chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a nurse via company representative concerning unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PEDVAXHIB. The reporter stated the patients had not followed the recommended schedule and may have possibly administered at extended intervals (inappropriate schedule of drug administration). No adverse effect reported. Additional information has been requested.
Injection at 1:45 within 10 min.just felt weird like off alittle . waited my 20 min. by the time I walked to the car I was the same maybe a little more ..walking slow. by the time I got home 15 more min... I was feeling really woozy... glad to be home.. I felt fine & happy.. except for the woozy feeling and started feeling loopy...like I had drank a couple drinks..Not thinking correctly..This lasted for at least 4 hrs then less for 2 hrs.. then I went to bed . woke up the next morning foggy headed ,,till about afternoon. along with a verY sore arm  and a huge lump at the inj site ..also it did hurt when I got it..both the needle and going in. The soreness left after 2 days the bump took longer. And I still have a bruise where I got it.  I did learn 1 thing,,DO NOT TEXT AFTER THE SHOT if you feel like this,,,,, didn't make much sense at all..And I didn't remember half of what I said till the next day and reread it,, ..Like texting while drinking...ugh. but I didn't feel bad except for my arm and little headache. I googled and saw where others had the same feeling ...loopy woozy after .
Pt. reported achy, malaise 3 hrs after dose. Took Ibuprofen 4 hrs after dose. Continued to feel bad with chills & headache that progressed to diarrhea, increased blood pressure & elevated blood sugar approximately 6 1/2 hrs after dose. Pt. said she didn't feel better until later the next day.
This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
swollen vein on his nick; high fever; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer.  A male patient of an unspecified age received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single, dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was calling on behalf of someone who received both doses of the vaccine and caller wanted to know if he should be worried about a swollen vein on his nick and a high fever. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient showed up for her 2nd dose. We were only giving 10 shots that day. The patient was not on our schedule and was not yet due for her second dose. This was not caught and patient received her 2nd dose 14 days after her first dose
Only half the dose was given; Moderna vaccine was running down her arm; A spontaneous report was received from a pharmacist concerning a 67-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) but only half the dose was given / under dose and the vaccine was running down her arm / product administration error was reported.  The patient's medical history and concomitant medications were not provided.   On 03 Mar 2021, the patient received their planned dose of mRNA-1273 (Lot number: 014M20A) in the arm for prophylaxis of COVID-19 infection.   On 03 Mar 2021, it was observed that only half the dose was given and Moderna vaccine was running down her arm. The pharmacist states that it was perhaps 0.25mL or less given to the patient. The event was considered to be a medication error.  Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event were considered resolved on 03 Mar 2021.; Reporter's Comments: This case concerns a 67-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot # 014M20A), reporting a medication error during product administration and underdose without any associated adverse events. Events considered resolved.
I63.9 - Stroke (cerebrum) I63.9 - Cerebral infarction, unspecified
Post vax, the pt limped for approximately 12 hours; guarded the thigh approximately 24 hours. Thigh swelled from thigh to knee. No reaction at actual injection site. Had a 2" red diameter red spot 2" to right of injection site that was not hot or tender. Took 7 days for edema to resolve.
Patient  visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating.  He was diagnosed with Covid Pneumonia.  Patient had underlying conditions (heart, lung and kidney disease)
received his first Moderna dose on 16/Mar/2021 came into the facility to see if he can receive his second dose now; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received his first Moderna dose on 16/Mar/2021 came into the facility to see if he can receive his second dose now) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (received his first Moderna dose on 16/Mar/2021 came into the facility to see if he can receive his second dose now). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received his first Moderna dose on 16/Mar/2021 came into the facility to see if he can receive his second dose now) 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.   Concomitant medications were not provided. Treatment information was not provided.
severe blood pressure drop 60/20, difficulty seeing, diaphoresis, resolution started after getting on stretcher for transport
About 5 hours after receiving the COVID-19 Vaccine EUA?? vaccine I developed a serious headache, fever, extreme chills, widespread body aches, and nausea (followed by vomiting another 4 hours later). I did not check my temperature during the night, but early the next morning my temperature was 100.6°. The headache, fever, chills, and body aches continued all of the day following the vaccine. Food didn?t taste right and my stomach wasn?t up for much food at one time. I tried to stay hydrated.
ZOSTAVAX vaccine was given around 11:45 am to this pt. About 2-5 minutes later, I noticed that pt's skin was pale. I asked pt if he was ok. Pt told me that he was sweating and I also noticed that his face and body were dripping of water. He also told me that he felt hot. I started to call 911 while waiting for 911 I checked his BP.
