chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 4 year old male pt with no reported medical history who on 01/26/04 was vaccinated SC into the right thigh with a second dose of MMRII (Lot # 646124/0615N). Concomitant vaccinations on 01/26/04 included a fifth dose of DTAP (Daptacel, Lot # C1612AA) IM into the left thigh and a fourth dose of IPV (Lot # X0367) SC into the left thigh. It was reported that the pt was not ill at the time of vaccination.  On 02/06/04 the pt's mother called the physician's office to report atht he pt had developed ecchymosis (black and blue) about 3 inches and to the left of the immunization site which was painful to the touch. The pt's mother reported that she first saw this ecchymosis on 01/27/04.  The pt was seen by the physician and on the right leg 4 inch by 2 1/2 inch erythematous lesion was noted. The pt was treated with Cutivate cream. As of 02/16/04 the pt had not yet improved and the area was sore to the touch. The pt was referred to a dermatologist. Additional information has been requested.
At five days after the second injection, noted swelling and purple discoloration Left third toe, continuing for 5 days, self treated with "buddy taping", and elevation. No improvement so contacted urgent care clinic to rule out fracture and noted minor swelling of Right second toe - on exam, noted approx .5 cm area of purple discoloration interdigital surface.
Heart attack; Myocarditis/ Shortness of breath/ Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and MYOCARDITIS (Myocarditis/ Shortness of breath/ Fatigue) in a 27-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 11-Aug-2023, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and MYOCARDITIS (Myocarditis/ Shortness of breath/ Fatigue) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and MYOCARDITIS (Myocarditis/ Shortness of breath/ Fatigue) had resolved with sequelae.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Concomitant medication was not provided. Treatment information was not reported.  Company Comment This spontaneous case concerns a 27-year-old male patient with no medical history reported who experienced the seriousness criterion medically significant and hospitalization expected event of myocarditis; and the seriousness criterion medically significant and hospitalization unexpected event of myocardial infarction unknown days after a dose of SPIKEVAX NOS vaccine. Concomitant medication details nor Treatment details were reported. The events had resolved with sequelae. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Patient received Afluria on 9/11/19. Then 4 hours after receiving vaccine, the patient reported that she felt "achy". She said she took 2 Alleve within 30 minutes. Then she had violent chills for 4 hours and her face was swollen. She called her primary care physician who instructed her to go to the emergency room. Patient went to the emergency room. The ER physician could not tell her exactly what was causing the reaction. Patient was discharged with Diphenhydramine and Prednisone. She called today, 9/15/19, to report the swelling and chills to us. She has had flu shots in the past without any severe reactions. Patient said she is doing better.
Swollen throat; Troubled sleeping; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swollen throat) and INSOMNIA (Troubled sleeping) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat) and INSOMNIA (Troubled sleeping). At the time of the report, PHARYNGEAL SWELLING (Swollen throat) and INSOMNIA (Troubled sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not provided.  Patient declined to give and any other information regarding vaccine or demographic info.
Red, swollen left upper arm, especially on its medial surface just above the elbow.  Tender to pressure.
5 doses were administered out of vial that was punctured 15 days ago; Vials are out of range for temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were administered out of vial that was punctured 15 days ago) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials are out of range for temperature) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were administered out of vial that was punctured 15 days ago) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials are out of range for temperature). On 30-Jul-2021, EXPIRED PRODUCT ADMINISTERED (5 doses were administered out of vial that was punctured 15 days ago) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials are out of range for temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   5 doses were administered out of vial that was punctured on 16 Aug 2021 and temperature was also recorded out of range. No concomitant medications were reported No treatment medications were reported
Insomnia. Initially prescribed Temazepam after 3 days of no sleep on 4/28, then on 5/5 prescription switched to Doxepin and Lunesta. sleep problems persist and still taking Doxepin and Lunesta.
Felt faint, appeared pale, sweating. BP95/62, P69. Rested in chair, sweatshirt removed.  Symptoms resolved. 2:40pm BP114/80, P69. Patient also reported slight metallic taste in mouth & slight tightness in chest with deep breath. Stated was "fine" @2:50pm & was talking & laughing w/fellow patient.  Escorted ambulatory to car driven by co-worker.
