chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately following vaccination (Tdap and MCV4) in a Health Department clinic patient experienced convulsive activity. Mom and nurse described eye-rolling with chest and arms/limbs contracting rythmically.  Health Department physician was immediately called to assess patient.  Patient was then moved from chair to an exam table.  Blood pressure rose to 90/60, then 110/70 within 5 - 10 minutes.  Pallor diasppeared and patient became more alert and conversant.  Patient could not recall all of the events.  There was no lip-biting or incontinence reported.  Neurological exam was normal.  Physician recommended follow-up with ER and/or PMD.
Patient reports pain and tenderness with palpation at site of injection. Onset 8/30/17 and continuing through 10/05/2017.
Suffered an  SAH from a ruptured carotid terminus aneurysm 2 weeks after vaccine.  Underwent coiling. Pt. started to not feel well a week after receiving the vaccine.
This spontaneous report as received from a consumer, as part of a marketing research program, refers to an unknown age and gender patient. Medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number were not reported). Concomitant therapy was not reported. On an unknown date, after the patient was vaccinated with PNEUMOVAX23, he/she developed pneumonia. The outcome of patient developing pneumonia was unknown. Causality was not reported. Additional information is not expected.
Pt recvd vax 9AM started screaming @ 5PM screamed for 4 hrs straight, uncontrollable; was hoarse p/screaming, had fever unable to check due to extreme screaming & kicking; very pale; called MD said give APAP wont last more than 24 hrs;
First day general malaise, feeling "under the weather" and tired. Next morning, chills, fatigue, body aches with nerve sensitivity (skin felt prickly" and low grade fever 99.9.  Slept until 11 am, woke up for a couple of hours, went back to sleep until 6pm, went to bed at ~11pm and slept until next morning. Could not go to work that day (day after vaccination). Fine the next day, all symptoms resolved.
To ER approximately 30 minutes after receiving injection. Complained of generalized chills, fever 100.3 up to 103, BP 145/71 at 1:15 PM and BP 73/43. Dopamine drip started. Admitted CCU 11/12/04. Off Dopamine drip. Discharge Summary received on 2/2/2005 states pneumonia. Medical Records received on 2/2/2005 states sepsis and fever.
Meningitis B vaccine given. The following day it was not swelling but it was severe pain, followed by a streak like red rash moving upwards and downwards from the injection site. Flu like symptoms followed except no fever. She has never had a reaction to any vaccinations. Ever. The concern lies in that it took an antibiotic to clear it up and now two weeks later she has a reoccurring side effect. Light swelling, very much red, and very hot and is spreading up and down her arm. This child is 18 never has reactions or illnesses. Something is wrong she never responds like this.
Numbness/pins and needles in left pinky finger, left wrist, left elbow.
Patient called pharmacy today at about 1:40pm notifying that she had been in the emergency room (ER). She stated she had severe arm pain after the immunizations. They diagnosed it as SIRVA in the ER and patient was given a cortisone shot. Upon following up with an orthopedic doctor, they ordered physical therapy for her as well.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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), outcome "not recovered", described as "headache". Additional information: The reporter was querying if the patient could take Tylenol since the patient was currently having a headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vial that was at room temperature since the 23Nov2021.; vial that was at room temperature since  the 23Nov2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial that was at room temperature since the 23Nov2021.) and PRODUCT STORAGE ERROR (vial that was at room temperature since  the 23Nov2021.) 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 26-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial that was at room temperature since the 23Nov2021.) and PRODUCT STORAGE ERROR (vial that was at room temperature since  the 23Nov2021.). On 26-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vial that was at room temperature since the 23Nov2021.) and PRODUCT STORAGE ERROR (vial that was at room temperature since  the 23Nov2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on visual inspection noting any vaccine state change looks normal , a bit cloudy , no particles, nothing look abnormal.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
