chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a work related injury; did not receive a second dose/first dose of the covid-19 vaccine on 04Jan2021; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number unknown), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the covid-19 vaccine on 04Jan2021. The patient did not receive a second dose due to a work related injury on an unknown date. The patient stated it was not due to the vaccine. The patient was inquiring if she needs to have the second dose or start over, or needs it at all for work. States work said she needed to have to come back to work. The patient has first appointment today to see about going back to work. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, there was not a reasonable possibility that the event "a work related injury" was related to bnt162b2. Event is due to work.
One week after Zostavax developed rash.  Later diagnosed as spongiotic dermatitis. Had never had before vaccine.
My wife and I had the same time and were vaccinated.  She immediately had a sore arm but it took 24 hours for me to feel it.  The following Monday (72 hours) I woke up with "the spins" and a mild headache.  These symptoms have come and gone for over two weeks now.  One day it will be better, the next worse, then even worse, then recovery, then almost gone, back to spins and dizziness.  I read somewhere it may be cykotines affecting my inner ear.  I also have a mildly stuffed nose but nothing out of the ordinary.  This stuffiness is allergies (seasonal?) related perhaps.  Today (4/29) it went back to "worse"
First Moderna shot- about 2 hours after shot developed symptoms. Body aches, headaches, and chills for the first 24 hours. After the symptoms eased up, I came down with a rash over more than half of my body
Started feeling "brain fog" a few days after second dose. It has been over a month and the fog has continued to be an issue. I struggle with memory loss and staying focused. The memory loss is very significant -- I will be working on a task and in the middle of it, forget why I am doing what I am doing. This causes extreme fatigue and thus stress headaches. In addition, my temper has become very short and I am quick to anger -- which is very unlike me. These symptoms are not getting better but are instead worsening. At this time I have not reached out for medical attention because I am unsure of how they would be able to help these symptoms. I fear if the symptoms do not relieve themselves or continue, I will be unable to perform my required daily tasks both at work and at home.
Initial healthcare professional report received on 12 Jan 2010: This patient (child under the age of 4 years) received on 0.25 ml IM dose of H1N1 (batch no. 104043P1) on an unspecified date. No adverse effects were noted upon administration.
terrible muscle pain, bottom of feet pain, not comfortable walking.. Extreme tenderness on eyeballs.  Chills,  shivering, headache, , upset stomach , could not eat., weakness. Pain and redness on innoculation site,  I felt awful. All symtoms lasted about 30 hours.
Side effects last; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects last) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects last). At the time of the report, VACCINATION COMPLICATION (Side effects last) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported  The treatment information was not provided.
15min post vax pt exp an anaphylactic rxn & was hosp;pt became hypotensive & was given epi & steroids;hosp MD felt pt exp was d/t MMR;
CG had received both COVID vaccines (12/22/20, 1/12/21) and has now tested positive for COVID on 4/8/21
Patient called the clinic and stated  he started having tingling, numbness, and hot to the touch in the left side of the face and lips.  Patient also stated that he is also having nausea and the top of his left arm is having numbness and tightness all the way down.  Patient received the vaccination at 8:45 AM this morning in the office and sat in our waiting room for 15 minutes per facility protocol and reported to staff was not having any symptoms when leaving.  Patient contacted our clinic 30 minutes after leaving facility and started symptoms had started 10 minutes after leaving facility.   Our office advised patient to be seen in the nearest emergency room.
Two patients had been vaccinated with vaccines which were shipped on May 22 and received May 28, vaccines were too long in transit packed for 2 day shipping/No AE; Initial and additional information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157728 (sibling).  This case involves a 14 years old male who was vaccinated with a 0.5ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] which were shipped on may 22 and received may 28, vaccines were too long in transit packed for 2 day shipping lot P2A89, Expiration Date: 14-Sep-2020 via unknown route in unknown administration site on 30-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Patients have no reported adverse events at this time.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
This spontaneous report as received from a company representative via registered nurse, refers to a 70 year old female patient. Concomitant medication and medical history was not provided. On an unspecified date 1 to 2 years ago the patient was vaccinated with live ZOSTAVAX. On an unknown date the patient experienced shingles. It began with spots above her eyes that hurt and itched. Her physician was contacted and antiviral solution was prescribed. The outcome of shingles was mot reported. The relatedness for shingles was not reported for live ZOSTAVAX. Additional information is not expected.
