chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient described extreme somnolence starting roughly 1 hour after receiving the vaccine, just after finishing lunch, Patient's self driving car was able to park in a safe lot, and he states he took about a 2 hour nap and woke much more alert. Patient reported no further ill effects except for alarm over the suddenness of the somnolent episode.
Next day after receiving 2009 H1N1 I got stomach cramps without diarrhea. This lasted eight days off & on; (she did not see her doctor). She had slight headache as well.
Erythematous, warmth, tenderness (L) deltoid region PPSV 23 site.
Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD, hypertension and anxiety and depression who presented on 2/6/2021 for evaluation of shortness of breath. Patient presented to our emergency room yesterday morning from local nursing facility rehab nursing staff reported that she had had a increased shortness of breath for the last 3 days she has been diagnosed with COVID-19 on 2-2-2021.  Patient has also received both COVID-19 vaccines.  Patient presented to the emergency room with labored respirations conscious awake and was on a non-rebreather at 15 L. upon arrival to our emergency room patient's temperature 101.6°, pulse 169, respirations 40 to blood pressure 142/91 and oxygen saturation 100% on 15 L non-rebreather.  Patient received a chest x-ray that showed chronic emphysema and fibrotic changes in the lung no acute processes identified.  Patient's white count 12.8, glucose 197, creatinine 1.2, lactic acid 4.6, cardiac enzymes negative, D-dimer 1180, patient has urine culture pending.  Patient has received about 3 L normal saline boluses patient was having hypotension 86/52.  Patient also received IV acetaminophen a 1000 mg IV in the emergency room along with Decadron 10 mg IV piggyback.  Patient was admitted acute care for the need of IV fluids and IV antibiotics for COVID-19 and sepsis  2/12 admit Brief history and initial physical exam: Patient is a 71 year old long-term resident of Rehab and Healthcare.  Unfortunately, she contracted coronavirus (COVID-19) at the nursing home.  Her respiratory status started to decompensate and so she was brought into the hospital.  Initial workup showed significant bilateral pleural effusions and ground-glass opacity of both lungs.  She had a significant supplemental oxygen requirement.  She was admitted for further evaluation and treatment.   Hospital course: The patient was admitted and started on IV Remdesivir.  She was given IV Decadron.  She was given immune support vitamins.  Despite this, her sepsis worsened.  When it became apparent that the patient was not going to recover, her daughter did make her comfort care only and hospice was consulted.  The patient was found to be appropriate for general inpatient hospice and was made comfort care.  Her requirement for morphine and Ativan did slowly rise.  Eventually, the patient did succumb to her respiratory failure.  Time of death was called at 10:00 p.m. on February 15, 2021   Discharge Condition: expired. Presume cause of death with cardiopulmonary arrest secondary to acute respiratory failure secondary to coronavirus (COVID-19) pneumonia   Disposition: Deceased
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with improperly stored doses of GARDASIL. No adverse events were reported. Additional information has been requested.
Within 30 minutes of receiving the Boostrix Tdap shot, I suffered a severe allergic reaction. My whole body became heavy, and I was unable to move or get out of bed. I felt a wave of extreme fatigue and weakness wash over me and was in a mental fog. My mental intake and comprehension, as well as my response time was greatly slowed. I was able to finally get out of bed about an hour after the reaction, but stayed in a mental fog for weeks, if not months after that. The fatigue is overwhelming and has not gone away.
This case was reported by a consumer via call center representative and described the occurrence of renal pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced renal pain and pain in arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the renal pain and pain in arm were unknown. It was unknown if the reporter considered the renal pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient stated that, beside arm being very sore the patient also experienced pain in kidney area on both sides. On 18th September 2018 08:00 am, the patient took 2 TYLENOL and nothing since then. The patient wanted to know was this a side effect. The reporter was not willing to share any contact details.