warmth at the site of injection; small red dot at the site of injection, patient presented to clinic with redness the size of "cupping hand in the shape of a C"; soreness at the site after vaccination; Initial information received on 25-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 52 years old female patient who experienced warmth at the site of injection, soreness at the site after vaccination and small red dot at the site of injection, patient presented to clinic with redness the size of "cupping hand in the shape of a c" after receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s) and family history were not provided. List concomitant or "no other vaccines": NO OTHER VACCINES.    On 20-Jul-2023, the patient received 1 ML (Milliliter) dose of suspect RABIES (HDC) VACCINE (Powder and solvent for suspension for injection) (1ST Dose in series) (Frequency: once), (Strength: Standard) (lot V1D643M and expiry date: 06-Sep-2024) via intramuscular route in the right arm for Immunization pre-exposure (Immunization).  On 20-Jul-2023, the patient developed soreness at the site after vaccination (vaccination site pain) (Latency: same day) following the administration of RABIES (HDC) VACCINE.  On 21-Jul-2023, the patient developed warmth at the site of injection (vaccination site warmth) and on Friday small red dot at the site of injection and in the afternoon patient presented to clinic with redness the size of "cupping hand in the shape of a c" (vaccination site erythema) 1 day following the administration of RABIES (HDC) VACCINE.  No further information provided by the reporter.   Action taken: Not applicable.  The patient was prescribed Cetirizine 10mg oral daily for 30 days and Cephalexin 500mg one capsule oral 4 times daily for 7 days. Caller also reporting patient was given instructions to use Benadryl OTC, caller unsure if topical or oral or dosage, also Pepcid OTC for Vaccination site erythema, Vaccination site warmth and Vaccination site pain.  At time of reporting, the outcome was Unknown for all the events.
swelling, redness, hard knot, extreme pain;MD recommended DPH; sx still persisting as of 26AUG;
Information has been received from a physician concerning a female who on 09-FEB-2007 was vaccinated with a first dose of Gardasil (Lot# 653978/0955F).  On 09-APR-2007 the patient was vaccinated with a second dose of Gardasil.  On 09-APR-2007, the patient developed pain in the arm.  The physician reported that the pain was not specified to the injection site.  The patient did not experience pain in the arm after the first dose of Gardasil.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Patient complained of rash on back that itches when in hot climate/setting for the past four days.  They look like 4 red bug bites.  I strongly recommended that he follow-up with his physician to determine if it is possibly something un-related to the vaccine components since he has been working outside.
Patient had respiratory distress (ex. Wheezing, stridor), dizziness, swelling fo throat. Gave Benadryl 25 mg IM 1 minute after vaccination, called 911 2 minutes after vaccination.
1 DAY POST VACCINATION - CLIENT COMPLAINT OF ITCHY AREA WHERE VARICELLA VACCINE GIVEN, SLIGHTLY RAISED AND RED. TYLENOL GIVEN BY PARENT AND ICE WAS APPLIED TO AREA. DENIED  FEVER. 2 DAY POST VACCINATION - CLIENT COMPLAINT OF NON ITCHY RED RAISED AREA 4 INCHES X 6 INCHES WHERE VARICELLA VACCINE WAS ADMINISTERED. AREA IS WARM TO THE TOUCH AND PAINFUL TODAY. PARENT DENIES THAT CHILD HAS FEVER. AREA WHERE MENVEO VACCINE GIVEN INDICATES A SMALL SWOLLEN AREA OF LESS THAN 3/4 INCH.
Shock down arm during shot administration, swelling, bruising, redness, heat. Cold compress, Tylenol and Ibuprofen.  Benadryl cream. 6 days
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 02-DEC-2013 the patient was vaccinated with a dose of PNEUMOVAX23 lot # J009827, expiration date 10-AUG-2014, intramuscularly in the arm. It was unspecified if this was the only dose of PNEUMOVAX23 this patient has ever been administered. Other suspect therapies included FLUVIRIN administered concomitantly on the same arm on 02-DEC-2013. On 04-DEC-2013 the patient presented at the pharmacy with rash on the arm where the vaccines were administered. It was unspecified when this rash developed. The patient sought medical attention. The patient was prescribed oral prednisone by his physician. The outcome of the rash on the arm where the vaccines were administered was unknown. The relatedness between the rash on the arm where the vaccines were administered and PNEUMOVAX23 and FLUVIRIN was not reported. Additional information has been requested.
patient reported muscle soreness that went all the down her arm on the first day.  second day patient developed a rash that was tender to touch.  third day patient went to see pcp and was diagnosed with a shingles outbreak.  patients daughter will keep pharmacy up to date with patient's progress.
