chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified injection site reaction. At the time of reporting the outcome of the event was unspecified. It was reported that 3 additional subjects experienced unspecified injection site reactions following administration of FLULAVAL. Another subject, A0949617A, experienced an entire arm reaction and chest reaction in addition to injection site reactions. This case was considered to be serious. Linked cases include A0949617A, A0950781A, A0950782A and A0950781A.
Fever over 101, night sweats, shaking chills, severe headache, localized reaction at injection site, severe muscle and joint aches, nausea,  brain fog, severe fatigue, neck pain
Total body aches; Injection site pain; Fatigue; Chills; Feverish; Headache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 14Apr2021 at 10:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid and moderate eczema. Concomitant medications included norethisterone acetate, ethinylestradiol (AUROVELA 1/20), levothyroxine (MANUFACTURER UNKNOWN), betamethasone (BETAMETHA), mupirocin calcium (MUPIR) and macrogol, propylene glycol, simeticone, sorbic acid, sorbitol, white soft paraffin (VANICREAM); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 10.30, as a single dose for COVID-19 immunisation. 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 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food or other products. On 14Apr2021 at 21:00, the patient experienced total body aches, injection site pain, fatigue, chills, feverish and headache. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of events total body aches, injection site pain, fatigue, chills, feverish and headache and included treatment with tylenol. The clinical outcome of the events total body aches, injection site pain, fatigue, chills, feverish and headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
c/o throat tightening & diff swallowing w/in 3-5min p/vax;skin moist, sl pale color;BP 190/110, P72, R15, 02 given & DPH;
Immediate light-headedness, cognitive fog, some shortness of breath following shot; some nausea. At 7 hours after shot, extreme fatigue, nausea, chills, body aches, headache, loss of taste, loss of appetite, shortness of breath.  At 10 hours after shot, continued symptoms plus full body ache in all joints; nearly unable to walk; 102 degree fever. 102  degree Fever lasted for 12 hours. 1 Day following shot--migraine headache, extreme body ache, still some shortness of breath, extreme fatigue, nausea. Two Days following shot--headache, body ache, fatigue, nausea. Three days following shot--headache, body ache, fatigue, nausea. Four days following shot--symptoms improving but still some headache, body ache, fatigue, nausea.
tingling/tingling from the corner of ear to the center of chin; Shingles; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tingling and shingles. On an unknown date, the outcome of the tingling and shingles were unknown.   It was unknown if the reporter considered the tingling and shingles to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. A month ago, the patient received 1st dose of Shingrix. About the same time, the patient developed an infrequent tingling from the corner of my left ear to the center of my chin. The patient had developed a mild case of shingles.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unknown dates between 06-MAR-2017 and 10-APR-2017, the multiple unspecified patients were vaccinated with improperly stored doses (also reported as doses were administered before temperature excursion) of VARIVAX (lot # L046887, expiration date 23-NOV-2017, dose, strength, route of administration were not provided). Sterile diluent used to reconstituted vaccines was properly stored. No adverse effects were reported. No product quality complain was involved. The vaccines were stored in the temperature between 6 and 14 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000161: US-009507513-1705USA000160:
Tested positive For Covid on 19Apr2021; Nasal Swab tested positive for Covid on 19Apr2021; body aches; Sorearm; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 12:15 (Lot Number: EW0150) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included hypothyroidism. The patient's concomitant medications were not reported. Relevant past drug history included Pennicilin and sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient first reported she received her first dose on 05Apr2021 and then got COVID on April 15th. She was due for her second vaccine on 26Apr2021 but due to isolation she was unable. She further reported that she had body aches and sore arm on 05Apr2021 for over a week. Nasal Swab tested positive for Covid on 19Apr2021 and was out of work for 10 days. The outcome of the events body aches and sorearm was resolving and for other events was unknown. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 on 30Apr2021.
