chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Profound fatigue for 12-15 days. I would lie in bed for hours, not sleeping, barely moving. I felt like my skin was very thick, like a large reinforced balloon or ball. I felt an intense sensation of energy pulsing through my body. In the beginning, it was predictable. Then after a week or so, it was usually in the late afternoon when I was with people (I teach private and small group piano lessons in my home). I would become aware of a sensation about the size of a pecan in the middle of my brain. It was always in the exact location. (I have never heard that we can feel anything in our brain, but I did. It was weird.) Then, immediately, I was just aware of profound fatigue throughout my body. There was no longer the "walnut" shape in my brain. This lasted about 2+ weeks. After that, there wasn't such a clearly defined shape in my brain, just a feeling. After the sensation, I would immediately stop whatever I was doing and lie down for 1-1.5 hours. This happened every day and continued for the next 7 weeks. To build up my endurance so it wouldn't happen, I would lie in bed for about 2 hours in the afternoon and sleep a little. But I'm not sure it helped or not.  I was afraid to drive more than a few miles from my home in case it happened while I was driving. My energy level was low at other times of the day, but I could cook and eat my meals. I did not go out except for a short trip to the grocery store. My sleep at night was normal.   The last time I had the sensation in my brain and had to lie down for an extended time was December 8. This whole experience completely disrupted my ability to teach all my students.  The first day without a daily afternoon nap was December 18, nine weeks since my booster. However, I have needed to take a nap now and then. Most days, even now, I continue to have a mild warning sensation in my brain that I'm about to have a fatigue session. Now they are much milder, but it's not passed.   Several times, I was on the highway when I felt a fatigue session coming on. Fortunately, I had discovered that if I breathed in for 4 counts, held my breath for 7 counts, and slowly breathed out for 8, the fatigue sensation would leave me.  I live alone, so all of this was frightening for me. I had extensive blood tests done on Dec 14 & 18 and am awaiting results.  Ears: On Thursday, October 21, I heard odd, swishing, rushing water sounds in my right ear. It felt as though there was a bug in my ear. I remember using my hand to try to get rid of it. The sounds and feeling subsided, but both ears hurt a little during the next few days, and there was clear fluid from them. On Sunday, October 24, there was blood in my right ear. When I saw Dr. the next day, he could see dried blood but had no idea of the cause. He prescribed prednisone 5 mg tablets.  Note: I had no adverse reactions to either of my Pfizer vaccines on 2-28 and 3-21.  At present: Even though this reaction to the booster is strange and lasting a long time, I am better, and I'm grateful for that.
pt to hosp with productive cough and worsening altered mental state; hx of dementia; poor oral intake; refuses tube feedings by family, but ok for comfort meds; dexamethasone and antibiotics given; pt's condition worsened and he passed away in the hospital
Patient presented at clinic for regualr visit and also his first HEP B vaccine. on this day.  The vaccine lot number recorded in the medical record reflects that of a HEP A lot number.  MA believes she administered the correct vaccine at the time of the visit, but clicked on the incorrect vaccine/Lot number in database.  Since it is not possible to determine which vaccine was actually delivered, we must consider that the incorrect vaccine  (HEP A) was given instead of the correct vaccine.
Mom reports one day after receiving vaccine (3/15/07) the area around injection site was red & swollen. 3/21/07 area 2 x (cm slightly indurated on right thigh - mom reports area smaller now than last week - slight ecchymosis & pinkness.
pt had shot, walked to waiting area, sat for a few minutes, then passed out very briefly (about 10 seconds). Came too and was fine
This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (incorrect product storage). No adverse event was reported. No concomitant medications were reported. The outcome of event was unknown. Temperature was maximum -3.5 C, time frame was no more than 1 hour every night (defrost cycling) and there was no previous temperature excursion. Call was because of a data logger. M-M-R II appears in the Product List as it was involved in the excursion, however no improperly stored doses were administered. This is one of several reports received from the same reporter. Additional information has been requested.
Neuropathy has extended from the ball of the foot to create numbness across the entire body. Including facial and tongue numbness.   Sense of smell reduced. Sense of taste reduced.   Burning and tingling in muscles.
