chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired after 2nd shot for 1 day; Fever 99 F after 2nd shot for 2 hours; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired after 2nd shot for 1 day) and PYREXIA (Fever 99 F after 2nd shot for 2 hours) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FATIGUE (Tired after 2nd shot for 1 day) and PYREXIA (Fever 99 F after 2nd shot for 2 hours). In February 2021, FATIGUE (Tired after 2nd shot for 1 day) and PYREXIA (Fever 99 F after 2nd shot for 2 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 99 (High) 99 F for 2 hours.         Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-408456 (Patient Link).
Information has been received from a consumer concerning his child who on an unspecified date was vaccinated with a dose of PROQUAD (lot number, injection site and route not reported). Subsequently the patient became autistic. It was unknown if the patient sought any medical attention. The outcome of the patient's experience was unknown. The consumer stated that PROQUAD caused his child become autistic. Upon internal review, became autistic was considered to be an other important medical event. No further information is available.
Lower spine and leg (both) pain, numbness, weakness, worse upon exertion. Exertion also induces light-headedness.
Evidence of neuropathic involvement with chronic constipation; Chronic significant constipation; Reports he has gained a few pounds; Legs feel weak after extensive walking or standing; Neurogenic claudication; Very mild pedal edema; This is a spontaneous report from a Pfizer sponsored program from a contactable physician  A 85-years-old male patient received received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation and tafamidis (TAFAMIDIS), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 61 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced evidence of neuropathic involvement with chronic constipation on an unspecified date with outcome of unknown, chronic significant constipation on an unspecified date with outcome of unknown, reports he has gained a few pounds (weight increased) on an unspecified date with outcome of unknown, legs feel weak after extensive walking or standing (muscular weakness)on an unspecified date with outcome of unknown, neurogenic claudication (spinal claudication) on an unspecified date with outcome of unknown, very mild pedal edema (oedema peripheral) on an unspecified date with outcome of unknown. The action taken for tafamidis was unknown.  Limited PO fluid intake Is active at the church. A lot of walking, no formal exercise. Therapeutic measures were taken as a result of chronic significant constipation (constipation) started some samples of Trulance from Gl.  Pfizer is a marketing authorization holder of Tafamidis in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Tafamidis has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on current available information, and a plausible temporal association, the causal association between the event neuropathy and the suspect drugs BNT162B2 and tafamidis cannot be totally excluded. The information available in this report is limited and does not allow  a medically meaningful assessment of the case.  In particular, the following relevant information is not available: suspect drugs start date, event onset date, relevant medical history, and concomitant medications.  Case will be reassessed once receiving additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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.
Developed chest pain, shortness of breath, and palpitations 8 days after second COVID vaccine, prompting PCP evaluation and ultimately hospital admission for concern for post-vaccine myocarditis
Developed swelling of right knee on 5/23, to urgent care on 5/24, then on 5/25 left knee and hands also swollen. Swelling subsided on 5/26. Swelling resolved on 5/29.
liquid antigen vial of without reconstitution with the lyophilized powder; was given the liquid antigen vial of without reconstitution; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th September 2021, the patient received Shingrix. On 20th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. A patient was given the liquid antigen vial of Shingrix without reconstitution with the lyophilized powder vial which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Difficulty Breathing; This is a spontaneous case from a contactable other HCP (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an unspecified route of administration in the right arm on 18Feb2021 at 15:15 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Asthma, Acid Reflux, Cardio embolic stroke, nocturnal hypoxemia and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was on concomitant medication (unspecified) taken within two weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Feb2021, at 18:00 the patient experienced difficulty breathing. The patient did not receive any treatment to the event. The outcome of the event was recovered on an unknown date in Feb2021.
nose bleed; This is a spontaneous report from a contactable consumer (patient's daughter). An elderly 79 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 17Jan2021 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications includes Aspirin. The reporter informed that her father (patient) received the first dose of the COVID-19 vaccine yesterday (17Jan2021) and today (18Jan2021), he experienced nose bleed. The patient had a nose bleed which lasted for a pretty long time. The patient just tried to stop it in a regular way. Just pinching the nose and stuff like that. The reporter did not know if there is any other medication that he takes only the Aspirin. The reporter just wanted to know if this was normal side effect. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (18Jan2021): New information received from a contactable consumer (patient's daughter) included: concomitant drug, event details.   Information on the lot/batch number has been requested.
