chrisvoncsefalvay/vaers-outcomes huggingface dataset:
made her very sick; This is a spontaneous report from a contactable consumer(patient) or other non hcp report based on information received by Pfizer from Regulatory Agency (Docket No. 85D-0249).   A 60-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/ lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient stated that the 1st dose made her very sick. The event outcome was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient reported dizziness S/P Influenza immunization.  Dizziness described as being 'light' and present while sitting upright with eyes open and closed.  Steady gait while ambulating, strong radial pulses, warm and moist skin at trunk, warm and dry at extremities, no loss of consciousness, not orthostatic, although dizziness subsided while supine.  Pt evaluated by a Physicians Assistant and released to follow up with PCP if symptoms persist.  Possible relation to to current prescribed medication, Zoloft.  Patient placed on Zoloft approximately 2-3 weeks ago and denied any side effects.
Pain and heat at injection site; Sick to her stomach; Feeling weak; Had to stay in bed; Arm was swollen; Couldn't eat anything; Nauseous; Fever; Pain and heat at injection site; This spontaneous case from the  was received on 11-Dec-2020 from other non-health professional via The agency (reference number: SEQW20-05716) and concerned a 70-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 16-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed.  On an unspecified date in 2020, the patient recovered from events of 'vaccination site warmth', fever and 'vaccination site pain'.   At the time of initial reporting on 11-Dec-2020, the patient was recovering from events 'stomach discomfort', 'weakness', 'bedridden', 'appetite lost', 'swollen arm' and nauseous, as she had improved.   The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: A 70-year-old patient was administered Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed. No alternative aetiology was provided. Causality is assessed as possibly related for vaccination site pain, vaccination site warmth, nausea, pyrexia, abdominal discomfort, decreased appetite, asthenia, bedridden and peripheral swelling.; Sender's Comments: A 70-year-old patient was administered Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed. No alternative aetiology was provided. Causality is assessed as possibly related for vaccination site pain, vaccination site warmth, nausea, pyrexia, abdominal discomfort, decreased appetite, asthenia, bedridden and peripheral swelling.
L UE swollen 1 1/2 x size of R UE 3x5cm red raised nontender warm wheal ext positive FROM.
a lock jaw and can not open her mouth on that side; a lock jaw and can not open her mouth on that side; mouth or jaw pain; mouth or jaw pain; swelling of the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 15:00 (Lot number: FA7485) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical Location: Injection Left arm, Lot Number: FA6780), administration date: 10Jul2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: TRISMUS (non-serious), ORAL DISORDER (non-serious) all with onset 06Aug2021 19:00, outcome "not recovered" and all described as "a lock jaw and can not open her mouth on that side"; ORAL PAIN (non-serious), PAIN IN JAW (non-serious) all with onset 06Aug2021 19:00, outcome "not recovered" and all described as "mouth or jaw pain"; PERIPHERAL SWELLING (non-serious) with onset Aug2021, outcome "unknown", described as "swelling of the arm".  Additional information: The vaccine was not administered at  facility. There were no emergency room and physician office visit. There were no prior vaccination within four weeks of first dose of BNT162B2. No adverse event prior vaccination reported.   No follow-up attempts are possible. No further information is expected.
I noticed a large bruise on the injection site later in the evening of the day of shot. 6 days later I still have the bruise.  No where  in information of these shots do they address bruising at the site of injection.  Is this normal? Thank you
This was a Pfizer Booster Shot taken to supplement my original J&J Jansen Vaccine originally given on 4/12/21. 4 to 5 days after the booster shot I began to experience tightness in chest, feeling of rapid heartbeat (pulse was normal). This lasted for several weeks ending approximately the second week of January.
No Adverse event; We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.) and NO ADVERSE EVENT (No Adverse event) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.).    Concomitant medication was not reported.  Patient took Covid-19 Vaccine (Monovalent) instead of the Moderna Covid-19 Vaccine Bivalent.  Treatment information was not reported.   This case was linked to MODERNATX, INC.-MOD-2022-679882 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-679882:same reporter
approx 3mos p/vax pt exp chickenpox w/approx 20 lesions. MD stated pt was not contagious.
pt recvd vax;stiffened up, eyes rolled back and she caught her breath;pt was real white;almost fainted; to er & dx of acute irritability;
Child cried, had perioral cyanosis, stiffened briefly and then fell limp in mom's arms.  Episode lasted under one minute.
Awoke from sleep at  approx 1:50 am , ambulated to bathroom for water, returned to bed, began to experience severe chills  and muscle shaking. Stated loss of conciouness for approx 10 second intervals with return to normal conciousness after 2 minutes with resolve of shaking During 2 minutes timeframe -Observed convulsions by partener with tonic extension of limbs and flexion of wrists. Partener also observed pale skin and "purple" tone to lips during 2 min time period. Took temperature approx 4 am. Was 99.3 degrees Farenheit. Client stated weakness for approx 2 hours after episode and return to baseline after 6 hours. Self administerd ibuprofen at 8:00 am.  Currently experiencing muscle soreness.
