chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in the injection site.; Redness in the injection site.; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient experienced redness and swelling in the injection site of approximately 3 to 4 inches. The reporter consented to follow up.  The reporter did not provide lot number and expiration date of the first dose of Shingrix. The case is linked to case US2020AMR012680 reported for the same patient (2nd dose).
Very disorientated.  Dizziness.  Headache.  Weak.  No balance.  Could not sleep.  In bed for at least 24 hrs.
Pt experienced unconsolable screaming for 4 hours, pallor, swelling erythema of the right thigh.
Patient presented to the ED on 3/5/21, 3/11/21, and 3/23/21. Patient presented to the ED on 5/10/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination.
Soreness first day Jan 27,2021then red patch hot to the touch swollen and red under injection site was noticeable on February 5,2021. Took ibuprofen. Patch is painful and hot and raised.
has chills; still has a fever,; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (has chills) and PYREXIA (still has a fever,) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced CHILLS (has chills) and PYREXIA (still has a fever,). At the time of the report, CHILLS (has chills) and PYREXIA (still has a fever,) outcome was unknown.            Patient has given rapid test and Abbott test result was negative.  Treatment and concomitant medications were not provided.
Information has been received from a physician concerning a patient who was vaccinated with a first dose of 0.65 milliliters of Zostavax (Oka/Merck).  Subsequently, on an unspecified date the patient experienced a rash-like reaction.  Unspecified medical attention was sought.  The outcome is not reported.  No product quality complaint was involved.  This is one of several reports from the same source.  Additional information has been requested.
On January 27, 2008 patient was given a Engerix-B injection, then the medical assistant realized the vaccine was outdated on January 25, 2008.
Rt leg red & sl swollen the night of the inject-continued to swell & get hot & angry looking;took to MD 5 days p/inject & was told by MD had infected leg where HIB vax given;
vivid dreams every single day; Disrupting sleep pattern; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (vivid dreams every single day) and SLEEP DISORDER (Disrupting sleep pattern) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Factor V Leiden thrombophilia and Stokes Adams syndrome. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA) and CEFIXIME (GENIXIME) for an unknown indication.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABNORMAL DREAMS (vivid dreams every single day) and SLEEP DISORDER (Disrupting sleep pattern). At the time of the report, ABNORMAL DREAMS (vivid dreams every single day) and SLEEP DISORDER (Disrupting sleep pattern) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-009257 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-009257:case for first dose
Patient started to notice erythema and warmth at the injection site on her left deltoid on Friday evening around 10pm. On Monday, 9/10 around 8:30am, she was getting dressed and noticed an area of erythema (about the size of a palm) under her left breast. No itching, burning, or vesicles present.
Patient was given two tetanus injections (ADACEL) in 1 year. Denies pain. Edema problems after 4 days.
This spontaneous report was received from a registerd nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # M017983 with expiration date of 30-MAY-2018; lot # M033583 with expiration date of 14-APR-2019 and lot # M041212 with expiration date of 21-JUN-2019) (strength, dosage schedule, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The reporter stated that the doses of the vaccine (lot # M017983) experienced a temperature excursion between >8 degrees Celsius but <25 degrees Celsius for 40 Hours 25 minutes and the doses of the vaccine (lot # M033583 and lot # M041212) experienced a temperature excursion between 0 degrees Celsius to 2 degrees Celsius for 4.5 hours. There were no previous excursions reported. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000930: US-009507513-1702USA000929: US-009507513-1702USA000927: US-009507513-1702USA000364.
I lost body strength and could not walk or maintain my balance, muscle aches. This also happened on the first shingrex  shot (7/17/2020) but this second was worse. I began to recover about  24 hours after the 2nd  vaccination but itnis now 48 hours and I am not completely back to my normal which is affected by my MS/
This spontaneous report was received from a Licensed Practical Nurse (LPN), referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot number M044719, expiration date 07-MAY-2018, for prophylaxis (dose, frequency and administration route were not provided). Concomitant therapies included a properly stored sterile diluent (lot number M011786, expiration date 22-SEP-2018). The data logger registered a temperature range of minus (-) 14°Celsius(C) to -10°C during a time frame of 3 hours. There was not a previous temperature excursion. No adverse effects were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1709USA004056.
