chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's parent). A 3-year-old male patient of an unspecified ethnicity received the 3rd dose of PREVNAR 13, via an unspecified route of administration, on an unspecified date at the age of 9 months, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient previously took 2 doses of PREVNAR 13, for immunisation: 1st dose at 4 months, 2nd dose at 6 months. The patient experienced liver problems on an unspecified date with outcome of unknown. The event caused patient's hospitalisation. As the patient was in the NICU, the vaccine was delayed and he wound up only getting three of the 4 recommended doses.
Within minutes of the administration of the vaccines pt became pale and felt lightheaded. She began c/o numbness in her hands with her hands feeling cold. I sat her on a chair with her head between her knees and had her breathe in a bag x 30 seconds. Soon after she began feeling better and her pallor started fading with resolution of numbness and lightheadedness. She left the office on her own accompanied by her mother.
Unsure exactly when reaction began. I woke up, went into the restroom to shower, and noticed a large, red circle on my arm with another smaller circle above the large circle. The injection site was where the smaller circle developed. It was warm, slightly itchy, blanched when touched. There no swelling, no signs of infection, no abscess, didn't feel any more firm than then rest of the tissue on my arm, no evidence of a bite or any other injury causing the reaction.   I did notice a very slight itch at the injection site within a couple hours of receiving the vaccine. The itching still persists today at the same degree it did that day. There is still a very slight redness in the area.
Injection site reaction on left arm swollen and red and swollen eyes almost closed. Patient received steroid and antibiotics from doctors.
The a.m. after vaccinations pt. noticed back of left arm sore & redness around injection site.  The redness continued to spread, was not to the touch.  It remained the next day also, pt. was seen in office.  Dx'd with cellulitis and was given anti-biotic Rx.
Memory problems; Dizziness; Little confusion; Disorientation; Don't feel safe driving/ can't drive; Joint pain; Fatigue; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory problems), DIZZINESS (Dizziness), CONFUSIONAL STATE (Little confusion), DISORIENTATION (Disorientation), FEELING ABNORMAL (Don't feel safe driving/ can't drive), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     Concomitant products included BUSPIRONE, CLONAZEPAM, PAROXETINE and DONEPEZIL for an unknown indication.   On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) (seriousness criterion disability). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory problems) (seriousness criterion disability), DIZZINESS (Dizziness) (seriousness criterion disability), CONFUSIONAL STATE (Little confusion) (seriousness criterion disability), DISORIENTATION (Disorientation) (seriousness criterion disability), FEELING ABNORMAL (Don't feel safe driving/ can't drive) (seriousness criterion disability), ARTHRALGIA (Joint pain) (seriousness criterion disability) and FATIGUE (Fatigue) (seriousness criterion disability). The patient was treated with IBUPROFEN for Joint pain, at an unspecified dose and frequency. On 21-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, MEMORY IMPAIRMENT (Memory problems), DIZZINESS (Dizziness), CONFUSIONAL STATE (Little confusion), DISORIENTATION (Disorientation), FEELING ABNORMAL (Don't feel safe driving/ can't drive), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-231068 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Information has been received from a 63 year old female with no known drug reactions/allergies and a history of Shingles about 8 years ago and a non active mycobacterium tuberculosis who on 28-JUL-2008  was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included BONIVA, ZITHROMAX  and some medications for non active mycobacterium tuberculosis. On the night of 28-JUL-2008 the patient started feeling nauseous and cold. She had no injection site reaction. The patient's nausea and cold persisted. The patient did not seek medical attention. Additional information has been requested.
Mo reports took to ER 3/15/07 6:00 pm with fever 103 deg and seizures seen in ER with diagnosis of flu. Mo was instructed at clinic prior to shots to give dose Tylenol (which she did) and every 4 hours x 24 2 hour had seizures at 6-7 mo. Child with PE of well toddler. Very playful and happy at exam visit.
Patient reports itching on his back approximately 3 days post vaccination. His wife confirmed there was no discoloration at that time. By the 27th, patient noticed a red itchy rash under his left armpit.  Within another day, vesicles started to form and he sought medical treatment. Appointment today confirmed that patient has a active shingles outbreak and patient is receiving anti-virals.
chest pain, leg swelling Narrative: Pt reports having chest pain 2 days after receiving vaccine on 3/12/21 and lasting 2 days. Reports bilat lower legs swelling starting 7 days after  vaccine and legs have remained swollen. Have not worsened but have not improved on 4/15/2021 post vaccine follow-up call. No pain or redness or soa.  H/O PE in 2017. Nurse advised pt with bilat leg swelling and no improvement and h/o of PE to go to ED & to let ED know of jj vac. Pt instructed to call clinic for f/u once seen.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/30/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient was to receive just Hib but instead was given Pentacel in addition to her scheduled vaccines of pediarix, rotavirus and Prevnar13 which caused  her to have an extra dose of DTAP and IPV.  Parents notified and no adverse reactions at time.
