chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After each shot, there were no immediate reactions as decribed in the anthrax handout.  But in late Feb 2004, a few months after receiving my sixth shot, I started to have sharp pain in the right hip but it eventually went away. At that time I considered it more related to resuming an exercise program to prepare for the fitness test.  In June 2004, pain started in the right knee which has never completely gone away.  These pains were occasional in nature and easily remedied with over the counter pain medication. In Jan 2005, I started to get random pains in my chest that were concentrated along the breast bone but radiate accross the chest and under the arm.  At that time I was deployed where an EKG was accomplished to rule out a cardiac problem.  Also at this time, the knee pain was persistent as well as occasionally the hip pain.  I was prescribed 800mg Motrin at that time which seemed to take care of the problems. In early May 2005, pain started in my neck.  It seems isolated to the top of the spine or base of the skull and never completely goes away even with 800mg of prescribed Motrin.  This was followed closely with pain in both shoulders.  On 11 May 2005, I went to Sick Call for the pains in my neck and was given 800 mg Motrin.  It did not completely eliminate the pain. On 6 June 2005, returned to clinic.  The neck pain was increasing and additional pains were developing in both wrists, both kness, both ankles, both elbows, and the pain in both shoulders was now constant.  The physician prescribed 15mg Mobic and ordered a series of blood tests.  The Mobic helps eliminate about 80% of the pains but not all of them. The pains do not seem to limit range or movement or strength, but they are always there.  Also, changing positions whether sitting, reclining, or standing of the limb does not provide releif from the pain. On 14 June 2005, I returned to clinic.  At this time, I was given a referal to Internal Medicine for a follow up.
Covid19 breakthrough.  1st vaccine received on 04/29/2021.  74 y/o with PMH IBS, Fibromyalgia, GERD, Type 2 DM, OSA, HTN, HLD, DVT, Pulm fibrosis presents to ED via EMS for c/o SOB, Cough x2 weeks.  CXR worsening diffuse interstitial opacities, requiring O2 at 4L NC-sats 93%, afebrile.  Started on IV ABX, IV Steroids and Remdesivir.
Patient is very red around the area of injection. It is a large red area, swollen possible infection per Dr pt went to see-got antibiotic to treat-Black and blue at site of injection.
This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, general body pain and queasy. On an unknown date, the outcome of the headache, general body pain and queasy were recovered/resolved. It was unknown if the reporter considered the headache, general body pain and queasy to be related to SHINGRIX. Additional details were provided as follows: This case was reported via a live click to chat. The age at vaccination was not reported. But, it could be 63 or 64 years old. The patient experienced headache, body aches (was achy) and general queasiness. For tolerance after the 2nd dose of SHINGRIX, refer US2018GSK115521.
Information has been received from a physician concerning a 9 week old health white male with no known allergies who on 03-NOV-2006 was inadvertently vaccinated SC in the left upper arm with a 0.5 mL dose of Varivax instead of Prevnar. Concomitant vaccination included "all the other typical 2 month pediatric vaccinations." There was no known illness at the time of vaccination. Unspecified medical attention was sought. The physician confirmed that this was not product confusion, just staff error. The baby experienced a 102 degree fever 1 day post vaccination which resolved that day or next. No other labs or diagnostic tests were performed. The baby has been symptom free since then. There was no product quality complaint involved. It was reported that the patient and his siblings have not had adverse events following prior vaccination. No further information was provided. Additional information is not expected.
