chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
Arm is inflamed, red, itchy. Moderate fatigue. Lightheadedness resulting in nearly fainting. Fever of 100-100.4.
Child has loss of conciousness, slight cynotic apperance, limb stiffened and jaw clenched. Regained conciousness but was very drowsy. EMS called.
Headache, Myalgia, NauseaVomiting, fatigue Narrative:  Took OTC ibuprofen  Other Relevant History:
Throat Hurts and he has a lot of yellow mucus; Throat Hurts and he has a lot of yellow mucus; This is a spontaneous report from a contactable consumer. This contactable consumer (Patient's Parent) reported for a 24 years old male patient that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC Number, UPC Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE (at the age of 24 years old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. He had Pfizer COVID shot a little over 2 weeks ago and he said his throat really hurts and he had a lot of yellow mucus. He wondered whether it was a known side effect or it could be just a cold and he wanted to know whether anyone reported such side effect. The outcome of all events were unknown.   Information on Lot/Batch number has been requested.
I developed on my arm under the injection site a lump the size of a half-dollar. I became dizzy and weak. then my back started to hurt. I got a very fast heartbeat. I slept for a long while. I also had chest pain.
Client started with insomnia 2 days post clinic. Insomnia has continued and her PCP suggested that it may be related to her Flu vaccine.
Patient states that around 30 to 45 minutes after the vaccine her leg and foot became numb and her speech seemed slow .  Patient called us on phone and stated she was going to the emergency room
8 days p/vax 31JAN92 cranky x 2 days; 10 days post vax 2FEB92 welts (hives started on knees & rapidlty spread all over body, joints enlarged & inflammed; next day all joints started turning black; called MD 2FEB92 started on DPH on 3FEB92;
No additional AE reported; an expired dose of PNEUMOVAX 23 was administered to the patient; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 06-OCT-2021, an expired dose (0.5 milliliters) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with lot # T007383 was administered to the patient for prophylaxis (route of administration and anatomical location were not provided). The dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) expired on 23-AUG-2021 and did not has prior temperature excursions. No additional information was provided. No adverse event.
Initially had a typical sore muscle response. About two hours after vaccine noted increased pain at left shoulder with movement. That night if I rolled over onto it, it would hurt to point of waking me up. Next day pain continued. By fourth day pain was worse and felt more like joint pain rather than muscle pain. Felt like a bursitis- with grinding feeling in shoulder with extension or movement such as brushing hair, turning steering wheel.
Mom reports noted few pox on injection site thought they were bug bites, later on noted them on various parts of body. Took daughter to pediatrician 05/28/02 reports dx'd with chicken pox. Was covered "from head to toe" also dx with ear infection. Prescribed antibiotic, Benadryl prn, Tylenol prn, calamine lotion. Reports daughter is afebrile discussed communicability.
Patient did not have her vaccination card with her and showed up with no appointment scheduled for that day.. She stated she was there for her second Covid Vaccine. Appointments that day were for Moderna Dose #2 appointments. After what was thought to be Moderna dose #2 given it was discovered by looking up in the EMAR system that she had received Pfizer as her first dose. Patient remained in clinic for 30 minutes for monitoring with no adverse side effects or symptoms.
Pt c/o nausea - dizziness - stomachache - fever. When seen in office temp-98.5 - arm warm to touch - red area - 4x6 inches.  Systemic and localized pain.
Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  rapid heart rate and felt hot..   Assessment : Time of assessment 1042. Alert and oriented, Tachycardia and patient noticed discoloration in his hands. Patient had completed his 10 of his 15 minute observation and reported feeling like his heart is racing and feeling hot. VS taken at 1042: BP 131/91, P 65, Oxygen sat 99%. He was assisted to the wheelchair and taken to the triage area. 1050: BP 130/78, P 56. After additional observation of 15 minutes, he reported no symptoms. 1108: Ambulatory out without any problems observed.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.   There were no vitals filed for this visit.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for  and additional 15 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
Fever of 2 degrees over normal, chills,aches, fatauge, weakness.