Day1- fingers hurt Day 2- dizziness, fatigue, not thinking clearly  Day 3- arm burning hot and swollen at injection site. Worsening Fatigue, headache.  Day 4- fatigue, headache, depression, arm still burning hot
Felt like fireworks in her chest, just bursting; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and CHEST DISCOMFORT (Felt like fireworks in her chest, just bursting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced CHEST DISCOMFORT (Felt like fireworks in her chest, just bursting). At the time of the report, CHEST PAIN (chest pain) and CHEST DISCOMFORT (Felt like fireworks in her chest, just bursting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient  has chest pain that gotten little worse and patient went to VAERS.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
1st dose on 8.10.2022, 2nd dose on 15.9.2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 08 October 2022).   On 15-SEP-2023, the patient received the 2nd dose of Twinrix. On 15-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 8.10.2022, 2nd dose on 15.9.2023).  The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-SEP-2023 The pharmacist called to inquire regarding how to proceed with the Twinrix Series. The healthcare professional reported that they had patients who received their second dose of Twinrix late. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter did not consent to follow up. The case is linked with US2023127574, same reporter.; Sender's Comments:  US-GSK-US2023127574:Second patient
He presented on 1/31 with cough and dyspnea. He was diagnosed with COVID-19 Pneumonia and COPD exacerbation. His course has been complicated by atrial fibrillation with RVR and worsening hypoxemic respiratory failure. He required AirVo 60 liter flow and 80% FIO2. He improved and was on 10 liters NCO2 by 2/14. He is now back on AirVo. Patient died at 2201 on comfort care orders.
rash on his right arm (opposite the injection site); but they are sensitive and haven't went away; it is just a smooth redness; his right forearm broke out in smooth, red spots; This is a spontaneous report received from a contactable consumer (Patient). A 86-year-old male patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: ENL318 Expiration date: unknown), via an unspecified route of administration, in Arm Left on 05Feb2021 as 1st dose, single for covid-19 immunisation (for prophylaxis). The patient medical history included ongoing asthma diagnosed when he was 39 years old and ongoing atrial fibrillation diagnosed about 16 years ago. Patient had taken 7 drugs, and he had been taking them for years and never seen any side effects from them. patient had not received any other vaccines on the same day as the COVID vaccine. On 07Feb2021, patient experienced he had broken out on the inside of his right forearm, with a rash, He has a rash on his right arm (opposite the injection site),, but it is not bumpy, it was just a smooth redness that measure about 3-4 inches in diameter, just below his elbow on the inside of his right forearm that does not have any extra heat, but it was sensitive to the touch and haven't went away. it was reported that, Rash had mostly stayed the same, but if anything, it was slightly improved. Patient was due for his second dose on 26Feb2021. He had not talked to his doctor but used some cortisone on it to treat. The outcome of events his right forearm broke out in smooth red spots, rash on his right arm (opposite the injection site) was recovering while other events were not recovered.  Follow-up (09Feb2021): This is a follow-up spontaneous report from a contactable consumer., new information included suspect product, events detail, batch no. medical history.   Follow-up attempts are completed. No further information is expected
Intolerable itchiness; Very large induration at injection site; Developed hives all over the body. Some quite large, including on the feet; mild GI upset; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:2), administration date: 21Jan2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (Dose:1), administration date: 26Dec2020, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Oct2021, outcome "unknown", described as "Developed hives all over the body. Some quite large, including on the feet"; PRURITUS (non-serious) with onset Oct2021, outcome "unknown", described as "Intolerable itchiness"; VACCINATION SITE INDURATION (non-serious) with onset Oct2021, outcome "unknown", described as "Very large induration at injection site"; ABDOMINAL DISCOMFORT (non-serious) with onset Oct2021, outcome "unknown", described as "mild GI upset". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, vaccination site induration, urticaria, abdominal discomfort.  Additional information: At unknown time after receiving booster (either day 1 or 2) consumer (a neighbour) reported getting intolerable itchiness but she was at work and did not want to take antihistamines while working. Antihistamines were taken at some point (when at home, not sure on which day) and helped with the itch.
5-10 minutes after HBV shot, started feeling hot, dizzy, H & V, tightness at back of neck, tremors, face flushed, sweaty and headache.
Went into room to administer the vaccines ordered. Had dad sign all documentation and dad advised oldest son to go first. When I was preparing the right delt pt mentioned how his heart was beating fast and his dad told him to look away. After administering vaccine he immediately sat down & I administered vaccines to the other two siblings. While walking to the waiting room area pt looked kind of dizzy & fell on his right shoulder and fell to the floor. Doctors immediately had him lay down & he was good after 20 min.
Flu- like symptoms, joint aches, became bed ridden, went on military sick call, 2 days Quarters prescribed.
Extreme fatigue, chills, sweats, body aches.... Tylenol for treatment
Had Varivax on 12/29/1998.  Broke out yesterday with small red bumps on back, chest, abdomen, a couple on arms.  questionable break through.
"Large lump" (cellulitis/abscess). Redness, pain, rupture and drainage. Course of 8 days. F/U visit w/doctor, antibiotics given.
