chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RBC, Hemoglobin, and Hct continue to elevate; RBC, Hemoglobin, and Hct continue to elevate; RBC, Hemoglobin, and Hct continue to elevate; CBC w/manual differential shows RDW - CV 22.9 % and RDW - SD 75.6 FL; 3 days after 2nd dose pain both legs from knee to bottom of both feet. Continuing still, today is day 6.; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6208), dose 2 via an unspecified route of administration, administered in arm left on 20Mar2021 at 08:30 (at the age of 77-years-old) as dose 2, single; and patient previously took BNT162B2 (Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in right arm on 25Feb2021 at 16:30 as dose 1, single for COVID-19 immunisation at other. Medical history included chronic obstructive pulmonary disease (COPD), Edema, Sleep Apnea, Irregular Heartbeat. And patient was allergic to ibuprofen and contrast dye. Concomitant medications included alendronate (FOSAMAX) 70 MG Oral Tablet Take 70 mg by mouth every 7 days. atorvastatin (LIPITOR) 20 MG Oral Table Take 1 tablet (20 mg total) by mouth at bedtime. calcium carbonate (TUMS) 500 MG Oral Chewable Tablet Chew 1 tablet three times daily. diltiazem (CARDIZEM) 60 MG Oral Tablet Take 1 tablet (60 mg total) by mouth twice daily. Fluticasone-Umeclidin-Vilant (TRELEGY ELLIPTA) 100-62.5-25 MCG/INH Inhalation Aerosol Powder, BREATH ACTIVATED Inhale 1 puff by mouth daily. furosemide (LASIX) 80 MG Oral Tablet Take 1 tablet (80 mg total) by mouth twice daily (8am/4pm) and Omeprazole 20 MG Oral Tablet Delayed Release Dispersible Take 20 mg by mouth daily. Prior to the vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks. On 23Mar2021, after second dose, the patient experienced pain in legs and feet. Treated for symptoms and bloodwork shows abnormal red blood cells. Labs repeated CBC with automated differential, CBC with manual differential shows RDW - CV 22.9 percentage and RDW - SD 75.6 FL. RBC, Hemoglobin, and Hct (Haematocrit) continue to elevate. The patient has been referred to hematology. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included blood test: abnormal red blood cells, computerised tomogram: unknown results, full blood count: RDW - CV 22.9 % and RDW -SD 75.6 FL (w/manual differential), haematocrit: elevated, haemoglobin: elevated, magnetic resonance imaging: unknown results (lower extremity), neurological examination: unknown results, red blood cell count: Elevated and ultrasound scan: unknown results. Therapeutic measures were taken as a result of events include medication for leg pain (bloodwork, ultrasound, CT, neurological nerve study, MRI and lower extremity).  Since the vaccination, the patient had not been tested for COVID-19. It was reported there was no prolonged hospitalization. The outcome of the events was not resolved.
Moderna COVID-19 Vaccine- Fever, Chills, Muscle and joint aches, headache, fatigue.  Self limiting, went to bed and woke feeling better.  Only fatigue now.
BODY ACHES; SEVERE CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, severe chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, severe chills, and fever. This report was non-serious. This case, from the same reporter is linked to 20210921477 and 20210921347.
Tinnitus.  Mild to moderate.   Began the next morning and still going on.
Caller states her 23 month old received the H1N1 vaccine in one arm and the seasonal flu vaccine in the opposite arm yesterday morning at 1130.  She is concerned because the child has a stuffy nose now.  The site where the H1N1 vaccine was given is red with a bump. No fever.  mother refused follow-up call.
This spontaneous report was received from a medical assistant and refers to an unknown number of unspecified patients. The patients' pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the unknown number of patients were vaccinated with improperly stored ROTATEQ for prophylaxis (dose, units, lot number and expiration date were not provided). Administered vaccine reached temperature excursion high of 15.9 Celsius degrees and lasting for 2 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007629: US-009507513-1705USA002132.
Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 13:00 as dose 2, single (Lot number: EW0151) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch number: ER8727, Administration time: 01:00 PM, Anatomical location: Left arm), administration date: Mar2021, for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 29Aug2022 at 05:00, outcome "recovered with sequelae", described as "Bells Palsy". The event "bells palsy" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy via acupuncture. Clinical course: The patient did not suffer from COVID-19 prior vaccination and it was unknown if COVID-19 tested post vaccination.