Patient has no previous history of anaphylactic reactions nor severe allergies.  Within the short period of time after one vaccination, he developed severe, class 6, allergies and had multiple visits to local emergency department.  Since that time, the allergic reactions have started to slowly dissipate somewhat.
Influenza; This is a spontaneous case, reported by other non-health professional to agency (reference number: SEQ20-00601) on 12-Feb-2020, concerning a male patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On 10-Oct-2019 at 15:45, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: right deltoid, batch number: 261204, dose and expiry date: not reported) for prevention of seasonal influenza.  On 10-Feb-2020, approximately four months after vaccination, the patient developed influenza although he received the vaccine.  On 13-Feb-2020, the patient fully recovered from influenza.   Per company, the event of influenza was assessed as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Follow up information received from other non-health professional on 13-Mar-2020: Additional reporter added. Flucelvax QIV details added [start date, route of administration, anatomical location and batch number]. The event of influenza updated [start and stop date added; outcome changed from not reported to recovered]. Narrative amended accordingly.   Company comment: The patient developed Influenza four months after vaccination with Flucelvax QIV. Chronology seems plausible. More information regarding medical history and diagnostic findings is needed. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient developed Influenza four months after vaccination with Flucelvax QIV. Chronology seems plausible. More information regarding medical history and diagnostic findings is needed. Based on provided information, causal role of the suspect product is assessed as related.
red bumps on the skin; lesions, like a chicken pox/ like lesions, like having chicken pox, like a chicken pox bumps on the skin; he was uncomfortable; symtoms of low energy; fever; chills; feelings of wanting to vomit without vomiting; skin itched badly; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2020, the patient received the 1st dose of Shingrix. On 5th July 2020, less than a day after receiving Shingrix, the patient experienced discomfort, energy decreased, fever and chills. In July 2020, the patient experienced nausea and pruritus. On an unknown date, the patient experienced red rash and varicella-like rash. On an unknown date, the outcome of the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus were unknown.   It was unknown if the reporter considered the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient experienced being like lesions, like having chicken pox and red bumps on the skin. The patient was uncomfortable with symtoms of low energy, fever and chills, feelings of wanting to vomit without vomiting. The patient's skin itched badly. The reporter consented to follow up.
CARDIO FITNESS HAD TRIPLED (UNEXPECTED THERAPEUTIC BENEFIT); This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced cardio fitness had tripled (unexpected therapeutic benefit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cardio fitness had tripled (unexpected therapeutic benefit). This report was non-serious.
3 X 1cm area of redness with small vesicles on left thigh (treated with Benadryl).
On 08/01/2001 at night, the patient developed redness, induration and mild tenderness at left deltoid site of DPT shot.
At 3pm on 08/09/2021 I started feeling very nauseous out of no where. I then started having severe allergic symptoms itchy eyes running nose severe sneezing , I thought I was having some type of odd allergic reaction, I then went home from work at apprx 6pm and took Benadryl. It started getting better at at apprx 9:30pm I started having severe heart palpitations. I did an EKG on my watch and was in AFIB, with a HR of 146. My son took me to the ER which confirmed this was AFIB RVR, I was admitted on the next morning.
Patient supposed to receive her first dose of Pediatric Pfizer COVID-19. Instead given Moderna Booster (0.25mL) in error. We informed her mother immediately and explained some signs and symptoms of adverse reactions. I also spoke with her pediatrician and informed them of the discrepancy.
High fever of 106. I took Tylenol and place a cold washcloth on my forehead and went down to 102 went to sleep. In the morning my fever was gone.
chest pain; 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 CHEST PAIN (chest pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain). At the time of the report, CHEST PAIN (chest pain) outcome was unknown.            No concomitant medications was reported by the reporter  No treatment medications was  provided by the reporter
Changes to the color of skin in both arms; Breast feeding; Little pain in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Changes to the color of skin in both arms), EXPOSURE VIA BREAST MILK (Breast feeding) and VACCINATION SITE PAIN (Little pain in the arm of injection) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced SKIN DISCOLOURATION (Changes to the color of skin in both arms), EXPOSURE VIA BREAST MILK (Breast feeding) and VACCINATION SITE PAIN (Little pain in the arm of injection). At the time of the report, SKIN DISCOLOURATION (Changes to the color of skin in both arms), EXPOSURE VIA BREAST MILK (Breast feeding) and VACCINATION SITE PAIN (Little pain in the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-060428 (Patient Link).