It was reported that a 24 year old female patient received a JE-VAX and a Typhim VI vaccination on 08/07/00. Reportedly that same day the patient complained of "raised tender area on the dorsum of the right hand 3/4 diameter, looked like a bruise. It was reported that a 24 year old female received a JE-VAX and a Typhin VI vaccination on Aug 7, 2000. Reportedly that same day the pt complained of raised tender area on dorsum of right hand 3/4 diameter, looked like a bruise. Follow up #1 (Sept 24,2002) During internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding.
Within 5 minutes of injection, I developed hives, itching, throat and mouth swelling/thickness
Nine days after Varicella vaccine c/o bruising, reddness and itching at injection site
Abdominal pain  Fever 100.1 Vomiting  Weakness  Arm hurt
Headache, Dizziness, Pain in the arm where the vaccine, these three the first 3 days. Right now arm pain and headache.
This spontaneous report was received from a Nurse and refers to a 16 month old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 24-MAY-2018, the patient was vaccinated with VARIVAX lot number M035141, expiration date 01-AUG-2018, subcutaneously for prophylaxis. On the same date, while vaccination, the patient moved when it was being administered and some leaked out at the injection site on the leg. The patient was supposed to be vaccinated with 0.5ml subcutaneously, but it was not sure how much was administered (underdose). No adverse events were reported.
Information has been received from a physician concerning a 26 year old female with no pertinent medical attention who on 23-FEB-2009 and 14-SEP-2009 was vaccinated IM with the first and second (lot# 0670Y) 0.5ml doses of GARDASIL. There was no concomitant medication. The patient developed a dermatologic reaction after the first dose of GARDASIL. The patient was taking oral prednisone for eczema as of April 2009. In July 2009 and August 2009 the patient was examined by a dermatologist and treated for atopic dermatitis. The patient developed a rash (worse than prior reaction) 3 days after the second dose of GARDASIL. The patient was examined by dermatologist in September 2009 and treated with a topical steroid cream. The patient sought medical attention through a telephone call. On 22-OCT-2009, the patient recovered. Additional information has been requested.
Pain, swelling, temp. 100.2 apr.9. Rx.with warm and cold commpress.  given Tylenol.
Red and swollen on left arm and pain in left arm. Unable to move it easily the first day. It is improving at this time, able to move her arm easily, but there is still some pain at the site. Did not take any OTC medication.
Patient reported that she remembers that her arm was sore for 2 weeks with her first Shingrix vaccine. No other adverse reported. No need to seek medical treatment. Did not further question what she did to treat the soreness since this occurred about 1 year ago.
102 temperature; hives; muscle weakness in the lower ext; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Feb2022 08:45 (Lot number: fk9896) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; PROZAC. Past drug history included: Dilaudid, reaction(s): "Known allergies: dilaudid". Vaccination history included: Bnt162b2 (lot number= el1283, Intramuscular, Left arm, administration date= 28Jan2021, 05:00 PM, dose number=2), administration date: 28Jan2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (lot number= ej1685 , administration date= 24Dec2020, 05:15 PM, dose number=1, Left arm), administration date: 24Dec2020, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 18Feb2022 12:00, outcome "not recovered", described as "102 temperature"; URTICARIA (non-serious) with onset 18Feb2022 12:00, outcome "not recovered", described as "hives"; MUSCULAR WEAKNESS (non-serious) with onset 18Feb2022 12:00, outcome "not recovered", described as "muscle weakness in the lower ext". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, urticaria, muscular weakness.  Additional information: Patient received the Benadryl as treatment of pyrexia, urticaria, muscular weakness. Patient missed day of work. Patient had Covid prior to vaccination and has been tested after vaccination.  No follow-up attempts are possible. No further information is expected.
She stated she had Moderna vaccine at Gillette on 3/25. She stated area has been itchy for a couple days and today she noticed a red rash near the injection site, that is warm, about 2-3 inches. She denies any other symptoms.
