chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; FALSE POSITIVE PCR TEST; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient underwent to SARS-CoV-2 PCR test and diagnosed with the false positive result and had suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of false positive PCR test and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000180230, PQM001525200 and PQM001525259. The suspected product quality complaint has been confirmed to be this record indicates an adverse event. there is no product quality issue reported. Approval to void this record due to no PQC identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210541182-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccine failure . This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
C/O right arm weakness, paralysis, headache, fever, body aches on 4-17-14.
diarrhea; pain; nausea; This is a spontaneous case from a contactable pharmacist via Support. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported) via an unspecified route of administration on 24Aug2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 25Aug2021, the patient experienced pain, nausea and on 26Aug2021, experienced diarrhea. The seriousness of the events was reported as non-serious. The outcome of pain and nausea was recovered on an unspecified date in Aug2021 and event (diarrhea) was unknown.  Follow-up attempts are completed. No further information is expected.
Patient made appointment online for Pfizer first dose shot. Patient came in and verified that this was the patient's first shot and had already filled out paperwork online. Pharmacist confirmed that this was the first shot for the patient as well before giving the shot. Pharmacist went over the details of the Pfizer 1st dose including the timing of the 2nd shot. Pharmacist informed the patient to stick with Pfizer for the second shot - "no Moderna or JJ" for the 2nd shot. Patient understood and agreed. Pharmacist went on to counsel for side effects and common remedies for symptoms. Patient understood that patient has to wait for 15 minutes post-vaccination before leaving. Pharmacist gave shot and then asked patient to move to waiting area. As patient moved to waiting area, patient asked the pharmacist, "What if he has already gotten the Moderna series though? How would the Pfizer affect him?" Upon hearing this, pharmacist asked the patient to confirm because patient told both pharmacist and technician that this is his first COVID vaccine. He said no, he meant that this was his first Pfizer shot, but he had completed his Moderna series in Feb/March. Pharmacist counseled patient afterwards and advised patient to double check with his physician.
15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL; They reported significant body aches; This is a spontaneous report from contactable physician. This physician reported similar events for fifteen patients. This is 6th of fifteen reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, 1.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 ml, they reported significant body aches, on an unspecified date. It was also reported that Many had GI symptoms (nausea, vomiting and diarrhea). The clinical outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
Difficulty in breathing, a fast heartbeat, and AFIB. Taken to the emergency room and patient died within 2 days.
Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.; Patient received vaccines past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2022 at 1:06 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Mar-2022 at 1:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that this vaccine was administered up until its Mfg Exp date of 04-Apr-2022.  No treatment medication were reported.
Initial misuse report received from a healthcare professional on 20 June 2013. A 32-year-old male patient had received a dose of ADACEL and then it was determined that he had also received a dose of ADACEL in October 2012. No adverse event was reported. List of documents held by sender: none.
Left upper arm redness, swelling and warm to touch also itchy and tender. Treated for cellulitis with oral antibiotic ordered 6/14/16 when pt 1st reported problem.
Psoriatic arthritis break out/flare up spots on lower leg; This is a solicited report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. Other Case identifier(s): 22K-163-4477236-00 (Company). A 63-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: Unknown), on 11Feb2021 as dose 2, single (Batch/Lot number: Unknown) and on 26Aug2021 as dose 3 (booster), single (Batch/Lot number: Unknown) at the age of 62 years, all intramuscular for covid-19 immunisation, adalimumab (HUMIRA), (Lot number: 1159670) at citrate free, subcutaneous for psoriatic arthropathy, ankylosing spondylitis. The patient relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic arthritis break out/flare up spots on lower leg". The action taken for adalimumab was unknown.  Clinical information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter considered "psoriatic arthritis break out/flare up spots on lower leg" related to BNT162b2. The reporter causality for the event of psoriatic arthritis break out/flare up spots on lower leg with Humira (Adalimumab) was no reasonable possibility.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Information has been received from a physician concerning a female of chronic cougher who on 04-MAY-2009 was vaccinated with the first dose of PNEUMOVAX. Concomitant therapy included Z-PAK. Subsequently the patient had an injection site reaction after her first vaccination. The patient had a fever of 103 Fahrenheit and extreme swelling of her arm. The patient sought medical attention and was seen in the physician's office. At the time of reporting the patient was not recovered. Follow up information was received from a physician via telephone on 06-MAY-2009. It was reported that the 54 year old female patient was vaccinated with a dose of PNEUMOVAX (lot# 662744/1085X) on 04-MAY-2009. Concomitant therapy included BENADRYL and TYLENOL. It was reported that the patient was seen in the physician's office on 06-MAY-2009 with fever (103F) and extreme swelling of the arm. On an unspecified date the patient recovered. This is one of several reports form the same source. Additional information has been requested.