1 of 5 pts w/in a 3 wk period who exp cellulitis following vax; no treatment; no cultures taken; unsuccessful f/u w/pt;
A report has been received from a pharmacist concerning a 32 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 29-Nov-2013. It was reported that two patient were administered expired FLUMIST on 29-Nov-2013. The outcome of the event of expired FLUMIST administered is unknown. The report was considered to be non-serious.
Could barely walk; felt like she was being stuck with pins; Sweating; Bones were aching, body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Could barely walk), PARAESTHESIA (felt like she was being stuck with pins), HYPERHIDROSIS (Sweating), MYALGIA (Bones were aching, body aches) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J2024) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced GAIT INABILITY (Could barely walk), PARAESTHESIA (felt like she was being stuck with pins), HYPERHIDROSIS (Sweating), MYALGIA (Bones were aching, body aches) and CHILLS (Chills). At the time of the report, GAIT INABILITY (Could barely walk), PARAESTHESIA (felt like she was being stuck with pins), HYPERHIDROSIS (Sweating) and CHILLS (Chills) had not resolved and MYALGIA (Bones were aching, body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Patient reported severe pain between breasts, coughing and shortness of breath, shaking, fever, and chills on Tuesday night (11/16/2010), then chills and night sweats on Wednesday night (11/17/2010).  Patient considered calling paramedics Tuesday night, but did not do so.  Pain, redness, and swelling at injection site area of right arm continuing.
It hurt as it went in really bad. My arm was so sore I couldn't lift it and used my other arm to rotate the vaccinated arm with my other arm. Felt feverish around 9pm. Fully body aches. Stayed in bed for 24hrs.
I didn't feel good the nite I had the shot, next day I stayed in bed with 101 fever.  The 6th of Feb, fever gone, but large lymph gland under the shot arm was obvious.  I have done lymphatic massage everyday since, and finally on Feb 26, it finally dissipated and will have a Mammo in May.
Approximately 25-50 vesicles on buttocks.  Rectal area and upper legs only.  Painful around rectum. Per HCP follow up report-Patient was immunized with Varivax 5/24/96 and presented at our office 2/10/00 with apparent varicella rash and diagnosed with varicella no shingles. Dr. wanted it reported that child developed this after proper immunization.
15 minutes after receiving vaccine, patient felt dizzy, hot, had swollen eyes, and rash on neck.  Pharmacist administered 50 mg of liquid benadryl Asked when patient had last eaten and provided 15mL of regular soda after learning it had been >6 hours
Client with sister and grandmother for GARDASIL an meningitis. Faints after-getting GARDASIL, which was second shot given on 8-5-13. Revives immediately. After monitoring vital signs for approx. 15-20 min. Client stable. Taken by grandmother to his PCP after leaving clinic site.
Patient had ZOSTAVAX injection Friday 6/22/12 called morning Monday June 25th with report of chicken pox like rash on arms and legs with no fever.
Patient had a headache around 11:00pm on 8/15/22 and went to bed. Patient woke up around 3:00am and vomited and felt feverish and returned to bed. Patient woke up at 7:30pm and call me he sounded strangely he was stuttering and struggling to communicate.  He told me he was sick and thought he had a fever and his stomach did not feel well, I suggested he shower and drink some water and call me back.  8:30pm Patient called me and sounded better but said he still did not feel well and was going to lay down. Patient called me at 3:00pm and was making no sense, he seemed disorientated and confused.  911 was called.  He was taken to the Hospital where he had an extremely high fever.  When I arrived he still had not been seen, once he was seen he was put on IV fluids and medications to bring his fever down. Patient remained confused, running a fever, exhausted and sick to his stomach through out the night and into the morning of 8/16/2022.  Around 11am he was no longer confused and was drinking and managing his fever with medications, he slept most of the day. Patient was his normal self but maintained a low grade fever while taking medication to suppress the fever until the morning of 8/19/2022.
