chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; aching, from back of neck to top of head; Feels pressure on R ear; Tension Headache; Dysfunction of both eustatcian tubes- suspect component of allergic rhinitis-flonase; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 35 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 01Aug2021 03:26 (Lot number: 038B21A) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic lumbar pain", start date: 14Nov2014 (unspecified if ongoing); "Tension headache", start date: 14Nov2014 (unspecified if ongoing); "Latent TB infection", start date: 03Jan2015 (unspecified if ongoing), notes: Latent TB infection; "Over weight", start date: 02Mar2015 (unspecified if ongoing); "H.Pylori infection", start date: 10Aug2017 (unspecified if ongoing), notes: H.Pylori infection. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aching, from back of neck to top of head"; EAR DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Feels pressure on R ear"; TENSION HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Tension Headache"; EUSTACHIAN TUBE DYSFUNCTION (non-serious) with onset 2021, outcome "unknown", described as "Dysfunction of both eustatcian tubes- suspect component of allergic rhinitis-flonase"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness". The events "headache", "aching, from back of neck to top of head", "feels pressure on r ear", "tension headache" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tension headache.  Additional information: History of tension HA noted. No history of migraine, Denies vision changes, balance concerns, head trauma, and parasthesias. Tension Headache - demonstrated neck stretches and exercises to improve pain, decreases tension. Advised heat, stretching, hydration. Patient was seen in clinic today 14Sep to follow up with provider along with professional medical interpreter, and accompanied by family member (on phone) for dizziness and headache.  No follow-up attempts are possible. No further information is expected.
neck inflammation; Thyroid TSH and TPO ab levels increased; TPO ab levels increased; This is a spontaneous report from a contactable consumer (patient himself). A 45-year-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, and Lot Number GB8727) via an unspecified route of administration, administered in arm right on 29Mar2021 16:00 (age at vaccination 45 years) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included bile salts, collinsonia canadensis root (CHOLACOL), phyllanthus niruri (CHANCA PIEDRA), vitamin d and ImmunoMod-A. The patient previously took oxycodone and lotrimin af. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient experienced neck inflammation on 30Mar2021, thyroid TSH and TPO ab levels increased on an unspecified date in 2021. It was reported that adverse event resulted in Emergency room/department or urgent care and physician office visit. The reporter assessed the events as non-serious. The patient underwent lab tests and procedures which included TPO ab: increased, Thyroid TSH: increased on unspecified date in 2021 (level increased after each vaccination) and Nasal swab test was negative on Jul2021. Therapeutic measures were taken as a result of the adverse events included vertigo meds, anti-inflammatory, Xanax and Prozac. The outcome of the events was not recovered.
No problems at all for 11 days. Then red and warm at injection site and slight headache. Nothing major just delayed.
major stroke; cannot speak; cannot move his arms; declining quickly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (major stroke) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (major stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly). At the time of the report, CEREBROVASCULAR ACCIDENT (major stroke), SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment information were not reported.  The patient was now in intensive care at the Hospital of Bay City in Michigan and he was declining quickly. Company comment:Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.
arm from above elbow to mid-forearm swelled severely & was very warm to touch;no fever;sx started 36-48hr p/vax; by 4 days p/inj was improving greatly;
Narrative: he patient had three doses of Moderna COVID 19 Vaccine in Feb/Mar/Nov 2021. The patient tested positive for COVID 19 on 10 Jan 2022. The patient presented to the ED with chest palpitations and shortness of breath and was admitted on 18 Jan 2022 with COVID pneumonia and afib. The patient was treated with metoprolol for the afib and oral anticoagulant for stroke prevention and oxygen. The patient was discharged on 26 Jan 2022 in stable condition.
On 3-10-10 pt received #2 GARDASIL. On 3/12/10 pt called to say she broke out in "all over" hives a couple of hours later. Took BENADRYL and had full relief and recovery. Pt also had taken a po med dispensed from here shortly after the immunization (metronidazole).
After administration of immunization patient chart was updated with outside immunizations and Hep A was one of the immunizations that was administered from outside facility.
Flu-like symptoms that evening and following day.  After 4 days my lower face and front of neck were numb.  Not so numb that I couldn't feel them but still numb.  That symptom persists.   Chronic headache and fatigue has increased.
Arm Swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm Swelling) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was reported.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm Swelling). At the time of the report, PERIPHERAL SWELLING (Arm Swelling) outcome was unknown. Not Provided      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 included BP medication, Cholesterol medication and Thyroid medication.  Treatment  drugs mentioned Tylenol   This case was linked to MOD21-069281 (E2B Linked Report).; Sender's Comments:  MOD21-069281:MOD-2021-067530 -2nd dose of vaccine
Achy arm tender to touch and puffy. Breast area (R side) tender. Not feeling well. Tired, body ached, fingertips numb, cold weats, arm splotchy & remains tender to touch.  Called ER - rx cold compress w/ Ibuprophen.