Information has been received from a 66 year old white female consumer with no known allergies or pertinent medical history who on 21-May-2007 was vaccinated SC with a single first 0.65 ml dose of Zostavax.  There was no concomitant medication.  The patient immediately developed a swollen and painful arm.  She also was experiencing bronchitis which "goes away and comes back".  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Follow up information received from the physician indicated that the patient was vaccinated IM (previously reported as SC) in the left arm with a first dose of Zostavax.  On 06-Jun-2007 the patient developed an upper respiratory infection which the physician did not believe was related to the vaccination.  The patient was also diagnosed with lateral epicondylitis which the physician did not think was at all related to vaccine, but the patient believed it might be.  Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and 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. On 02-APR-2016, the patient was treated at an urgent care and primary care facility, for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe 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.
Information has been received from a certified medical assistant concerning a 75 year old retired white female with chronic obstructive pulmonary disease, hypertension, and Ca++ Granuloma LUL, who on Jun 02 2004 was vaccinated IM with a 0.5ml third dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). It was noted that the patient received a dose of pneumococcal 23v polysaccharide vaccine in both 1991 and 1998, and had no reaction at that time. On June 02 2004 the patient developed cellulitis, It was noted that the patient experienced a local reaction within an hour of injection and developed cellulitis in the arm, The patient was seen again on June 03 2004 and is currently being treated with oral antibiotic therapy. Additional information is expected.
After Receiving DTAP immunization in left IM muscle one day later presented with redness, heat and hardness of site. Was Rx antibiotics as well as benadryl
Fever - started 10 day after immunizations & lasted 4 days.  Rash - started 6 days after immunizations & lasted 6 days.
headaches; stomach issues; This is a spontaneous report from a contactable consumer or other non hcp as reporter (patient). A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (lot number, expiry date was unknown), via an unspecified route of administration (lot number and expiry date was unknown) as a Unknown dose, single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On unknown date, patient experienced headaches and stomach issues after the covid vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Information has been received from a pharmacist (R. Ph) concerning her 61 year old mother with no medical history and no previous history of shingles and no drug allergies/reactions who on 23-APR-2011 was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # 670381/0171AA, exp: 07-MAY-2012) into right arm. Concomitant therapy included DTaP, ATACAND and LIPITOR. The reporter stated that at time of administration her mother experienced stinging and burning and then felt hot across her upper arms to her shoulders with the heat spreading to her spine. The heat stopped at the spine. Both arms and legs felt very weak and heavy. The reporter had her mother sit down, and she performed standard of care. Her mother's blood pressure was 133/82 and her pulse was 77. The reporter stated that she monitored her mother until she felt better. The reporter stated she followed up and phoned her mother and she was recovering, "everything was fine". Her mother just had some soreness at the injection site. The patient did not seek medical attention. No lab diagnostics studies were performed. Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Nurse reported improperly stored ROTATEQ (dose, route and frequency, lot# were not reported) was inadvertently administered to an unspecified number of patients. No adverse effects reported. This is one of the two reports from the same source. Additional information has been requested.
Sudden vertigo and nausea, 10 days and 17 days after vaccination. The first time was from a seated position; my field of vision rotated swiftly by 90 degrees and then back to normal. The entire incident started and finished within 1 second, but was followed by nausea for the following 24 hours. The second time was from a standing position and I almost fell over. The second incident of vertigo lasted 1 second and was also followed by nausea.
Bell's Palsy -  Received vaccine on 10/ 04/ 2008 developed facial weakney Treatment zorivax / Prednisone  on 10/05/2008. Seen on 10/06/2008, follow up pending for 1 week.
This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On 16-FEB-2017, the patient received an improperly stored dose of ROTATEQ lot # M025568, expiration date 07-NOV-2017, (dosage and therapy route were not provided) for prophylaxis. Information regarding concomitant therapies was not reported. The dose of ROTATEQ was exposed to a temperature >32°F but <31°F and was out of range for 52 hours. A data logger was used to track the temperature and there were no prior temperature excursions. No adverse experiences had been reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient called today stating noticed a rash at site of injection yesterday with itching and pain starting 2 days prior to that. Patient states size of rash is 3 quarters length and 1 quarter in width. He also noticed some fatigue and urine darker than normal yesterday, better today. States could be due to not drinking a lot of water. I advised patient to contact provider to describe above symptoms especially dark urine to see if they want to run some labs.
