chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 14 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Golf ball size lump on my arm at injection site that lasted 3 weeks and didn't reduce in size. Inability to use arm without extreme pain. Rash that felt like a burn on arm 12 weeks pregnant at the time of injection  Pregnancy was lost
Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 23-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Cellulitis-started on ATB and KENALOG injection. local redness, swelling-used BENADRYL, ice.
Information has been received from a health professional concerning a 52 year old female patient who on Sept 29 2004 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Subsequently in approximately Sept 2004, the patient developed redness, soreness and pain in the injection site. Unspecified medical attention was sought. The reporter would like an investigation into the lot number. The health care professional reported similar experienced for three other patients (WAES04100USA00320, WAES0410USA00566, WAES0410USA00568). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
flu-like symptoms Narrative:  Per supervisor report: "took 2nd COVID-19 Vaccine on 4/5/2021 c/ flu like symptoms. "  Other Relevant History:
Various body parts started feeling itchy on Thursday, 8/26. Thought initially it may have been mosquito bites. The next day, my arms and legs were covered in red bumps and patches. Took Benadryl that night but symptoms became worse the next morning. Irritated areas included my arms, legs, back and feet. Went to my primary care doctor on Saturday, 8/28.  Doctor  told me it was urticaria (hives). Prescribed Zyrtec and Prednisone which I began taking that day.
8/7/03-fever started that afternoon. 8/8/03-fever continued as high as 102.4. Mother giving child Tylenol and Motrin, giving fluids.
Anaphylactic response on my left arm, high fever, headache, chills, body aches
Patient received vaccine at approximately 1:10pm. Patient's mother called for help after the patient lost consciousness and fell, hitting his head on a shelf on the way to the floor at approximately 1:15pm.  By the time we arrived, the patient was seated but slumped against his mother.  He was extremely pale but conscious.  We applied an ice pack to the back of his neck.  The patient reported wanting to lay down and close his eyes.  We instructed the patient to stay awake and engaged in conversation to ensure he stayed conscious.  The paramedics arrived at this point and transported him to the emergency room.
Itching; Scratching; unexpected bloody discharge; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SCRATCH (Scratching) and BLOODY DISCHARGE (unexpected bloody discharge) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), SCRATCH (Scratching) and BLOODY DISCHARGE (unexpected bloody discharge). At the time of the report, PRURITUS (Itching), SCRATCH (Scratching) and BLOODY DISCHARGE (unexpected bloody discharge) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information reported.
Afternoon was flushed, burning face. 12/09/15 didn't feel well. 12/10/15 racing heart; tightness in chest and left axilla, flush, pounding, pulsing in head.
Became very pale within 5 minutes of vaccine. Mom stated pts eyes rolled back and she "Passed out" in waiting room ~10 mins after vaccine. Pt initially unresponsive to voice but slowly recoevered. Mother not concerned initially as pt has hx of fainting after piercings. Pt recovered and taken home. Mother called the following day to say her daughter had been pale and moving slowly for 24 hrs after vaccine. Appeared sleepy and slightly disoriented. Full recovery at time of discussion with mother the following day.
Headache, sever chills, grogginess, lethargic, just feeling sick
Twinges of pain in underarms, breast, chest. Eventually spreading to fingers, knees, shins, ankles and feet.
Numbness in wrist, elbow and shoulder of arm ADACEL was administered, began within a few minutes of injection. Numbness was in (R) arm. Full range of motion of hand, elbow, and shoulder, equal strength, intraradial and ulnar pulse, good capillary refill, sharp and light touch diminished. No hives or respiratory distress. To ice and use MOTRIN for 6 hrs as needed. Sent to neurology since numbness continued. Seen on 6/10/09 by neurology. Neurology note attached.
body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; solution for injection; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 30Dec2020 08:00 AM at a single dose for covid-19 immunization. Medical history included crohn's disease, asthma and has known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but had received other medications within 2 weeks of vaccination. The patient reported that approximately 12 hours (30Dec2020 08:00 PM) later after the first injection, she had some body aches. The outcome of the event was unknown.
has a bruise that is black and blue; has a bruise that is black and blue; LITTLE BIT OF SORENESS, where shot the shot was; HEADACHE; TIREDNESS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (has a bruise that is black and blue), VACCINATION SITE BRUISING (has a bruise that is black and blue), VACCINATION SITE PAIN (LITTLE BIT OF SORENESS, where shot the shot was), HEADACHE (HEADACHE) and FATIGUE (TIREDNESS) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (has a bruise that is black and blue), VACCINATION SITE BRUISING (has a bruise that is black and blue), VACCINATION SITE PAIN (LITTLE BIT OF SORENESS, where shot the shot was), HEADACHE (HEADACHE) and FATIGUE (TIREDNESS). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (has a bruise that is black and blue), VACCINATION SITE BRUISING (has a bruise that is black and blue), VACCINATION SITE PAIN (LITTLE BIT OF SORENESS, where shot the shot was), HEADACHE (HEADACHE) and FATIGUE (TIREDNESS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.