Shot was very easy, painless. That night I began to have muscle aches and a headache. I woke up several times through the night, not sure if that?s why, but was unusual. The next morning (6AM) I had a slight fever (normally 97.4 on my thermometer but was at 98.9), body aches, headache, and a heavy (dry) cough. I also was exhausted/drained. I called in sick and slept until about noon. After I woke up and was awake for a little while (still feeling the same way), I had a temp of 100.5 on this thermometer. I had raspy lungs and was coughing quite a bit. I took Ibuprofen for my headache and it helped. I used Theraflu to help me breathe before going to sleep. This morning my body aches are gone and although I still have a cough, it is very much better. I?d say 90% better. My temp was still high this morning, but is steadily moving toward normal every time I check, without any medication.
Narrative:  Patient with history of hypertension developed sore throat and elevated BP following 2nd dose of Pfizer covid vaccine. She was taken to community ER for management.
Full body itchiness and dermatographia starting 12 days after the booster. No changes to diet, new soaps, lotions, detergents, etc.  Given 40mg of prednisone for 5 days and xyzal. This drastically reduced symptoms. After course of prednisone itchiness and redness is back
Client is a 10 year old boy who developed right arm and chest discomfort.  He received his second dose on 12/6/21 but his mom mentioned he was a little more anxious today.  Mom mentioned she gave him a xanax prior to vaccinating.  Vitals Hr: 100 O2: 96 R:20 BP: 130/86
This spontaneous report was received from a registered nurse and refers to a 19 year old female patient. The patient's concurrent conditions and medical history were not reported. On 06-JAN-2017, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 101 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
No immediate adverse events or signs/symptoms post vaccination.  On 12/03/2021 at approximately 1420 Patient was found on the floor by staff from a fall incident he was complaining of pain to neck and back and due to personal hx of cervical fractures EMS notified for transport to ER. Poor oxygenation noted and oxygen applied via nasal cannula while awaiting EMS transport to Hospital ER.  At approximately 1700 Nursing Home received word that all scans/x-rays were normal and resident would be returning to Nursing Home. Some time after this notification while resident was still in the ER he developed a cardiac dysrhythmia which he succumbed to.
Client had PPD and immunization done 4/16/03. Came to clinic for reading 4/18/03. Stated complained of red swollen area at injection site. Has 4 x 5cm red swollen, hot area on left deltoid.
pt recvd vax 1130AM mom states 330PM pt became fussy & lt leg swollen; arrived @ clinic 420PM w/fifty cents piece size swelling & painful to touch; fussy but easily consoled;given APAP; no swelling of rt leg
Swollen, numb, stiff left knee.  Swollen, numb, stiff left index finger.  Swollen stiff numb right knee.
This case was reported by a consumer via call center representative and described the occurrence of eruption in a 77-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (1st dose received in May 2018). In August 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced eruption, pruritus, erythema, skin irritation and raised rash. On an unknown date, the outcome of the eruption, pruritus and erythema were not recovered/not resolved and the outcome of the skin irritation and raised rash were unknown. It was unknown if the reporter considered the eruption, pruritus, erythema, skin irritation and raised rash to be related to Shingrix. Additional details were provided as follows: The patient received the second shot of the Shingrix approximately four weeks before the date of reporting in the early afternoon. The patient claimed that over a period of four weeks, he experienced periodic outbreaks of what looks like mosquito bites on his torso also claimed that they were itchy and outrageous and irritating. After three days, the outbreak would resolve and then another outbreak would appear. He described the outbreak as raised and red and he had one on his chest, hip, buttock and umbilicus over the four week period. One outbreak resolved and then everything would be quiet and then another outbreak appeared. This case has linked to case US2018GSK174669, reported by the same reporter for same patient.
