chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hypoxic brain injury after a possible averted SIDS event. Five hours (approx.). Receiving second series of vaccines. 9/9/09 Hospital records received DOS 4/17/09 to 5/6/09. Assessment: Anoxic brain injury, Seizures in response to acute event. Acidosis, Cardiopulmonary arrest, Respiratory failure without hypercapnia. Parent found infant in crib, face down, blue, not breathing. Vomited after rescue breaths. EMS found baby unresponsive, apneic, and pulseless. Cardiac Arrest CPR. Upon arrival at previous facilty was intubated. Pupils fixed and dilated. After transfer was awake, fussy. Unable to fix or track with eyes. Increased tone all extremities. Tense abdomen with lack of bowel sounds. Anasarca. Phenobarb coma to suppress seizure activity. Hypotension. Pneumothorax. ARDS. Mechanical ventilation. TPN. Second pneumothorax. Stridor after extubation. Significant brain damage. Dysphagia, spasticity, clonus. NG dependent.
Fever, swollen tonsills, submandibular and post occiptal glands.  Sore throat, nasal congestion, rash-papular face, chest hands, and arms.
SEVERAL HOURS AFTER IMMUNIZATION PATIENTS ARM GOT SWOLLEN/HARD/PAINFUL AT INJECTION SITE. NO REDNESS OCCURRED.
Severe body/muscle aches, headache, extreme fatigue, fever up to 101.1 and chills
1/2 dollar-sized reddened area to injection site. Irritable and fussy. Temperature 99F. Gave Tylenol, Advil and cool compresses.
pt mom called 16NOV95-advised pt sick 29OCT95 w/fever & sore throat eval by ER;took pt to MD unable to dx-referred hosp dx Guillian-Barre Synd;Is now in rehab for peds
Rash in a few different areas of body; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist and was calling on behalf of his friend that was the patient. The age at vaccination was not reported. The patient received Shingrix shot at pharmacy a little bit more than two months ago. The patient experienced rash in a few different areas of her body. The patient had recovered from the rash. It took a few days to clear up. This case has been linked with US2019157515, reported by the same reporter.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: She has had some body aches and headache (Sunday) and then redness, itching and rash at injection site she says benadryl has helped/ counseled to contact md if it continues or worsens
Patient was hospitalized with due to COVID-19 after being fulling vaccinated.  Patient expired on 8/10/2021
Narrative: COVID infection following COVID vaccine series 01/21, Pfizer, dose #1 02/10, Pfizer, dose #2 09/10, Pfizer, dose #3 12/24 COVID swab, result: detected 12/22 pt cc: diarrhea, fatigue, dyspnea, rhinorrhea exposure: unknown 12/24 SARS-COV-2 Variant Sequencing: pending 12/24 pt admit to ED cc: "I have cough, runny nose, sore throat and body aches" dx: Coronavirus - 19 LOS: 1day 12/29 clinically resolved
Soreness; Stiffness in Injection Arm; Redness; Chills; Headaches; Muscle Pains; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), INJECTION SITE INDURATION (Stiffness in Injection Arm), ERYTHEMA (Redness), CHILLS (Chills) and HEADACHE (Headaches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0132LOA and 030M2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2OA) for an unknown indication.    No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 11-Feb-2021, the patient experienced PAIN (Soreness), INJECTION SITE INDURATION (Stiffness in Injection Arm), ERYTHEMA (Redness), CHILLS (Chills), HEADACHE (Headaches), MYALGIA (Muscle Pains) and PYREXIA (Fever). At the time of the report, PAIN (Soreness), INJECTION SITE INDURATION (Stiffness in Injection Arm), ERYTHEMA (Redness), CHILLS (Chills), HEADACHE (Headaches), MYALGIA (Muscle Pains) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received my vaccination 2 pm. Left my office about 6. I was feeling very weak and lightheaded. My neck hurt and my back hurt. I live close, so it only took me 15 min to get home. By 6:30 I was very lightheaded and felt as if I were going to pass out. I have a BP cuff at home. My BP was 88/54. It?s been running 140-150 over 80s. My HR was 110. By 7 pm I was having hard chills. By 8 pm my temp was 102.7. Took Tylenol and hydrated. It slowly passed. By midnight temp was down to 99.5. This morning everything is normal.
Moderate Fever ~ 101 F, Malaise, Moderate Diarrhea, chills in evening, body aches,
Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Rash started 3 days after vaccination. Started in both upper extremities and spread to chest. Patient states severe itching that did improve slightly with hydrocortisone. On the 5th day rash is starting to recede.