dull, nagging headache that is in the top of her head that is moving down; She does not feel the way she normally feels.; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history included unspecified surgery on an unknown date in Dec2020. Patient was on low dose aspirin 81mg from a surgery. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication. On an unknown date, patient woke up with a dull, nagging headache that was in the top of her head that was moving down. Patient did not feel the way she normally feels. The clinical outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous prospective pregnancy report as received from a consumer, for GARDASIL a pregnancy registry product, concerning a 27 year old female patient with erythromycin allergies/ erythromycin reactions and none pertinent medical history. The patient received a first dose of an unspecified HPV vaccine "a little over a week ago (approximately 2013) and might possibly be pregnant." The patient became pregnant. The LMP and EDD were not known. The pregnancy outcome was outcome pending. Consumer stated "he thought the patient (his girlfriend) was at the end of menstrual cycle now" and "the patient (his girlfriend) received GARDASIL, intramuscular, injection 120Y (lot number not provided) in approximately 2013 because she had a positive HPV test." No concomitant medication. No sought medical attention. No treatment was given for AE. No lab diagnostics studies performed. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In approximately August 2015 (reported as since 06-AUG-2015), the patient had been administered doses of improperly doses RECOMBIVAX HB lot # K014548, expiration date reported as 27-AUG-2016 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-JUL-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 3 times with the following lowest recorded temperature: 34F (1.11 celsius degrees) for 88 hours, 32 F (0 celsius degrees) for 120 hours and 33 F (0.555 celsius degrees) for 40 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient was given kinrix however was not due for DTap or Polio. Patient exhibited no adverse reaction. Patient will be monitored.
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medications was provided. No treatment medications was provided.
Muscle aches all over, low grade fever (100), upset stomach, & tiredness.  Lasted for 24 hours, then back to normal
Right after vaccination, patient felt itching, flushing, sweeling of skin/tongue, throat tightness, nausea, anxiety, sweating, and difficulty swallowing.  (BP 180/100 HR 96) Patient took 25mg of benadryl and was seated for monitor about 30 min until symptoms were improved.
Soreness in shoulder/neck/back/arm on the injected side of body (right side). No worse than annoying, but enough to make me avoid any heavy lifting or other physical exertion with that arm (or turning my head too far). The pain started decreasing after about two weeks, and was mostly gone in around a month.
This spontaneous case was initially received on 14-Oct-2015. The case report was received from a Non Health Professional and concerns a 54 years old patient with unknown gender. Weight: not provided, Height: not provided. The patient received Flu shot (Influenza Vaccine). Additional suspect drug: PNEUMOVAX. On an unknown date, after starting treatment with Flu shot the patient experienced soreness in the arm where the vaccines were administered. Reporter's assessment: none stated.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 16-year-old female patient who received BEXSERO. Concomitant products included Hepatitis A vaccine and MENACTRA. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain, nausea and dizziness. On an unknown date, the outcome of the injection site pain, nausea and dizziness were unknown. It was unknown if the reporter considered the injection site pain, nausea and dizziness to be related to BEXSERO. Addition details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient experienced nausea, dizziness, and left arm (injection site) pain after receiving BEXSERO vaccination. On the same day, the patient also received MENACTRA and Hepatitis A (unknown manufacturer) vaccination in right arm. The patient's date of birth, initials, date of vaccination and adverse event onset date were unknown.
Patient was meant to receive the Pfizer bivalent booster but received the monovalent by mistake. Pfizer drug safety report reference number D3VH0R6L
Initial and follow-up information has been received from a physician concerning a 14 year old male who on 29-AUG-1996 and on 03-NOV-1999 was vaccinated with the first dose and second dose of MMR II, respectively. On 22-DEC-2009 (also reported as on 02-JAN-2010) the patient experienced left mumps. On 24-DEC-2009 (also reported as on 04-JAN-2010) the patient was diagnosed with mumps. The patient was afebrile (also reported as the patient had a fever of 102F). The patient also had one day of swollen neck, vomited 2 days x 3 and felt weak. The first blood work was done on 04-JAN-2010 (also reported as on 24-DEC-2010) and the results indicated IgM<1:10. It was reported that the patient's cousin also had mumps. At the time of the report, the patients outcome was unknown, this case was non-serious. Additional information has been requested.
Fever 100 degrees, aching joints, sore muscles, shortness of breath, lethargic, abnormal blood sugars
60 yo female with PMH of hypothyroidism, overweight, osteopenia, basal cell carcinoma, hep C, alcohol dependence, and schizophrenia reported having a mild rash on uppper thighs that lasted one day after her first dose of covid-19 vaccine, 2/8/2021. Pt reported this ADR on 3/1/2021 when she came back for his second dose. Both were administered without complications & RASH ON THIGHS
Pt had pain and redness at the injection site after receiving the injection on 5/15/18. The pain subsided midday on 5/17/18 but the redness has gotten worse. The redness has spread down towards the patient elbow. He does not report pain at this time, but the redness is an issue of concern as it has gotten worse. Pt is starting to take BENADRYL 25 mg.