This spontaneous report was received from a female patient of unknown age regarding herself. The medical history, concurrent history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. On an unknown date, the patient experienced painful, hard, red lump at the injection site after receiving ZOSTAVAX. The outcome of the events were unknown. Additional information is not expected.
pt was not seen in clinic; mom went to ER 17OCT w/t106 & swollen face;
He has blood in his urine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2022 (Lot number: FL8094) at the age of 11 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BLOOD URINE PRESENT (non-serious) with onset 27Feb2022, outcome "unknown", described as "He has blood in his urine". Therapeutic measures were not taken as a result of blood urine present.  Additional information included:  The reporter was wondering if that was a side effect from the COVID shot, or don't know if he need to go to the hospital. The patient had no prior Vaccination and no lab test (within 2 weeks).  No follow-up attempts are possible. No further information is expected.
Mixed series - COVID 19 vaccine 1st dose Pfizer and 2nd dose Moderna No treatment required, vaccine series considered complete
I woke up at 3 am Sunday pukeing then real bad nausea along with dry heaving through Thursday. I have not been able to keep anything but a couple bites of bread and a few sips of water. Friday nausea way less nodry heaving. My copd got really bad at the same time as well i was gasping for air the whole time. I had to have aero care bring me a new oxygen canister that i could wear continuously. That adversed reaction also is much better now. The hospital would have kept me if i went to the emergency room.
Patient came in requesting his 2nd shingles shot.  I was very new to computer system.  I had an inexperienced technician inputting the prescription. It would not process through the insurance, but to keep the customer happy, I went ahead and gave him his shot, planning to bill later.  On 10/13/21, it was determine that the patient had already received 2 doses of Shingrix, so this was actually a 3rd dosage.  No adverse effects were reported.
States she woke up from a nap about 10:30 AM on 9/23 with a rash on her face, trunk, and upper legs. States "her mother thought it looked like "hives". No increase temp. Said the rash itched a little. Encouraged to see her doctor. Reported later when contacted in the afternoon that she had gone to "Prompt Care". She had been on an antibiotic for the last week. The doctor at Prompt Care stated she had a reaction to the TDAP. She received PREDNISONE and BENADRYL. 9/27 - Spoke to pt. and she said she was feeling much better and looking better.
The effects of the first shot have already been reported however fatigue did start.  After the second shot my body got more and more tired after only doing a little of work, Had to sit or lay down. Doctors appointments were made with two doctors. August 13, 2021 with cardiologist and August 17, 2021 with primary physician. On August 12, 2021 patient went to emergency room with a fast heart rate and shortness of breath.
she was bleeding (from the eyebrow, it broke a little bit); been laying in bed, is weak, doesn't want to get up; she does not help herself as if she had no movement in her body; Doesn't want to eat; fell a couple of times from bed and chair; she hit her eyebrow and broke it a little bit; Weakness; This is a spontaneous report from a contactable consumer reported for a patient (his wife). A 79-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 25Mar2021 10:00 and first dose received on 4Mar2021 ( LOT:EN6201) both as single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Patient received her first dose within 4 weeks prior to vaccination. Patient experienced bleeding (from the eyebrow, it broke a little bit) on 25Mar2021, fell a couple of times and doesn't want to eat. On 26-MAR-2021, Patient been lying in bed, weak, doesn't want to get up, Patient was fell out of bed and she does not help herself as if she had no movement in her body. The outcome of the events she was bleeding (from the eyebrow, it broke a little bit) was unknown and the outcome of the other events was not recovered.  Follow-Up (29Mar2021): New information from a contactable consumer followed: Clinical information included new events, outcome details and historical vaccine.
Stomach Discomfort.; UTI Symptoms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach Discomfort.), URINARY TRACT INFECTION (UTI Symptoms) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026AZ1A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included LEVOTHYROXINE, LOSARTAN and ATORVASTATIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach Discomfort.), URINARY TRACT INFECTION (UTI Symptoms) and CHILLS (Chills). The patient was treated with VACCINIUM MACROCARPON FRUIT (CRANBERRY JUICE [VACCINIUM MACROCARPON FRUIT]) for Stomach discomfort, UTI and Chills, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach Discomfort.), URINARY TRACT INFECTION (UTI Symptoms) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.