This case was reported by a physician and described the occurrence of blurred vision in an adult female subject who was accidentally exposed to diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis, The subject is a nurse. Medical history included that the subject wore "glasses". The physician reported that on 08 February 2006, "between 1:00 p.m. and 2:00 p.m., "some of the vaccine (Pediarix) squirted in the nurse's eye behind her glasses. A few hours later, at approximately 5:30 p.m.," the nurse experienced blurred vision in that eye". At the time of initial reporting, 08 February 2006, the blurred vision was ongoing.
No additional adverse effect reported; ROTATEQ that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 05-JUL-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1707446, expiration date was reported as 19-FEB-2022, but upon internal review was established as 09-FEB-2022 (exact dose was not reported) for prophylaxis. The administered dose was stored in a temperature of 48.0 degrees Fahrenheit (F) for 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports received from the same reporter.
Rebound Covid; Rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 57-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes type 2" (unspecified if ongoing); "hyperlipidaemia" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]; ASA; LIPITOR; HYDROCHLOROTHIAZIDE; REVATIO.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (23Jun2022) Negative; (26Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical Course:Rebound Covid at 2 weeks, initially tested negative after 4 days post paxlovid. Then symptoms started again on day 7 later and then tested positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events Drug ineffective , covid 19 and the suspect drug cannot be excluded.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Mom reports that patient has a history of fainting after vaccine administration. Patient complained of feeling dizzy and lightheaded after receiving Covid vaccine. Patient fell from standing position and hit his forehead against store aisle. NP was called by Pharmacist, to assist/evaluate. Patient alert and oriented upon NP arrival. BP 116/60, pulse 76, O2 sat 99% on room air. Patient with normal neuro exam. Patient returned to baseline.
Death  4/7/2021 Causes of death listed on death certificate: 1) Acute respiratory failure  2) Chronic kidney disease  3) Diabetes mellitus  4) Atrial fibrillation  Other: COVID 19
Information has been received regarding a case in litigation from a lawyer and a male patient of unknown age referring to himself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-MAR-2014, the approximately 67 year old patient was administered the ZOSTAVAX by a physician at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a physician's office for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, and economic losses. The outcome of the shingles was unknown. Causality related. Additional information has been requested.
Multiple white on erythematous base oral lesions to gums in buccal creases, upper bilateral. Assumed to be thrush, but no response to diflucan or mycelex after 1 day; actually worsened.
Narrative:  Patient came to the vaccination clinic for the flu shot and after the shot he came to charge nurse and reported t that he is having problem with his left arm after the second dose of Pfizer vaccine. patient reported that first dose was okay after the second dose he developed rashes and he cannot life his arm. he didn't seek medical attention. and got flu shot on the same arm and never reported this event to the flu vaccination nurse.
After giving pt L deltoid bivalent immunization, nurse moved over to R side  Repairing to give pt varicella vaccination on SQ, Right arm. Prior to administration, Pt asked nurse various questions regarding arm soreness. Nurse answered pt question and was distracted. Vaccination administered intramuscularly. In finishing documentation realized error. Reported to PL as soon as possible.
This is a spontaneous report received from a non-contactable pharmacist via a Pfizer sales representative. The pharmacist reported similar events for 3 patients. This is the 2nd of 3 reports.  A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced pain when administering Prevnar 13 on an unspecified date with outcome of unknown. Therapeutic measures were not taken as a result of the event. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017420663 Same reporter/drug/event, different patient;US-PFIZER INC-2017420662 Same reporter/drug/event, different patient.