Hospitalization for shortness of breath due to COVID-19 on dates 7/27/2022-8/7/2022.  Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
RAISED RED AREA IN AND AROUND THE SITE OF INJECTION. WITHIN 24 HOURS SYMPTOMS OF REDNESS BEGAN AND SPREAD TO A RADIUS FROM INJECTION SITE OF APPROXIMATELY 4 -5 INCHES. MARGINS ASYMMETRIC. SLIGHTLY RAISED.
PATIENT EXPERIENCED REDNESS AND SWELLING EXPANDED AROUND THE INJECTION SITE.  REPORTED ARE FELT "ITCHY." PATIENT APPLIED ICE PACK TO THE AREA AND WAS SEEN BY A PHYSICIAN WHO PRESCRIBED ANTIBIOTICS.
Hardened area at injection site, severely red, pain going into left breast and neck, swollen lymph nodes, and headache. Healthcare professional questioned Polyethylene glycone.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-AUG-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
This spontaneous report was received from a Nurse refers to an unspecified number of unspecified patients of an unknown age and gender. The patient's relevant medical history and concurrent condition were not reported. On 17-FEB-2016, an unspecified patients were vaccinated with an unspecified number of improperly stored VARIVAX (Merck) lot # L040422 (15-OCT-2017) and lot # L042265 (26-OCT-2017) (dosage not reported). It was stored at 20F temperature and time frame was 599 hours. There was no previous temperature excursion. No adverse events reported. No product quality complaint reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
HPV9 was given instead of PCV. (As the clinic was out of PCV). At this time no known reaction - Provider continues to monitor.
Fussiness, crying, difficult to console for 5 hrs and 30 minutes.  Lump on right lower thigh. Lump may have been tender by mom's report. Event occurred 6 days after vaccine administered.
CHIEF COMPLAINT: Chest pain, headache, vomiting. OTHER SYMPTOMS: HA, chills. Patient is currently admitted to hospital.
Papulosquamous rash over the arms hands, neck and upper trunk that is intensely pruritic
530PM eyes started itching by time of getting up next AM pt had runny nose, hives & itching;pt was taken to ER @ hosp;
This medically confirmed spontaneous report (initial receipt: 20-Oct-2011) concerns a 12 month old patient. On 19-Oct-2011 the patient received influenza virus vaccine. On the same day the patient also received MMR II, VARIVAX and Hep B. The patient subsequently developed croup. The patient received dexamethasone on 20-Oct-2011. The event outcome was not reported.
Erythema, irritation, local warmth, and tenderness of 7cm diameter surrounding the injection site of MMR. Pt also had fever of 105 degrees F.
Next day reaction included severe chills, body aches, headache, earache, several bouts with diarrhea, pain in right side of neck, elevated temperature 99.2 ( usual temp ranges between 97.2-97.7) Symptoms began approximately 11:30 am - took Tylenol about 1 PM - by 5:30PM felt better.  Had a light dinner and by 10:30PM symptoms started again.  Took Tylenol again and went to bed.  Did not sleep well- next day very fatigued with a queasy stomach  at time of this report still an elevated temp of 99.2.
hypotonic-hypoactive episode with low grade fever and vomiting.  HHE onset around 4 hours after vaccination, duration of symptoms approx 3 days.  vomiting started 2 days after vaccine.
Headache for 2 days Body aches for 3 days  Striking Nerve pain in my keloid under right breast after first injection and second injection  Body aches for 3 days Nauseous day 3  Dizzy day 2 and 3  Hives/itchy rash started day 2 and currently still have itching rash all over body.
On right arm: area below where PNEUMOVAX 23 (deltoid IM) 5 1/2 inches height x 5 1/2 width redness, swelling, lot of pain to pt. Can't raise up arm all the way and hot to touch starting at 2 PM and got worse overnight. She has not slept a bit; hurt all night and all day and has not let up. Has taken APAP with no relief of pain. Review w/pt. that if the onset on hives, swelling of lips, closing of throat to seek medical attention. 9/30/18 at 3:35 PM - pt's daughter called back saying that the area had spread to her elbow. We informed her that in adult patient they were at increased risk of injection site redness, muscle pain, limitation of arm movement, and injection site swelling. Day 2 spread to elbow told patient to contact Dr. if symptoms worsen after 3 days, or if symptoms last longer than 7 days. After review complete patient management of local reaction.
1-2 weeks after influenza vaccine was administered patient started with sharp pain in L Lateral Shoulder.Patient states "Shoulder feels cold". Patient having limited ROM.
after vaccination with fever; headache; body aches; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 1st of 6th reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, headache and body aches on an unspecified date. Event took place after use of product. The outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034234 Same reporter/drug/event/different patient;US-PFIZER INC-2021034230 Same reporter/drug/event/different patient;US-PFIZER INC-2021034231 Same reporter/drug/event/different patient;US-PFIZER INC-2021034232 Same reporter/drug/event/different patient;US-PFIZER INC-2021034233 Same reporter/drug/event/different patient
Information has been received from a nurse midwife concerning a 22 year old female with no pertinent medical history who on 22-OCT-2007 was vaccinated intramuscularly into the left deltoid with a third dose of GARDASIL. There was no concomitant medication. On 22-OCT-2007 the patient experienced a sore left arm. The patient took MOTRIN and it relieved the sore arm. The patient also experienced discomfort in the left arm.
unconsolable crying x 6hrs 26APR96;on APAP;no fever;27APR96 extra quiet, sleepy moaning 26APR96
After shingrix vaccine I got kerititis. 8 months later it still keeps coming back.