1/28 - Woke up to pain/soreness in underarm 1/29 - Underarm pain continued; discovered red, hot, raised and slightly itchy rash around injection site at 4pm; discovered underarm swelling at 4:30pm  Treated rash topically, one time, 1/29 with Hydrocortisone Cream Treated 1/30 with antibiotic (for the swelling out of fear of infection) for 7 days
A nurse called reported that TENIVAC was given to 2 patients on 29Sep2023 but the TENIVAC was expired on 24Sep2023 no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA301830.  This case involves 11 years old male patient and nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (HEPA B VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Immunisation; POLIO VACCINE (POLIO VACCINE) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 29-Sep-2023, the patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA; Expiry date: 24-Sep-2023) (Strength: Standard, Frequency: once) via intramuscular route in the left deltoid for Immunisation.  On 29-Sep-2023, the nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, A nurse called reported that TENIVAC was given to 2 patients on 29Sep2023 but the TENIVAC was expired on 24Sep2023. Caller asked if it is a valid dose. This situation is reported as a medication error due to expired vaccine administered.   Action taken: not applicable.  Outcome: Unknown   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.
One week after my injection on 1/15/21, on the evening of Friday 1/22, my left arm felt warm, was reddened, somewhat swollen and itchy. It has continued for the past 5 days, with the itching and reddening decreasing a little bit each day.  I was surprised that this reaction occurred a full week after vaccination. Should I still take the 2nd dose?
Redness and heat from injection site left deltoid down inner arm at least 6 inches to elbow. No treatment done.
she received the first COVID (coronavirus) vaccine and she was sore for three days after/her arm still hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "she received the first COVID (coronavirus) vaccine and she was sore for three days after/her arm still hurt".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2nd dose had headache, body n bone aches. 3rd dose. After 5 hrs of vaccine bad nausea. At 12:30  am wed morn, bones n skin hurt so bad could hardly walk along with severe chills and headache. Lasted til 10:00 am. Then felt like throat n lungs burning, like bronchitis, tongue feels swollen n tingly with loss of taste. Lips are darker color with tingling and swelling feeling along with sensation of severe chappedness. Wed thru Friday afternoon couldn't eat due to severe nausea n headache. This is Monday October 4 and my lips, tongue throat and lungs have not changed. I went to doctors office n was told it's a neurological affect from the Pfizer vaccine but felt he was blowing me off. It was not my regular PCP. He said to take 25mg of benedryl 2x a day for about 4 days and follow up with regular PCP there. Then as I was leaving, I heard him making comments n laughing.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 07-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On unspecified dates, the vaccine had two temperature excursions; one for 48 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another one for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a retired nurse via call center representative and described the occurrence of discomfort in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced discomfort, pruritus, fever and prostration. The patient was treated with ibuprofen. On an unknown date, the outcome of the discomfort, pruritus, fever and prostration were unknown. It was unknown if the reporter considered the discomfort, pruritus, fever and prostration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine in right deltoid, and experienced continued discomfort and itching, extreme prostration. She reported after both doses of her SHINGRIX vaccines, she had a temperature of 103 degree F, even after taking ibuprofen. She did not know lot number, expiration date, and/or did not provide other details at the time of initial chat. For tolerance after 2nd dose of SHINGRIX, refer case US2018219535. Lab Comments: On unknown date, body temperature was measured.
Looks like Arthus- type reaction to the tetanus component of the DTaP vaccine- area of induration/ erythema in right thigh 48 hours after vaccine.
chills and achy joints    repeated again the next night without the achy joints but with diarrhea
Adminstered vaccine at 12 noon. At roughly 12:03pm the patient started experiencing signs of syncope. She had pale blue lips, ringing in ears, changes in vision/blurry vision, she felt dizzy/light headed. The symptoms began improving at roughly 12:10 and had almost completely resolved by 12:15. I kept the patient for an additional 15 minutes for monitoring. I counseled patient on what to do if they felt as though they were going to pass out. I provided a cold compress for the back of the patient's neck, and had ammonia inhalant on standby but didn't have to use to help keep patient conscious.  By 12:30 the patient was feeling completely normal again. Her mom/stepmom was with her and was able to drive her home. I asked them to reach out in case of any other symptoms developed.