elevated temp (degrees unk-no thermometer) chills, stuffed up nose, runny & sore eyes, head cold, sore throat, back & both legs ache, itchy ears 2"x3" lump in rt arm that is sore;
Her arm was sore; had no energy; felt extremely tired for several days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore), ASTHENIA (had no energy) and FATIGUE (felt extremely tired for several days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included PANTOPRAZOLE for an unknown indication.    On 18-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Her arm was sore), ASTHENIA (had no energy) and FATIGUE (felt extremely tired for several days). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Her arm was sore), ASTHENIA (had no energy) and FATIGUE (felt extremely tired for several days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-328467, MOD-2021-328498 (Patient Link).
Dizziness, Myalgia, Started with headache, then myalgias, left arm pain traleling up her neck; now feels like both of her legs are numb. Narrative: Referred to ER; escorted to ER @1:30pm
No additional AE reported; an expired MMRII was administered to a patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication or drug reactions/allergies was provided.  On 02-AUG-2021, an expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) (lot number R031679 has been verified to be valid, expiration date reported and validated as 01-NOV-2020) was administered to the patient as prophylaxis (administered dose, vaccination scheme, route of administration and anatomical location of vaccination were not reported) (expired product administered). The vaccine was reconstituted using the sterile diluent (STERILE DILUENT) (lot number S002624 and expiration 05-NOV-2021, both verified as valid). No additional adverse event (AE) reported.
Hives on arm. Shot was given-on entire arm but more by injection site. They itched-went away in 2 days.
Nerve pain in lower left back/hip; nausea; painful rash with blisters on lower left back; swollen inguinal lymph nodes; from March 22 to present; diagnosed as Shingles
PEDIARIX combination vaccine with the Hep. B was administered plus a single dose of ENGERIX B Ped. dose, giving the client an extra dose of Hep. B and not administering the 1st HIB dose. Client had no adverse events or unusual signs and symptoms.
COVID-19 (10Jun2021-20Jun2021); COVID-19 (10Jun2021-20Jun2021); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4431061-00.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 08May2021 as dose 1, single (Batch/Lot number: unknown) and on 25May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 10Jun2021, outcome "recovered" (20Jun2021) and all described as "COVID-19 (10Jun2021-20Jun2021)". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After an hour of receiving my vaccine, I started feeling  a little jittery, my heart rate went up to 113. I felt very short of breath. worst when walking and talking that improved with me sitting. Nausea with lots of drool. Around 4:30 I started feeling body aches . Then at 5 on my way home, i started feeling extreme pain in my joints, to where i couldnt hold the steering wheel tight. Around 7:30 I started having shaking and aching. Around 9:30 I ate potatoes, and took motrin and it helped a little. I felt weak and washed out like I ran a marathon.  I was still feeling fatigue and wiped out, I had no energy.  I took my pulse ox and it was 95-96.  I am now having muscle pain at the injection site, and injection site is very sore.
A week after DTAP given mom reports he had "inflamed blood vessels in legs and toes". Pt not seen by Doctor- when seen exam was normal.
her arm hurt immediately / pain from her arm upto her neck; feeling sicker than a dog; she started throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (her arm hurt immediately / pain from her arm upto her neck), ILLNESS (feeling sicker than a dog) and VOMITING (she started throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (her arm hurt immediately / pain from her arm upto her neck), ILLNESS (feeling sicker than a dog) and VOMITING (she started throwing up). At the time of the report, PAIN (her arm hurt immediately / pain from her arm upto her neck), ILLNESS (feeling sicker than a dog) and VOMITING (she started throwing up) outcome was unknown. Not Provided          No Concomitant medications were reported. No Treatment information was reported.