This spontaneous report was received from a online article via company representative regarding to unspecified number of female patients of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with GARDASIL, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that on unspecified date, the patients had adverse events. Additionally it stated that the pharmaceutical companies which made GARDASIL, as well as the Department of Health and Human Services which hold patents and earns profits from GARDASIL said that they were all coincidence also that the mainstream media denied that these events were even happened. The relatedness between the event and therapy with GARDASIL was not reported. This is one of several reports from the same source. Additional information is not expected as follow up information cannot be obtained.
patient yesterday (June 20, 2022) received an expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a unk patient who received HAV (Havrix) (batch number Km72c, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th June 2022, unknown after receiving Havrix and Havrix 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 by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:21-Jun-2022 Reporters comment: This case was reported by a medical assistant. The reporter did not consent for follow-up and did not provide patient information Additional Supportive information: The patient received an expired dose of Havrix vaccine, which led to expired vaccine used.
Severe chills, muscle aches, nausea, headache. Lasted 45 minutes. Treatment: sleep.
Patient explained that about an hour after receiving the vaccine she had a lot of pain in her arm. By the next morning she could not move her arm. She went to Urgent care on 10/01/22. There they took an x-ray and told her it was damage to the joint and she had inflammation there.  She has been using OTC ibuprofen, ice, and massage to help alleviate the pain.  She is still having a lot of pain and is following up with her PCP. She has since regained some range of motion in the arm.
This report was received from Pfizer, Inc. and was assigned manufacturer report number 2015344694 for PREVENAR 13. This was originally reported by a pharmacist concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On an unknown date, the patient experienced that her hands/arms swell (oedema peripheral) and she believed that she was allergic phenol (drug hypersensitivity). The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            No concomitant and treatment medication information was reported.
Started with a large red patch of skin that was angry red and itches like crazy. Almost 10 days after vaccination.  Continues  to itch and seems to flare up and gets angry red.
Fatigue, fever (101+), joint pain, muscle aches, migraine, tonic-clonic seizure
HEADACHE FEVER BODY ACHE WITHIN 24 HOURS WAS FATIGUED OUT OF SORTS
Today worker woke up and noticed a reddened warm area at vaccine site. Worker seen by the Health Center today.   localized reaction to left upper are at site of vaccine. Site 4.5 cm redden, warm and slightly raised in a rough circular pattern.  Worker denies pain, itching to site.  Worker denies any other symptoms denies resp distress, denies having any fever or chills, itching, swelling of tongue.  Ice to area  Follow up with the Health center on Friday 8/4/23
a patient was possibly administered a expired dose of PROQUAD.; No adverse effects; This spontaneous report was received from a health care worker and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown.  On 24-JAN-2019, the patient was vaccinated with a possibly expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # N020615 and expiration date 22-JAN-2019, for prophylaxis (dose, strength, frequency and route of administration were not provided).         The patient experienced no adverse events.
swollen lymph nodes in arm pits - pt reported has had the same symptoms the previous 2 times she got the vaccine . last two time symptoms lasted 1 week.
Treatment of COVID-19; Treatment of COVID-19; vaccine dose number: 1; manufacturer: janssen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 2,  single (Batch/Lot number: unknown), in left arm and on 20Jul2022 at 18:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 07Mar2021 at 10:00 as dose 1, single (Lot number: 1805020), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Oct2021, outcome "unknown", described as "vaccine dose number: 1; manufacturer: janssen"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Plaxlovid from 07Apr2023 to 12Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lip sore; knot; itchy; red; felt warm on the Left arm,just below the injection site; rash; soreness of the Left arm the day of injection; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (lip sore), MASS EXCISION (knot), PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (felt warm on the Left arm,just below the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness of the Left arm the day of injection). On 26-Jan-2021, the patient experienced LIP PAIN (lip sore), MASS EXCISION (knot), PRURITUS (itchy), ERYTHEMA (red), FEELING HOT (felt warm on the Left arm,just below the injection site) and RASH (rash). At the time of the report, LIP PAIN (lip sore), MASS EXCISION (knot), PRURITUS (itchy), ERYTHEMA (red), FEELING HOT (felt warm on the Left arm,just below the injection site) and RASH (rash) outcome was unknown and PAIN IN EXTREMITY (soreness of the Left arm the day of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not provided. No relevant concomitant medications were reported.
Client called and states she had a headache before the vaccination and the next day the headache continued. She had pain and inflammation on her left cheek and a lesion on her left eyelid
Post immunization lightheadedness, pale, hot, diaph skin, tingling in his head from watching injection, lasting 5-10 mins, laid pt on bed, legs elevated, 500ml water.
redness, swelling, pain, tenderness, fever, fatigue, headache chills, throat issues, fast heartbeat
p/vax pt devel a full blown case of chickenpox;pt sought unspecified medical attention;
patient developed headache 2 hours after vaccine. HA has sustained for the past 6days
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses in VAQTA immunization series, lot number L022259, expiration date: 06-APR-2017, lot number M003011, expiration date: 15-NOV-2017 and lot number M021124, expiration date: 02-FEB-2018, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Incoming call from patient, reporting possible COVID-19 side effects / adverse reaction:  Pt called in to report after 2nd dose Pfizer vaccine yesterday 5/24, she feels chest tightness, shortness of breath , rapid heartbeat, and feeling ""anxious like something bad is going to happen.""  Advised to seek emergency care or call 911. Pt states her family member can drive her to the emergency room. Pt verbalized understanding.