Fever, aches, chills, general pain all over the body, light sensitive, headache/migraine
her sister has had shingles even though her sister had the Zostavax vaccine; her sister got shingles twice and they were severe; her sister has had shingles even though her sister had the Zostavax vaccine; her sister got shingles twice and they were severe; This spontaneous report was received from an Advanced Practice Registered Nurse (APRN) and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported).   It was reported that the patient had had shingles (herpes zoster) even though she had the zoster vaccine live (ZOSTAVAX) (vaccination failure); she got shingles twice (unknown dates) and they were severe.     The outcome of vaccination failure and herpes zoster was unknown.        The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was not reported.   This one of two reports from the same reporter.; Sender's Comments:  US-9507513-1806USA003205:
patient indicated that arm was sore for a couple of days after injection, got better than began hurting again. indicated that hurt in muscle on left deltoid and it is painful for her to lift arm up
Within hours after vaccine, onset of diffuse pain and aching in both arms and shoulders which has persisted for several days. No specific tenderness at injection site. Pt has had flu vaccine without incident in the past. Pt had vaccine at a local store, not at our clinic.
Pt with a history of DM type II, obesity, and HTN. Pt found to be COVID-19 positive. Pt admitted for acute respiratory and sepsis.
9/12/07 Swelling and tenderness at site of injection less than 24 hr after injection Recommended Rx with ice
Weakness; pain in left armfrom scapula down left arm. Extremelypainful to touch and move.; 3 days agonoted multiple red spots on left hand(palm sized) that is painful to touch.; Rash seems to be spreading.; 3 days agonoted multiple red spots on left hand(palm sized) that is painful to touch.; Extremely painful to touch and move.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GP7534) via an unspecified route of administration in the left arm on 21Mar2021 at 12:30 as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 28Feb2021 at 12:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, the patient experienced weakness and pain in left arm from scapula down left arm and extremely painful to touch and move and three days ago noted multiple red spots on left hand (palm sized) that is painful to touch and rash seems to be spreading. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events weakness, pain in arm, red spotty rash, painful rash, extremely painful to touch and move and spreading rash were ongoing at the time of this report.  No follow-up attempts are needed. No further information is expected.
Rash through the body start the day MMR, Varicella, PREVNAR13 and DTaP were given.
Under 16 y.o. vaccinated. Parent entered DOB as 2005 instead of 2006. This was not discovered until after the second dose was administered. No other adverse events occurred.
Information has been received from a physician concerning a 17 year old female who on about 22-FEB-2007 was vaccinated with a dose of Gardasil. On 22-FEB-2007, immediately following vaccination, the patient experienced nausea and headache. Shortly thereafter, the patient experienced vomiting and developed a fever which lasted for 1.5 days. Unspecified medical attention was sought. The symptoms resolved. Additional information has been requested.