I can't sleep; I have a lot of headache, like constantly headache; Sweating; I am feeling nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 (Lot number: EN6208, Expiration Date: 06Jun2021) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 18Mar2021, outcome "not recovered", described as "I have a lot of headache, like constantly headache"; HYPERHIDROSIS (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Sweating"; NAUSEA (non-serious) with onset 18Mar2021, outcome "not recovered", described as "I am feeling nauseous"; INSOMNIA (non-serious), outcome "unknown", described as "I can't sleep". Therapeutic measures were taken as a result of headache.  Additional information: Narrative case summary and further information: Selected Report Type Initial, Is the patient also the reporter Yes, Reporter type Consumer or other non-health professional. Primary / Prescribing Healthcare Professional Info, HCP postal address:. Is Covid Vaccine a Pfizer product Yes, Covid Vaccine manufacturer Unspecified, Dates for Covid Vaccine (Start Unspecified Stop Unspecified), NDC number of Covid Vaccine Unknown, UPC number of Covid Vaccine Unknown, Expiry Date of Covid Vaccine 06Jun2021. Other Products No, Patient History No, Investigation Assessment No. Additional Context: Consumer stated, "she called for report, she had her vaccine (Pfizer Covid Vaccine) on Thursday no on Tuesday, no on Wednesday and on yesterday she have a lot of headache, like constantly headache and last night it was like sweating and she was feeling nauseous, it's her first dose for the vaccine." Date of vaccine administration 17Mar2021. Adverse event start date 18Mar2021. Consumer further stated, "Is anything reported before like this for study, she can deal with it, it's nothing like the emergency. She think it's for the starting feeling like that." Reporter Type she is working for Hospitality. When probed for the mailing address of the pharmacy, consumer stated," (Pharmacy name), it's all she have, she don't know the zip code". Telephone#: Consumer stated, "she don't know that, she don't have." NDC# and UPC# Consumer stated, "she do see anywhere." Anatomical site of vaccine administration Right Arm. When probed for the indication, Consumer stated, "For the prevention of pandemic." When probed are you still experiencing the problem, Consumer stated, "Yes, and she don't know how it's going to be tomorrow." Outcome of event she don't she just tell you what she feel last night, she is calling because she can't sleep." Treatment Tylenol, Ibuprofen for headache. Dose 200 mg, Formulation Tablet.  No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose or H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
To whom it May concern: I want to report that after the first dose of Pfizer's COVID-19 vaccine I suffered from peripheral facial paralysis and it affected my mouth. My right upper lip does not rise and I have trouble eating, drinking, and washing my mouth. This is the first time something like this has happened to me. Thanks for your attention.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, (dose, lot number, expiry date and route was not reported). No concomitant medication was reported. On an unknown date the patient experienced multiple myeloma. It was reported that the patient is to begin treatment for multiple myeloma with BORTEZOMIB. The outcome of multiple myeloma was unknown. The reporter considered the event multiple myeloma to be life threatening. Upon internal review the event multiple myeloma was considered to be medically significant. Additional information has been requested.
24-36 hours after MMR - pt had generalized urticaria. No symptoms of anaphylexis. Resolved with single dose of Benadryl.
pt recvd vax 20 mins later & exp vomiting x4, flushing, nausea, elevated blood pressure, dizziness & neck aches; sx were improved by 19:00 hrs & resolved by 21:00 hrs on the same day; vax series has been discontinued;
Approximately 10 days after receiving my first Moderna covid vaccine, I began developing a very bad  case of hives over most parts of my body.  The doctor has diagnosed it as chronic idiopathic uticaria (no known cause). The hives have been extremely itchy and have even woken me at night.  I have been on the following medicines to try and curb the relentless symptoms -- hydroxine, clarinex, xyzal, and prednisone.  There has been no let up or decreasing of symptoms since they started.  My dermatologist who is treating me has also seen this in one or two of her other patients and thinks the delayed response could be related to the vaccine.
Currently pregnant with due date 12/26/2021  Having heart palpitations and shortness of breath
Developed a bright red rash to bilateral lower extremities below the knees. Left leg more redden and swollen to the touch than right leg.  Warm to touch, itchy and burning sensation to left leg mainly.