Extremely sore muscles and body aches. Chills/shivering. Very very bad headache
extremely cold hands; warm feeling on face; spot grew to about the size of a baseball; warm to touch; red spot at the injection site; painful to touch; mild pain in her left arm; A report was received from a consumer who is patient's husband. The consumer reported that his wife, 41 years old female patient was participating in the mRNA-1273 Emergency Use Program and experienced Pain - Left Arm, Red - At Injection Site, Swelling - At Injection Site, Painful to Touch - At Injection Site, Warm to Touch - At Injection Site, Warm Feeling on Face, Extremely Cold Hands.  No relevant concomitant medications were reported.   The patient received their first planned dose of mRNA-1273 on 12-JAN-2021 in her Left upper arm.  The patient had some mild pain in her Left arm the same day she received the Moderna COVID-19 Vaccine. Also when she woke up on the day of 19-JAN-2021 with a Red Spot at the Injection Site and reported that it was Warm and Painful to Touch.   On 20-JAN-2021, the spot on her arm grew to about the Size of a Baseball and continued to be painful and hot to touch. The spot on her  arms has not changed from 20-JAN-2021 to today 21-JAN-2021 and reported that she developed a Warm Feeling on her Face and Extremely Cold Hands.  No treatment information was provided.
Inadvertantly received Pneumonia vaccine as a Tb test indradermally.  Within 20 hours developed hot painful, swelling area around size of golfball on forearm that developed into cellulitis requiring hospitalization with IV antibiotics and dressing changes within 48 hours of vaccine administration.  Still on treatment ll days later and may require surgical debridement of site later next week.  10/21/08 Reviewed hospital medical records of 10/3-10/5/2008. FINAL DX: no d/c summary available.  H&P states LUE cellulitis s/p inadvertent SQ injection os pneumococcal vaccine, failed oral antibiotics Records reveal patient experienced immediate injection site redness, swelling & pain.  Had received pneumo vaccine via ID on 10/1/08.  RTC on 10/2 & tx w/oral antibiotics but condition worsened & developed chills & red streaks up the arm.  Exam revealed well demarcated large raised red area on volar aspect of left forearm w/central bullous formation, exquisite tenderness, red streaking up the arm to the axilla.  Tx w/IV antibiotics, pain meds & warm compresses.  ID consult done. Improved & d/c to home on continued antibiotics.
Narrative:  73 YOM with hx of HRN, BP, GERD, T2DM, elevated LFT, diabetic neuropathy, carpal tunnel, PTSD, ED, hypercholesterolemia, prostrate CA died at outside hospital on 6/21/21 from apparent cardiac arrest. Pt received COVID vaccine doses on 2/14/21 and 3/13/21. Death was unrelated to vaccines.
Patient is an employee and he received 2 doses of the Pfizer vaccine  1st dose at Hospital on 1/19/2021 and 2nd dose at clinic on  2/09/2021. Patient tested positive for COVID-19 on 7/27, @ a pharmacy testing site. Patient is severely immunocompromised, is on Mycophenolate for anti rejection of a kidney transplant in 2009
Severe headache immediately after receiving H1N1 injection. BP 90/60 Headache subsided in 20 min No breathing problems.
WHEN SHE WOKE UP ON THE 16TH I NOTICED REDNESS AT THE SIGHT OF THE Dtap SHOT. I GAVE HER TYLENOL BECAUSE SHE HAD A SLIGHT FEVER. ON THE 17TH I NOTICED THE AREA OF THE SHOT IS RED(ABOUT THE DIAMETER OF A GOLF BALL MAYBE A LITTLE BIGGER) SORE TO THE TOUCH AND SWOLLEN.
Reactions - no immediate reactions but at 05:00 that day - the pain at the injection site was 2. March 4th at 05:00 am - pain was an 8 on left arm. 99.4 was my fever - I was achy and very fatigued. At 08:00 am still the same as 05:00 am. 09:00 am still had temperature and I was achy but not as fatigue. 08:30 pm - pain at injection site was 2 and achy and very fatigued that night. I had a temp. 3/5/2021 - more normal with temperature and no aches or pains. 5/17/2021  ER and 5/18/2021 - at hospital for chest pain and temperature of 99. Diagnosed me with Pericarditis and three artery blockages. (They didn't officially admit me but just observed me within 24 hours).  COVID symptoms: I went on August 11 around noon - all of a sudden felt sick - it was very low pressure which affects my sinuses and all. My taste went down for 5% for 2 seconds and then nothing after that - it's still like that; And then no sense of smell - and no that is between 0-5%; dull headache; congestion; runny nose and eye pain. I kept on eye at it at first. 8/16/2021 - Tasted 0 and smell - headache wasn't as bad; congestion had blood in the mucus (on the 17th, I had more blood in the mucus, too). But my eye doctor also had started me on Restasis - causing eye burning and I stopped it and the blood in mucus stopped. August 13th - called the doctor on 8/12/2021 - he gave me a prescription for a COVID test - and we scheduled a telehealth on 8/13 - and he said I could take the COVID test that day but they were closed by noon and I went to Urgent Care, that day - and I had results on Saturday. 14th, - negative results.  I went to the Ear, Nose and Throat doctor on Thursday, August 26th. He diagnosed me -after doing a  scan up the sinuses - moderate nasal polyps on the right side. He put me on Xhance Nasal Spray for polyps; Prednisone and Z pack; and he ordered a COVID antibodies blood test (SARS COV2 AB IGG Spike, semi QN) - result was greater than 20H - positive for antibodies. I had problems with the Prednisone - I finished the 9 day course of treatment on the 4th and I had withdrawal symptoms. While I was on it I had high anxiety.  On Monday,  I had wave of total body debilitating pain and couldn't lift my arms - for about 20 minutes. My condo has a water leak and I had to move to a hotel and that happened at the hotel.  About 20 minutes later, the pain passed and went away.   I went to ENT doctor  today- polyps didn't change. So I go back next Thursday to discuss doing the Polyp surgery or doing a trial that would last 3 to 4 weeks. (They would inject something up there and it would release the polyps over a length of time). I will most likely get surgery. The pericarditis - unknown as far as if I'm recovered or not.
