chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. A 50-year-old male patient received PREVNAR13, via an unspecified route of administration on 22MAR2012 at 0.5 ml , once. The patient medical history was not reported. The patient's concomitant medications were not reported. On 22MAR2012 or 23MAR2012, after receiving the dose of PREVNAR13, the patient experienced pain at injection site, tenderness at injection site and muscle and joint pain, was not applicable. Therapeutic measures taken for the events, pain at injection site, tenderness at injection site and muscle and joint pain, were unknown. The clinical outcome of the events, pain at injection site, tenderness at injection site and muscle and joint pain, was unknown. Follow-up (24MAY2012): Follow-up attempts completed. No further information expected.
The shot was given in my left arm while I was working at the hospital.  A week later my tendon in my left arm has begun to ache.  The pain has come and gone for the past month and is slightly relieved with Advil.  It aches at night.
fever, headache, nausea, muscle pain, weakness, swollen lymph node in left armpit, swelling/pain at injection site, rotating nystagmus, visual blurring
Burning Arm initially, later that day, high fever, chills, vomiting, body aches, and overall clamminess that lasted for 2 days.
R arm felt numb and cold during vaccination; 30 min following vaccine pt had nausea and lightheadedness
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: 4 minutes after the injection she felt faint and passed out in the chair-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: With the help of 2 customers we gently placed her on the floor and raised her feet abouve her head.  A customer (RN) from the ER said to put a cold compress on her chest.  She checked her pulse (strong) Patient said that she has fainted before when blood was drawn and when she had a shot as a teenager.  She is not diabetic and stated that she ate before arriving at the store.
IT WAS WEDNESDAY BEFORE LAST. I WAS GETTING SICK FOR A TERRIBLY LONG TIME AND THOUGHT IT WAS THE AUTIOIMMUNE DISEASES I HAVE. WHEN IT STARTED GETTING BAD I DIDN'T HAVE MONEY TO GO TO THE HOSPITAL OR INSURANCE BECAUSE I HAD TO STOP WORKING DUE TO COVID. SO BY THAT WEDNESDAY I WAS SO COLD AND COULDN'T STOP WITH THE CHILLS AND WHEN MY MISSES CAME IN I HAD TO RUN TO THE BATHROOM AND NEEDED HELP TO GET OFF THE COUCH. WHEN SHE PICKED ME UP SHE SAID I WAS HOT LIKE LAVA. SHE THEN GOT ON THE PHONE BECAUSE SHE WAS CONCERENED WITH ME. WHEN I GOT BACK TO THE COUCH FROM THE BATHROOM I COULND'T MOVE. I HAD NO ENERGY. FAMILY FRIEND CAME OVER TO PICK ME TO TAKE ME TO THE ER. BUT WHEN I WENT FROM SITTING TO STANDING I HAD A MINI SEIZURE AND PASSED OUT ON THE FLOOR - FROM WHAT THEY TOLD ME. THE AMBULANCE CAME BY AND TOO ME TO THE ER. THEY GAVE ME BLOOD TRANSFUSION BECAUSE I WAS COMPLETLY PALE. BLOOD PRESSURE AND HEART RATE WAS COMPLELTY LOW. THEY STABLIZED ME AND PUT ME IN THE ICU. THEY THOUGHT I HAD COVID IN MY HEART FOR A WHILE BECAUSE I HAD SOMETHING GOING ON WITH MY HEART. THEY HAVE ME SET TO SEE A CARDIOLOGIST. I HAD NO IDEA I HAD COVID BECAUSE I HADN'T LEFT MY HOME SINCE DECEMBER. MY BLOOD PRESSURE IS STILL LOW AND MY LEGS ARE STILL SWOLLEN BUT MUCH BETTER. I'M GETTING BETTER. THEY GAVE ME A LIST OF DIAGNOSIS - KIDNEY FAILURE, ACUTE RESPIRATORY FAILURE WITH HYPROXIA AND OTHERS.
COVID-19 infection; COVID-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "not recovered" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: I tested positive for covid on a friday; (28May2022) negative, notes: I tested negative Saturday, Monday (at home antigen); (29May2022) negative, notes: I tested negative Saturday, Monday (at home antigen); (30May2022) negative, notes: I tested negative Saturday, Monday (at home antigen); (31May2022) Positive, notes: on Tuesday symptoms returned and I tested positive (at home antigen). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient did not take other medications in two weeks, Patient received Anti-viral treatment for Covid-19 Treatment start date 22May2022 and stop date 27May2022. Covid rebound after taking full course of paxlovid. Patient was tested positive for covid on a friday. Started paxlovid on sunday and tested negative Saturday, Monday (at home antigen). Around lunch time on Tuesday symptoms returned and tested positive (at home antigen). Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash started on the forehead of patient on 12/15 (first noted in the evening, aprx. 6pm), wrapped around to neck and all the way down the back. Low grade fever began 12/13 overnight and the fever continued while the rash was present. The rash lasted through 12/16. No raised bumps present but discoloring of the skin, hot to the touch and itchy after the first night.
