chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nurse reported that a 4 month old male received Prevnar, IPV, DTAP and haemophilus B vaccines on 2/20/01. Immediately, post vax, he developed a fever. The next morning, he developed a hard knot at an unspecified injection site and his movement was restricted. He was treated with alternating doses of ibuprofen and acetaminophen. On 2/22/01, his body temperature was 98.2F.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 23-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursions of 48 hours. The highest recorded temperature was 52 F (11.11111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Vial stored in refrigerator post expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial stored in refrigerator post expiration date) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator post expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial stored in refrigerator post expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vaccine was placed in refrigerator on 30 Oct 2021. There was no temperature excursion. No adverse event was reported.  No treatment medications were reported.
Patient's mother brought her back to the clinic saying she had a rash.  She did have diffuse hives and was itchy.  She was given Benadryl 18.75mg orally with minimal relief.  She was then given dexamethasone 8 mg  IM with good relief of symptoms.  Patient was monitored in the clinic for an hour and was discharged home on prednisolone bid for 5 days and famotidine daily for 14 days.
Hep B vaccine was administered IM left deltoid at approx 10:00 am. At 1:15 pm patient developed coryza, eyes watery, plugged ears, flushed face.
Was given DTAP (L) deltoid 6 PM 9/27/12. 1:00AM 9/28/12 developed headache, severe muscle ache & joint pain, fever 100 degrees.
raised red area, approximately 2" x 4" around the vaccine area. The skin feels hot. It started as a circle-type shape and has filled into an oval-type shape over the last two hours. No other symptoms.
This case was reported by a consumer via call center representative and described the occurrence of erythema in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was recovered/resolved. It was unknown if the reporter considered the erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported for the patients. The age group was not reported, but was selected as adult as per vaccine indication. The reporter had siblings (unknown number) that also experienced redness. This case has been linked with the case US2018148549, reported by reporter for herself.
Initial report received on Nov 14 2005 from a consumer. A 41 year old female patient with a history of allergy to penicillin and whooping cough in Feb of 2005 was administered (route not reported) Fluzone SV 2005-2006 USP, lot number U17622A ( the lot number reported was not a valid lot number for the flu vaccine) in the left arm on Nov 11 2005 at 11:30am. At 13:30 that afternoon she experienced a severe coughing spell and was seen by a nurse. She took Benadryl liquid and the cough subsided but she had difficulty breathing. At 18:30 that evening she was seen in the ER and was treated with intravenous fluids and medications. The name, route and site of administration of medications used to treat these events were not reported. Blood work, urinalysis and a chest x ray were completed in the ER. The patient was release to go home that same evening. The patient had recovered from these events at the time of this report.
This spontaneous report was received from a medical assistant via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, anatomical location, lot# and expiration date were not reported). Concomitant therapies were not reported. On an unknown date, 1-2 days after administration of GARDASIL 9, the patient developed severe swelling of a lymph node, in the left neck area. The patient's mother took the patient for evaluation at unspecified otolaryngologist on an unspecified date. Otolaryngologist surgically removed the lymph node (on an unknown date) and the specimen was sent for pathology evaluation. At the time of the report the pathology results were pending. The outcome of the event was reported as not recovered. The causality assessment between swelling and removal of the nymph node and GARDASIL 9 was not provided. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Several hours after receiving the 2nd shot I notice the right side of my mouth, lip, and down towards my chin started feeling numb.  I thought prehaps the next day or 2 my feeling would return and the numbness would be gone.  It's  now 4/16/21 and the numbness is still there.
Body aches, chills, joint pain and arm pain. Lasted for 10 hours roughly
BlurredVision, Confusion, Dizziness, TIAStroke, droopy left eye Narrative:  ct of head- negative for acute disease during this event -reports had trouble finding words after first dose of Moderna vaccination  Other Relevant History:
Redness, swelling, pain, warmth; about 10 cm diameter @ site of inoculation.
DOCUMENTED VARICELLA HERE IN OFFICE ON 10/21/2004. NO ADM. HISTORY KNOWN .
SMALL ITCHY RASH APPEARED NEAR THE INJECTION SITE; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis, seasonal allergic rhinitis and penicillin allergy. Patient previously received anectine and experienced allergy. Concomitant medications included risedronate sodium (RISEDRONATE), estradiol (ESTRACE), macrogol 3350 (MIRALAX) and vitamin D (MANUFACTURER UNKNOWN) all for unknown indication and from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 14:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 06Apr2021, at 19:00 after 5 days of vaccination, the patient experienced small itchy rash. It appeared on Tuesday and was about the size of a quarter near the injection site, but not where the needle went in. The adverse events did not result in doctor or other healthcare 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 small itchy rash appeared near the injection site was unknown.    No follow-up attempts are needed. No further information is expected.
LEFT ARM MUSCLE PAIN; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced left arm muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm muscle pain. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; bnt162b2 (BNT162B2), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Known allergies: No. Concomitant medication(s) included: FLONASE [MOMETASONE FUROATE], start date: Mar2022, stop date: 15Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2023) Negative; (23Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 15Oct2023 to 19Oct2023 for COVID 19 Treatment. After a full course of Paxlovid tested negative on 21Oct2023 and positive on 23Oct2023 with symptoms similar to a cold (sneeze, runny nose).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe rash all over the body; This is a spontaneous report from a contactable nurse. A 12-year-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The nurse reported that they were about to administer meningococcal vaccine b (MENB) vaccine and an HPV vaccine to the patient and a warning for the administration of vaccines flared the medical record due to a previous reaction to the administration of pneumococcal 13-val conj vac (dipht crm197 protein). The nurse reported that the patient developed a reaction to pneumococcal 13-val conj vac (dipht crm197 protein) as a severe rash all over the body on an unspecified date but not diagnosed as an anaphylactic reaction, and this reaction was experienced only once. The nurse requested the information about the possible cross reactivity between the vaccine pneumococcal 13-val conj vac (dipht crm197 protein) and meningococcal vaccine b vaccine or HPV vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
NEUROPATHY 3/8/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED NEUROPATHY 3/8/2023 ATHEROSCLEROSIS OF AORTA
Patient hospitalized for Febrile Neutropenia, medulloblastoma, pancytopenia within 6 weeks of receiving covid vaccination.