Miscarriage/D and C.11/10/2009 MD and hospital records for 11/4 and 11/5-2009. Patient nine weeks pregnant, transvaginal US noted no FHT. Scheduled for D&C 11/5/2009. DC DX S/P suction D&C.
Information has been received from a physician concerning a female patient who was vaccinated with a first dose and second of Gardasil.  Subsequently the patient fainted after the first injection.  Unspecified medical attention was sought by the patient.  Subsequently, the patient recovered.  It was reported that patient did not experience any adverse events after the second vaccination.  Additional information has been requested.
a recurring and debilitating headache; Stuffiness in ears after both doses; Arm swelling; Arm soreness/ soreness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), HEADACHE (a recurring and debilitating headache), PAIN IN EXTREMITY (Arm soreness/ soreness in right arm) and EAR CONGESTION (Stuffiness in ears after both doses) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0022C21A and 051C21A,) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling) and PAIN IN EXTREMITY (Arm soreness/ soreness in right arm). On an unknown date, the patient experienced HEADACHE (a recurring and debilitating headache) and EAR CONGESTION (Stuffiness in ears after both doses). At the time of the report, PERIPHERAL SWELLING (Arm swelling), HEADACHE (a recurring and debilitating headache), PAIN IN EXTREMITY (Arm soreness/ soreness in right arm) and EAR CONGESTION (Stuffiness in ears after both doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-270799 (Patient Link).
This spontaneous report was received from a 67 year old female patient concerning herself. The patient's medical history included back issues. The patient had allergy to unspecified anti-inflammatory medications and Selective Serotonin Reuptake Inhibiting Drugs (SSRI's). On 20-SEP-2013 the patient was vaccinated with PNEUMOVAX23 one shot dose in her upper right arm (route not provided). There was no concomitant medication. The patient reported that after she had received the PNEUMOVAX23 she experienced several adverse experiences. She stated that on 2-SEP-2013 she had excruciating pain in her right arm, her right arm was immobilized, she could not raise her right arm, and the muscle in the arm was experiencing extreme pain. On Friday night and Saturday on 20-SEP-2013 and 21-SEP-2013, the patient experienced soreness and tenderness in her shoulder joint. At the time of the report, the patient still had a twitch in her arm, weakness and momentary pain. The patient was using warm/wet compresses on her arm as treatment for the adverse events. There were no laboratory tests or diagnostic studies performed. The patient's outcome from she could not raise her right arm/her right arm was immobilized, soreness and tenderness in her shoulder joint and the muscle in the arm was experiencing extreme pain was unknown. The outcome of excruciating pain in her right arm/momentary pain, weakness and twitch in her arm was reported as not recovered/not resolved. The patient sought medical attention by speaking with a pharmacist. Additional information has been requested.
This spontaneous report as received from a male pharmacist (via a company representative) refers to himself. On an unknown date reported as a couple years ago when the patient was approximately 65 to 66 years old the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously. On an unknown date the patient experienced an injection site rash. Pharmacist described the rash as similar to chicken pox. Pharmacist was fully recovered on an unspecified date. The causal relationship was not reported. Additional information is not expected.
Approximately 3 hrs after receiving shot, had sudden severe asthma attack. Felt fatigued, increased body temperature, and headache for the next day and a half.