chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. Linked case: 2018SA267494 (same reporter). This case involves a 67 years old male patient who received expired vaccine FLUZONE QIV. The patient's medical history and concomitant medications were not reported. On 21-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5899MA via intramuscular route in the left deltoid. It was a case of actual medication error due to expired vaccine used. It was unknown if patient experienced any adverse events following vaccination. 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.
Ataxia, visual and auditory hallucinations, and clonic movements of lower extremities.
Pt's mother called clinic advice nurse on 8/29/07 at 18:05 PM. States went to ER 8/28 left arm swollen from wrist to shoulder, right arm has quarter size swelling. Pt. received vaccines on 8-27-07.
Heating at injection site, acute body spasms in head, arm, stomache, dizziness, tightening pain in chest area, heart. Alerted Nurse and they directed me to a separate cubicle with bed to lay down.  Nurse asked about symptoms, took pulse.  After 10-15 minutes most symptoms discontinued except for chest discomfort. After chest/heart discomfort continued the following days, I contacted my PCP.  He administered electrocardiogram 08/30/2021. He prescribed blood pressure medicine, blood tests, allergist, ultrasound and other steps. The intermittent chest discomfort mild headaches continue today, creating sleep issues and anxiety.
Fever and chills started first night (10-12 his after injection) and were relatively mild. By morning it was just a headache and a little malaise. About 24 hours after, I started to get worse. The fever came and went for about 48-60 hours. It was consistently between 101 and 102, but peaked at 103.2 about 36 hours after. The chills and full body shakes happened during 3 nights.
hot; Itchy; Bee sting; Insect Stings; Swelling; Moderna site itchiness; Moderna site rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot), PRURITUS (Itchy), ARTHROPOD STING (Bee sting), ARTHROPOD STING (Insect Stings) and SWELLING (Swelling) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    It was unknown if the patient was enrolled in clinical trials.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot), PRURITUS (Itchy), ARTHROPOD STING (Bee sting), ARTHROPOD STING (Insect Stings), SWELLING (Swelling), VACCINATION SITE PRURITUS (Moderna site itchiness) and VACCINATION SITE RASH (Moderna site rash). At the time of the report, FEELING HOT (hot), PRURITUS (Itchy) and VACCINATION SITE PRURITUS (Moderna site itchiness) outcome was unknown and ARTHROPOD STING (Bee sting), ARTHROPOD STING (Insect Stings), SWELLING (Swelling) and VACCINATION SITE RASH (Moderna site rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The treatment medication was not provided.
Headache; This is a spontaneous report from a Pfizer-sponsored program via Regulatory Authority.  A contactable consumer reporting for a 57-year-old female patient who received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR TAB 11MG), via an unspecified route of administration from 02Feb2021 (Batch/Lot number was not reported) to 02Feb2021, at 11mg (tablets) for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient also received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. On an unspecified date, the patient experienced headache. Stated she had a mild headache lasting about 1 hour after COVID vaccine. Patient was off the medication two times due to recommendation from MDO while receiving first and second dose of vaccine. Patient was off medication one week after first dose and 4 days after second dose. Outcome of the event was unknown. The action taken in response to the event for tofacitinib citrate was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe migraine - unresponsive to over the counter medications; lasted nearly 12 hours.  Muscle pain and aches - the injection site was the most painful (to the touch).
Itchy red rash, warm, hard circular bump (grown to size of silver dollar) at injection site,  with mild pain when touched
high fever for 2 days p/shot; fever reached 105; fussy; APAP maintained;
External clinic requested intranasal influenza vaccine to vaccinate 5 year old patient. Inpatient pharmacy at one hospital was out of vaccine so requested vaccine from another facility. Vaccine that was delivered was presumably expired. Expiration date was not checked by the pharmacy personnel that received the vaccine prior to sending it to the external clinic. Clinic staff also did not check expiration date prior to administering the vaccine. Patient received the expired vaccine. Family has been contacted with the suggestion that the patient be re-vaccinated.
Patient is a 87 yo female patient of PRIVATE, MD with history of afib, GERD, RLS presented to local Hospital with generalized weakness           Severe Hyponatremia 116 on admission-improved Possibly in the setting of SIADH likely from COVID-19 infection Patient urine osmolality 315, serum osmolality 236, urine sodium 55 Patient was on normal saline at 50 overnight with minimal change in serum sodium. Nephrology has been consulted. Patient may benefit from salt tablets and fluid restriction. Sodium at 125>>127>>131>>134   UTI: Patient UA concerning for infection.  Urine culture positive for Proteus species Continue IV ceftriaxone. Completed IV ceftriaxone therapy while in the hospital.   Hypotension: Resolved   Covid-19 Virus Infection Date of onset of symptoms: 12/10 Symptoms present on admission: Upper respiratory symptoms fever and diarrhea Date of covid positive test: 12/13 Vaccination status: vaccinated Imaging: cxr clear Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Consultants following:  Anticipated special isolation end date: 12/20   Atrial fibrillation On digoxin and Xarelto and as needed flecainide   Restless leg syndrome Requip  GERD Pepcid   Diarrhea Resolved   Chronic fatigue disorder and generalized weakness PT/OT evaluation Physical therapy had recommended home health care, patient denies need for home health care and would be staying with her daughter.  Patient would reach out to her PCP if she needs home health care.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-OCT-2015 12:41, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 4.6 and -2.0 (13 hours 45 mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This case was reported in a literature article and described the occurrence of hemophilus influenza meningitis in a 12-month-old female patient who received HIBERIX. On an unknown date, the patient received HIBERIX at an unknown dose. On an unknown date, an unknown time after receiving HIBERIX, the patient experienced hemophilus influenza meningitis (serious criteria GSK medically significant) and hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hemophilus influenza meningitis was resolved with sequelae and the outcome of the hearing loss was not recovered/not resolved. It was unknown if the reporter considered the hemophilus influenza meningitis and hearing loss to be related to HIBERIX. Additional information was provided: This case was reported in a literature article and it described the occurrence of Haemophilus influenzae meningitis in a 12-month-old female child who had received unspecified Hib vaccines (manufacturers unknown). Approximately 7 years after this event, when the patient was 8 years old, her younger sister became unwell at 13 months of age, 3 weeks after being vaccinated, and died from disseminated vaccine-derived varicella infection. In the course of her illness, the patient's sister was diagnosed with severe combined immunodeficiency with a compound heterozygous missense mutations in recombination-activating gene 2. As a consequence of this, the rest of the family was tested and the patient and her father were found to have heterozygosity for the R73H mutation in the same gene. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On unspecified dates, the patient received an unknown number of unspecified Hib vaccine. Dosages unknown; administration routes and sites unspecified; batch numbers were not provided. On an unspecified date, an unknown period after the vaccination, the patient developed meningitis. The pathogen was identified as Haemophilus influenzae but its serotype was unknown. The authors commented that Haemophilus influenzae had been identified; but they did not provide any detail on the actual investigations performed. Treatment was unknown. Outcome was recovery with sequelae (hearing loss, severity unknown). The authors did not comment on any possible causal relationship between the vaccine and the event. The authors concluded that "although the varicella vaccine is contraindicated for most patients with known immunodeficiency, its efficacy and safety profile in immunocompetent children is excellent, and the benefits of the vaccine far outweigh the rare adverse events that can occur in children with undiagnosed immunodeficiency. Newborn screening for T-cell receptor excision circles can enable the early identification of T-cell developmental defects before live virus vaccines are administered. Unfortunately, such screening was not available for this patient at birth."
Tested positive for COVID19; Tested positive for COVID19; flu like symptoms; dose number 3; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Lot number: EW0185) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6200), administration date: 23Feb2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9809), administration date: 03Feb2021, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 24Nov2021, outcome "recovering" and all described as "Tested positive for COVID19"; IMMUNISATION (medically significant) with onset 07Oct2021, outcome "unknown", described as "dose number 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset 18Nov2021, outcome "recovering", described as "flu like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive, notes: Covid test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, influenza like illness. Clinical information: It was unknown if the patient had received any other vaccine in four weeks. It was reported that the patient had flu like symptoms, 6 weeks following booster shot. The patient tested positive for COVID19 on 24Nov2021. The patient did not suffer from covid prior vaccination.
pt recv vax 15MAY96 & mom called clinic on 31MAY96 to report that pt had t105 evening of 15MAY96 & 911 was called-pt taken to ER p/having sz @ home;about 10 days later again had fever of 104 w/gen body rash;
Patient endorsed unilateral eye twitching with subsequent development of generalized unilateral facial droop. Seen by provider the evening of 1April2021 where he was diagnosed with Bells Palsy.
Information has been received from a registered nurse via Pfizer (manufacturer control # 2016524387) on 28-NOV-2016 referring to a currently 88 year old female patient. Information about concurrent condition, medical history, drug reaction/allergies and concomitant therapy were not reported. On an unknown date in between 2005 and 2008, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date (reported as several years ago), the patient experienced redness, swelling and was not feeling well after receiving PNEUMOVAX 23. The outcome of the events was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Patient came into the clinic stating he thought he might have a few satellite lesions from his smallpox vaccination.  The possible lesions were located just above and below the left elbow. The patient noticed them first thing at around 0600 on 5 Feb 2013. He immediatly covered them with bandages provided to conver the smallpox site. During examination of the site the patient stated "they itched a little but other than that felt great."  Patient was instructed to continue covering the smallpox site and the additional lesion, as well as, monitoring each lesion.  Patient was given additional bandages and some non-adhesive pads and coban to prevent irritation.  Patient was instructed to contact the immunizations clinic in a week to follow up and/or if he had any questions.  Patient understood all instructions.
A few weeks after the booster I had a headache and cough. The cough persisted due to post nasal drip. It was difficult to sleep.
2 year old female received hepatitis A vaccine for 1st time. Approximately 15 min later became cyanotic, hypotensiv. Epinephrine given, Benadryl given Orapred given. Pt observed fro 2 hours and discharged was sx free.
Bloody nose for 2 1/2 hours, on 6-21-19. Pt was seen in the emergency room, a nasal clamp was placed, without results. Pt was found to have a platelet count of 6000, was transferred to Medical Center. He was treated with Prednisolone & Tranexamic Acid and diagnosed with Acute Idiopathic thrombocytopenic purpura.
On December 23, 2022, I began to feel yucky, and it progressed through the night. The next morning, I had classic cold symptoms. I wasn't coughing but I felt different than a cold. I tested positive for COVID-19 on December 24, 2022. I went to urgent care at 4:00AM. They were not open, so I got a telehealth appointment. I had a home molecular test that tested positive as well and provided this for the urgent care. I was prescribed PAXLOVID and began taking it the same day. My symptoms were gone the next day. I tested positive for another 6 days. But then I got sick again with a rebound COVID-19 infection that lasted about 7 days with head cold symptoms.
Redness, swelling-L arm x 1 week-hot to touch-itching. Rx: Benadryl. Erythema over dorsum of left shoulder going down almost to  elbow-around the biceps-little bit in triceps area.
The patient also indicated she has been experiencing bad joint pain in hip, knee, and lower back; Headache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). Other Case identifier(s): EC-2018-043854.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since 29Mar2022 (ongoing) (Lot number: 11111111) at 20 mg, oral for thyroid cancer. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Jun2022, outcome "recovered" (24Jun2022); ARTHRALGIA (non-serious), outcome "unknown", described as "The patient also indicated she has been experiencing bad joint pain in hip, knee, and lower back". The action taken for lenvatinib mesilate was temporarily withdrawn. Therapeutic measures were taken as a result of headache.  Additional information: Patient indicated they have been experiencing new chronic migraines that last for days after adjusting her dosing schedule of lenvima. The patient indicated that about 6-8 weeks ago the patient's specialist took patient off lenvmia for 3 weeks after she was recovering from hand&foot syndrome. After restarting the medication the specialist instructed the patient to take medication for 3 weeks on 1 week off. The patient advised that when starting back on the medication she had headache that lasted the entire week monday through friday with concentrated pain above right eye. The patient indicated no relief with Tylenol and Excedrin but the headache got better and went away by the end of the week. The patient also indicated she has been experiencing bad joint pain in hip, knee, and lower back while taking lenvima and patient indicated these symptoms only began shortly after patient received pfizer covid 19 vaccinations and shingles vaccination. The patients prescriber is aware of all the patient's side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 days after the vaccination was given patient's speech drastically reduced. She went from saying short phrases to no words at all and also, that same day began the habit of smacking herself in the head. I was hoping these issues would clear up on their own but now it has been almost 3 months and has not gotten better. The only word she can say now is "mamma" when prior to the shot she could say "what's that" "who is that" "Dog" "Dad" "sissy" "no" "hi" and "I love you". This is a huge regression in speech. Patient is still hitting herself in the head too, it seems to out of frustration. I believe she is now disabled from this vaccine.
Patient had no reaction at the time of the vaccine or after.  patient came in to receive his 3rd dose, he is redoing the Pfizer series after having stem transplant  his 2nd Pfizer was 21 days ago, it should have been 28 days ago.  patient received 3rd dose 7 days early.
Anaphylactic shock; This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old female patient received BNT162B2, (COMIRNATY, lot #: EL3302), via an unspecified route of administration, administered in Arm Left on 25May2021 14:17 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not received other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced anaphylactic shock on 26May2021 22:00, It lasted for about 30 hours for her daughter and got worse over time until her entire body was red and swollen on May2021. Caller stated they went to the Emergency Room and her daughter was given an epi pen and steroids because antihistamines were not helping. Caller mentioned later in the call that her daughter went to her doctor on 27May2021 at 1300 for this, to Urgent Care on 27 May2021 at 2100 for this; and finally to the Emergency Room today 28May2021 at 0200 and was treated in the emergency room and not admitted to the hospital. Caller stated her daughter was improving since being treated at the Emergency Room. Patient went to physician Office. No relevant tests was reported. Outcome of the events were not recovered.  Follow up needed, further information has been requested.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild
got the Shingle shot. Still got Shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot several years ago and still got shingles, but it was not that bad. The patient stated that then he/she got double shot and hoped it worked better. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received treatment with Paxlovid from 30Jun2022 to 04Jul2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Took shot 1/14, experienced burning around the injection site and sore arm, not out of usual. However, next morning (1/15) woke up with a headache and slight fever. Upon going to the kitchen to take medication for the headache, passed out on the floor. Was dizzy for the entire day, and could not leave the couch upon being helped there by my family. Dizzy symptoms continued into 1/16, but were not as intense as 1/15.