Patient reported to Health Center on 10-14-14.  Patient states, "I woke up and my left upper arm and shoulder ached.  It has not gone away."  Patient states continuous dull ache in upper left arm. Compares ache to #3 on 1-10 pain scale. Full Range of motion.  Pain level increases slightly with motion.  Medicated with Ibuprofen 200 mg. (1) Tab PO @ 8:00 A.M. on 10-14-14.
Not well; Feels like having a flu; Feels a bit of temperature; Received Moderna booster/ She is not immunocompromised; Feels yuck/ Feeling worse today; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels yuck/ Feeling worse today), MALAISE (Not well), INFLUENZA LIKE ILLNESS (Feels like having a flu), PYREXIA (Feels a bit of temperature) and EXTRA DOSE ADMINISTERED (Received Moderna booster/ She is not immunocompromised) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 037K20A and 043L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and GABAPENTIN (NEURONTIN) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced FEELING ABNORMAL (Feels yuck/ Feeling worse today) and EXTRA DOSE ADMINISTERED (Received Moderna booster/ She is not immunocompromised). On an unknown date, the patient experienced MALAISE (Not well), INFLUENZA LIKE ILLNESS (Feels like having a flu) and PYREXIA (Feels a bit of temperature). On 02-Sep-2021, EXTRA DOSE ADMINISTERED (Received Moderna booster/ She is not immunocompromised) had resolved. At the time of the report, FEELING ABNORMAL (Feels yuck/ Feeling worse today), MALAISE (Not well), INFLUENZA LIKE ILLNESS (Feels like having a flu) and PYREXIA (Feels a bit of temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported of consuming female hormone, daily dose for blood pressure (had been taking that for a long time), baby aspirin and Neurontin at night.  Patient wanted to know if Tylenol or Ibuprofen can be taken.   This case was linked to MOD-2021-306735, MOD-2021-306715.
It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Is this correct? / YES; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Is this correct? / YES) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Is this correct? / YES). At the time of the report, VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Is this correct? / YES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided by the reporter. No treatment was provided by the reporter.
Pain and swelling of both breast. Went to dr for breast exam and two lumps were found.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017 (reported as since 28-FEB-2017), the patients were vaccinated with improperly stored doses of VARIVAX lot # M023384, expiration date 11-MAY-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 2 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
The site of injection is a little bit red; HCP administered Flucelvax Quad PFS in the fat and not in the muscle; This spontaneous case was received on 01-Oct-2020 from other non-health professional (consumer) via Health Authority (reference number: SEQW20-02713) and concerned a 59-year old female patient.  The patient's concurrent conditions included diabetes type 2, hypertension, hypercholesterol, thyroid disease and mild asthma. The patient's concomitant medications included lisinopril, Lipitor (atorvastatin calcium), Januvia (sitagliptin phosphate), metformin, Baby aspirin (acetylsalicylic acid), Synthroid (levothyroxine sodium), calcium, vitamin D (colecalciferol) and insulin pump, all used for unreported indications.  On 01-Oct-2020 the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: arm and route of administration: reported as 'in the fat') for influenza prophylaxis. The batch number reported was 276554 and expiry date was 30-Jun-2021. HCP (helth care professional) administered Flucelvax Quad PFS in the fat and not in the muscle (explicitly coded as 'inappropriate route of vaccination'). The HCP pinched the skin so the fat could stick out of the arm and injected the syringe.  On the same day, after receiving Flucelvax QIV, the site of injection was a little bit red.   The outcome of 'vaccination site erythema' was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment: The event of 'vaccination site erythema' is assessed as related, while the event of 'inappropriate route of vaccination' is assessed as not related to Flucelvax QIV.; Sender's Comments: The event of 'vaccination site erythema' is assessed as related, while the event of 'inappropriate route of vaccination' is assessed as not related to Flucelvax QIV.
This spontaneous report was received from a pharmacist via a company representative regarding a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient complained of a swollen and red arm (unspecified arm). The patient was referred to her primary care physician and was diagnosed with severe cellulitis. The patient was given an unspecified treatment. The outcome of the event was unknown. The relatedness between the event and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
Arm soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, over a year ago, the patient reported that, experienced arm soreness after shingrix vaccination. No additional information available. The reporter did not consent to follow up.