Headache, Myalgia, Arthralgia,  Chills, fatigue, stiffness Narrative:
been sick/she is kind of halfway sick; been sick; lost a bunch of weight; already had three of her shots; This is a spontaneous report from a contactable consumer (Patient). A 94-years-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced seriousness for been sick, lost a bunch of weight and already had three of her shots, she is kind of halfway sick, she confirms she didn't have any experience to report. Patient states she is calling because they didn't give her a card. When probed for telephone number, the caller explains she doesn't have but one number, and she is kind of halfway sick. Patient already had three of her shots at (#) She doesn't know what happened but she doesn't have a card. She clarifies she took three shots already. She was looking through her purse and she doesn't have a card for that, but she has already had three shots already. She confirms she didn't have any experience to report. they said she already had two shots already, but she still couldn't understand that the last one she had was taken at #,that's the hospital where she goes. Reporter clarifies she doesn't know if she got the Pfizer COVID-19 vaccine. Patient thought everybody was getting one. Patient clarifies # is her regular hospital. She went there the first time, and she went there the second time, and the last time she went, she thought that was it. She kept seeing in the papers that they might give her another shot later. She didn't pay that much attention, but after she left one hospital, she didn't know where to go for another one. She clarifies it was in some papers that gave her and she didn't look at it. It was her fault. The first time, she went back to the hospital, and the last time was at hospital. She will be sure she look good next time. It was her fault. She is not able to provide an NDC/Lot/Expiry date. She mentions she might get her granddaughter to call. Her granddaughter lives in #. The patient thought she wouldn't take the Covid-19 shot, but her granddaughter told her to take it. Her granddaughter took her shot at the same the caller did, the same date. She said when she went to get her shot, the hospital staff asked her if she was coming to get her shot. After she got the shot, the staff told her she was through, and that was her last shot. She was born in that section of the hospital where she got her shot. Patient will contact her granddaughter in #and tell her what happened about her getting sent a card. She was reading in the paper, or book, that she was supposed to get another shot, but the caller doesn't know. She really doesn't want another shot, she's too old. She did good. Patient underwent lab test and procedures included weight. The outcome of events was unknown.  Information about batch/Lot number has been requested.
Patient who was a healthy child from what we were aware of had received her regular 6 month vaccinations at 7 months which included the flu shot. Around 1:30 am 11/15/2016 first seizure occurred. She blanked out and started foaming at the mouth. Called emergency to which nothing was really done and was sent back home. 11/15/2016 at 8am another seizure occurred this time she was in a blank state and face and lips turned purple/blue. Called emergency again to where her eyes began to rol back while in ambulance. They took an anal temperature and had a 102 fever. They gave her Motrin and tylonal and had her go to her primary doctor the same day. Her doctor requested an eeg and was told that she had abnormal results. She was put on keppra 100 mg but was taken off and put on another type of medication that is a  suppository. Was told she had febrile seizure.
Within 1.5 weeks of getting the first dose of the vaccine, I lost about 70% of my hair. The hair loss was so bad that I shaved my head on August 25. Other symptoms were minor and expected: sore arm, extreme exhaustion/tiredness.
Patient became lightheaded and stated she felt ?weird.?  Nurse offered Gatorade, which did not help, so nurse initiated a code green-request for paramedics.
Nausea-8hrs after shot until 30 hrs later Chills - 12 hrs Fever- 24 hrs Body aches and pain- 48 hrs Dizziness- 36hr after shot until 60 hrs after shot.  Fatigue- 48 hrs
breathing diff-wheezing-very pale; t105, vomiting (projectile) was fine the following day; pt not to recv another DTP;  APAP suppository, sponge bath temp was down p/2-3 hrs called MD
Soreness under her arm unsure if muscle or lymph nodes; Pain under the arm, under the injection site in which it was a soreness; Aching in arm; Achy; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer (patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 04Feb2021 at 10:30 as first dose,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. On 04Feb2021, the patient experienced after is that she felt a little achy and 04Feb2021 at 8:00 pm that evening her arm was aching, patient took an Ibuprofen and had no problem afterward, On 05Feb2021, the day after patient mentioned had pain under the arm, under the injection site in which it was a soreness which had no lump. She cannot discern whether it was a lymph node or muscle, but is leaning more into it being a muscle because patient could feel a pulling sensation when patient raises her arm at the shoulder. Patient was asking if these are common side effects and for how long do these usually last. On 06Feb2021 soreness under her arm, unsure if muscle or lymph nodes. The outcome of the events achy, pain under the arm, under the injection site in which it was a soreness were unknown, soreness under her arm was recovering and aching in arm was recovered on 04Feb2021.  Follow-up attempts are completed. No further information is expected.
Arm ache after first dose; Achy all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, PAIN, and HEADACHE in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroid disorder.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY, PAIN, and HEADACHE. On 05-Mar-2021, PAIN IN EXTREMITY had resolved. At the time of the report, PAIN and HEADACHE outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Action taken with mRNA-1273 in response to the events was not applicable. Concomitant product include Three medicines for blood pressure, and Thyroid pills.
Light headed, whoosey, began about 45 minutes after injection. I was driving home and this resulted in my hitting a curb with my car