chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subsequent to first dose of Haemophilus b conjugate vax, this pt developed meningitis and a cerebrospinal fluid analysis was positive for Haemophilus type b due to vaccine failure. These events were considered other medical events. Subsequently, the pt "survived." Sixteen additional pts had similar experiences following exposure to Haemophilus b conjugate vax.  Received on 11/19/2000: "Information has been received concerning a 39-month-old caucasian male patient who on 01/15/1992 was vaccinated with a first dose of Haemophilus b conjugate vaccine.  Subsequently, the patient developed meningitis and a cerebrospinal fluid analysis was positive for Haemophilus type b due to vaccine failure.  These events were considered other medical events.  Subsequently, the patient "survived".  Sixteen additional patient's (WAES #'s 00072311, 00072312, and 00072314 through 00072327 had similar experiences following exposure to Haemophilus b conjugate vaccine.  Additional information has been received from a published abstract titled "Haemophilus influenzae invasive disease among children aged <5 years--epidemiology in the United States, 1994-1995" from the 34th National Immunization Conference on Vaccine Preventable Diseases (WAES # 00102472); abstract is attached.
Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 06May2021 at 09:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID vaccine. On 06May2021 at 20:00 the patient experienced tinnitus which started the evening she received the vaccine and has continued ever since. It was reported to be all the time. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event tinnitus was not resolved/ongoing at the time of this report.   No follow-up attempts are needed. No further information is expected.
11:25am- Pt found rash @ left arm and return to covid vaccination station after 15 minutes observation (pt had 2nd pfizer covid vaccination).  Pt denied SOB and difficulty to breath.  VS stable. Continue to monitor pt 30 minutes per Doctor's order. 11:55am- rash noted @right thigh, pt denied SOB, report given to Doctor, Benadryl 25mg po given per Doctor's order
Patient began breaking out with herpes simplex two days after vaccine. Though this was not the first herpes simplex occurrence for the patient, it was the worst ever experienced. As of this reporting date of 9/29/2022, the symptoms are still present over half of her face and are not responding to Valtrex as well as they normally do. Patient is taking 1 gram Valtrex daily, after an initial two doses of 2 grams.
My daughter received her 3rd injection of GARDASIL vaccine on Feb. 9th 2009.  She had severe headaches ever since.  We took her to the emergency room on Feb 13th.  They ran a series of tests which included a brain scan.  Nothing abnormal showed but she never got rid of her headache.  To this day she is fatigued, dizzy, has headaches, blurry vision and arm pain.  These side effects were never mentioned yet when I looked on the web many people said they had the same side effects after the vaccine.  I am taking her to her pediatrician tomorrow to have him evaluate her again and we will go from there.
pt recv vax 26SEP95 & 3JUL96 pt devel a chicken pox rash w/multiple lesions all over body;No further details were provided;
Patient's wife called and stated that his arm was in significant pain. She stated that the pain was such that he could not lift a full glass of water.
(L) arm- 8x12cm erythema and induration from DTaP. (R) arm 2.5x5cm erythema Rx from Varicella.
Middle 1/3 of R thigh erythematous, warm to touch, indurated.
A vaccine of 0.1mL of Jynneos given intradermal - Should have been 0.5mL given subcutaneous.
Swelling / result of alcohol getting into the injection site; Soreness / result of alcohol getting into the injection site; Redness / result of alcohol getting into the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included bexsero (received 1st dose on unknown date).   On 10th June 2020, the patient received the 2nd dose of Bexsero (intramuscular). On an unknown date, less than 4 months after receiving Bexsero, the patient experienced injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to Bexsero.  Additional details were provided as follows: The patient was vaccinated with 2nd dose of Bexsero. After vaccination patient experinced  soreness, redness, and swelling that was fist sized. The reporter stated that patient reports going to Urgent Care for these symptoms. The patient was told that  symptoms were the result of alcohol getting into the injection site from cleaning the skin. The reporter consent to follow up.
This happened to  me after doses #1 and #2 as well. I went into a very heavy depression, was extremely despondent, and was unable to focus or care about anything that normally would have mattered to me. In other words, I became highly depressed.
Raised, reddened are at site of injection  (L) deltoid. Reddened are about 25 cm with tenderness. A febrile, denied nausea/vomitting body aches.
Information was received from a nurse concerning the father of patient reported that his son was vaccinated in 1990 with MMR.  In 1990 after vaccination the patient developed hives.  Subsequently the patient recovered from hives.  Additional ifnromation was received from the physician who rpeorted that he did not give the first dose of MMR.  The physician reportted on an unspecifued date the patient receibed second dose of MMR and there was no reaction.  Additional information was expected.
pt recv vax summer of 1995 & exp inj site redness;this is one of ten pt from this site who exp the above rxn;
Patient was immunocompromised but did not indicate on the screening questionnaire and did not discuss with pharmacist. They were administered Moderna Booster dose instead of Moderna 3rd dose.