Began to hurt to breathe on 8/31/21. Any time I would take a breath I would get a sharp pain. Dealt with it until 9/3/21 until I was advised to go to the emergency room.
Is it possible that as a result of giving me multiple vaccinations all at one time - that this could have created an "opportunity" for something like shingles to surface? I had also received an SI joint injection (corticosteroid) on Aug. 25th, 2011 (same hospital).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment Paxlovid from 14Aug2023 to 19Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
After the regular symptoms started to wear off (body aches, fatigue, headache) I developed swelling and pain in my left armpit. Enough that I couldn't sleep due to it. It is still there today, but slightly less painful.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: This case was reported for reporter's mother. The age at vaccination was not reported. The reporter stated the patient got the Shingles vaccine and got shingles. The patient was in pain for 3 months. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR249095:same reporter.
8 days after vaccine, woke up and injection site was bright red and the size of a dime. Area was incredibly itchy and there was about a 5 inch rash around the injection site; 8 days after vaccine, woke up and injection site was bright red and the size of a dime. Area was incredibly itchy and there was about a 5 inch rash around the injection site; 8 days after vaccine, woke up and injection site was bright red and the size of a dime. Area was incredibly itchy and there was about a 5 inch rash around the injection site; This is a spontaneous report from a contactable other healthcare professional (Patient).   A 33-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via Intramuscular route into left arm on 22Jan2021 at 02:15 pm as dose 1, single (Age at vaccination: 33-year-old) for Covid-19 immunization. Medical history included: Poly cystic ovarian syndrome. The patient had no Known allergies. The patient had not received any other vaccine within 4 weeks. The patient was not pregnant at the time of vaccination. The patient neither had covid prior vaccination and nor tested for covid post vaccination. Concomitant medications in two weeks included: semaglutide (OZEMPIC), spironolactone, ergocalciferol (VIT D) and birth control medicine (unspecified). On 30Jan2021 at 08:00 AM (8 days after vaccine), the patient woke up and injection site was bright red and the size of a dime. Area was incredibly itchy and there was about a 5-inch rash around the injection site. The patient did not receive any treatment for adverse events. Outcome of events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
numbness from top of head all the way to the bottom of feet, heavy feeling in foot and arm on the left side, on right big toe numbness
30OCT that noc inj site was very sore w/large bump;31OCT bad h/a inj site very sore;1NOV lethargic, severe h/a, T103, muscle aches;2NOV T103, diarrhea, muscles aches;3NOV recovering still some diarrhea;treated self w/APAP & ASA
See attached notes. Pt is here for symptoms starting after immunizations given 3 days ago. Starting Saturday didn't feel well - some dizziness. Next day, while in church, felt hot "inside" but not hot to touch. HA, dizzy. SA briefly - not nausea. Yesterday didn't feel well - HA, dizzy, felt "hot" but normal temperature. Felt weak. Drank 2 water and 3 gatorade bottles, but didn't help. Feels a little better today. HA fairly constant. Eating ok but less. Ate chicken, raw veggies, pumpkin bread for dinner last night. Some cough and sore throat this morning. IB being used - for comfort.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-AUG-2016, the patient was vaccinated with a dose of improperly stored GARDASIL or GARDASIL 9 and lot number K010215 with expiration date of 05-MAY-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 96 hours. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
Seizures NOTE this is typical of symptoms this patient has d/t seizure disorder already known, Episode occurred after vaccine. Numbness and tingling of tongue and tingling of L arm  Narrative:  has history of seizures. PCP does not believe it to be related. States typical of her seizure disorder.   Other Relevant History:
This spontaneous report as received from a nurse refers to a adult patient of unknown age and gender. On 19-MAY-2106, the patient was inadvertently vaccinated with one pediatric dose of RECOMBIVAX HB (lot # M001578 and expiry date: 21-NOV-2018). No adverse effect reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. Additional information has been requested.