Severe illness with fever, generalized myalgias and severe large joint arthralgias (hips, knees, etc) which prevented ambulation, SEVERE PERSISTENT GENERALZED HEADACHE  WITH PHOTOPHOBIA. Most symptoms subsided with the exception of headache, which decreased in intensity but is still persistent.
Mother states child developed fever of 101.5F (ax) the night after vaccinations. She was whiney, sleepy and had redness of both legs radiating to trunk. Symptoms lasted 7 hours and was relieved with Tylenol. The pt vomited occasionally for the next 48 hours.
I woke up with a red bloody eye., in my right eye. Looks like a blood vessel busted while I was sleeping.
shingles; 16th time having shingles (herpes zoster); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023SA031067 (Sanofi).  Initial information was received on 24Jan2023 regarding an unsolicited valid non-serious case received from a consumer/Non-HCP. This is linked to cases 2023SA031061 and 2023SA029739. This case involves a 61 years old female patient who experienced developed shingles a couple of days after received the vaccination: 16th time having shingles while receiving vaccines pneumococcal vaccine CONJ 20V (CRM 197) Prevnar 20 and meningococcal W 135 (T CONJ) vaccine (Menquadfil). The patients past medical treatment included takes acyclovir daily prophylactically. The patients past vaccination(s) included MMR in Nov2022 and MENACTRA with on a 5 year cycle. The patients past medical history and family history were not provided. At the time of the event, the patient had ongoing Asplenia since Jun2012 and Diabetes mellitus (DM) for two years. On 02Jan2023, the patient received a dose Of suspect Prevnar 20 not produced by Sanofi Pasteur with Unknown formulation, strength, dose, route, batch number and expiry date for prophylactic vaccination. On 19Jan2023, the patient received a dose of 0.5 ml dose 4 of suspect meningococcal A-C-Y-W 135 (T CONJ) vaccine solution for injection (lot: U7459AE, expiry date: 30Nov2024) via intramuscular route in the left deltoid for immunization. On 19Jan2023, the patient developed shingles a couple of days after received the menquadfi vaccination, 16th time having shingles (herpes zoster) following the administration of meningococcal A-C-Y - W 135 (T CONJ) vaccine and 17 days following the administration of Prevnar 20. It was reported "Caller previously reported to Sanofi Medical Information that she developed shingles a couple of days after she received the M ENQUADFI vaccination. She received the MENQUADFI vaccine on 19Jan2023. The report was taken and submitted to PV on 24Jan2023. The caller stated that her shingles have mostly cleared up. She mentioned that she is prone to shingles since she lost her spleen in 2012. This was her 16th time having Shingles. The caller noted that they are not sure if her most recent encounter with Shingles was caused by the MENQUADFI vaccine. but her doctor recommended that she report it anyway". Action taken with meningococcal vaccine (menquadfi) and pneumococcal vaccine CONJ 20V (CR M 197) (PREVNAR 20) was not applicable. The patient was treated with acyclovir (aciclovirl for Herpes zoster). At time Of reporting, the outcome was Recovering/Resolving. Additional information was received on from consumer/Non-HCP. Outcome was updated to recovering. Clinical course updated & text amended accordingly.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Chills/ Fever 101.3/ Nausea/Loss of Appetite/Next day fever 100.2/Bedridden 5 days/totally fatigued the whole 5 days/slept most of the time.  Finally coming around on day 6, for someone who is never sick.
This spontaneous report as received from a Registered Nurse refers to a male patient of unknown age with no spleen with no pertinent medical history and drug reactions reported. On 12-DEC-2012, the patient was vaccinated intramuscular with 0.5 ml PEDVAX HIB (lot # not provided). No concomitant medications were reported. The Nurse stated that on 12-DEC-2012, the patient was administered an improperly stored dose of PEDVAX HIB. Nurse noted that the PEDVAX HIB was drawn up in a syringe and not immediately administered but stored in the refrigerator for 1 to 2 hours before being administered to the patient. No adverse effect reported. Additional information has been requested.
Information has been received from a health professional concerning a 10 year old female who "sometime last week" on approximately 15-OCT-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) and hepatitis A vaccine (inactive) (VAQTA). The patient was sitting on the exam table when vaccinated. Post vaccination she "passed out, fell on her face, and hit her lip". The patient was monitored at the office and recovered. There was no product quality complaint. This is one of several reports received from the same source. Additional information has been requested.