Body aches; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 08May2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00, as a single dose for COVID-19 immunisation. On 09May2021 at 11:00, the patient experienced body aches, sore arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body aches, sore arm and fatigue was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
felt unwell; palpitations; chest pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 25-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history was not reported. No previous cardiac anomalies prior. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, The initial series with Pfizer SARS Covid-19 and 2 between Apr2021), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, The initial series with Pfizer SARS Covid-19 and 2 between Apr2021), for COVID-19 Immunization. The following information was reported: CHEST PAIN (medically significant) with onset Dec2021, outcome "not recovered"; MALAISE (medically significant) with onset Dec2021, outcome "not recovered", described as "felt unwell"; PALPITATIONS (medically significant) with onset Dec2021, outcome "not recovered". The event "palpitations" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: unremarkable; Electrocardiogram: unremarkable; Electrocardiogram ambulatory: unremarkable. Therapeutic measures were not taken as a result of malaise, palpitations, chest pain. Clinical course: Seriousness assessment was not life threatening but persistent and bothersome. Significant but not life threatening. The significance is persisting. He considering going to the Emergency Room but he did not feel his symptoms were life threatening.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events 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.
This spontaneous report was received from a pharmacist regarding a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N003993 with expiration date 20-OCT-2018 (dose was not reported), intramuscularly for prophylaxis. On the same day that night, the patient experienced swelling at injection site (injection site swelling) and took Aspirin, Medrol dose pack and kept ice packs on the injection site. The outcome of injection site swelling was reported as recovered. Causality assessment was not provided by the reporter.; Sender's Comments:  US-009507513-1708USA009384:
4 x 3 inch lump, red at site of Varivax.  No fever.  Now looks like Red sunburn 3-26-08.
hives; multiple anaphylactic reactions; suicide tendencies; it rendered her immobile; angioedema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (COMIRNATY), administration date 26May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 05May2021, for Covid-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 2021, outcome "unknown", described as "multiple anaphylactic reactions"; SUICIDAL IDEATION (medically significant) with onset 2021, outcome "unknown", described as "suicide tendencies"; IMMOBILE (medically significant) with onset 2021, outcome "recovered", described as "it rendered her immobile"; ANGIOEDEMA (medically significant) with onset 2021, outcome "recovered", described as "angioedema"; URTICARIA (non-serious) with onset 02Jun2021, outcome "not recovered", described as "hives". The events "multiple anaphylactic reactions", "suicide tendencies", "it rendered her immobile", "angioedema" and "hives" were evaluated at the physician office visit. Therapeutic measures were taken as a result of anaphylactic reaction, suicidal ideation, immobile, angioedema, urticaria. The reporter stated that it was her first time having that condition in her life. Between Jun2021 and Sep2021, she experienced multiple anaphylactic reactions, she also had angioedema to the point that it rendered her immobile though it has resolved now; however, hives is still persistent to her up until today, she have consulted with doctors already and was given medications such as, epipen, inhaler, Xolair, and some other antihistamines and mast cell stabilizers. The reporter stated that it had affected her life since then, to the point that she had to stop going to work, was not being able to put any clothing because of her condition, went to counseling for her suicide tendencies, she shied away from her community for the longest time and her financial status were also affected.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 8 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 8 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.
miserable and from the back that is already bad; miserable and from the back that is already bad; This is a spontaneous report from a contactable consumer(patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on an unspecified as dose 1, single for COVID-19 immunization. Medical history included ongoing back pain Caller stated she has back pain for 3 years due to she fell down the stairs. She said she took the first shot of Pfizer covid vaccine and they told her no Tylenol. She said she takes Tylenol 4 times a day for her back pain , ongoing fall Caller stated she has back pain for 3 years due to she fell down the stairs. She said she took the first shot of Pfizer covid vaccine and they told her no Tylenol. She said she takes Tylenol 4 times a day for her back pain. The patient's concomitant medications were not reported. Patient have a question. Yesterday she had her first shot, the Pfizer one and right when she was leaving they said something, no Tylenol. Then she go, but then she did not get to ask a question because she have been taking Tylenol for severe back pain. she fell down the basement stairs and she have been taking 650mg, Four times a day. So she said okay. Patient guess she just cannot take Tylenol then. So, then she got up and of course miserable and from the back that is already bad. So can she not take that it all. Should she go, she mean that's 650, she know was a lot, 4 times a day or should I try ibuprofen. she think they said something, she briefly heard something. she thought that they said something that if you take Tylenol with Pfizer it was less effective. Therapeutic measures were taken as a result of miserable and from the back that is already bad. The outcome of the events was miserable and from the back that is already bad unknown and for event miserable and from the back that is already bad was not recovered.     Follow-up attempts are completed. No further information is expected.