Pt called and said had FLUVIRIN and PNEUMOVAX on 9/1/12 and has "severe headache and neck and back pain". Has history of neck and back surgery but doesn't think he aggravated it.
Pt. presented with reddened eyes & generally not feeling well. - T 98'-80-16-130/90.  I had her lay down-rest with cool cloth.  I flushed eyes, - Medicated with Benadryl  25 mg.  45 minutes later, pt. felt better but had achiness all over.  I gave her Motrin 800 mg at 2:30 & she went home.  11-5- I called pt. today to follow up & she said that she vomited X 1-  Temperature maxed at 98.9- & she feels achy all over.  Site of injection is tender & puffy.
<15 min p/MMR vax recvd pt devel 3cm radius of erythema w/o swelling; ice applied, rxn resolved p/15 mins;
Pt. remembers feeling like he was going to black out. Pt. found laying on waiting room floor.
Covid Arm - itchy, red rash occurring 8 days after shot was administered; Swollen lymph nodes in armpits
pt had a massive stroke at 6:15 pm on 3/23/2021 when he was using the bathroom trying to have a bowl movement.  He used his phone to text his mom to tell her he had a seizure.  He was slurring, vomiting, and falling down.  Ambulance was called.  He was transport him to Hospital.  Pt was aspirating.  He was never treated as a stroke patient.  He was monitored overnight.  On 3/24/2021 the ER physician had a phone consult w/ a neurologist.  He was referred to be transferred to another hospital.  He was was being bagged in transit to hospital.   He went into the ER stroke unit.  Dr.  called mother to let her know that if he didn't have emergency brain surgery he would die.  Mother told him to save her son.  He survived brain surgery and was put in the Neuro ICU.  On 4/3 He was transferred to the Stroke Team floor.  On 4/8 he was transferred to Rehabilitation Hospital.  He will be at this location for weeks or months.
Onsent Tinnitus 2 days after vaccine - last 1 month. received booster also tinnitus onset after  2 days
Exhausted, dizzy, nauseated, rapid heartbeat, pain in joints all over body, fatigue
Information has been received from a consumer concerning a female relative with a fruit allergy (all) and a vegetable allergy (all) who in approx. 9/00 was vaccinated with a dose of MMRII. Immediately after vaccination, the pt developed swelling around the injection site. Within 20 minutes of vaccination, the pt developed swelling around different spots on her body and cluster hives. Unspecified attention was sought. No further information was provided. Additional information has been requested.
Temperature was gone up to 102.2F; Slowbody movement; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature was gone up to 102.2F), HYPOKINESIA (Slowbody movement), HEADACHE (Headache) and CHILLS (Chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Overweight.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). On 01-Dec-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature was gone up to 102.2F) and HYPOKINESIA (Slowbody movement). At the time of the report, BODY TEMPERATURE INCREASED (Temperature was gone up to 102.2F), HYPOKINESIA (Slowbody movement), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Body temperature: 102.2 (High) temperature was gone up to 102.2F.         The reporter was calling on behalf of the patient. The patient had booster shot on 30-Nov-2021 and had headache and chills. On 01-Dec-2021, at the time of call, the patient showed slow movement of body and the temperature was gone up to 102.2F.  No Concomitant product use was reported. No treatment information was provided.
11/4/15 pt admitted to hosp w/(B) lower extremity weakness and numbness and paresthesias of (B) hands.
On 08/29/2001 the patient's mother noted red bumps "mosquito bite appearance" around the injection site, quarter to half dollar size. The patient had 2-3 blotches above the site. Three days later the patient had a small spot below the site. The patient was treated with Benadryl for the itching. On 09/15/2001 the patient broke out with 10 spots on her back, more vesicle looking, not clear fluid, white inside. The patient had a few spots on her belly, legs, and shoulder. 09/19/2001 the areas dried up.