recovered and my platelets are low. I still have to follow-up with my PCP and my hematologist has to check my bone marrow as the next step of treatment.
Information has been received from a certified medical assistant and a health care worker concerning a 61 year old male patient who on 08-OCT-2008 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 661528/0867X), in his left arm. Concomitant vaccination included influenza virus vaccine (unspecified) in his right arm. The certified medical assistant reported that the patient's wife stated he experienced redness and warmth on left arm and it was getting better. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
1st day, and 2nd day, slight hearing loss particularly to mens speaking voice on TV. Now gone. 1st night frquent night time urination, now gone.
THE PATIENT CALLED THE PHARMACY YESTERDAY STATING THAT HIS RIGHT ARM STILL HURTS WHERE HE GOT HIS COVID VACCINE (HE GOT SPIKEVAX) AND WAS INQUIRING ABOUT HOW LONG IT MIGHT LAST.  HE SAID IT STILL WAS SORE AT THE INJECTION SIGHT AND SLIGHTLY DOWN HIS ARM.
Severe diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 11Mar2021 at 13:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, allergy to latex and adhesive. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks of vaccination were not reported. The patient previously received capsaicin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 12Mar2021 at 16:00, the patient experienced severe diarrhea. Therapeutic measure was not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe diarrhea was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
This spontaneous report received from a nurse referred to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that occasionally her physician office practice will administer a properly stored dose of GARDASIL (lot number and expiration date unknown by reporter) to an unspecified patient over the recommended maximum age of 26, up to 30 years of age, if prescribed by physician and specifically requested by patient.A No adverse effects reported. dditional information is not possible as consent to contact was not available.
Information has been received from a nurse practitioner who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (Lot number not provided) (manufacturer unknown). The consumer reported that in the "mid 1990s" after the first two vaccinations she had swollen feet. Subsequently, after the third vaccination she had arthritic reaction that lasted 8 months. At the time of the report the status of the patient was unknown. Follow-up information has been received from the nurse practitioner who reported that she was vaccinated with the three doses of RECOMBIVAX HB between 1992 and 1994, she was unable to given exact dates. She stated that she has informed her internist of the vaccine and the post symptoms. Additional information is not expected.
Client complained of swelling, redness and pain to R arm at vaccination site since 5am 1/11/06.  Also c/o vomiting x10 since 5am as well.  No fever.  Arrived to clinic about 8:50am c/o nausea slight swelling with quart size redder area noted to R arm.
approx 2wk p/vax, area lt arm became reddened & swollen to the size of 4 quarters;pt treated @ hosp for cellulitis on 21MAY96 w/Cefadroxil
Cutaneous lupus-erythematosus-like reaction arising after COVID-19 vaccination; This is a literature report for the following literature source(s):   A 33-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "no significant past medical history" (unspecified if ongoing), notes: None. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation.  The following information was reported: CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant), outcome "recovered", described as "Cutaneous lupus-erythematosus-like reaction arising after COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Negative, notes: after treatment with fluocinonide 0.05% ointment; Biopsy: vacuolar interface alteration with superficial and, notes: mid-dermal perivascular and periadnexal lymphocytes; Eosinophil count: Not identified; acid-Schiff stain: no significant increase in thickness of the, notes: basement membrane; perivascular collections of lymphocytes., notes: Spaces between the collagen and dermal mucin are evident the spaces between collagen and dermal mucin are evident; vacuolar interface alteration and moderately brisk, notes: superficial perivascular and periadnexal lymphocytes; superficial to mid-dermal perivascular and, notes: periadnexal lymphocytes. There is very scant deep perieccrine inflammation; unremarkable; mildly increased dermal mucin, and the periodic, notes: acid-Schiff stain showed no significant increase in thickness of the basement membrane; Tumour marker test: clusters of positive cells within the infiltrate, notes: x 200. Therapeutic measures were taken as a result of cutaneous lupus erythematosus.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event Cutaneous lupus erythematosus and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Vomiting and Diarrhea for approximately 12 hours prior to transfer/admittance to Medical Center.
9 days post vaccination, Patient started feeling malaise, cold and nausea. 11 days after she developed mild fevers of about 100.6. 12 days post vaccination, she is still experiencing nausea and then broke out in a head to toe rash. Her rash is itchy and painful.