Experienced an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Experienced an adverse reaction) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Experienced an adverse reaction). At the time of the report, ADVERSE REACTION (Experienced an adverse reaction) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Relevant concomitant medication was not reported.  Treatment information was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Suspected vaccination failure; Shingles; Rash; Pain; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and between 1 and 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient reported that approximately 1 to 2 months after 2nd dose was received, the onset of pain occurred. The patient recently went to the hospital where they did a heart work up and had no significant findings. At the appointment with family physician, the patient had a rash, and the physician diagnosed the rash as shingles. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation for shingles was not provided. The emergency room visit required. The reporter consented to follow up.      Lab Comments: On an unknown date patient underwent heart work up and had no significant findings.
rash & low grade fever w/sore throat-began 1NOV96;saw workers comp MD that day-excused from work;told to take APAP;4NOV96 returned to office rash resolving;temp nl-feels better;returned to work
chief complaint of a possible allergic reaction onset today. Patient received the first dose of the COVID vaccine. Afterward she noticed her face and neck felt mildly swollen. Her chest also became mildly red. At this time she feels a little improved but her face still feels like it is swollen. Patient was transported here by EMS
Nurse error- pt scheduled 1st & 2nd appointment for Pfizer, but had already received Moderna 1st dose on 4/29/2021.  Nurse vaccinated pt with Pfizer vaccine then realized the error.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Approximately a 12 cm area of erythema noted at injection site.  site warm to touch, induration noted. This ocurred 3 days post immuniztions.  p.o. Benadryl given per Mom, Rx Omnicef given per M.D.
Patient had a rash on body (back and belly) near arm where shot was. Pt. took BENADRYL and was getting better.
At 6 pm, patient developed soreness around lower abdomen area and at the injections site on left arm. She had slight fever the next day and slept in the afternoon which was unusual for her. She didn't have bowel movement for 3 days until Oct 8.
On 5/6/21 my diabetic sugar number dropped to 58. My numbers had been a little low since the injection but none that low. I had a fall that caused a rotator cuff injury and whiplash.
On 6-18, 2022 I started having sinus pressure and headache. The following day, 6-19-2022, I woke up with head congestion, a dry cough and fatigue. I used a Covid19 home test with positive results. My doctors office was closed 6-20 so I called them on 6-21 and they ordered a prescription for PAXLOVID. I started taking the medication on the same day. I was also taking OTC DAYQUIL severe. I am recovered. I am reporting a breakthrough case of Covid19.
Information has been received from a physician concerning a 63 yr old female who on 13Feb06 was vaccinated pneumococcal 23v polysaccharide vaccine (lot650330/0748P). Concomitant therapy that day included Hib conj vaccine (manf unk). Subsequently, the pt experienced myalgia and pain, swelling and tenderness at the pneumococcal 23v polysaccharide vaccine site of injection. The upper arm became swollen, red, purplish. There were also clear vesicles. The joint area became swollen. After the pt developed the symptoms she called the physician. The pt was not seen by the physician. The symptoms were considered to be nonserious. The pt was prescribed prednisone and was told to use cold compress. A low grade fever was also reported. The pt recovered. Additional information has been requested.
INTERMITTENT TINGLING IN LEGS; NUMBNESS IN EXTREMITIES; PAIN IN CALVES; SEVERE ARM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUL-2021, the patient experienced severe arm pain at injection site. On 25-JUL-2021, the patient experienced intermittent tingling in legs. On 25-JUL-2021, the patient experienced numbness in extremities. On 25-JUL-2021, the patient experienced pain in calves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe arm pain at injection site, and had not recovered from intermittent tingling in legs, numbness in extremities, and pain in calves. This report was non-serious.
Patient came to the pharmacy on 8/18/21 @ 11:10am and said that  the day after she received her Moderna vaccine in the left arm, her right arm started hurting  and  became swollen.  She said she could not move her right arm therefore she said she went to her physician and her physician told her to take her gout medication at an increased dose.  She said it lasted for about 5 days; the swelling went down but he arm was still a little tender.
Vomiting, chills, nausea with 1 hour of administration. ZOFRAN 8 mg tid prn nausea.
Prolonged severe joint pain x 2 weeks. Resolved after week 3; Marked fatigue x 4 weeks. Resolved after week 5 Headaches, stuffy nose resolved after week 1; Complete loss of sense of smell partially resolved after week 6. Fully resolved after 3 months. Repeated rapid and PCR tests were negative for covid. No Sinus infection present. Same as with prior two doses of same vaccine but much worse and more prolonged.