Arm hurts so bad; Just don't feel well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts so bad) and MALAISE (Just don't feel well) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts so bad) and MALAISE (Just don't feel well). At the time of the report, PAIN IN EXTREMITY (Arm hurts so bad) and MALAISE (Just don't feel well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
I exp redness, swelling from shoulder to elbow (right arm) tenderness and no lymph nodes.The symptoms lasted 48 hours.
atrophy; shoulder sore; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206), via an unspecified route of administration in the right arm on 10Mar2021 at 13:00 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unspecified date at 13:00, the patient experienced his triceps muscle became like a ball. He had suffered atrophy and his arm became smaller as though, he had removed a cost after his hand was in a sling for several weeks. His shoulder was still sore from the injection. Therapeutic measures were not taken for the adverse events. The clinical outcome of extreme atrophy and shoulder soreness were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Thursday following vaccing chills, friday headache. saturday through monday well/fine. 5/12/21 woke up one sided weekness, pale, could not talk, wife, called 911. episode lasted 15-20 minutes per wife. went to ER, was diagnoses with TIA, suspecting vaccine but not confirmed at this time.
This spontaneous report was received from a medical assistant concerning multiple unspecified patients (demographics unknown). On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL (dose, route and lot # not provided). No adverse effects were reported. Additional information has been requested.
I initially had itchiness at injection site, then more of my arm. At 15 minutes I talked with the nurse, she looked at and we talked for quite a bit what I should do but I was feeling just fine and left to go home and take benedryl. I had just left the hospital (25 mins post shot) and my throat and tongue started swell rapidly. I called 911 and the county rescue responded. My breathing was normal by then. My body has been itchy all over since then and my throat remains minor swollen. I did not get an epi shot since I was mostly okay and the EMTs were convinced I had a panic attack so I just went home.
5-6 hours post vax, the pt developed a high-pitched cry. The parent states "tried everything to console the baby including a car ride."
On 12/15/99, the pt developed swelling at the injection site. The pt was reportedly improving as of 12/16/99. This is one of two pts from this facility who had an adverse experience following receipt of vax.
PUFFY FACE/ SWOLLEN FACE; SWOLLEN EYE; DRY BLOTCHES; HIVES-LIKE RASH; This spontaneous case report was received from a nurse (PVX2019-583) on 05-Mar-2019. It described a female consumer who experienced puffy face/ swollen face, swollen eye, dry blotches and hives-like rash following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis. She also used an unknown face wash.   The consumer's concomitant medication included Cyred (desogestrel and ethinyl estradiol) for an unknown indication.   It was reported that the consumer took the first two dose of Vivotif on 28-Feb-2019 and 02-Mar-2019, respectively. On 01-Mar-2019, she used a facewash (nurse did not know the name). On 02-Mar-2019, she experienced the following events; puffy/ swollen face, dry blotches, hives like rash, swollen eye. These symptoms occurred just on her face, neck and one of the eye. She took the third dose on 04-Mar-2019.  She took Benadryl (diphenhydramine) a couple of time for itching on 04-Mar-2019.  The action taken with Vivotif with respect to the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was dosage maintained.  The action taken with face wash with respect to the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was unknown.  The clinical outcome of the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was not resolved.  The reporter's causality of Vivotif with respect to the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was possible.  Company's Comment: In this case, it was reported that a female consumer who experienced puffy face/ swollen face, swollen eye, dry blotches and hives-like rash following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. The events appear to be due to a hypersensitivity reaction to Vivotif. Also, hypersensitivity reaction is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
spike in blood sugar over 600; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events spike in blood sugar over 600/blood glucose increased  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) spike in blood sugar over 600.  Treatment information was provided as she took 10 units of insulin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), spike in blood sugar over 600 was unknown.
Presented to ED with increased shortness of breath x 1 week and associated nausea/vomiting, cough, fevers, headaches, and body aches. Exposure to multiple COVID positive contacts. Was hypoxic on arrival to ER and tachypneic. Placed on HFNC but subsequently required intubation due to continued desaturations. Noted to have severe anemia and severe multi-lobar ground glass opacities consistent with pneumonia. Upon placement of central line, patient went into cardiac arrest and ROSC was unable to be achieved.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Seizure-Medium
Toddler, age 4, received a pediatric orange cap dose. Patient had no symptoms, but recommended to continue the series in the infant doses.
This case was reported by a physician via sales rep and described the occurrence of axillary pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced axillary pain and myalgia upper extremities. On an unknown date, the outcome of the axillary pain and myalgia upper extremities were recovered/resolved. It was unknown if the reporter considered the axillary pain and myalgia upper extremities to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had 30 days of 10 by 10 arm pain in the left axilla, trapezius muscle. The reporter agreed to follow up with GlaxoSmithKline with reporter assistant.