Patient reports swollen left arm & arm pit, and body aches.    He was seen by Dr. on 8/11/2022 and was prescribed  antibiotics.  I spoke to RN and she said prescriber diagnosed with allergic reaction to vaccine, but said the patient had no signs of anaphylaxis.  I told her the symptoms are similar to the side effects; RN said that was listed on form.   At pickup,   I told patient that the prescribe diagnosed him with Pfizer allergy.   He said he  doesn't know if it's an allergic reaction, but there was a reaction.  I advised if he gets any future Pfizer vaccinations, he needs to notify the immunizer of this whole situation.
extreme fatigue, muscle pain, headache       treated with acetaminophen, resolved by 48 hours outbreak of hsv, beginning 4/8/2021, unresolved as of 4/16/2021
Pain at injection site started within hours Late evening it progressed to muscle aches in shoulders, neck, and upper back Awoke multiple times between 2:00a and 5:00a with increasing muscles aches and headache Read about side affects around 6:00a and took an ibuprofen 800 At this time (~7:45a) muscle aches and headache seem to be lessening
Two days after vaccination, patient reports a rash forming. It started at her left arm and spread across her torso, and then down her stomach and to her legs. The rash is red, itchy, and painful. The patient has an appointment with her doctor today (7/5/22) to discuss the potential causes and treatment options.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were inadvertently vaccinated with improperly stored M-M-R II (lot#, expiration date, dose and frequency not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician cannot be contacted.
administration of expired vaccine that is in thefridge for more than 30 day / administration of expired vaccine that was on the counter for more than 100hours/ administration of expired vaccine that is in thefridge for more 30 day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine that is in thefridge for more than 30 day / administration of expired vaccine that was on the counter for more than 100hours/ administration of expired vaccine that is in thefridge for more 30 day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine that is in thefridge for more than 30 day / administration of expired vaccine that was on the counter for more than 100hours/ administration of expired vaccine that is in thefridge for more 30 day). On 27-Apr-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine that is in thefridge for more than 30 day / administration of expired vaccine that was on the counter for more than 100hours/ administration of expired vaccine that is in thefridge for more 30 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up information received on 30-Apr-2021 contains non-significant information. On 10-May-2021: Follow-up information received on 10-May-2021 contains non-significant information.
pt recvd vax; exp pain originating at inject site & radiating into Lt neck & shoulder; c/o weakness Lt arm; was afebrrile; tx ibuprofen; heat qid to area;
itching at the injection site; arm pain; body aches; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), PAIN IN EXTREMITY (arm pain), MYALGIA (body aches), FATIGUE (fatigue) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), PAIN IN EXTREMITY (arm pain), MYALGIA (body aches), FATIGUE (fatigue) and HEADACHE (headache). On 17-Apr-2021, MYALGIA (body aches), FATIGUE (fatigue) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) and PAIN IN EXTREMITY (arm pain) outcome was unknown.            The concomitant medications information was not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
This spontaneous report was received from a physician referring to a 4 month old female patient. No concurrent or historical conditions were reported. On 24-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # L012521, expiration date February 2017), 0.5 ml, intramuscular in the left thigh (Inappropriate schedule of vaccine administered) and on the same day the patient was also vaccinated with M-M-R II (Lot # K004948, expiration date 04-APR-2016), 0.5 ml, subcutaneous in the left thigh, instead of PREVNAR (wrong vaccine administered). No concomitant medications were provided. No adverse effects were reported. Additional information is not expected as the physician did not want to be contacted regarding the report because the patient was not longer with her practice.
Parents concerned at "shaking, lethargy and fever" that started within 12 hrs of immunizations on 6/23. Highest temp per father 101 approximately lasted x2 days. Also "slight red" on day 2.
Patient experienced fever, cough and seizure. Discharge Summary received on 2/7/2005 states SOB and myalgia. Medical Records received on 2/7/2005 states atelectasis.
Arm and shoulder pain. H/A, stomach cramps, congestion, cough. Doesn't know if she has allergy to egg or not, but doesn't eat eggs. Didn't inform employer of reaction to eggs.
Patient refers to having felt pain, "a heat" and burning at the time of the administration of the vaccine. Also refer that he felt like "the vaccine ran through his body, burning him". The patient reaffirms that at the time of reporting the incident, he continues with pain in the arm area and feeling lumps in the axillary area.
But does not want to take Modernaa since a friendof mine ended up with blood clot in her lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (But does not want to take Modernaa since a friendof mine ended up with blood clot in her lungs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (But does not want to take Modernaa since a friendof mine ended up with blood clot in her lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (But does not want to take Modernaa since a friendof mine ended up with blood clot in her lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported. No concomitant medications were reported.  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.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of pulmonary embolism. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient 'ended up with blood clot in her lungs'. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of pulmonary embolism. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient 'ended up with blood clot in her lungs'. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.