chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Benign Prostatic enlargement" (unspecified if ongoing), notes: Benign Prostatic enlargement. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 15Dec2022 to 20Dec2022.   Clinical course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201400117 same patient, different dose and event;
This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels light- headed every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling light headed every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Patient stated he developed itching, redness, irritation and blisters at the site of injection and as of today he is still experiencing the above reaction.
Nausea, dizziness, headache, diarrhea, chills, feverish, sore arm at injection site, muscle weakness
Got the shot too high almost into shoulder  Swelled up extreme pain couldn't lift left arm for 2 days had chills and fever all day Saturday got shot on Friday Monday mostly ok but arm still sore
Feel weak and like faint; Get very painful cramps in leg; Severe headache; Muscle pain & Pain everywhere & Hands and fingers hurt very much & Knees hurt very much & Feet hurt very much; felt like i got hit by a trcuk &felt like i was in a fight with a boxer; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like i got hit by a trcuk &felt like i was in a fight with a boxer), ASTHENIA (Feel weak and like faint), MUSCLE SPASMS (Get very painful cramps in leg), HEADACHE (Severe headache) and MYALGIA (Muscle pain & Pain everywhere & Hands and fingers hurt very much & Knees hurt very much & Feet hurt very much) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included METFORMIN, GLIPIZIDE, LISINOPRIL, METOPROLOL and ROSUVASTATIN for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced FEELING ABNORMAL (felt like i got hit by a trcuk &felt like i was in a fight with a boxer), HEADACHE (Severe headache) and MYALGIA (Muscle pain & Pain everywhere & Hands and fingers hurt very much & Knees hurt very much & Feet hurt very much). On an unknown date, the patient experienced ASTHENIA (Feel weak and like faint) and MUSCLE SPASMS (Get very painful cramps in leg). At the time of the report, FEELING ABNORMAL (felt like i got hit by a trcuk &felt like i was in a fight with a boxer), ASTHENIA (Feel weak and like faint), MUSCLE SPASMS (Get very painful cramps in leg), HEADACHE (Severe headache) and MYALGIA (Muscle pain & Pain everywhere & Hands and fingers hurt very much & Knees hurt very much & Feet hurt very much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021. Updated additional events.
about 12 minutes after receiving the vaccine had a sudden onset of sharp headache while seated.  When she stood up became lightheaded and dizzy and nauseous.  She also had elevated Blood pressure p to 168/108.  After 35 minutes her positional symptoms persisted with BP still elevated 159/102.  No respiratory or skin symptoms. She was transported to the ED and had a head Ct which was normal, discharged with pain medications.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: About 5 minutes after receiving vaccine, patient was seated in observation area and notified facility staff member who was in charge of observing patients that he felt faint.  Staff member reported patient quickly turned extremely red and was showing seizure-like activity, unconscios. She alerted the pharmacists to come over I came over and patient appeared bright red, pupils extremely dilated and was not conscious, grabbed pt arm he woke up and then showed typical vasovagal symptoms thereafter.
Received FLUVAX 9/29/10. Woke up 10/3/10 with symptoms HIVES and shortness of breath. Took BENADRYL with poor relief and was seen in clinic. Pat was transferred by Amb to ED. Has been admitted to Hospital 3x's since vaccine cont with s/sx of lethargy. Hives GI symptoms Resp s/sx.
Late period.; Thigh pain; Abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 11:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. 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 vaccination. On 22Apr2021 at 12:00 the patient experienced the events late period, thigh and abdominal pain. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events late period, thigh and abdominal pain were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
swollen lymph node behind the jaw on the right side.   became noticeable a week after vaccine shot. condition progressed for ~3 days and persists now (a week after first noticed)  I have not talked to healthcare professional about this as this is listed as known side effect of COVID vaccine.
This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 11Feb2021 (on Thursday, as reported) at 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient would like to know what the normal side effects of BNT162B2 were and if her side effects were considered usual or unusual. She received 1st dose of BNT162B2 on Thursday and she was reporting not feeling well, very fatigued and tired, stomach pain and diarrhea, in Feb 2021. Patient would like to know more information about the demographics of the participants who experienced side effects from BNT162b2 and what to do about her side effects from it. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Narrative: Patient experience nausea, vomiting, and headache 2 days after receiving the first COVID-19 vaccination.