RN Message Notes: Key Symptoms and Assessment: no new/worsening sx, x3-4 days ago difficulty walking/staggering, able to stand up, has to use assistance to walk, baseline ambulates independently, denies SOB, O2 92%  Pertinent History: ER 7/29/23 covid, DM2, HF, HTN, Chronic Respiratory failure  Other: none    Additional Information:
Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 20-DEC-2010 at a family medical practice, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-OCT-2016, patient was treated at an urgent care clinic for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 09-MAR-2017, patient was treated again at a medical clinic for ongoing and worsening symptoms, accompanied by scarring and residual pain from shingles. Patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
received 1st dose in 2020 and never came back for the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st August 2020 with batch number 7RK7K and expiry date 26th November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-JAN-2023 Reporter's comment: The registered pharmacist (RPH) called to enquire how to proceed with Shingrix Series second dose (completing the series), should patient restart the series by getting two extra doses and if there was any harm with three doses. The patient never came back for the second dose.  The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient received their second dose of Moderna at 4:14PM. 15 minutes post vaccination, mom stated the patient was complaining of chest pain. Patient described it as someone sitting on her chest. Denied difficulty breathing.  Patient was taken to triage area, vital signs taken, and called 911.  Two minutes later, mom stated to nurse that patient was experiencing slight difficulty breathing. Vital Signs were: BP 82/50  HR: 104  O2 97% on room air, RR : 22 normal with no retractions or wheezing.  Patient was speaking normally. No SOB noted. Patient was A& O x 4.  Mom stated patient had no reaction to first Moderna dose. No allergies to medications or foods. No rashes at injection site or on body.   RN handed off to paramedics who took patient to Hospital at 4:58PM.
High fever 1 day after vaccine of 102, SOB since vaccination (unresolved), chest 4 days after vaccination (resolved)
Increase in pain and general loss of energy - pain constant and did not respond to regular pain reducers; used pain meds, pain patches, ice packs and no relief. Episode lasted over 30 days.
Male child 9 years old here for second / final pediatric Pfizer vaccine with mother here, see times/date above stated "I am so hungry" before vaccine mom reports ate rice and brown sugar before arrival, appeared appropriate during (1430) vaccination, after waited in mom's arms then fainted 1-5 min (No fall) carried to cot, vitals taken, awoke after min on cot supine, 1433 B/P 94/58 HR 98 SPO2 100% RR 23 1443 after Capri Sun juice box and talking laying down noted and stated episodes of heart palpitations with circumoral cyanosis. (1437) 94/58 98 P 100% O2 (1440) P 108 (1441) HR 92 (1445) Dr called patient circumoral cyanosis & feeling "sick" and looking worried when HR elevated felt palpitations during increased HR episodes. 1445 MD called, EMS emergency called due to episodes of increased HR to 121 cycling up and back to 90's. When HR increased 115-120 client reports palpitations, appears lethargic but awake, circumoral cyanosis (green or blanching around lips) 1450 observing, 96/63 P 121 SPO2 100%. 1454 Paramedics here - father of client came, family prefers, desires child to by taken now by ambulance to Hospital ER. Dr. given report by RN, RN, Mgr. All here aware of all above.
Temp Excursion - Yes; The vial went to temperature excursion; No adverse event; erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (Temp Excursion - Yes), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial went to temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Temp Excursion - Yes), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial went to temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (Temp Excursion - Yes), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial went to temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (Temp Excursion - Yes) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial went to temperature excursion).    No concomitant medications were reported. It was reported that the patient was administered dose after 30 day use by date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial underwent temperature excursion. 9 days past expiry date the patient received the vaccine.   No treatment information was reported.   Reporter did not allow further contact
I had no adverse effects on the first two injections but the booster which was lot number 014F21A is another story.  I was sick on the night of the injection which was November 4th thru Sunday November 7th 2021.  I had the chills, tired, and was having a hard time breathing - took Asthma meds on the 4th, the same on the 5th, 6th but breathing was a lot better -  but on the 7th i could not keep anything down or in.  My face was red and lips and eyes swollen.  This is what happens when i have something with sulfa, sulfites or citrus in it.  By late Sunday night (7th) I was normal.  I will never do this again - ever
Within 12 hrs of vaccine, marked confusion and then ischemic colitis the following day.
Patient is fully vaccinated and boosted twice.  COVID positive on 5/10/2022 at ED vist. He has URI congestion, no cough, fever, chills or dyspnea.  Today he had chest pressure, lasted about two hours. No diaphoresis or radiation. No abdominal pain, myalgias, headache or diarrhea. BP (!) 146/38  | Pulse 68  | Temp 99 °F (37.2 °C) (Oral)  | Resp 18  | Ht 180.3 cm (5' 11")  | Wt 99.8 kg (220 lb)  | SpO2 97%  EKG: Sinus brady rate 56.  Left BBB. Cr 1.76. Troponin normal. CXR: No acute pulmonary process. Stable, discharged with instructions.
received anthrax vaccination on 9/20/07 left arm. The night had swelling and redness at injection site. Later in the evening pt noted red, raised, itchy bumps on left arm. The next day the rash on on both arms and her abdomen. Denied headache, fever, SOB or diarrhea.
Fainted at first vaccine, felt progressively sicker through series.  Ended up with many issues including fatigue and auto-immune issues.
Per patient (reaction occurred after leaving the clinic): Hives 30 minutes after vaccination; resolved with Benadryl