This spontaneous report as received from a nurse refers to a 15 year old patient of an unknown gender. On 19-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # H012643 and expiry date: 30-MAR-2015). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
This initial non-serious spontaneous case, was received on 02-Oct-2017, from a pharmacist, concerning a of 72-year-old elderly male patient. The patient's current conditions included diabetes, HTN (hypertension), ulcerative colitis, osteoarthritis from unspecified dates and the concomitant medications taken were PROAIR, amlodipine, ASA, Calcium w/Vitamin D, Clonidine, FLONASE, Glipizide, Glucosamine, LEVEMIR, HUMALOG, Metformin ER, Multi vitamin, BENECAR HCT, Sulfafalazine, Triamterene HCTZ for unknown indications. On 02-Oct-2017, the patient was administered with the FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 178701, expiry date: Apr-2018). It was reported that the patient was administered with the PFS vaccine that was stored in 54 F up to 120 hours excursion time. No adverse events were reported. The reporter assessed the event as non-serious. Non-significant case correction received with IRD on 02-Oct-2017: corrected verbatim of the event drug administration error from 2 doses administered/2 vaccines administered to up to 120 hour excursion time, max temp reached of 54F. 2 doses administered/2 vaccines administered.
low fever; severe chills,  mild headache, lethargy began somewhat abruptly 22 hours after injection. Pain in arm persists after 30 hours
Herpes Zoster diagnosis in one-dose varicella vaccine recipient. Symptoms include: unilateral painless rash, vomiting. Treatment not given.
intense itching within 2 minutes of injection 1235 VS: T98.3, SpO2 98%, 158/89 25mg Benadryl PO per MD order 1335 pt stated itching was less intense  1350 Dr. interviewed patient and released home
Lightheaded 5 minutes after vaccine; BP 144/91, pulse 81. After resting, follow-up BP/pulse: 127/91, 83 and 136/86, 81.
Redness and swelling approximately the "size of a golfball" at the injection site-MMR-left arm.
Development of eczema (on hands) two months following second vaccine; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 8-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Lot number: FK5127) at the age of 8 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications included: FLU VACCINE taken for Immunization, start date: 02Nov2021, stop date: 02Nov2021; CLARITIN and unspecified DAILY VITAMIN. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE; Lot Number: FK5127), administration date: 08Nov2021, when the patient was 8 years old, for COVID-19 immunisation.  The following information was reported: HAND DERMATITIS (non-serious) with onset 26Jan2022, outcome "recovering", described as "Development of eczema (on hands) two months following second vaccine". Therapeutic measures were taken as a result of hand dermatitis.  Additional information: Known allergies were reported as not applicable. The patient received other vaccine within four weeks prior to the COVID-19 vaccine. The patient had no prior history of eczema. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included over the counter (OTC) Hydrocortisone cream for hand dermatitis. Since the vaccination, the patient had not been tested for COVID-19.
Information has been received from a 63 year old female consumer with a penicillin allergy and no other pertinent medical history who on 17-OCT-2007 was vaccinated in the left arm with a dose of  ZOSTAVAX. Concomitant therapy included SYNTHROID, meloxicam, an unspecified medication for "when your arteries get clogged up" and vitamins (unspecified). Subsequently the injection site became reddish, the area was the size of a quarter. Medical attention was not sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is in follow-up to report(s) preciously submitted 12/21/2007. Information has been received from a 63 year old female consumer with a PENICILLIN allergy and no other partinent medical history who on 17-OCT-2007 was vaccinated in the left arm with a dose of ZOSTAVAX (Merck). Concomitant therapy included SYNTHROID, MELOXICAM, an unspecified medication for "when your arteries get clogged up" and vitamins (unspecified). Subsequently the injection site became reddish, the area was the size of a quarter. Medical attention was not sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Follow-up information was received from someone in the physician's office. The patient was vaccination IM in the left deltoid with a first dose of ZOSTAVAX (Merk) (lot #657766/0920U) on 17-OCT-2007. Subsequently the patient developed a red reaction the size of a 50 cent piece. The patient's outcome was not reported. No further information was provided. Additional information has been requested.
pt felt dizzy, fainting, could not see, pt was lying down on the floor, but never lost consciousness. few minutes later, pt felt better, pulse checked as normal, pt was sitting down for several more minutes, returned to normal
pt recvd vax & was a nonresponder; pt was given a booster dose, response status unk; clarification is being sought; also reported as exp arthritis;
lymph node swelling and tenderness; lymph node swelling and tenderness; tenderness at the site of injection; moderate lethargy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single and administered in arm left, administration date 01May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Other medical history: Arthritis; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "recovering" and all described as "lymph node swelling and tenderness"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovering", described as "tenderness at the site of injection"; LETHARGY (non-serious) with onset 2021, outcome "recovering", described as "moderate lethargy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain, vaccination site pain, lethargy.  Additional information: first two doses resulted in lymph node swelling and tenderness plus tenderness at the site of injection and moderate lethargy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 09-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot #U028178, expiration date: 08-MAR-2023 (strength and route of administration were not provided) for prophylaxis (Product storage error).  On an unknown date, before the administration, the vaccine underwent temperature excursion at -12.5 Celsius degrees (C) for 1 hour. No previous temperature excursions were reported. No adverse event were reported (No adverse event).