About 2 weeks after receiving the first dose (21-Mar-2021) I noticed that the tinnitus in my left ear was louder than normal. I have had tinnitus at varying levels since I ruptured my ear drum at age 12.  A few days after the second dose (18-Apr-2021), I developed tinnitus in my right ear. No change to the tinnitus level in my left ear. I have never had tinnitus in my right ear. The tinnitus level in my right ear is about a third of the level of my left ear. It has been 2 months since I received the second dose and the tinnitus levels have not reduced.
My body aches continuously. I used to be able to sleep on my sides and I can no longer do so because of pain. My neck and back hurts all the time. My hips hurt and back hurts continuously. My fingers ache and the joints. It's hard for me to bend my fingers now. My wrists hurt, forearms and actual shoulders.
Very painful, swollen lymph nodes in the armpit and breast on the same side that the vaccine was given; Very painful, swollen lymph nodes in the armpit and breast on the same side that the vaccine was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 08:45 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Very painful, swollen lymph nodes in the armpit and breast on the same side that the vaccine was given".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, HA, nausea, joint pain, and pain and redness at injection site
Definite vision changes and need to get prescription redone as had exam with prescription done two weeks prior to shot.  Also constant tearing and redness in both eyes.
Developed a blister at the injection site; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE VESICLES (Developed a blister at the injection site) and PAIN IN EXTREMITY (Arm pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INJECTION SITE VESICLES (Developed a blister at the injection site) and PAIN IN EXTREMITY (Arm pain). At the time of the report, INJECTION SITE VESICLES (Developed a blister at the injection site) and PAIN IN EXTREMITY (Arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment was provided.
Client received a non WHO approved COVID-19 first dose COVID lot# A030621 on 04/21/2021. Client denied having any symptoms after receiving the COVID-19 vaccination. Vaccine Operations Lead RN recommended that according to CDC Guidelines client needed to restart vaccination series with Pfizer, Moderna, or Janssen COVID-19 vaccines. Co Lead RN then educated the client per CDC guidelines of the COVID-19 vaccines. Client received Janssen COVID-19 vaccine dose lot#1822809 at 1:47 PM. Client completed 30 minute observation and exited facility with steady gait with daughter at around 2:20 PM.
Daughter was injected with flu shot AFLURIA vial 0112 at the pharmacy. That night went to take bandaid off and noticed a huge red-big bump on arm right below site and she felt like vomiting that morning and dizzy and ran a 99.9 temp and sweating the next day the same. Was told by her doc. and pharmacist to put cool pack on it and BENADRYL. She slept most the day. 3 days later bump is starting to go down, and she's feeling better.
I frequently feel like I am on a float in the ocean and it keeps continually moving; keep getting lightheadedness and dizzy spells; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810), via an unspecified route of administration in right arm on 14Feb2021 at 15:00 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included MS (multiple sclerosis) from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D) and iron supplement taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021, she keeps getting lightheadedness and dizzy spells. She frequently feels like she was on a float in the ocean, and it keeps continually moving. The patient did not receive any treatment for the events. The outcome of events was not resolved.   Follow-up attempts completed. No further information expected.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch knot at the site of injection), VACCINATION SITE NODULE (Itchy knot at the site of injection), VACCINATION SITE PRURITUS (Itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch knot at the site of injection), VACCINATION SITE NODULE (Itchy knot at the site of injection), VACCINATION SITE PRURITUS (Itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch knot at the site of injection), VACCINATION SITE NODULE (Itchy knot at the site of injection), VACCINATION SITE PRURITUS (Itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. Treatment include Benadryl cream and symptoms are ongoing.
Initial information was received on 12-Aug-2020 regarding an unsolicited valid non-serious case from a nurse via phone. This case involves an 11-year-old female patient who received MENACTRA vaccination to close to a previous one (extra dose administered). The patient's medical history, past medical treatment and vaccination were not provided. The patient concomitantly received a dose of TDAP on 11-Aug-2020 in the left deltoid for prophylactic vaccination. On 01-Jun-2020, the patient was vaccinated with a dose of MENACTRA (batch number and other dosing details were not reported) and again received another dose (0.5 ml) of same vaccine on 11-Aug-2020 (lot U6691AA and expiration date 21-Mar-2021) via an unknown route in the left deltoid for prophylactic vaccination. It was an actual medication error case due to extra dose administered. No adverse event was reported at the time of reporting. Laboratory data, corrective treatment and outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case (for previous dose).
Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours) in a 36-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) , while the parent received the product for COVID-19 vaccination.     No medical history was provided.    On 03-Jul-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021 at 4:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Jul-2021,  after exposure to mRNA-1273 (Moderna COVID-19 Vaccine), the adult was diagnosed with EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours). On 31-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was punctured on 30-JUL-21 at 4.45pm, it was used and then put back into the refrigerator on that day. Then on 31-JUL-2021, it was used again at 10:45AM and it was left out of the refrigerator, the last dose was given at 3:45PM was noted. No concomitant medications are provided by reporter. No treatment medications are provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Updated  reporter contact information. Ethnicity and race info are updated from unknown to Not Hispanic or Latino and other respectively.
Patien received menectra and boostrix vaccine at the same time.  Within 5 minutes, she manifested seizure for a very short time.  Patient's mom who was with her, called pharamcy staff for help.  When we saw patient, she was conscious and laying down on the floow.   Nurse practitioner came and checked her vitals.  Temperature 98.0F Oxygen level 99%. Pulse:54  BP 98/52   We called 911.  911 team came and checked on her.  A while later, the patient walked home.
I received my first dose of Pfizer COVID shot 27Aug2021 at 5:40pm.  On the morning of 28Aug2021 around 11:45am I started seeing dots and floaters in my left eye.  On 30Aug2021 at 12:30pm went to eye doctor to get checked out.  Stated that I had a vitreous detachment that is causing the dots and floaters.  May or may not be due to vaccine but also had a friend that had the same symptoms after the vaccine so reporting this incident just in case.  Eye doc stated he will see me again on 29Sep2021 to check again.  He is estimating that the dots/floaters should dissipate in strength within 2-4 weeks.
Site: Swelling at Injection Site-Medium, Additional Details: (tech) administed booster dose of moderna to patient and immediately after the injection, injection site started to swell within a minute. Swelling went down after about 10 minutes.  We did give patient 1 dose of benadryl 25 mg.  I asked patient if she wants us to call an ambulance. Patient refused.   Patient's daughter n law is coming to pharmacy who is a nurse practioner.  She will follow patient home.  Patient says she is feeling okay now.
Menstruation restarted despite being on a medication specifically to stop that occurrence (Nexplanon). Has occurred twice since receiving the second dose of the vaccine (in June and August). This causes significant psychological distress.
developed rashes on both of her calves; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: developed rashes on both of her calves). The patient was treated with medication unknown (Topical Cream). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient self-reported this case. The patient received her first dose of Shingrix and she developed rashes on both of her calves.  The rash on the left calf had resolved but the one on the right calf was still present.  The doctor gave a topical cream to treat the rash but it had not gone away. The reporter did not consent to follow-up.
Itchy rash, mild runny nose day of admin. Rash appeared next day. Antihystamine helping.
Raised red itchy rash. Painful to scratch. Swollen lymph node in left armpit. OTC pain reliever.
Irregular abdominal cramps and menstrual bleeding happening every 2 weeks and lasting for everal days (4/21st, 5/5th, 5/21st). Typical menstrual cycle was regular once per month prior to COVID vaccine.
ADMISSION: 10/12/2022 - 10/15/2022  DISCHARGED TO HOME. PATIENT WAS ADMITTED THROUGH THE ED FOR SEPSIS & ELEVATED TROPONIN.  TX INCLUDED VANCOMYCIN. Does not qualify for Decadron or remdesivir or baricitinib as the patient is not hypoxic.
soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included mepolizumab (Nucala Injection).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was also receiving monthly Nucala injections. The patient had no reaction to the Shingrix vaccination aside from soreness at the injection site. For tolerances of 2nd dose, refer case US2019AMR084184.
Within 2-3 hours had severe cough lasting through the night. Within 16 hours had headache followed by nausea and vomiting. Gave patient MAXALT 5 mg for 3 doses, and no response. PHENERGAN suppositories did help nausea, patient went to emergency room on 9-13-10 at 10 AM. Headache was better in 2 hours without treatment. Had memory loss  (partly) from 6AM - Noon on 9-13-10.
nausea; Headache; feeling ache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), HEADACHE (Headache) and PAIN (feeling ache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 038A20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID) for an unknown indication.   On 20-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 23-Mar-2021, the patient experienced NAUSEA (nausea), HEADACHE (Headache) and PAIN (feeling ache). At the time of the report, NAUSEA (nausea), HEADACHE (Headache) and PAIN (feeling ache) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported. Action taken with mRNA-1273 in response to the event was not applicable.
Fever 101~ Tender and swollen at injection site. Red and raised Rash on entire deltoid at the injection site.