chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of submandibular gland swelling in a 59-year-old male subject who received flu vaccine (Dresden), MALARONE tablet over a period of 2 weeks for malaria and typhoid and typhus vaccine. The subject has no relevant medical history and no concurrent medications were reported. On or about 16 January 2009 the subject received an unspecified flu vaccine (manufacturer unknown), MALARONE (GlaxoSmithKline) and typhoid and typhus vaccines (both from unknown manufacturers). On 31 January 2009, the subject experienced swelling of the right submandibular salivary glands. Pain was also reported. Treatment with MALARONE was discontinued. At the time of reporting, the events were unresolved.
Uneventful pregnancy, no complications, due end of Dec 2021. Symptoms included dizziness evening of vaccination and general malaise into the following day. Within 24 hours nausea and vomiting occurred.
Mom reported began vomiting around 8 or 9 pm on 12/29/06. Temp 102.4 (R) Irritable. Saw doctor two days later and was admitted to hospital with "flu and bronchitis. See attached.  4/24/07 D/C summary came w/VAERS report which reveals patient experienced severe diffuse cough, earache, nausea & vomiting for 3 days prior to admit on 1/8/07-1/11/07.  Had been treated as outpatient for several days w & neb tx w/o improvement.  Temp on admit was 100.8, resp 32.  Exam revealed wheezing & rhonchi.  Treated w/IV antibiotics & nebs.  Treated for bacterial appearing conjunctivitis.   Wheezing resolved by d/c but had continued cough.  Continued on nebs, cough meds & antibiotics upon d/c. FINAL DX: community-acquired pneumonia, allergic bronchoasthma, respiratory distress, conjunctivitis, and acute influenza Type B.
pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue area. C/o LA hand coldness.
Prevnar 13 was not ordered, but was administered on May 30th, 2023.  No symptoms or treatment required. patient guardian was contacted by physician.
Ever since I got the vaccine I have been having cold sore breakouts once a month; Ever since I got the vaccine I have been having cold sore breakouts once a month; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex and "Cold sores" (ongoing), notes: Before the vaccine it was less than twice a year. Concomitant medications included: ABILIFY and ZOLOFT. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number unknown; Anatomical site: left arm; Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: ORAL HERPES (non-serious), CONDITION AGGRAVATED (non-serious) all with, outcome "not recovered", and all described as "Ever since I got the vaccine I have been having cold sore breakouts once a month". The event "Ever since I got the vaccine I have been having cold sore breakouts once a month" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown whether any therapeutic measures were taken as a result of the event oral herpes and condition aggravated.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
From initial information received on 11/12/03 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a 12 year old female patient received a dose of FLUZONE, lot number not reported, administered on 11/10/03 at 6:00 PM (route and site of administration not reported). The next morning, the patient developed pain and swelling around the site of injection. The child missed school on 11/12/03. The patient's recovery status was not reported. No additional information was not received at this time.
Information has been received from a mother concerning her 12 year old daughter who on 30-JUN-2008 was vaccinated with GARDASIL vaccine (yeast) (Lot# not reported). There was no concomitant medication. On 04-JUL-2008 the patient experienced hair loss. The patient's hair loss persisted. Laboratory tests performed including thyroid test, joint test and autoimmune test were reported as "fine" (dates Unspecified). The patient's outcome was unknown. Additional information has been requested.
first dose given 07/09/2021 no reactions except sore left arm for 3 days . second dose got dizzy headache and then next day  my feet and legs started hurting me badly. i now have blood clots in both my legs and have to have surgery if i dont die from it first
almost died; This case was reported by a consumer via media and described the occurrence of near death experience in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated the patient almost died from Meningococcal B vaccine and still 2 years later has repercussions. The reporter stated, this was a for profit vaccine, and would never advise anyone to get it. The follow-up would not possible as no contact details were available.
Pain in left leg. Unable to fully walk due to pain in left leg from the foot to the butt cheek when trying to step down fully.
Within in one hour burning sensation of the lips and tip of tongue Within 60 hours burning sensation increased throughout mouth and traveled down throat and mucusol system.
L. upper arm became hard, warm, red, tender and itchy.  "It looked like a giant hive." Area several inches in diameter.  Did not notify HCP.  Applied lotion for "itching".  Area still slightly red, no warmth, no induration, no pain on 12/16/2009.  Advised to seek medical assistance if this occurs again.
This spontaneous report received from a patient concerned a 69 year old female (local case ID# 002498740). The patient's height, and weight were not reported. The patient's concurrent conditions included giant cell arthritis, polymyalgia rheumatica, and rheumatoid arthritis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. Concomitant medications included tocilizumab. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers   On 16-MAR-2021, the subject experienced nerve issue. On 16-MAR-2021, the subject experienced throat ache. On 16-MAR-2021, the subject experienced pain. On 16-MAR-2021, the subject experienced sick. On 16-MAR-2021, the subject experienced left arm swollen. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced little red around injection site. On 16-MAR-2021, the subject experienced swollen around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, throat ache, tired, pain, sick, nerve issue, left arm swollen, little red around injection site, and swollen around injection site. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Months after vaccination (Jan 2022) he experienced a Renal infarct with mesenteric adenitis. Had to go on blood thinner.
Reynard syndrome episode one of first signs - loss of blood to both hands, cold, resisted attempts to warm whiten skin back up until episode resolved itself within an hour; fever, chills, aches, including intense pain throughout back of neck, throbbing pain rt calf & ankle. Fever and pain abated after 9 hrs. Residual side effects into day two: headache, achy joints, fatigue.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of VAQTA (dose and route not reported) lot number 0628AE expiration date 26-JAN-2015 that was improperly stored. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough COVID-19 infection. Patient tested positive on SEPTEMBER 27, 2021. Patient was fully vaccinated on APRIL 7, 2021.
In May 2022, I began to feel like my lower back was a little achy. About a month ago I began having trouble lifting my legs and feet up. I didn't visit my doctor until August 2022. My doctor gave me steroids and muscle relaxers to help. Now my L2 and L3 vertebrae are rubbing together as seen on X-ray. I see a spinal specialist tomorrow. There is spinal curvature in my spine.
This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown demographics. On an unknown date these patients were vaccinated with doses of ROTATEQ (dose, frequency, therapy route, lot # and expiry date unspecified) which were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event was unknown. Reporting pharmacist considered the event to be not related to ROTATEQ. This is one of several reports received from the same source (MARRS # 1502USA002297 and MARRS # 1502USA002298). Additional information has been requested.
Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 90 minutes after injection my heart began to race, I experienced lightheadedness, tremendous anxiety, confusion set in, I was extremely shaky. On the way home, I became disoriented and got lost several times and then I drove through a stop sign and was hit by another car, no serious physical damage to me. These symptoms continued, unabated throughout the day, finally beginning to diminish at about 5 pm. Today 24 hours later I have anxiety and the chills. I have never experienced adverse effects to a vaccine before except for a vaccination against a cholera outbreak administered in 1972.
Constant Pain, Swelling, and Redness at and around injection site i.e. left upper arm near deltoid area.
Initial case received on 31 December 2009 from a health care professional. A 47 year old female patient received an intramuscular right deltoid injection of ADACEL (Lot number C3352AA) on 21 December 2009 and a left deltoid injection of FLUZONE SV on 21 December 2009. Concomitant medications included unspecified "birth control." She is allergic to sulfa. The patient had no illness at the time of the vaccination. Since vaccination on 21 December 2009, the patient has experienced a "dull constant muscular pain" and "occasional but frequent burning" and "tingling" in right arm in the bicep and deltoid area. Treatment medication of ibuprofen was not effective for pain control and the pain was reported to keep her up at night. As of this report the patient had not recovered. Follow-up information was received on 08 February 2010 from a healthcare professional. The patient received no other vaccinations within 4 weeks prior to date of 21 December 2009. The pain, burning and tingling in the right deltoid and bicep had improved. Unspecified treatment medication were prescribed. Follow-up information was received on 08 April 2010 from a healthcare professional. The patient last contacted the physician's office on 15 January 2010 and at that time her pain was improved, but present with any arm elevation. Treatment medications (previously unspecified) included gabpentin and Lortab at bedtime (HS) for pain and generic Lodine twice daily (BID). At the time of this report it was unknown if the patient fully recovered. Documents held by sender: none.
Pt. called Mon. 11/25/13 to report redness and swelling (R) arm 2x the size of arm starting at 3 PM and increasing next day. Ice, elevation - Monday 11/25 - symptoms disappeared. Pt. refused transport to ER on 11/23/13.
peeling of the skin on the hands; This spontaneous case was reported by a patient and describes the occurrence of SKIN EXFOLIATION (peeling of the skin on the hands) 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) (unknown route) unk dosage form. On an unknown date, the patient experienced SKIN EXFOLIATION (peeling of the skin on the hands). At the time of the report, SKIN EXFOLIATION (peeling of the skin on the hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. Treatment information were not provided.   Reporter did not allow further contact
about 30 minutes after shot was having  extreme fatigued to the point i had to go home and lay down. Bad head ache, chills, upset stomach, Fever of 100.0, extreme soreness at the shot site.  A little bit of a cough and stuffy nose. lasted about 3 days. the headache is still lingering.
When the pharmacist was rubbing the alcohol on the top of my shoulder I thought that was a strange place for a shot. She told me there would be a small stick, the stick didn't hurt but she injected the medicine into my shoulder joint. The pain was so bad I thought I was going to scream. I have a VERY high pain tolerance. By the time I got home (about 3 miles) I could tell it was not letting up any. Within an hour I could not move my arm out from my body. I put ice on it and took naproxen. I could not stand for anything to touch it and it was swollen. I called my own doctor and went to the office today and when she saw it she told me I needed to go to the pharmacy and tell them it looked awful and to find out why she would give me a shot on top of my shoulder. The pharmacist said she was looking for muscle (I have no muscle up there, I have a bicep). She told me just to keep putting ice on it and taking TYLENOL or whatever. When I got home she called me and told me to alternate heat and cold and to be sure and use the arm to keep it from freezing up. I am scared to death to get the 2nd shot in this series. She told me to notify you.
passed out; Hit his nose, got a bleeding and open wound; chills; weakness; dizziness; started to fall again.; headache; myalgia,; swollen calf; hit the bridge of this nose; This case was reported by a consumer and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), wound bleeding (serious criteria GSK medically significant), chills, weakness, dizziness, fall, headache, myalgia, calf swelling and nose injury. On an unknown date, the outcome of the passed out, wound bleeding, chills, weakness, dizziness, fall and nose injury were unknown and the outcome of the headache, myalgia and calf swelling were recovered/resolved.   It was unknown if the reporter considered the passed out, wound bleeding, chills, weakness, dizziness, fall, headache, myalgia, calf swelling and nose injury to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter stated that, night after the Shingrix shot, the patient had chills, weakness and dizziness. The patient got up to use restroom and passed out on the way. The patient had hit the bridge of this nose on furniture but unsure exactly how it happened. The patient proceeded to bathroom sink and started to fall again. The patient had bleeding and open wound on bridge of nose. The patient went onto had headache myalgia and swollen calf for a few more days. The reporter agreed to follow up from GlaxoSmithKline.
3rd shot (booster) received on December 7, 2021.  On December 11, 2021 I started to get rashes on my legs and arms and that has now  turned more severe into hives and welts mainly concentrated on legs and elbow area of arms.  This has been going on for 3 weeks now.  When I wake up in the morning there is no hives or rashes.  However, as the day progresses it gets worse and is very bad by about 10pm.  I  fasted on 12/27/21 for the full day and there was only the slightest signs of a rash on a small area of my calves with no itching.  On 12/28/21 I had a simple breakfast of oatmeal and a banana and within an hour after eating hives have developed on my legs.
TINNITUS, INFLAMMATION OF MY IDEOPATHIC NEUROPATHY, MUSCLE AN JOINT ACHES
possible erectile disfunction; This spontaneous case was reported by a non-health professional and describes the occurrence of ERECTILE DYSFUNCTION (possible erectile disfunction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERECTILE DYSFUNCTION (possible erectile disfunction) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (possible erectile disfunction) outcome was unknown. Not Provided          Concomitant medication information not provided. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Patient felt burning in her arm and the arm started to swell. This occurred for approx. 30 minutes. Patient iced arm for approx. 10 min and took Benadryl to subside swelling.
8-22-04 - fever of between 101.5 and 104.3..fever persisted through 8-23.  Fever has returned at sporadic intervals (up to 102.8) and a rash appeared as of the AM on 8/25.  Patient has not recovered as of the date of this report.  Have treated fever with Tylenol.
Patient received second dose of J&J Vaccine on 12/4/2021.  Approximately 14 minutes after vaccination the patient reported feeling diaphoretic and exhibited pale skin.  Patient denied chest discomfort or SOB.  Vitals were stable.  Cold compress was applied, apple juice was given.  The patient was monitored an additional 15 minutes without incident.  Patient left the clinic stable and reported feeling well.   Patient was notified to notify PCP of incident.
tenderness, swelling & erythema about 3x4inches in diameter around inj site
About 12 hours after vaccine my arm pit was hurting and that evening I noticed swelling in my axillary area and extended into my upper chest and neck area and chest wall. I have monitored the area and will seek further medical care if it persistent.
Extreme soreness in injection site of annual flu shot. More severe than any previous vaccine I've received in the past. Though it lessened after 3 days, overall soreness has continued for 14 days. Limited mobility in arm.
Pain, hot to touch, swelling on R deltoid and up to neck.  Ill feeling.  Seen by FNP.  Placed on Prednisone.
Patient experienced lightheadedness and dizziness 5 minutes after administration. Side effects lasted a total of 5 minutes and were alleviated after patient laid on the floor with feet elevated.
Flu-like symptoms; Pain in arm; Arm felt weak/Not as strong as it used to be; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Pain in arm), MUSCULAR WEAKNESS (Arm felt weak/Not as strong as it used to be) and MYALGIA (Muscle aches) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included MELOXICAM (MOBIC), LORATADINE (CLARITINE), PANTOPRAZOLE and PARACETAMOL (TYLENOL) for an unknown indication.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Pain in arm), MUSCULAR WEAKNESS (Arm felt weak/Not as strong as it used to be) and MYALGIA (Muscle aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Pain in arm), MUSCULAR WEAKNESS (Arm felt weak/Not as strong as it used to be) and MYALGIA (Muscle aches) had not resolved.      No treatment was taken by the patient for the events.   This case was linked to MOD-2021-017196 (E2B Linked Report).; Sender's Comments:  MOD-2021-017196:Same patient: 1st dose case
Patient received the covid vaccine on 12/20/2020. She reported that she started to have chills (temp reading were in 98.0s), headache, bodyaches, and swelling of the Right groin on 12/21/2020. She was evaluated by her PCP (in person) and treated with Ampicillin x 7 days . She did NOT inform her PCP about her covid vaccination status. HAs, bodyaches, chills, and R groin swelling resolved by 12/26/2020. On 12/28/2020 she c/o new onset of nasal congestion. Denies fevers or cough.  She tested positive for covid on 12/28/2020 at Employee Health. Has FU appt with PCP in one week and EH on on 1/7/2021.
Mom called. States "He got his 1st  half of the flu shot last month at his Dr and he got his 2nd half yesterday from the Health Dept. He started throwing up within an hour of getting the shot." Child doesn't have a rash, fever or diarrhea. Still unable to keep food down. 12-16-04. Instructed mom to call out provider if indicated to watch for signs of dehydration.