Immediately after administering the vaccine, the patient bled and the injection site began swelling up. I talked with the patient to inquire on whether she was feeling any lightheadedness or dizziness and she declined. The injection site continued to swell up to about the size of a quarter.
Vaccine given IM about 9:30am to right deltoid muscle.  Patient monitored for 15 minutes, felt okay and left monitoring area. Patient returned after about 20 minutes from vaccine (a little after 9:50am) complaining of itching of throat, shortness of breathe, and feeling very hot and "off"  Due to SOB and itching in throat administered 1 dose of Epinephrine autoinjector 0.3mg shortly upon her return, called EMS. EMS arrived and evaluated patient, patient refused transport to hospital since she was feeling better except for jitters/shaking from epinephrine. We monitored patient for additional 20-30 minutes. Patient walked around store, felt fine and drove home.  Called patient, verified still feeling mostly better with some slight itchy throat. Patient will continue to monitor.
Developed slightly raised red rash to right upper thigh at injection site 6-7 cm, mildly tender to touch.
Gave Prevnar shot in Left arm, then moved to right arm to give Fluad.  Was talking after giving him Fluad, then he got a glazed look in his eyes, almost like a seizure type reaction, and his head dropped.  We called 911 immediately and he became responsive again after about a minute.  Paramedics took him to hospital.  Wife called us later to let us know he was fine and doctors think it was a nervous reaction to vaccination.
Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minutes.  Two hours later, itching began on left leg and arms.  Noted red blotches to these areas.  Face began to feel very prickly and flushed, felt lower lip swelling and left eye began to feel funny.  Observed one hive to cheek.  Was able to take a Benadryl 25mg capsule within about 10-15 minutes after this developed.  Symptoms began to subside after this.  Felt  back to normal the next day.  Just moderate injection site pain for 1-2 days.
Patient had dull headache for 2 days, then more intense headache for several days along with onset of cold symptoms and congestion.  She also had local injection site reaction that became itchy and raised on day 4 post-vaccine and continued for several days in this manner.
Developed tinnitus in near-constantly in my right ear and intermittently in my left ear the morning after receiving the vaccine. I am currently 12 days post vaccine and it has not subsided.
Pt felt lightheaded, ears started ringing, one episode of emesis, lasted <10 minutes from time of injection, then resolved.
patient experienced severe leg cramps at night in both legs (calf area); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose:2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "patient experienced severe leg cramps at night in both legs (calf area)".  Additional information: After receiving his booster COVID vaccine, patient experienced severe leg cramps at night in both legs (calf area). Cramps have gotten less severe but still has them occasionally. Patient's booster was in Dec2022. Patient did not have this issue with the first 2 shots. He is concerned about getting additional boosters. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was kinda weak, not feeling real well. I went to see my cardiologist and let him know that I had discovered blood in my stool. They ordered blood work and my hemoglobin and rbc was so low the told me to go straight to the hospital. They gave me 3 units of blood. They did a colonoscopy and endoscopy, and have not determined the cause of the bleeding. I was admitted in the Hospital for 3 days.
personality change;clingy w/parents, fussy, low grade temp 101 x 2 days; dec appetite;
Sense of direction was off kilter while driving, felt so turned around when trying to come home; Arm hurt but after a few hours it went away; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (Sense of direction was off kilter while driving, felt so turned around when trying to come home) and PAIN IN EXTREMITY (Arm hurt but after a few hours it went away) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bladder infection. Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) for Bladder infection.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt but after a few hours it went away). On 22-Aug-2021, the patient experienced IMPAIRED DRIVING ABILITY (Sense of direction was off kilter while driving, felt so turned around when trying to come home). On 19-Apr-2021, PAIN IN EXTREMITY (Arm hurt but after a few hours it went away) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (Sense of direction was off kilter while driving, felt so turned around when trying to come home) outcome was unknown.            The patient stated that he received first dose of Moderna vaccine on 22 March 2021 and did not experience any symptoms post-vaccination.  The patient stated that he received second dose of Moderna vaccine on 19 April 2021 and had arm hurt, which went away after a few hours.  On 22 August 2021, the patient reported that his sense of direction was off kilter, while driven home from a family members house. The patient also reported that he drive that route a lot and have never felt so turned around when trying to come home.  The patient stated that he is taking sulfamethoxazole and trimethoprim for a bladder infection since three weeks. No treatment medications were reported.
pt got both doses of moderna at age 17 when it was only approved for 18 years and older
AFTER ABOUT 45 MINUTES OF RECEIVING THE VACCINE, MY BOTTOM LIP STARTED TO TINGLE.  WITHIN A FEW MINUTES OF THAT A HIVE APPEARED RED AND MY LIP STARTED TO SWELL.  I TOOK BENADRYL, WHICH SEEMED TO HELP STOP THE SWELLING.