Fever for a few days following; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever for a few days following) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PYREXIA (Fever for a few days following). At the time of the report, PYREXIA (Fever for a few days following) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Pt given 2 Hepatitis hosts at time of visit. No symptoms. For reporting purposes only
Hives; Rashes all over my body; Really irritating itch; Dry spots coming all over body; This is a spontaneous report from a contactable healthcare professional, the patient. A 23-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Sep2021 at 10:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Sep2021 at 00:00, the patient experienced hives, rashes all over her body, really irritating itch and dry spots coming all over her body. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified steroids, cream and diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives, rashes all over her body, really irritating itch and dry spots coming all over her body was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
I had zero to little period for 2 months.; Now I have a period so bad every month that last 3 weeks long and the bleeding wont stop; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 49year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jul2021 at 16:00 (Lot number: EW0180) at the age of 49 years 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 1, SINGLE, Lot Number: EW0180, Anatomical Location: Left arm, Administration time: 14:00, Route of administration: Unspecified), administration date: 17Jun2021, for COVID-19 immunisation.  The following information was reported: HYPOMENORRHOEA (non-serious) with onset 03Aug2021 at 12:00, outcome "not recovered", described as "I had zero to little period for 2 months"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Now I have a period so bad every month that last 3 weeks long and the bleeding wont stop". It was unknown therapeutic measures were taken as a result of Hypomenorrhoea and Heavy menstrual bleeding.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
NAUSEA, FACIAL ITCH., ELEVATED BP. BENADRYL 25 MG PO 1 CAP GIVEN AND EPIPEN 0.3 IM GIVEN. CALLED 911. PATIENT TRANSPORTED TO ED
Around 48 hours after the vaccine i started getting a rash of itchy pink blisters of different sizes around my upper legs and stomach mostly.
NauseaVomiting fatigue, tingling Narrative:  Dentist with tingling down left arm into 5th digit-started Jan 4. Before that she has left arm pain, fatigue. Nausea and fatigue has resolved. Still has tingling down arm-complains of left neck stiffness.
p/vax pt devel rash; got worse later in evening; taken to ER; some rash remains
On Wednesday October 19, 2022 at (local Library). PHN, EMT, along with the local Homeless Outreach Team approached an unsheltered client 62 year old male at 9:45AM. Client was alert and oriented x3 and was able to verify his identity, provide consent to receive his Pfizer Bivalent Booster (Lot #: GJ6665 Exp.: 10/20/22). Client had previously received his primary vaccines (Moderna 1st dose (Lot #: 009D21A) on 06/11/2021 and Moderna 2nd dose (Lot #:026D21A) on 07/09/2021. Client reported no known allergies, and no known medical conditions. At 9:46AM, client verbalized understanding of potential side effects and adverse effects. 9:50AM after given consent the Pfizer Bivalent Booster was administered. 9:51AM client became unresponsive to verbal and physical stimuli. Retired officer assisted PHN to providing sternal rub and was still minimally responsive to stimulation. PHN assessed breathing during event and noted breathing maintained good quality. 9:52AM, EMS was activated by Police Officer. 9:55AM, PHN attempted to take pulse from client but was thready and weak. 9:58AM, Fire Department and Ambulance arrived and care was transferred. 10:02AM, ambulance left with client and taken to hospital.
I experienced a severe migraine headache and threw up several times.  I woke up out of my sleep around 4:30 in the morning with the headache and felt weak and dizzy all day.  On 1/27/2021, the headache was gone, but I felt weak.
A non-serious spontaneous report of administration to individual over 49 years was received from a health professional concerning a 64-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 29-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Affected arm sore, hard to lift arm, chest pain/SOB for 2 days, finger tips numb, headache and fever.
Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (Night sweats). At the time of the report, NIGHT SWEATS (Night sweats) had resolved.            Action taken with mRNA-1273 in response to the event were not applicable.  Treatment information was not provided Concomitant medication were not provided.   This case was linked to MOD-2021-056567 (Patient Link).
Red rash and single hive on right thigh. Patient given 6.25mg diphenhydramine and discharge home from clinic w/ parent.
This spontaneous case, initially received on 18-Oct-2016, was reported by a non health professional and concerns a 78-year-old male patient. Weight: not provided; Height: not provided. Drug history included Flu vaccine (reaction: dizziness / lightheadedness, allergic reaction) and Terazosin (reaction: allergies). Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received AFLURIA from 09-SEP-2016 to 09-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date a week after vaccination, the patient started to have pain in the shoulder. The pain level is 1-5 on a scale of 1-10. The pain appears and disappears sporadically. The pain is present without touching. The patient states he has not gone to a doctor about the arm pain. Outcome for all events: not reported.
Enlarged and painful node in right neck     Resolved five weeks after administration of first dose   Burnt/scorched tongue sensation Some loss of smell and taste     Both ongoing through administration of 2nd dose
Painful and swollen lymph node in armpit on the left side/arm vaccine was administered.. continuous problems (since first vaccine) with very heavy, long, abnormal periods and extreme pms symptoms that I?ve never had before getting the vaccine.