Began as typical malaise but escalated into major arthritic condition of hips and arm and shoulder arthritic pain. Malaise flu like symptoms lasted for two months but major arthritic symptoms have lasted including pain at shot site in left arm.
Sweatiness; Feeling of fog and 'out there'; headache; Dizziness; Chills; Nausea; fever; Tired; Unable to get of bed; Fatigue; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), FATIGUE (Fatigue), DIZZINESS (Dizziness), HYPERHIDROSIS (Sweatiness) and FEELING ABNORMAL (Feeling of fog and 'out there') in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced TENDERNESS (tenderness). On 14-Apr-2021, the patient experienced FATIGUE (Fatigue), MOBILITY DECREASED (Unable to get of bed), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (fever) and FATIGUE (Tired). On 15-Apr-2021, the patient experienced DIZZINESS (Dizziness). On 16-Apr-2021, the patient experienced HYPERHIDROSIS (Sweatiness), FEELING ABNORMAL (Feeling of fog and 'out there') and HEADACHE (headache). On 15-Apr-2021, MOBILITY DECREASED (Unable to get of bed) outcome was unknown. On 16-Apr-2021, CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (fever) outcome was unknown. At the time of the report, TENDERNESS (tenderness), FATIGUE (Fatigue), DIZZINESS (Dizziness), HYPERHIDROSIS (Sweatiness), FEELING ABNORMAL (Feeling of fog and 'out there'), HEADACHE (headache) and FATIGUE (Tired) 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. reports he got his flu shot on 11-6-18 and 6 hrs later he experienced shivering and shaking and BP was low 113/52 around midnight-he went to sleep and woke up feeling completely fine. States he had same rxn 3 yr ago after flu shot.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & devel a fever which persisted for 3 days;also cried inconsolably for more than 4hr;
8 mo. old inadvertently given a Hep. A vaccine intended for a different patient.
Vaccine given was past expiration date. Expired on 7/8/2020, was given 7/20/2020. Called vaccine manufacturer and confirmed that dose would not be valid. Called Dad. No signs or symptoms of any adverse reaction to vaccine.
Rt side of face - Bell's Palsy, 2 weeks after receiving FLUVIRIN. Pt's doctor states the vaccine triggered the chix pox virus.
A spontaneous report has been received from a Physician concerning a 3 year old, male patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient was administered nasal FLUMIST Quadrivalent on 26-Nov-2013 and experienced urticaria reaction in about twelve hours on 26-Nov-2013. Outcome of the reported event was unknown. The reporter considered the event to be non-serious by reporter.
Fever up to 102.6, severe chills, headache, rapid pulse. MD visit, prescribed Tamiflu prn. Did not take. Afebrile by 9:00 10/23/09; all symptoms resolved
Patient reported that after receiving the Pfizer Bivalent Covid Vaccine and Fluad Vaccine that he experienced hives.  Recommended patient contact his provider and let his provider know what has occurred.
After getting my SHINGRIX shot, the keloid on my shoulder began to itch a great deal. Also, a tiny mole on my calf began to itch just as much. With both spots bothering me (itching quite a bit throughout the day as well as nighttime) I went to the dermatologist. She took a biopsy of the mole and it was found to be malignant melanoma. I subsequently had to have surgery to remove the Stage 1 melanoma mole and corresponding lymph node. My oncologist says the SHINGRIX vaccine caused my body to crank up my immune system and in doing so, the immune system was attacking the melanoma growth. This is the activity that caused the itch. I'm lucky. My immune system could not win against the melanoma, but it caused a reaction that got me to make an appointment with my dermatologist, which caused me to catch the growth in a very early phase.