Pfizer Vaccine - period is now late by 12 days.  I usually have a regular cycle.  I am not pregnant.
Fever to 104.5, malaise, occurring approx 4-6 hrs after vaccine administered.
administered dose past the manufacture expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  9 doses were administered from two different vials. On 15-Oct-2021, 3 doses administered. On 22-Oct-2021, 6 doses administered.
This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 29-OCT-2013, the patient was vaccinated with an expired dose of 0.2 milliliter (ml) of PNEUMOVAX 23 (lot number and expiry date were reported as 1947AA and 20-OCT-2013 respectively), intramuscularly. On 29-OCT-2013, the patient was also vaccinated with 0.3 ml of PNEUMOVAX 23 (lot number and expiry date were reported as J004332 and 26-SEP-2014 respectively), intramuscularly. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
This case was reported by a consumer via sales rep and described the occurrence of local swelling in a female patient who received FLULAVAL quadrivalent. In 2015, the patient received FLULAVAL quadrivalent .5 ml. On an unknown date, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown. It was unknown if the reporter considered the local swelling to be related to FLULAVAL quadrivalent. Additional details were provided as follows: In 2015, the patient experienced lump on the arm after vaccination with FLULAVAL QIV. The patient's information or lot number and expiration date of the vaccine were not available.
after taking vaccine has headaches; muscle ache legs arms; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "after taking vaccine has headaches"; MYALGIA (non-serious), outcome "unknown", described as "muscle ache legs arms".  Additional information: Event took place after use of product. Patient claimed after taking vaccine has headaches and muscle ache legs arms. She recently lost both parents to Covid and not sure if this is afresh or the vaccine side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My eyes have been very dry and burning since I received the vaccine.  I have to breaks often from work etc to close my eyes to get relief.; My eyes have been very dry and burning since I received the vaccine.  I have to breaks often from work etc to close my eyes to get relief.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 29Apr2021 at 16:00 (at the age of 56-years-old) as dose 2, single for COVID-19 immunization, in Pharmacy or drug store. Medical history reported as none. Patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not take any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 08Apr2021 at 16:00 as dose 1, single for COVID-19 immunization. On 29Apr2021 (same day of vaccination), patient eyes have been very dry and burning since received the vaccine. Patient had to breaks often from work etc., to close eyes to get relief. The events were assessed as Serious (Disability or permanent damage). The treatment was not received for the event. The patient has been tested for COVID-19 since the vaccination. The patient underwent lab tests which included SARS-CoV-2 Test (Nasal swab, Quick test): Negative on 02Jun2021 quick test. The outcome of the events was reported as not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
p/vax pt had local react @ inj site; seen by MD w/quarter size area of erythema; one papule/vesicular lesion at edge of erythema
pt recvd vax 22AUG95 & 6OCT95 lab eval revealed that the pt did not seroconvert;No further details were provided;
Dizziness/ SOB about 30 minutes after injection, utilized inhaler, relaxed in bed.  SOB and dizziness resolved GI symptoms started about 2 hours after injection - took protonix and maalox resolved by evening , Tingling in legs/feet in evening -Premedicated with Extra strength Tylenol and Benadryl for both doses of vaccine.
Pt recv vax on 1/5/99; on 1/12/99 pt exp edematous, pain of left knee & thigh, unable to walk; tx=Ibuprofen
First was dull headache at back of my head, 5 hours after vaccination. 15 hours, heaviness in body, slight body aches, dizziness, extremely sore arm (the LEFT one I had the vaccination in), Lymph nodes in RIGHT armpit were swollen.Temperature up to 100 for a couple of hours. It all subsided after 24 hours post vaccination.
pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3.  It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown.   No follow-up attempts are possible, No further information expected.
inadvertently administered an expired Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received HAV (Havrix adult) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 20-JUN-2023, the patient received Havrix adult. On 20-JUN-2023, an unknown time after receiving Havrix adult, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Havrix). The outcome of the expired vaccine used was 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: 20-JUN-2023 It was reported that a patient was inadvertently administered an expired Havrix which led to expired vaccine used. The reporter enquired that should the patient be revaccinated. The reporter did not consent to follow up.