difficult to eat; had a reaction to the second dose; sore throat; roof of mouth sore; roof of mouth swollen; roof of mouth red; night sweats; didn't feel good; headache; feverish; sore left upper arm / sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore left upper arm / sore arm), NIGHT SWEATS (night sweats), FEELING ABNORMAL (didn't feel good), OROPHARYNGEAL PAIN (sore throat) and ORAL PAIN (roof of mouth sore) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced MYALGIA (sore left upper arm / sore arm). On 03-Jun-2021, the patient experienced NIGHT SWEATS (night sweats), FEELING ABNORMAL (didn't feel good), HEADACHE (headache) and PYREXIA (feverish). On 05-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), ORAL PAIN (roof of mouth sore), MOUTH SWELLING (roof of mouth swollen) and ORAL MUCOSAL ERYTHEMA (roof of mouth red). On an unknown date, the patient experienced EATING DISORDER (difficult to eat) and VACCINATION COMPLICATION (had a reaction to the second dose). On 09-May-2021, MYALGIA (sore left upper arm / sore arm) had resolved. On 04-Jun-2021, NIGHT SWEATS (night sweats) had resolved. At the time of the report, FEELING ABNORMAL (didn't feel good), OROPHARYNGEAL PAIN (sore throat), ORAL PAIN (roof of mouth sore), MOUTH SWELLING (roof of mouth swollen), HEADACHE (headache), PYREXIA (feverish), ORAL MUCOSAL ERYTHEMA (roof of mouth red), EATING DISORDER (difficult to eat) and VACCINATION COMPLICATION (had a reaction to the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products reported  No treatment products reported
Flu and pneumonia vaccine given in same syrinage. Currently in process of re-vaccinating per CDC. No adverse effects.
After administering Tdap within seconds pt after pt got/stood up, feel & hit her head on the wall. I examined the head no lump or laceration noted. Pt regain total concents within seconds & didn't complain of anything. RN in charge notified. After close observation. Pt was released at 335.
Patient's wife called around 10:30a on 06/30/2021 and said he had a knot under his left arm. She stated his arm was sore in addition to knot. It was recommended by pharmacist that he could take acetaminophen for the soreness and apply a cool compress for the swelling. I asked her to call us if anything changes or if she notices any new symptoms. We will follow up with patient in 24 hours to assess how he is doing.
Information has been received from a physician concerning a female patient who in 1997, was vaccinated with a first dose of VARIVAX (Merck) (dose, route, lot number not reported) and in 1998, was vaccinated with a second dose of VARIVAX (Merck) (dose, route, lot number not reported). In October 2011, the patient developed herpes zoster in her eye and became blind in that eye. Unspecified antibiotics were given for herpes zoster in her eye and became blind in that eye. At the time of the report the patient's outcome was recovering. The patient sought unspecified medical attention. Herpes zoster in her eye and became blind in that eye were considered to be disabling. No further information is available.
Started out with fatigue and a cough that was different then my normal cough. Then I started feeling a headache and a stiff neck and then I lost smell and taste at that point. And just over the day the symptoms got worse. I had body aches. I began to feel better around the 6/26. but 6/27 i still had a cough and fatigue. The whole time i was running a low grade fever. On 6/28 the fever came back. The cough got worse the fatigue got worse and all the symptoms came back. On the 6/18 we went to urgent care and that is when i found out i had COVID-19. On the 6/30 we called the doctor and they had me retest and it was very positive and stated i had a rebound case. They put on the Paxlovid on the 6/18. The rebound case lasted until 7/11, that was my first day with no fever. And everything at that point got better. This week my smell is starting to come back and i am feeling pretty normal. I was in bed for the first 2 weeks.
Patient woke up on 10/31/19 and noticed a rash on her neck. As the day progressed, she noticed that her tongue had swelled and she was having difficulty swallowing and breathing was more labored. She is currently at the ER undergoing evaluation.