Information was received on 26-MAY-2017 from a lawyer regarding a female patient of unknown age. he patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) on or about 03-AUG-2009, at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-NOV-2014, the patient was treated by a physician at a hospital for a vesicular outbreak that was diagnosed as severe shingles. On or about 01-DEC-2014, the patient was treated again for ongoing and worsening symptoms by a physician who affirmed the diagnosis of shingles. On or about 29-DEC-2014, the patient required further treatment by the physician and  was diagnosed with the condition of shingles and chronic nerve pain. The patient was prescribed valacyclovir (manufacturer unknown), hydrocodone, acetaminophen (NORCO), and oxycodone, acetaminophen (PERCOCET) for management of her painful symptoms. 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.
17 year old patient presented to clinic with parent to receive first covid vaccine, patient was administered Moderna vaccine instead of Phizer.
excursion vaccine was administered with no adverse event; vaccine Act-HIB for which cold chain break is reported with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported with no reported 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 the 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.; Sender's Comments:  US-SA-2023SA124713:MASTER CASE
I had a sore arm and headache after taking the 2nd dose. I also tested as a positive/negative for Covid-19. My symptoms were body weakness, scratchy throat, headache, coughing, loss of smell & taste, tiredness, and hard to breathe. I was down for 5 to 8 days. And I was off from work for 14 days. I took Nyquil, Ibuprofen, and Alka-Seltzer. I still experience shortness of breath and still deal with a loss of taste & smell. I have to take naps periodically, so I still experience a lot of tiredness. I no longer work due to these symptoms.
I've notice I have a headache with neck tension and shoulder/upper back muscle tension each afternoon/evening since the injection on 5/28/21. The headache feels like a muscle or tension headache or even a sinus headache. Sometimes it affects my temples, jaw, sinuses, forehead, and back of head and I also feel muscle tension in neck, shoulders, and upper back. I feel relief with 400mg of Advil or even a shoulder or neck massage.
Client received her first dose Pfizer COVID vaccine lot # FF8839 exp. 12/2021 on 10.05.21. At 1758, client reported to the first vaccinator RN at the vaccination table that she was ?feeling blurry vision for 3-5 seconds and a feeling of wave of heat from the top of her head down to her thighs.? At 1759, she said it ?went away.? Client denied any SOB, dizziness or any other anaphylactic signs or symptoms. The second vaccinator RN took client?s vitals at 1802: blood pressure (BP) 130/67, pulse (P) 69, respiration (R) 15, oxygen saturation rate (O2) 99 %, and at 1816: BP 117/64, P 67, R 13, and O2 99%. At 1816, client?s friend came over to check on client who was the driver for client and another friend who was waiting at the observation area which client stated she was ready to leave because she said she ?felt fine? and denied any anaphylactic signs or symptoms. PHN suggested to client to go continue her observation time until 1828 at the observation area with her friends. She verbalized understanding. PHN educated client to follow-up with health care provider regarding if should receive second Pfizer dose and about immediate medical care if symptoms returned or escalated. No medications or other interventions were indicated. Lead RN checked on client at 1825 which client told her via second vaccinator RN interpreter she drank water provided at the observation area and stated, ?all good.? Lead RN walked client who was walking with a steady gait and her friends at 1831 from site to the parking lot.
The site is still red, painful and hot to the touch; The site is still red, painful and hot to the touch; The site is still red, painful and hot to the touch; This is a spontaneous report from a contactable consumer (reported for herself). A 49-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 13Feb2021 08:15 at single dose in left arm for COVID-19 immunisation. Medical history included diabetes type 2; no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included sertraline; acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE). The patient previously took the first dose of bnt162b2 on 19Jan2021 07:15 (at the age of 39 years old) in left arm for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It has been over 72 hours since the vaccination. The site was still red, painful and hot to the touch which started from 13Feb2021 08:15. Not sure if this was normal for this to continue so long. No treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Pt started having symptoms  body aches, pain, cough, fever, and generalized weakness, the past 3 days.  Denies any N/V.  Does admit to some diarrhea.  States watery and foul smelling.  Pt was given 1 L of IVF, started on decadron and rocephin and doxycycline.  Pt was admitted for further workup. Sats noted to be low at 85% and pt was placed on supplemental oxygen in ED. She received 2 doses of remdesivir.  Got 3 days of abx inpatient.  Got 4 doses of steroids.  She was stable and discharged on 1/26/22. However, she was admitted again on 2/2/22 . She had also not been complaining any chest pain dizziness or shortness of breath.  In the ER chest x-ray showed pneumonia. MRI showed acute stroke.