Fever as high as 102.6, chills, severe headaches, muscle and joint aches, sore arm at injection site
made me ill (flu like)for 48 hrs after the second dose; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (made me ill (flu like)for 48 hrs after the second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (made me ill (flu like)for 48 hrs after the second dose). At the time of the report, INFLUENZA LIKE ILLNESS (made me ill (flu like)for 48 hrs after the second dose) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.
faint; passed out; feeling crappy; This case was reported by a consumer via call center representative and described the occurrence of faint in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd September 2020, 1 days after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant) and feeling unwell. On an unknown date, the outcome of the faint, passed out and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the faint, passed out and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patient received the 1st dose of Shingrix vaccine. The patient woke-up the next morning feeling crappy and faint. The reporter also stated that she passed out on 2nd September 2020.  The reporter stated pharmacy would not provide her with second shot due to her passing out. The reporter had no physician, but gave permission to follow-up with pharmacy.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR247386:same reporter
Red rash on forehead, upper lip area and most of my face.  Burning mouth with fine blisters on roof of mouth,  burning  red eyes, burning tingling mostly on left forearm now spreading to neck area.  very fatigued, low grade temp
Patient passed out and was unconscious for a couple seconds. No treatment was given. Patient was conscious and alert afterwards
Patient reported to pharmacy on 7/1 complaining of left scapular stabbing pain. Patient received covid vaccine dose 2 on 6/26. Patient reported feeling the same pain directly after vaccination and for 1 hour post vaccination. Patient states that the pain then stopped until 6/30 when she awoke with the same pain. Patient has a history of back pain and is on current medication therapy for it. She tried ibuprofen, heating pads, and stretching to relieve stabbing pain in scapular region. Patient says nothing relieved the pain and she had to leave work due to the pain today. I recommended patient speak with her PCP on Tuesday 7/6 during her regular appointment to be further assessed and recommended she try ice therapy to reduce pain until then.
Red, swollen and painful injection site; Red, swollen and painful injection site; red, swollen and painful injection site; Stuffy,runny nose; Stuffy,runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EL9262, Expiration Date: May2021) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number :1), when the patient was 70 years old, for Covid-19 Immunization, reaction(s): "red, swollen and painful injection site", "red, swollen and painful injection site"; Bnt162b2 (Dose number :1), for Covid-19 Immunization, reaction(s): "red, swollen and painful injection site". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Red, swollen and painful injection site"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "red, swollen and painful injection site"; NASAL CONGESTION (non-serious), RHINORRHOEA (non-serious), outcome "unknown" and all described as "Stuffy,runny nose".  Additional information: Time the Vaccination was given as 7:15 AM  No follow-up attempts are possible. No further information is expected.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022; lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion.  On 11-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
11/12/21 woke at 2:00 am to severe pain down both legs.  11/12/21 went to PCP and was given MethylPREDNISolone 4MG DOSPAK 21S.  Symptoms of tingling in feet & legs continued.  Had numbness in foot and went to Pediatrist on 12/08/21 and was given Prednisone 20MG Tablets - 9 days.  Symptoms of tingling in feet and legs continued. Started having tingling and loss of control in my hands.  12/17/21 tingling was so severe in both legs & arms went to Hospital.  Follow-up with Neurologist and diagnosed with GBS.  Scheduled for IVIG on 01/17/2022.
No adverse reaction. However, the 2nd dose was administered wrong. The doctor office later had me come in on 2/11/21 and gave me the Pfizer bio-tech (en6201) shot. That shot was less than 28 days from the first shot and was the wrong brand. In addition, I had a third shot (Pfizer, en6202) on 3/3/21 when the doctor office called me back in.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Mar2023 to 06Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
After the shot, I felt ill for about 48 hours. This included a slight fever, chills, headache, and joint pain. All symptoms subsided expect the joint pain which has been especially painful in my left elbow. The joint pain occurs on the left side of my body to include my knees when I work out. The pain in my left elbow limits my ability to rotate/move my elbow and has significantly affected my ability to complete my usual workout routine.
3:00 PM extremely sore left arm above the elbow(injection site arm) to the point where I could hardly flex my arm 4:00 PM general body aches, chills      5:00 PM feeling worse, nausea  6:00 PM get home, vomit x 2, temp is 104, take 1000mg of Tylenol, cold towels on my face  7:00 PM take another 500 mg of Tylenol, temp still 104.  8:00 Temp 103.  9:00 PM  Temp 102.  10:00 temp 100, took another 1000 mg of Tylenol.  11:00 PM temp 98, symptoms nearly all gone, hungry so I had two bowls of chicken noodle soup.  2:00 AM took another 1000mg of Tylenol as precaution.  Felt normal the next day.  No problems to date.
Initial misuse report received from a health care professional on 24 October 2013. A patient aged 65 years or older had received a dose of FLUZONE ID on an unspecified date No adverse event was reported. List of documents held by sender: none
Patient had swelling of her left arm from shoulder to elbow the next day.  Patient visited an ED.  They were unsure if it was caused by the injection or and infection had occurred.  I was unable to get any medications that were prescribed for this.  Patient states swelling has decrease since then.