Patient received vaccine , waited about 5 minutes and then passed out for about 5 seconds. She did not fall on the floor nor hit her head. She reported no adverse reaction  from any previous vaccines but she reported she hadn't eaten all morning and she had a fear of needles
Patient arrives to observation at 12:40 following feeling lightheaded and sweaty after receiving the vaccination.  BP 100/63 HR 75 oxygen sat 100% on room air.  She was given some gold fish crackers and water.  12:55 BP 105/75 HR 82 Pulse oxygen 100% on room air.   patient stated she feels better and was escorted to the exit in a wheelchair and was with her husband.
First dose (6/2/03)-nausea and vomiting Second dose (6/5/03)-nausea and vomiting; inflammation at the injection site Third dose (6/9/03)-fever 104 (controlled with Tylenol); vomiting; hallucinations-room full of water with sharks (secondary to fever?)
Patient received covid vaccine on 5/11/23 and reported feeling fatigued the next day.  Patient's wife reported patients increased fatigue throughout the next couple of days where he could not get out of bed. Patient was admitted to the hospital on 5/15/23 where he was diagnosed with bronchitis and degenerative neuro system. The patient passed away on 5/28/23.
The child's mother reported to the Nurse Site Supervisor at some point, days following the vaccines; reporting the child's leg was swollen. No additional complications/concerns reported. Immunization nurse called the Patient's Mother on 3/2/16 for follow up. At that time, the Mother shared her daughters legs (at administration sites) were swollen and tender for a few days after her appointment. No additional signs/symptoms reported. At this time the swelling was resolved. The parent declined initial f/u with PMD as she did not feel it was needed.
Chronic urticaria from January 31, 2022 to present. Scalp, face and body covered in hives every day; multiple times a day. Excessive itching/burning sensation.
Pulmonary embolism on 5/26/21 - tested positive for Covid in emergency room after diagnosing pulmonary embolism.  No symptoms of Covid until lung pain from embolism began.  Hospitalized for 3 days treating PE and prescribed blood thinners for at least 6 months to prevent potential reoccurrence.
Started to itch 1/12/21. Today, 1/13/21,  it is red with a little lump under the skin. Doesn't hurt.
Information has been received from a consumer concerning her 14 year old daughter with sulfonamide allergy who on 26-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine. At the same time the patient was vaccinated with the second dose of varicella virus vaccine live (MSD). The consumer reported that the patient had blood drawn for routine blood work after receiving the vaccinations and the patient fainted approximately 20 minutes immediately after the blood was drawn. Subsequently, the patient was recovered. The patient sought unspecified medical attention at the office. Additional information has been requested.
On 03/11 I received 1st shot of Moderna COVID-19 Vaccine EUA,  after about 8 mins I became very light headed and short of breath after about 10 mins.  I felt a rush come over my body followed by rapid heart beat. These symptoms lasted about 2 mins then subsided. I really didn`t want panic everyone  or go to the hospital all I wanted was fresh air so I left, admittedly not my smartest move but I knew my doctors office was right across the street.  After 24 Hrs. still Light Headed, no breathing issues, heart rate normal  sore arm no rash.
THE Night of the injection a fever developed.  Severe fatugue and feeling sick. After two days this subsided but had impacted my immue system enough to cause a relapse of Babesia to the point where I had encephalitis.  The encephalitis caused confusion and reduced mental ablity to the point where I had to leave work and go on short term disablity which am on still.  The people administering the vacine asked me if I was immune compromized and I told them YES. They asked why and I told them Lyme Disease. They administered the Vaccine any way.
So it felt like a bad cold. I had some coughing (more so at night). I had to sleep on 2-3 pillows to keep my head elevated. I took NYQUIL and DAYQUIL along with PAXLOVID. I felt tired and run down. This all started on June 26th and I tested positive through July 16th. I was still able to exercise but not to the extent I usually do. It was like a bad cold. I never had a loss of sense of taste or smell. I didn't have any stomach issues. It was mainly congestion, postnasal drip. Most nights I would have to have a cough drop for sleeps sake. I was able to keep working from home, which was great. It did not seem debilitating at all, just an annoyance.
DEATH ON 1/4/2021, RESIDENT RECIEVED VACCINE ON 1/2/20
I was not feeling good after the shot. Nothing specific. Then the cold hit around 11/12/2021. I was not feeling good. I felt run down. It was a nasty cold that did not want to go away.  I do not know if it has anything to do with the vaccine. I am pro-vaccine. 11/19/2021- that is  when the pain started in my left shoulder and arm. The burning and firing pain. It was 2 days later when the lesions started breaking out. 11/30/2021 and 12/07/2021 I went to the doctor. The doctor diagnosed it as shingles. I talked to the nurse during the week trying to control the pain. The nerve pain that it causes is the most excruciating pain and its all the way from the center of my neck, it wraps around the left side from my spine to the center of my chest. I had lesions are on my fingertips. It feels like my fingernails are going to come off. The worse pain radiates from the shoulder. The pain is called PAN. The doctor increased the gabapentin and added the carbamazepine 200 mg twice a day and increased the dosage on hydrocodone. I would not say that it was the shot. It is just the incidental things that have happened since the 3rd dose of Pfizer. As of today, 12/14/2021- I am still under the care of a doctor for the pain of the shingles. The lesions are healing.
I experienced flu-like symptoms that began around 6 pm day of shot and lasted throughout the night and into the next day. Had headache, chills, back pain and ended up sleeping over 12 hours.  I don't know if I had a fever as I did not have a thermometer.
Intense nausea and stomach pain. The nausea started around 5pm and intensified all night, keeping me from being able to sleep. It slowly subsided leaving me uncomfortable for the next two to three days before it went away completely.
Case number PHEH2014US024279, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 52 year old female patient. Medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. No further information was provided. Follow up received from nurse 21 Jan 2015: updated site of vaccination and reporter comment.
Joints are in pain; I cannot moved normally/ I can not do any job with my hands; This is a spontaneous report from a contactable consumer. A 58-years-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via unspecified rout of administration on an unspecified date (at the age of 58-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joints are in pain and can not moved normally. It was reported that "after my second doses of the covid vaccination my joints are in pain. My blood test are fine but I can not moved normally. My joints are in pain even after a take a pain medicine. I am 58 years and never had any conditions to be worried but is been 6 month after my shot that I can not do any job with my hands". Treatment for joints are in pain was given. Outcome of the events was not recovered.   Information on lot/batch number has been requested.
I was given a full dose for my booster due to my chronic illness. It started with an eye twitch that would happen three-four times a day. After about five day I would start getting the eye switch that would spread down my face to my mouth. It was on my left side and it would last for about 30-45 seconds and happen up to a dozen times a day. I also was experiencing chest pains that would last for about 30 seconds at a time. The chest pains and the twitching was not necessarily paired together with each episode. After about 3 weeks I had an appointment to see my doctor and she referred me to see a neurologist. I saw the neurologists on 04/13/2022 did an extensive exam and he recommended an MRI because he thinks I have Bell's Palsy. On 04/28/2022 I had an MRI which came back normal. I have a follow up appointment in 10/2022.
Four weeks after the vaccine I started to have lower abdominal pain for a 24-hour period. I am on Birth Control, Falmina and it was before the Placebo Pills Started. I passed a large clot  of blood the next day and went to Urgent Care. It was sent for Pathology and it was deemed a Deciduous casting. I had a Pelvic Ultrasound the following week and it was normal. The clinic I went to for follow up was.
12JAn94 low grade fever during the day & by evening 11PM to 1AM t103; lt thigh (inject site) was red, swollen & hand; warm bath & pt given APAP;
2 urticarial like lesions on either side of the mouth (like clown makeup). Child is otherwise fine.
11 x 19 cm raised, red urticarial-appearing patch upper outer L arm at site of Tdap immunization mile excoriation at lower edge.  BENADRYL 25mg @ hs
approx 1hr p/vax dizzy whil walking in store, held on to dress rack for support, no fall, dizziness resolved p/15min;no SOB, no further episodes reported as of 11/17/99;
Heart rate from 58 that went up to 90; A spontaneous report was received from a nurse, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart rate from 58 that went up to 90.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date in Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date in Dec 2020, the patient experienced a heart rate from 58 that went up to 90. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, heart rate from 58 that went up to 90, was reported as resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.