3 days after injection. Bruising around injection site. Large rash on arm, very itchy
I had nausea, cramping in stomach, loss of appetite and diarrhea and severe pains in my stomach. The chills for 3-4 chills.
itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The patient experienced intense itching at the injection site.  The reporter did not consent to follow-up. All information was not available.
Received vaccine on 2/6/2021.  was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower.  caregivers noted her extremities were cool and face was red.  temp was 97.4.  She was placed in wheelchair with book in the living room.  caregivers noted she was not turning pages of the book as she usually would.  She was tracking, so they don't think she had a seizure.  Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911.  She was found with agonal breathing, CPR started, intubated by EMS,  taken to the ER and diagnosed with cardiac arrest upon arrival.  CPR was continued until family could be reached and decision was made to stop resuscitation.
Flu like symptoms; This is a spontaneous report from a contactable consumer. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was 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 four weeks prior to the vaccination. On an unknown date the patient experienced flu like symptoms, lasted for two days post vaccination . The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event flu like symptoms was resolved on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .; She feels sick & doesn't feel right; Feeling not the same person as she was; Stomach issue; Other side effects; Rash,a few on her back,a band with little dots on the chest,a few on her back; She still has bad headache; She still has bad headache and is kind of nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .), MALAISE (She feels sick & doesn't feel right), FEELING ABNORMAL (Feeling not the same person as she was), ABDOMINAL DISCOMFORT (Stomach issue) and VACCINATION COMPLICATION (Other side effects) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038AZ1A and 019M20A/ 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chickenpox. Previously administered products included for an unreported indication: FLU. Concomitant products included DICLOFENAC for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .), MALAISE (She feels sick & doesn't feel right), FEELING ABNORMAL (Feeling not the same person as she was), ABDOMINAL DISCOMFORT (Stomach issue), VACCINATION COMPLICATION (Other side effects), RASH (Rash,a few on her back,a band with little dots on the chest,a few on her back), HEADACHE (She still has bad headache) and NAUSEA (She still has bad headache and is kind of nauseous). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .) had not resolved and MALAISE (She feels sick & doesn't feel right), FEELING ABNORMAL (Feeling not the same person as she was), ABDOMINAL DISCOMFORT (Stomach issue), VACCINATION COMPLICATION (Other side effects), RASH (Rash,a few on her back,a band with little dots on the chest,a few on her back), HEADACHE (She still has bad headache) and NAUSEA (She still has bad headache and is kind of nauseous) outcome was unknown.            This case was linked to MOD-2021-288308 (Patient Link).
Information has been received from a physician who heard from the local news, that a female who was vaccinated with a dose of GARDASIL vaccine (yeast) experienced nausea and vomiting and was hospitalized (length of time unspecified).  The patient's outcome was not reported.  In follow-up, the office nurse reported she was not familiar with any adverse events being reported from their office.  Attempts are being made to verify the existence of an identifiable patient and reporter.
Heart issues; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (Heart issues) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISCOMFORT (Heart issues). At the time of the report, CARDIAC DISCOMFORT (Heart issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-403371 (Patient Link).
on 19May2021 /received an expired dose of Kinrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number XC575, expiry date 2nd February 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a patient received an expired dose of Kinrix, it expired on 2nd February 2021 and was administered on the same day as reported which led to expired vaccine used. The reporter consented to follow up.
pt recvd vax & 24 hrs later exp joint pain, & numbness & swelling of the lt hand; sx were treated w/Motrin & Anaprox;
She got her vaccine, she had severe shaking chills and vomiting for several hours starting at 2:00 AM.  She was extremely sick all night.  2 days later she had extreme diarrhea.  She took Imodium for her symptoms.  Then a day after that she had another attack of diarrhea, again treated with Imodium.  She was then OK, and then got a cold.  She did not seek medical attention.  She states that this reaction was so bad she felt she was going to die.