an expired dose of QUADRACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from ann other health professional via regulatory authority (Reference number- 00377535) and transmitted to Sanofi on 01-Dec-2020.  This case involved a 6 year old patient of unknown gender who was vaccinated with a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] which had the expiry date of 10-Sep-2020, via unknown route at an unknown administration route on 18-Nov-2020, as an prophylactic vaccination (expired product administered).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a true medication error due to expired product administered (latency same day).  Reporter wanted to know if there was a window on expired products and if the patient needed to be re-vaccinated.   At the time of this 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.  There will be no information regarding the batch number for the case.
Info has been received from a health professional concerning a female who was vaccinated with a dose of varicella virus vaccine live. One year after vaccination, the pt developed a mild case of chickenpox. It was reported that the lesions were large and needed to be lanced. Unspecified medical attention was sought. At the time of the report the pt had recovered. There was no product quality complaint involved. Additional info has been requested.
Client was vaccinated with intradermal vaccine 0.1ml  jynneos/BN vaccine twice, on left forearm by two deferent vaccinators , wheal did not form on either attend.
This is a spontaneous report from a contactable other hcp (patient).  A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via unspecified route of administration on 19Jan2021 14:00 at a single dose on left arm for covid-19 immunization.  There was no medical history reported. Patient has no known allergies. Concomitant medication included Atenolol 25 mg, vitamin C 1000mg, vitamin D 5000mg; all on unspecified dates for unspecified indications.  On 19Jan2021 at 14:15, the patient stated that "after the injection I went to the waiting area. I started to feel tingling on my left side of my face and then my nose and a little on the right cheek. I got the injection at 2 pm and now is 8:28 and I still have the tingling." Patient has not received any treatment. There were no other vaccine administered in four weeks. Patient has no COVID prior vaccination and has not tested post vaccination. The outcome of the event was not recovered.  Information on the Batch/Lot number has been requested.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknwon date the patients were vaccinated with an improperly stored ROTATEQ oral (dose and lot # were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Around 3:00 AM I woke up shivering. The shivering was severe although I didn't feel all that cold.  It was borderline uncontrollable and it was difficult to walk (and I had an accident on the way to the bathroom).    I have never had a similar reaction to a flu vaccination before, though I have received them yearly for decades.  In addition, the usual level of arthritic pain I have in my shoulders and hips was exacerbated. I fell asleep in perhaps two hours after putting a heating pad on my chest and on one especially sore shoulder, and I was still shivering when I drifted off.   I am fatigued and achey today, but feel much better than I did during the night, and not shivering.
Experiencing moderate pain, swelling and redness in shot area. This reaction occurred exactly one week after receiving the shot.
14FEB99 inc temp, nasal drainage, cough, Robitussin DM, sudafed, APAP;flu dx;
Developed morning pain and stiffness of bilateral hands/fingers (mainly joints). During the day symptoms improve, however come back next am.
On 1/1 I woke up with a fever of 100.3 which went away on its own within an hr.  I had a headache, congestion, a mild running cough and lost my sense of smell, but no more fever which all lasted for about 3 days.  1/3 I went to Urgent Care because I was feeling so bad and had a COVID test which came back positive and advised if symptoms got worse to return.
1 1/2 hours after vax adminstered pt screamed x 2 1/2 hours high pitched scream, vomited 2 times. ER advised to give Tylenol, low grade fever of 100 rectally. Redness at site size of dime.
patient received COVID 19 booster 10 mcg dose on 6/2/2022, developed type 1 diabetes with symptoms starting on 6/12/22. She presented with blood sugar 344 and 3+ glucose in urine on 6/15/22 at my office. Not in DKA.
Within 2 hrs of vaccine administration feel pin point red macular rash from neck down on palms & soles confluent rash.
Developed hive-like rash to bl legs 5 days after administration of vaccine with clearing around site of immunization on left thigh. No other signs of illness. No other recent exposures.