Immediately got weak dizzy and nauseous. Started to black out and nurse laid me down. Blood pressure and heart rate dropped low and I broke out in sweat. Couldn't get back up for over an hour without blacking out. Then got chills and arms tingling.  started to feel a bit better after 2 hours. Very tired and weak for next 2 days
Assessment & Plan (3/14/2017 12:58 PM). Pustular rash (782.1 | L08.0) Story: Patient received TDAP and PNEUMOVAX yesterday as well as beginning diclofenac and developed pustular, erythematous rash on both wrists with edema as well as scattered lesions on her arms and trunk. She also has a contact dermatitis from her bilateral knee braces. Impression: I sent pictures to Dermatology resident. He felt this was consistent with an eczematous drug eruption and for us to treat with prednisone 40 mg now and every morning x 5 days. We could stop then. He felt that it was likely though that she would flare again and would need a 3 week taper in total, 40 mg, 30 mg, 20 mg. He also recommended a fluorinated steroid. We gave her fluocinonide twice daily and told her to stop diclofenac.
sudden LOC 10 mins p/immun, hypotension w/progressive to slurred speech, SOB, dec responsiveness x 6 hrs;
Mild fever 99.4-100.4, chills, body aches, soft bowel movements.
Initial symptoms woke up lost his balance and lower extremity weakness, and hospitalized for 4 weeks, and eventually diagnosed with Idiopathic transverse myelitis on 3/2015 after what pt feels is related to the Pneumovax immunization.  He has a ngeative MRI and negative inflammatory last test.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR. Provider d/c note: "Reason for Admission: depressed mood, paranoid delusions, suicidal thoughts, reduced self care, Covid-19 active infection    Brief Summary of Hospital Stay: Medications started with Lexapro and Zyprexa and titrated to response. Tolerated medications. Encouraged participation in group therapy addressing reality testing and coping skills. Patient was mostly guarded during stay. Received a court order for treatment. Recovery from covid-19 was unremarkable."
in a lot of pain; Inadvertently, she was given 2 COVID vaccines instead.; Inadvertently received dose 3 and 4 the same day; Inadvertently received dose 3 and 4 the same day; Received  Pfizer Covid  vaccine instead of flu vaccine; This is a spontaneous report from a contactable consumer (the patient) .    A female patient of an unspecified age received bnt162b2 (BNT162B2) dose number three, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included knee arthroplasty.     The patient's concomitant medications were not reported.  The patient experienced in a lot of pain (non-serious) on Sep2021 with outcome of unknown , inadvertently, she was given 2 covid vaccines instead.  (non-serious) on Sep2021 with outcome of unknown , inadvertently received dose 3 and 4 the same day  (non-serious) on Sep2021 with outcome of unknown ,  received  Pfizer Covid vaccine instead of flu vaccine  (non-serious) on Sep2021 with outcome of unknown.  Course of the event The caller was supposed to get the flu vaccine and the Covid 19 vaccine booster or third dose but the pharmacy gave the caller 2 Covid 19 booster vaccines. She wants to know what to do. Caller states she is recovering from a knee replacement surgery and is in a lot of pain.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
That evening I had aches, then woke up the next morning with fever, chills, body aches. That later progressed to nausea, sore throat, swollen lymph nodes, and a cold sore on the left side of my lip. Before the cold sore emerged I was having tingling in my lip, thinking it was from the CS. However it professed to my mouth, then my whole face. Had tingling in my legs. Shots of pain throughout my body. Weakness.
Delayed injection site reaction: Redness, itching, swelling, heat at injection site.
pt recvd 1st & 2nd doses of Hep B vax JUN90 & 13JUL90. On 17JUL90 exp pain & weakness in left shoulder, upper left arm & scapula area.12DEC90 pt devel red rash on buttocks,back,arms,legs,& neck.
Mom reports temp 103 on 6/8/04 at 10.00am . Baby crying non stop, non consolable. Mom had given Motrin temp not coming down. Instructed to give Tylenol 80mg + bathe in tepid water until she could get a ride to doctor's office at 1300 on 6/8/04. Temp 99.8. Mom had bathed but did not give Tylenol. Tylenol given with alt Tylenol Motrin+
significant myalagias; significant fatigue; This case was reported by a physician via call center representative and described the occurrence of myalgia in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and fatigue. On an unknown date, the outcome of the myalgia and fatigue were unknown.   It was unknown if the reporter considered the myalgia and fatigue to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. An unspecified number of patients received 1st dose of Shingrix and experienced significant myalgia and significant fatigue. The reporter was asking that how important was it to patient to receive 2nd dose of Shingrix. This case has been linked with US2019AMR105829, same reporter.