lt arm over elbow & triceps area revealed erythema & warmth distal to the sight of the inj;
Weakness, numbness R side of body, numbness R side of face.  9/12/2008 Link to 324856./pc 9/12/2008 PCP records received. WCC 6/27/08 with normal exam except ecchymosis doe to a ball injury of the L hand.  HPV#1. Seen 9/5/08 with c/o weakness, R sided numbness and R sided facial pain which began after HPV#2 on 8/27/08. Sx had resolved by OV. DX:  HPV reaction.  Seen again 9/10/08 for L sided lower back pain and R sided leg pain.  Irregular heartbeat  noted on PE as well and tenderness of the R calf. DX: Leg and back pain, irregular heartbeat.  Sent for EKG Holter monitoring and X-rays.
caller could not clarify the type of reaction; This spontaneous report has been received from a female consumer of unknown age referring herself. Concomitant medication, pertinent medical history, and drug reactions/allergies were unknown.  On an unknown date, the patient was vaccinated with shingles vaccine Zoster Vaccine Live (ZOSTAVAX) for shingles prophylaxis (formulation, strength, dose, route, lot#, and expiration date were not reported), but she was unable to clarify whether it was a Merck vaccine or not.   On an unknown date, the patient experienced a reaction, she could not clarify the type of reaction (ill-defined disorder). It was unknown if lab diagnostics or studies were performed or the patient had sought medical attention. No further details were given. The outcome of the event was unknown.  The causality between the event and the vaccine was not reported.
This spontaneous case reported by a consumer, describes the occurrence of dizziness (feel dizzy), feeling hot (feel warm), headache and arthralgia (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 050E21A) for COVID-19 immunization. No medical history reported. On Sep 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 16, 2021, patient experienced  dizziness (feel dizzy), feeling hot (feel warm), headache and arthralgia (joint pain). At the time of the report, dizziness (feel dizzy), feeling hot (feel warm), headache and arthralgia (joint pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information provided.
Colorectal cancer - Procedures: laparoscopic assisted low anterior resection with diverting loop ileostomy. Recovery in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
Burning sensation, itching, blisters around injection site, swelling, soreness, fever, injection site hot with large lump, swelling.
Pain in Right deltoid area. Redness 8 inches by 7 inches in circle around site. Center of circle has a darker red area with a cluster of blisters. Swelling in deltoid area is double the size of normal.
Headache within 10 minutes Sore left hand when I woke up around 6 am Within 18 hours tiredness, fever, chills, muscle aches
child spit up about half of it; the vaccine was given to a child and spit up about half of it; This spontaneous report was received from an office manager (other) referring to a two-month-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 13-MAY-2021 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 mL, orally for prophylaxis (strength, lot number, expiration date were not provided).  On the same date, the reporter stated the vaccine was given the child, who spat up about half of it. (infantile spitting up, underdose). No treatment was provided for the event. On an unspecified date in May 2021, the patient recovered from infantile spitting up No additional AE reported.  The causal relationship between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and infantile spitting up was not provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-NOV-2015 at time- 10:19, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperatures at which the product was stored were 3.2 and 2.6 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Parents and purple lips; Bad pain in vaccinated arm (sore to touch, hurts to move arm, cannot raise arm over head); Bad pain in vaccinated arm (sore to touch, hurts to move arm, cannot raise arm over head); This is a spontaneous report received from a non-contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 16Mar2021, at 13:30, as single dose for covid-19 immunization when the patient was 45-years-old.  The patient medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. There were no concomitant medications.  In Mar2021, a patient experienced parents and purple lips and bad pain in vaccinated arm (sore to touch, hurts to move arm, cannot raise arm over head) on an unspecified date.  No treatment was given for the events. The outcome of events was unknown.
pt recv vax NOV96 & sometime p/vax pt exp tremors of the head, neck & hands;neurologist was consulted & on 16JAN97 neurological sx comprise a rather prominent tremor affecting head, neck & hands;brisk deep tendon reflexes;
Right upper thigh multiple flesh colored papules no vesicles. Left upper thigh only a few flesh colored papules less than right thigh. No treatment given.
Screamed uncontrollably for 4-5 hrs the evening of 1st inject settled down about 9-10PM & slept rest of noc;
Headache, Myalgia, Diarrhea, very fatigue Narrative: