chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 10 days after the second dose of vaccine, I started to experience the shorten of breath, and abnormal heart pulsation.  I thought it was temporary it will be gone soon, but it didn?t. On March I went to the doctor, and told her about my symptoms and said that they started after the vaccination. My doctor said that these kind of symptoms were not reported, so it shouldn?t be related to the vaccine and suggested me to check my thyroid function as I have a history of hyperthyroidism.  So I made an appointment with Dr., she prescribed me a beta blockers to calm my heart down. I did a comprehensive blood test, and my thyroid is normal, so my shorten of breath and heartbeat is unrelated to the thyroid.  My symptoms is still present, even while I?m typing this message I have a hard time to make a deep breath.  Today I saw an article, that people experience the same symptoms as I had and they encouraged to report them to this site.
Patient felt light headed/dizzy and sweaty after receiving vaccine. Assisted to mat on floor and feet elevated. Symptoms resolved. No loss of consciousness or injury. Initial vitals 121/79,  pulse 72-regular, rr 16.  Sat up after 10 minutes, BP 112/66, pulse 75. Bottled water provided. Observed and monitored for 30 minutes after incident with no further symptoms. She declined further evaluation and was released. BP prior to leaving 100/76 (patient states this is at baseline), pulse 85 and regular.
Information has been received regarding a case in litigation concerning a female who on 07-Jan-1994 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. On an unspecified date, the woman became pregnant. It was not reported if the patient was pregnant on the date of vaccination. It was reported that the patient suffered injuries (not specified) and her "fetus suffered death." Intra-uterine death was considered to be an other important medical event (OMIC). No further information was provided.
An 8 month old female received her first dose of Prevnar on 5/10/00 and a few days later, became fussy, irritable and cranky. Her appetite decreased. Her symptoms resolved within 3 days.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), PYREXIA (fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had antibiotics later) in December 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID), ROSUVASTATIN and TESTOSTERONE (TESTOSTERON [TESTOSTERONE]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 25-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 26-Feb-2021, the patient experienced MYALGIA (myalgia) and PYREXIA (fever). On 26-Feb-2021, HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. On 27-Feb-2021, MYALGIA (myalgia) and PYREXIA (fever) had resolved.            Concomitant medications was not provided by the reporter.  Treatment information  was not provided .   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Attached Additional info-1 : VAERS, Patient initials, age, AE's, concomitant medications,second dose detailswere added
I experienced a weird taste in my mouth shortly after the shot and the day was fine I just felt kind of drained and that night is when it started I was puking my eyes were watering my throat hurt and I couldn?t hardly sleep the next day I?ve experienced a lot of body aches
gets the flu shot every year and then gets the flu every year; Initial information received on 30-Dec-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp via social media.  This case involves patient of unknown demographics, who gets the flu shot every year and then gets the flu every year while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date was unknown) for prophylactic vaccination.  It was reported that patient gets the flu shot every year and then gets the flu every year (vaccination failure) (unknown latency).   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (gets the flu shot every year and then gets the flu every year).  Outcome: unknown  Seriousness criteria: medically significant for event vaccination failure; Sender's Comments: Sanofi company comment dated 30-Dec-2021: This case involves patient of unknown demographics with influenza Vaccine (Manufacturer unknown) who had vaccination failure. The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Shortly after the vaccine, patient described getting itchy all over as well as flushed. Patient was given benadryl (50 mg) by mouth and dealt with symptoms for about 3 days. Issue is resolved, but patient is consulting with MD to see if she should take the second dose.
Have been in remissions from Grave's disease - auto-immune disease -  for over a year. I had gone in for a routine blood exam (may 10th) - my Dr (May 11th - routine visit)  saw that my thyroid numbers were elevated. Before the shot, I had no symptoms and now I have had symptoms of Grave's disease. I am starting to get tremors and a bit of an elevated heart rate. When I go running,  it gets elevated I have to stop. Weight loss.
Nose bleeding twice the second day (04/04/2021) and twice the third day (04/05/2021) after the injection.
About 1.5-2 hours post immunization the patient returned having developed a headache and a quarter sized welt that was lightly red, swollen and very tender to touch, just below her left collar bone about 4 inches from the injection site. The welt was outlined and observed and the patient was given 25mg of Benadryl. After about 20 minutes the swelling and tenderness had spread to an area approximately the diameter of a tennis ball. At this point she was refered to see a doctor at the Health Center. The nurse called to follow-up once the patient arrived as she had not seen this type of reaction after the vaccine. After discussion the physician was going to look at her. Reportedly the swelling had begun to retract and the patient apparently returned to work later that day, talking about her plans to receive the second dose.
This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Right after the shot, she felt stiffness in both arms and across the shoulders.), DYSGEUSIA (She also had metal taste in her mouth.), FEELING ABNORMAL (She also feels some sinus issues but it is very minor/ her system is warning her down), UPPER-AIRWAY COUGH SYNDROME (She has nasal drip but always has that. She just feels like her system is waring her down.) and FEELING COLD (She feels like she has a cold) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Right after the shot, she felt stiffness in both arms and across the shoulders.), DYSGEUSIA (She also had metal taste in her mouth.), FEELING ABNORMAL (She also feels some sinus issues but it is very minor/ her system is warning her down), UPPER-AIRWAY COUGH SYNDROME (She has nasal drip but always has that. She just feels like her system is waring her down.), FEELING COLD (She feels like she has a cold) and FATIGUE (She feels beat, feels run down, feels tired). At the time of the report, MUSCULOSKELETAL STIFFNESS (Right after the shot, she felt stiffness in both arms and across the shoulders.), DYSGEUSIA (She also had metal taste in her mouth.), FEELING ABNORMAL (She also feels some sinus issues but it is very minor/ her system is warning her down), UPPER-AIRWAY COUGH SYNDROME (She has nasal drip but always has that. She just feels like her system is waring her down.), FEELING COLD (She feels like she has a cold) and FATIGUE (She feels beat, feels run down, feels tired) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: TCR received contains non significant information.
TOOK TWO UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 01-Apr-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201904-000254 (PVX2019-780; female) and PVX201904-000255 (PVX2019-781, male) were created and cross-linked in the database.  This case report describes a female consumer who "took two unrefrigerated doses", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took two doses of Vivotif, which was unrefrigerated for 48 to 72 hours at 68 degree Fahrenheit.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201904-000255:
Chills, headache, fever, muscle pain,, lethargy, nausea, lack of energy, general malaise
Itching that continues to exist at the site, discoloration of my skin on the site & a raising itching, mildly sore rash developing on the site of injection.
Swollen and red, Left deltoid area, Benadryl, Motrin, cool compress.
This is a spontaneous report from a contactable consumer. A 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took thiomersal and experienced an unspecified adverse reaction; diphtheria vaccine and experienced drug allergy and swollen lymph nodes under arm; and flu vaccine and experienced swollen lymph nodes under arm. The patient experienced chest pain for a week and also had costochondritis or ribs inflamed on an unspecified date.
Patient called and said that days after her vaccine with us her left eye got swollen like bags. she put iodone and rubbed alcohol, on the area which she thinks made it worse. Then the other day the other ey got swollen. I inquired  what food she ate and she said hot dog/sausage. I advised her to talk to her primary care provider and not to use alohol or iodine. She said she had never had reaction to any vaccine before and she had influenza vaccine in October 2020
Mild low grade fever; body chills and aches; headache; extreme fatigue; felt like a mild flu. I was 21 or 22 weeks pregnant. I stayed in bed for 24 hours. I did take acetaminophen - I took it because I'm pregnant and fever is contraindicated. I had been sick for about a week when I got the COVID test. January 31, 2021 - Got a Sore throat (never febril) and headache.- gradual onset - no fever involved - runny nose and cough is what it progressed for. Symptoms onset and course were consistent with common cold. And that made me call in sick for work. Pregnancy History - 2nd pregnancy and have had one birth of twins - Para 14-2. May 21, 2021. Uncomplicated singleton pregnancy. IVS pregnancy - it was. I did start taking Albuterol inhaler recommended by Ugent Care Dr. I had a routine OB appt with doctor - February 8 -  who listened to my lungs. Lungs - wheezes secondary to asthma; nothing concerning. February 4, 2021 I had a virtual visit  with URGENT CARE- their virtual clilnic- who recommended monitoring system and the COVID test.
Headache and nausea the 26th and 27th and 28th. Feeling better the 29th. the 30th I was fine until about 5 PM and then I felt very ill. Had a fever (highest was 100.8) (which lasted for days) - at least a week that it was 99.9Pand started getting joint pain and muscle aches; nausea; headache. The 30th was a terrible night. I called the DR.  that night and they had me come into a COVID test on the 31st.  Terrible head pain and earache - amoxicillin for my ears; Dexamethasone  - for steriod for the body aches and pains; Norco - or Hydrocodone - I took that as a half a pill a night for 3 or four nights. Z-pack for three or four nights when I started getting chest congestion.  I was off work until 15th when I went back to work. I was not 100% but tired. I'm slowly getting better and second dose of the vaccine on the 19th (and I was sick that night - had a high fever - 101.9). Was 24hours of dry heaving; called in sick on the 20th but felt better by the afternoon.  Hospital to get the prescription for the ear pain (it might have been on the 5th or 6th of January in the middle of the night).
After 1st: swollen node in throat, breast pain on right side After 2nd:  (shot at 4:30pm) sore arm, then next morning, aches thorughout body - muscles and joints all day. exhuastion. Chills started around 2 pm 4/2; then fever began about 30 minutes later lasting into early morning hours of 4/3 and spiking to 105.5 - with Motrin and Tylonal every 3 hours it held b/t 102.8 - 103.8.  4/3, no fever but hurt, tired, foggy brain. 4/4, muscle aches, not feeling right, headache  4/5  (today) headache, body "off" - don't feel right - body feels slow and heavy, bad headache still
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 82 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 09-Sep-2016, the patient received ALFURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 09-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Symptoms : sore arm where shot was administered, headache, fatigue, loss of appetite, light sensitivity, body ache, chills.
Spoke with patient regarding symptoms on 8/6/22. Per symptoms presented on 8/1/22. Patient states tested positive for Syphilis on 8/2/22. Patient states had sores, fever, and a cough. Patient states went to the Urgent care on 8/4/2022 and was diagnosed with strep throat. Patient stated being treated for Strep Throat. Attempted to get further clarification from patient. Patient stated it was hard for him to speak. Patient stated I could contact him via text regarding further questions. Reached out to client via text with permission for further clarification on 8/6/22 regarding symptoms. Unable to get clarification due to patient not responding to all of the information requested. Patient encouraged to follow up with primary care physician regarding any symptoms. Patient did not respond. Made an additional attempt to reach out to the patient on 8/8/2022. No response received.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about November 2015, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient was subsequently treated at an urgent care center for a vesicular outbreak that was diagnosed as severe shingles (onset not provided). As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
INJECTION SITE REACTION BEGAN NEXT DAY, BUT THIS AM WORSENED BEYOND JUST REDNESS. AREA OF REDNESS EXPANDED, SWELLED, AND WAS WARM TO THE TOUCH. PT REPORTED GENERAL FEELING OF MALAISE.
Vax injection at 4:05 pm, Symptoms started at 4:10 pm.  burning throat, difficulty swallowing, tightness in chest.  25 mg benadryl given with a little improvement.  Symptoms return and worsen- 25 mg benadryl given and rapid response called.  Taken to ED and admitted.  Given 125 mg of solu-medrol IV and albuterol inhaler.   Symptoms eased and discharged to go home.    01-15-2021-  4:30am woke with burning in throat mild difficulty swallowing.  Took 50 mg benadryl and inhaler.  Symptoms eased. 01-16-2021- felt better 01-17-2021- 5:00 pm- noticed onset of tightness in throat, feeling of something caught at back of throat and start of mucus drainage.  Continued clearing of throat.   Took 25 mg of benadryl and inhaler.
12 hours to 3 days post vaccination I did have fever unresponsive to Tylenol and Ibuprofen, body aches, and nausea. Starting 8/17/21 I have been experiencing a heavier menstrual cycle than I've ever experienced with thick quarter sized clots or larger. Currently monitoring.
PATIENT HAD COVID-19 VACCINE Dose 1 date: 01/07/2021,  Dose 2 date: 01/28/2021, AND TESTED POSITIVE TO COVID-19.
Patient started to develop tingling in his lower lip and some hives with sweaty palms. Provider observed Patient. Vitals stable. Patient was given Benadryl of 50 mg IM per provider order. Patient monitored for 45 minutes and released to home without further needs.
Patient received 2 doses of fluad, 1st on 09/24/2021 2nd at 10/10/2021
Temp 98.4. 4/8/04 fever. 4/8/04 fever, left deltoid area reddened, warm to touch, with swelling, irritable. Referred to personal doctor. Local reaction.
Child developed fever 102.6, vomited 12/06/2001 presents with sore arm.
2 year old male patient received the TWINRIX vaccine; Adult product administered to child; Drug dose administration interval too long; This case was reported by a physician via call center representative and described the occurrence of overdose in a 2-year-old male patient who received HAB (Twinrix) (batch number 57E3G, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Patient received VAQTA (Hep A vaccine) and ENGERIX-B (Hep B vaccine) on the 11/02/2020 (received VAQTA on 11th February 2020) and Engerix B (received Engerix B on 11th February 2020).   On 24th August 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 24th August 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced overdose, adult product administered to child and drug dose administration interval too long. The action taken with Twinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the overdose, adult product administered to child and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical doctor reported that the 2 year patient received the Twinrix vaccine, which led to overdose, adult product administered to child and lengthening of vaccination schedule for hepatitis B component. No further events were reported. The reporter consented to follow up by email.
Pt had signed up  and received 2 doses of fluad one month apart. The duplicate was not caught and pt was given a second dose. Pt reported mild regular symptoms and was unharmed.
Fever to 103 degrees, serum sickness type symptoms with back pain, onset 4-6 hours after vaccine.
01/23/22 presents to ED for "Unresponsive". PMHx of "hypertension, depression, BPH, GERD, and chronic back pain"
chills, body aches, fever, nausea, vomiting, dehydration, fatigue. Body aches were so severe that I could hardly walk. I vomited 6 times the day after the vaccine, and nearly fainted. Dehydration and fatigue continued for 5 days after the vaccination.
Information has been received from a 63 year old female without pertinent medical history or drug allergies who on 05-MAY-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 06-MAY-2011 the patient developed shingles. Concomitant therapy included TYLENOL and promethazine. The patient was treated with acyclovir for shingles. At the time of the report, the patient had not recovered. Additional information has been requested.
Administration site is red and swollen about 4 inches in diameter. Pt advised to take ibuprofen for pain/swelling and BENADRYL for the itch. Also advised to notify primary care doctor.
The vaccine was administered into the right deltoid muscle. The patient seemed dazed and appeared pale. When asked if he was ok, he stated he had been feeling nervous.   After this the patient stared blankly ahead and his breathing choked and stopped momentarily. I assumed anaphylaxis at first and prepared an Epi-Pen. Still seated, he collapsed forward. I attempted to hold him up to stop him from hitting his head on the cart in front of him. There were some slight twitching/jerking movements in his arms.  The patient eventually came to and was able to sit up. He was in a sweat and stated he needed water and some air, but was well enough where he declined an ambulance. The patient was provided a bottle of water and allowed to sit in the vaccination area for about 20 minutes to recover.
Pt has had muscle pain under vaccine site with movement for several months. She has not seen a physician.