Information has been received from a pharmacist concerning an adult female client who was vaccinated post-partum with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # not reported) in September 2002 and on 10/21/2002.  Subsequently, the client failed to seroconvert to measles.  Unspecified medical attention was sought.  The reporter was questioning if the patient should be revaccinated. It was noted that the patient is not breast feeding.  Additional information has been requested.
Severe chills 14 hours later, swelling rash and pain on second day on till today 9/8/18. Issues with rotator cuff came back.
FEEL THE POINT OF INOCULATION; SORENESS OF ARM; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes type 2, and seasonal allergies, and other pre-existing medical conditions included no known drug allergies. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced feel the point of inoculation. On 06-APR-2021, the subject experienced soreness of arm. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness of arm, and feel the point of inoculation. This report was non-serious.
Patient described full body hives which were very itchy and painful. I asked further questions about size and shape to try and determine if they were more blister-like and electrical-pain or circular and itchy pain (to determine shingles outbreak vs hives). I referred the patient to speak with her general practitioner or an urgent care personnel ASAP. She called her PCP and spoke with a triage nurse and a PA, who determined that she was likely experiencing an allergic reaction to the SHINGRIX vaccine. They told her at that time to start taking Benadryl around the clock. She was vaccinated on Monday, started noticing hives Tuesday/Wednesday, called and spoke with me Thursday, and spoke with her office Thursday. I called her again on Saturday the 22nd to follow up with her.
High fever consistently around 102 to 103 for 2 days. Lethargic tiredness fatigue body aches
given a 9 month old the Havrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old patient who received HAV (Havrix 720) (batch number 2jd3y, expiry date 4th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2021, the patient received Havrix 720 (intramuscular) and Havrix Pre-Filled Syringe Device. On 21st September 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the medical assistant. The medical assistant calling from pediatric office about having given a 9 month old patient, the Havrix vaccine, which led to Inappropriate age at vaccine administration. The reporter did not consented to follow-up.
rash on right side, mainly on her neck from her spinal cord to her adams apple; diagnosed with shingles on her right side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (rash on right side, mainly on her neck from her spinal cord to her adams apple; diagnosed with shingles on her right side) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HERPES ZOSTER (rash on right side, mainly on her neck from her spinal cord to her adams apple; diagnosed with shingles on her right side). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) on 10-Mar-2021 for Shingles, at a dose of 1 gram three times a day. At the time of the report, HERPES ZOSTER (rash on right side, mainly on her neck from her spinal cord to her adams apple; diagnosed with shingles on her right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was reported.
On 4/14/2021 patient woke up with stomach cramps and diarrhea.  states he could not walk, and had no energy from dehydration.  patient states he had SOB.  Patient has emergency alert system, so he pressed the button and an ambulance took him to the ER.
C/O (L) shoulder pain (superiorly, diffuse - not well localized). Exacerbated by overhead activities, worse w/movement, lateral deltoid region, top of shoulder, stiffness, weakness, shakiness of (L) hand w/use. (L) shoulder muscles w/mild atrophy diffuse. Symptoms started when vaccine was administered & no improvement since treated w/
July 2021= Acute Lacunar infraction in rt side of brain. Blood clot in brain caused a stroke, resulting in 6 months paralasys so far. Numb left side of face, constant headache and ringing, dizziness always forgetful and lack of energy. I cannot perform my daily duties anymore. My Dr says its called "Dead Brain". Onset of Dimentia.
pt recv vax 3SEP96 & 6hr post vax devel allerg rxn in the form of a very bothersome rash consisting of pustules on hands in the web spaces that was more severe on rt hand, fatigue, abd pain & yellow-orange stools;vaginal bleeding;
Initial and follow up information has been received from a Registered Nurse concerning a 96 year old female patient with a congestive heart failure. On 01-OCT-2007 the nurse reported that patient's son reported that on 27-JUN-2007, the patient who lived at a long term care facility received five times the recommended dose of Pneumovax 23. Prior to the vaccination, the patient was walking independently and doing her own care. After vaccination, the patient developed multiple aches, pain, fatigue and labored breathing. It had been reported that her vital signs would be monitored on 27-JUN-2007 through 29-JUN-2007. On 08-JUL-2007, the patient died. The cause of death was unknown. No further information, including lot number, was available. Additional information has been requested.
Extremely tired, full body chills, severe underarm pain and visible and palpable large lump under arm. Injection site redness, pain and swelling. Upper chest pain on deep inhale