Initial and follow up information was received from a physician and a registered nurse concerning a 71 year old retired white female with no known allergies, diabetes mellitus non-insulin dependent and a thyroid disorder who on 18-NOV-2005 was vaccinated intramuscularly with a 0.5 ml dose pneumococcal 23v polysaccharide vaccine (lot#651318/1006P).  Concomitant therapy included levothyroxine Na fluoxetine, metformin, trazodone HCL, "dislosenant", gabapentin, atorvastatin calcium (LIPITOR) and "prophylthiuracil".  On 18-NOV-2005 at 11:00 the patient developed a severe local inflammatory reaction with redness, swelling, warmth, and pain at the injection site.  The patient called the physician who recommended rest.  No lab tests were performed.  There was no other treatment.  On 21-NOV-2005 the patient recovered.  No product quality complaint was involved.  No further information is expected.
Fever of 101, chills, muscle aches, headache about 13 hours after injection. All of those side effects are gone but I still have a red, itchy hot spot on arm where injection given.
Severe (L) shoulder pain that worsened with movement - movement significantly restricted x 4 days following vaccine continues to have pain now two wks post vaccine - not as severe but still present with reaching above head
I received my first vaccine on March 16th and began experiencing light-headedness and some dizziness two days following the vaccine.  This has continued - on and off throughout the day - since then .   I did not see this side effect listed so I'm not positive that it is linked to the vaccine but I tend to think it is as I have never experienced this feeling before.  It is relatively mild and it is not impacting my day-to-day activities, but I definitely feel it.
Case number PHEH2012US017416 is an initial spontaneous report received from a consumer on 30 Aug 2012. This report refers to a 19-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that she was vaccinated only with the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: 10047) intramuscularly on to unspecified site and did not receive the Men A lyophilized conjugate on 24 Aug 2012. No adverse event was reported following the maladministration.
High degree of swelling and pain in upper arm (injection site). Rash on arms, legs, stomach, back, buttocks. Treatment at ER - prednisone (prescribed for 4 days), claritin, pepcid, benadryl (as needed).
Fatigue; muscle soreness; swollen lymph nodes under arm 24 hrs after vaccination; This is a spontaneous report from a contactable consumer. An adult male patient of an unspecified age (Age: 58, unit: unknown) received second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular route of administration, administered in left upper arm on 08Feb2021 as dose 2, single for COVID-19 immunisation and first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an intramuscular route of administration, on an unspecified date as dose 1, single for COVID-19 immunisation. The patients medical history and family medical history was reported as unknown. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Feb2021, the patient experienced fatigue, muscle soreness and swollen lymph nodes under arm 24 hrs after vaccination. The event fatigue, started within 24 hours of vaccination. Facility type vaccine was reported as nursing home or senior living facility. The patient did not receive treatment for the events. These events did not require the initiation of new medication or other treatment or procedure. The clinical outcome of events was reported as recovered on unspecified date.    Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
T104 24hrs post shots; This is the second time there has been a problem w/very high temp p/shots;
PT has not yet been contacted to evaluate if any adverse reactions were present. CDC was contacted, they stated there was no serious risk with giving the extra dose of KINRIX. CDC stated PT will not need the regular adolescent dose that is administered at the age of 11-12 of TDAP, will need a booster of TD at the age of 18.
Shot 1: Pain and bruising at injection site Shot 2: Slight fever, shoulder muscle pains (some shooting), wrist aches, fatigue- all starting 20-24 hours post shot -swollen lymph node in armpit of the same arm as injection approximately 36 hours after injection all other symptoms receded overnight -took aleve at about 1500 the day after injection and nyquil around 19:30  the day after injection
Pt was given the vaccine and he began to feel faint. This was the patients first dose of pfizer. He was guided to the floor. Patient did not experience shortness of breath, chest tightness, or difficulty breathing. Patient was guided to the cot and paramedics arrived on scene.
Information was received from a licensed practical nurse who reported that an unknown number of unspecified patient or patients were administered improperly stored GARDASIL 9 lot #M034780, expiration date 15-APR-2019, (dose and route of administration not provided) on 11-MAY-2017. No adverse effects reported. Temperature: 12°C Time frame: 17 hours Previous temperature excursion: Yes, 11.4°C for 17 hours on 17-APR-2017; 16°C for 3 hours on 01-MAY-2017. Data logger involved: Yes. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA006221: US-009507513-1706USA000340: US-009507513-1706USA000343: US-009507513-1706USA000341: US-009507513-1706USA000342: US-009507513-1706USA000339.
After 9 days my arm developed a bump under the skin, turned red (with the red increasing by the next day) and itching real bad, and sore to the area.  I called my doctor and was told to put ice on it and rub it.  I did not understand why after 9 days I was having what I called a reaction to the shot.
hives or little bumps; injection site red; arm felt itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (hives or little bumps), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PRURITUS (arm felt itchy at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE URTICARIA (hives or little bumps), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PRURITUS (arm felt itchy at injection site). The patient was treated with CALAMINE for Hives, at an unspecified dose and frequency. At the time of the report, INJECTION SITE URTICARIA (hives or little bumps), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PRURITUS (arm felt itchy at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Areas erythema involving most of back, left arm and (R) anterior chest. Itching developed rash 3/5-3/6- Pt applied Witch Hazel.