Sore throat; throat swelling; runny nose; nasal/sinus congestion; low grade fevers; headaches.
Patient started to feel pain at the injection site right after the shot on 02/28/2020. She then developed redness and inflammation on the day after. On 03/01/2020, patient called pharmacy and reported that she still has pain, redness and swelling at the injection site. Patient was advised to seek medical care and she wants to wait another day to see her doctor if it persists.
Generalized weakness and muscle spasms starting soon after the injection-no rash but had feeling of chest pressure like elephant on chest for two days.
Immediate tingling in legs, heartburn, heart racing - decreased to mild symptoms within a few hours Next few days continued heart racing, heartburn, chest pain Hospital May 23rd - EKG, Xray and bloodwork - released with anxiety meds (Xanax) - no relief Hospital May 30th - EKG, Xray, Bloodwork, CT Scan - released with GI Meds (Omperozole, Mylanta, Lidocaine) - no relief July 9th - Urgent Care - Dr said to follow up with GI but go to ER if it gets worse Had to go off GI mes to test for Hpylori July 26th - Tested for HPylori - Negative and treated for SIBO (never diagnosed but assumed) September - Prednisone more tests October 1st - Endoscopy - put on meds
Fever, rash, lasted 12-24 hrs according to mother, induration & erythema at site of injection.
Pain in lower left belly. Pain would continue to come and go, often fairly severe and other times just a nuisance. Began tracking the days it was most noticeable and it seemed to occur around ovulation and lighten up during the start of menstrual cycle. Menstrual cramps became much more painful than normal for most following cycles. The next 4 cycles were about one day longer than normal. Brought up these concerns during my well-woman visit in November 2021 and received ultrasounds and birth control (Falmina). Had to stop taking the birth control due to adverse reactions after 1.5 weeks. As of January 2022, pain is more mild and still comes and goes in the same pattern. Unsure if this is at all related to the vaccine or just a matter of timing, but wanted to report just in case!
Fatigue, very High temp from 99-104 for two days, intense migraine(no light),  very dizzy- could not function, nauseated,-can?t eat, rash & flushed face & felt as if I was allergic with itching all over, could not rest, could not sleep due to migraine pain, face very itchy, neck stiffness hard to lift my arms parallel with my body! I had to take Benadryl which didn?t really affect my allergic reaction until the 3rd day I noticed it begin helping with the allergy symptoms! I had Covid twice & these side affects were as bad as my worst day in Covid! I am now scared to take the second shot!
Patient received initial MENVEO 8/21/12 and another on 10/23/12. No adverse event (s) were reported. Parents notified verbally stated no adverse effect noticed.
Swollen lymph node in left armpit. It ended up getting almost the size of a golf ball and then became infected. I found a telehealth doc and he prescribed antibiotics. It eventually went away. However, now it comes back (small) every now and again. I never had this before getting my second vaccine.
No additional adverse effects reported; the patient was administered improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to a 4-year-old male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneously, lot # T001187 was verified to be valid, expiration date reported and established as 11-JUL-2021 (dose and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent.  The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (10.9 Fahrenheit degrees) for 2 hours and 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved.  The patient did not experience any additional adverse events.
Red rash approx. 2 1/2 inches in diameter at the shot site 7 days after injection with some itching  Itching has diminished somewhat since initial rash appearance Redness still remains at this point in time
patient recieved a dose of Janssen and later experienced fever and a skin breakout on the face and neck
Vertigo.  Spinning world feeling after swimming on at least 2 occasions.  A feeling of lightheadedness, somewhat faint, more recently, coming on suddenly and then passing.  I have never had these symptoms before.  They started coincident with the vaccines.