Information has been received from an investigator regarding a 2 month old male who received his 1st doses of Prevnar, Hib-Titer, Infanrix, IPV and Engerix-B vaccines on 12/28/01, as part of a post-marketing safety trial. On 1/10/02, at 02:00, the mother took the infant into her bed for breast-feeding and the infant remained in bed with her. At 06:00, the mother awoke to find the infant dead. The coroner reported the cause of death as SIDS. The investigator believes that SIDS (expected per package insert) was not related to vaccine administration. The medical monitor's assessment of relatedness is unknown. This report of a serious labeled event is being submitted in a 15-day time frame, as requested by the FDA. Per F/U 4/1/02: Date of death is reported as 1/9/02 on autopsy report. COD was reported as SIDS (bed-sharing context). There was pulmonary congestion and edema and thymus weight 37 grams (enlarged). Follow up on 01/28/04: "Follow up information received on 01/14/04 provided a change in the event date.  Information has been received from an investigator regarding a 2 month old male who received his first doses of Prevnar, Hib-Titer, Infanrix, IPV, and Engerix-B vaccines on 12/28/01 as part of a surveillance trial. On 01/09/02, at 03:00AM, the mother took the infant into her bed for breastfeeing and the infant remained in bed with her.  At 6:00AM, the mother awoke to find the infant dead.  The coroner reported the cause of death as Sudden Infant Death Syndrome. The investigator and the medical monitor agreed that SIDS (expected per package insert) was not related to vaccine administration.  This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by the FDA."
Right side of the head has a headache, pain goes down to neck and across the shoulder down the back area, loss of strength, pain in chest.
Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were priovided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group selected as an adult as the patient was employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the Glaxosmithkline response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 6 of 9 linked cases reported by same reporter.
Digestive issues; Chills; Body aches; Exhaustion; This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (Digestive issues), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Exhaustion) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DYSPEPSIA (Digestive issues), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Exhaustion). At the time of the report, DYSPEPSIA (Digestive issues), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Exhaustion) outcome was unknown.            Patient experienced digestive issues, chills, exhaustion, and body aches after the 2nd dose of vaccine which is 22Apr2021.  Action taken with mRNA1273 Moderna vaccine was Not Applicable
Area is red; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group adult was selected as per vaccine indication. The patient got shingles 2nd shot and the area was red.
administered expiration date on the diluent and not the powder portion of the ActHib with no adverse event reported; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (MI) (Reference number- 00515128) and transmitted to Sanofi on 11-Mar-2021.  This case involves a patient (with unknown demographics) who received expired diluent and not the powder portion of the HIB (PRP/T) VACCINE [ACT-HIB] lot number not reported (Diluent expiry date 07-Mar-2021) via unknown route in unknown administration site for prophylactic vaccination on an unknown date.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (Latency same day).  A representative from a health department wanting to know if we have information on how to proceed after an expired dose of ActHib was administered due to having a clinic in their area that administered a dose of ActHib that was expired. The caller reported that the clinic used the expiration date on the diluent and not the powder portion of the ActHib; that the ActHib expired on 07Mar2021; that she does not have any information on the event.  It was not reported if the patient experienced any adverse event.  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.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0BM20A) for COVID-19 vaccination.     The patient's past medical history was not reported .     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested COVID positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Triggered autoimmune disorder; extreme debilitating general fatigue & muscle weakness in arms/legs; tachycardia; muscle rigidity causing difficulty walking; debilitating headaches; vertigo w/nausea; muscle stiffness in jaw leading to significant weight loss; chronic inflammation.  These are the most prominent and persistent symptoms and events.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the  prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Itchy red swollen patch near the injection site lasting for 5 days post injection. Recommended cold compress. TYLENOL for pain. Antihistamine for itching. If no improvement or gets worse follow up with MD.
4/22/21, 7pm ET: Chills, fatigue 4/23/21,1pm ET through 4/24/21 10am ET: Chills, fatigue, slight fever (99.8º), nausea, muscle aches, headache,
Redness to surrounding tissue, nodule formation, itching of skin at VP site. Patient took some Benadryl unknown outcome
Patient had felt dizzy when standing up after waiting for 30 minutes and was feeling alright during the 30 mins. She sat down after feeling dizzy and we took her blood pressure and it was within normal limits of 120/80. After sitting and having food and water (patient states that they didn't eat or drink in a while), about 40 minutes later the patient had chest pressure and started having difficulty breathing. The blood pressure was taken again and was down to 108/68 and ems was called. EMS says that she was healthy and fine and let her stay at the facility after being checked out
allergic reaction; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 78-year-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot/batch number not reported), via an unspecified route of administration on an unspecified date in Nov2020 at single dose for immunisation. The patient medical history and concomitant medications were not reported. Patient had an allergic reaction to pneumococcal 13-val conj vac (dipht crm197 protein) vaccine last 17Nov2020. The outcome of event was unknown.    No follow-up attempts are needed, information about lot/batch number cannot be obtained.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/05/21 2nd dose01/26/21 Diagnosed covid positive:08/25/21 Symptom onset:08/22/21 Exposure: Symptoms:fever, cough, sore throat, diarhea, chills, muscle aches,
Repeated vomiting from following an (6 o'clock) lasting 16hrs. No fever or diarrhea. No one else sick at home.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX23 was uknown. THe pharmacist was requesting a lot check for PNEUMOVAX23 lot H014653 (Expired date 19-APR-2014). This is one of several reports from the same source. Additional information has been requested.