pt exp fever, dry cough, chills, calf pain, fatigue, rigors & maculopapular rash devel on limbs; lab features revealed HGB, WBC & ESR were above upper limits of nl w/rt upper lobe infiltrate; liver enzymes & kidney func nl;dx vasculitis;
Immediately after the injection she felt a hot flash; Then an hour later she had a rapid heart rate; Then an hour later she had a rapid heart rate and heartburn; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Immediately after the injection she felt a hot flash), HEART RATE INCREASED (Then an hour later she had a rapid heart rate) and DYSPEPSIA (Then an hour later she had a rapid heart rate and heartburn) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008021A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced HOT FLUSH (Immediately after the injection she felt a hot flash), HEART RATE INCREASED (Then an hour later she had a rapid heart rate) and DYSPEPSIA (Then an hour later she had a rapid heart rate and heartburn). On 29-Jul-2021, HOT FLUSH (Immediately after the injection she felt a hot flash), HEART RATE INCREASED (Then an hour later she had a rapid heart rate) and DYSPEPSIA (Then an hour later she had a rapid heart rate and heartburn) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Double vision, blurred vision, tingling in feet and legs and thought the body, pain in left side, difficulty walking, extreme elevated blood pressure
Flushed in face; Tired; Inappropriate schedule of vaccine administered; Large blister inside of mouth, "a huge bump above edge of upper teeth on top of jaw", huge blister that was pushed up and fluid filled sac; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Large blister inside of mouth, "a huge bump above edge of upper teeth on top of jaw", huge blister that was pushed up and fluid filled sac), FLUSHING (Flushed in face), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 01-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE on 22-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Allergy to molds.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced ORAL MUCOSAL BLISTERING (Large blister inside of mouth, "a huge bump above edge of upper teeth on top of jaw", huge blister that was pushed up and fluid filled sac) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced FLUSHING (Flushed in face) and FATIGUE (Tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) at an unspecified dose and frequency. On 01-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (Large blister inside of mouth, "a huge bump above edge of upper teeth on top of jaw", huge blister that was pushed up and fluid filled sac), FLUSHING (Flushed in face) and FATIGUE (Tired) outcome was unknown.            Patient stated that she gargled half peroxide and half water for blister burst treatment. Concomitant medications were not provided.   Reporter did not allow further contact
Two people now have Covid and are quarantined after they were vaccinated.; Two people now have Covid and are quarantined after they were vaccinated.; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that there were people on the cruise ship and everyone had to be vaccinated except for the ones under the age limit. They had to be tested for Covid before the cruise but two people now had Covid and were quarantined after they were vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021690810 same reporter/drug/event different patient
Tingling; weakness in hand; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to some antibiotic. Concomitant medications included cannabidiol (CBD OIL), diclofenac (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN) and famotidine (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 11:30, 1-2 minutes after the shot, the patient experienced tingling in hand and weakness in hand which continued for 36 hours. The patient did not receive any treatment for the reported events. The clinical outcome of the event tingling and hands weakness of was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Two days following the first dose of the vaccine I experienced a fairly bad Lyme Disease flare up. While I already experience joint pain due to Lyme, it was greatly intensified after the vaccine, causing me to have to take off work. I?ve also been experiencing a persistent migraine starting two days after receiving the first dose and continuing into today (3 days after vaccination). This migraine is causing random, extremely painful ?stabs? in the left side of my head.
Information has been received from a physician's assistant concerning a 13 year old female patient who on 08-JUL-2009 was vaccinated with the second dose of GARDASIL (lot# 660391/0063X). Concomitant therapy included MENACTRA received on the opposite arm of the GARDASIL. On 09-JUL-2009 the patient experienced vomiting, chills and weakness that lasted 2 days. Patient sought unspecified medical attention. Additional information has been requested.
redness & swelling of upper arm;15cm x 15cm area of induration, redness & heat;inner aspect of lt upper arm;
Within 1-2 minutes my son passed out and started violently shaking/convulsing. His chin was pinned to his chest, he struggled to breath and was making a sound as if he was loudly snoring but seemed to be struggling to breathe. I was unable to wake him. I'm not sure how long it lasted but maybe 2 minutes or so. He woke up and asked what was going on as we had all been standing over him trying to unsuccessfully wake him.  He shared that he thought he'd been asleep and had been dreaming. He also shared that his throat hurt very much. He had the shakes for about 30 minutes after and was extremely exhausted. He slept for 14 hours as soon as we arrived home.
Syncopal collapse 5 minutes after administration of vaccine which was well tolerated; patient was energetic in clinic room, was jumping, then fell and struck chin / right cheek on ground; spontaneously regained consciousness within 30 seconds; became alert and responsive to previous exam level