chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 1/2 day following immunizations 2 days after immunization - redness, swelling, pain on right arm at site of MMR. Spontaneous resolution of symptoms by 3 days following immunization.
The patient received a Janssen COVID vaccine on 4/8/21 at around 5:00 pm.  The patient was nervous during the administration and reported never receiving a flu vaccine in the past.  The common side and serious side effects were discussed with the patient.  The vaccine was administered to the patient without issue.  The patient and husband instructed to wait 15 minutes after the administration of the vaccine as is the recommendation per the CDC.  About 5 minutes after the administration of the vaccine, the patient's husband notified the pharmacy staff that his wife was not felling well.  Pharmacist responded to the patient.  The patient reported shortness of breath and feeling hot and stated she was about to pass out.  Pharmacist was instructed to retrieve the Epi-Pen from the immunization cart and assist.  Code White was called and Division 1 staff responded and assisted.  The patient was lowered to the ground and her feet were elevated.  It was at this point that it was determined that the patient was not experiencing anaphylaxis based on the symptoms she was reporting and exhibiting.  The patient was instructed to remove mask to help obtain better breaths and remove the patient from hyperventilation.  An icepack was obtained and placed on the patients neck once she was able to sit up.  The patient's symptoms improved to the point of moving to a chair.  The patient sipped water and continued deep breathing.  The patient's symptoms continued to improve and she was able to leave.
Flushing, shortness of breath, back pain after flu and pneumonia shots approximately 503 pm. EPIPEN given at 5:06. Breathing improved. Paramedic arrived at 5:15 pm.
This spontaneous report was received from a health care worker state immunization official regarding an unspecified number of patients of an unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route, lot number and expiration dates were not provided). Concomitant medication was not provided. No symptoms reported. This is one of two reports from the same (source MARRS #1504USA005150). Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-JUN-2015 the patient was vaccinated with two improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 mL (lot # H017304, expiration date 11-JUL-2015, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion twice. The first cumulative excursion time and lowest recorded temperature was 16 hours, 33 Celsius degree. The second cumulative excursion time and lowest recorded temperature was 64 hours, 34 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
States that he received the shingles and covid vaccines last Wednesday.  Had symptoms one hr after the vaccines for 12 hrs of chills, SOB, and weakness.  The next day, he started with stiffness, and muscle fatigue in neck and shoulders bilaterally.  He then noticed the rash on the 23rd. Is still feeling off with his breathing, has COPD but seems worse than normal. Had little cough and mucous couple days ago but gone now. Just still feeling sob. .  Has been worse since the vaccines.  No warmth.  Some itchiness.    Rash on both arms, notes on back. And some itching.
Arm turned red and developed a rash that lasted several days. The arm is still discolored as of Dec. 28, 2018 and has a general feeling of malaise in that arm.
Acute hepatitis. Transit and now resolved. Chest pain admission 11/17/05 likely related, non cardiac cause as final diagnosis. Medical records include pharyngitis, bacterial infection . msv
I had sore arm for whole week after shot. It felt sore and achy. But got better as time passed. However, on April 11th arm felt itchy and my arm was red at injection area. I could see a small round visible bump or welt at injection site and about an inch and a half down there was a crescent moon flat like lump or welt. It felt warm and I could tell it was affecting my circulation. So I decided to rub it kinda hard. And massaged my whole arm. Afterward I could feel that must?ve helped. Because my arm started twitching from the shoulder my hand then my forearm. I finally fell asleep and the next morning the swelling was gone along with the redness. But it?s sore of course from my rubbing. Circulation is way better. So I hope that?s it. And no other problems occur.
enlarged lymph nodes over the right side of the body and not painful; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Sore arm) and LYMPHADENOPATHY (enlarged lymph nodes over the right side of the body and not painful) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Breast cancer left side).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Sore arm). On an unknown date, the patient experienced LYMPHADENOPATHY (enlarged lymph nodes over the right side of the body and not painful). At the time of the report, FATIGUE (Fatigue) and MYALGIA (Sore arm) outcome was unknown and LYMPHADENOPATHY (enlarged lymph nodes over the right side of the body and not painful) had not resolved.            Concomitant product use was not provided. Patient had visited the health care physician who recommended patient to do ultrasound of the neck. Treatment information was not provided   This case was linked to MOD-2021-220848 (Patient Link).
25APR96-DT lt deltoid severe swelling,erythema to mid forearm,deltoid&suprospintive;also w/total body myalgias,fever (unmeasured)
pt recv vax; devel a rash & fever of 103-104;sx resolved subsequently;
Pt. states that after receiving the 1st dose of J&J 10/08/2021, started experiencing symptoms that evening of fever (101.), vomiting, chills, night sweats, fatigue, nausea, shortness of breath, and chest heaviness. Emergency Room visit 10/13/2021 (Blood Work *Normal) treated with Steroids *allergic reaction to vaccine, Benadryl. No noted Primary visit. Still continuing to experience symptoms.
4/23/21 - His oxygen saturations are low enough to start steroids and remdesivir.
On 1/19/2000 I began getting very cold and could not get warm. I went to bed and woke up during the night sweating as if I had fever and it had broke. I had a sudden onset of hoarseness and coughing that lasted throughout 10/20/2009. At approximately 7:00 PM I felt exhausted and my sides were aching. I felt so bad that I went to bed early. I woke up at approximately 6 AM  on 10/21/2009 with my eyes very sore to touch and they were swollen shut. My entire face was swollen as was my hands. I immediately took a Benadryl. I was seen by Dr. I advised him of the flu shot I was given and all of my symptoms. He tested me for the flu which was negative and confirmed I had a reaction and gave me a steroid shot.  As the day has gone on I  have gotten very pale and my heart is racing. I am wondering now if I need to go back to the doctor.
Body aches starting within hours, general feeling of malaise, possible gastrointestinal distress. Symptoms are still being experienced 13 days later.
MA administered the Pfizer COVID-19 Vac Bivalent 16 hours after the vial was punctured. Vial was stored appropriately and was never out of temperature range.  No issues reported from patient at this time.
The vial was initially stored in refrigerator on 05-Dec-2022 and was administred on 09-Jan-2023; No Adverse Event; Patient received dose after the 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Dec-2022 and was administred on 09-Jan-2023) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Dec-2022 and was administred on 09-Jan-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Dec-2022 and was administred on 09-Jan-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after the 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Dec-2022 and was administred on 09-Jan-2023).    No concomitant medications were reported.   The vial size was 2.5 milliliter. The vial was initially stored in refrigerator on 05-Dec-2022. The vial did not undergo any temperature excursion.  No treatment details were reported.   This case was linked to MODERNATX, INC.-MOD-2023-696087 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-696087:Patient 7 out of 8 Patients
This is a spontaneous report from a contactable consumer who reported for herself. A 65-year-old  female patient received PREVNAR 13, intramuscular in the right arm on 31Oct2017 at 0.5 ml, single to prevent pneumonia, and FLUZONE, intramuscular injection in the left arm on 31Oct2017 at unknown dose for immunization. Medical history included ongoing Hashimoto's disease diagnosed in 1998, double pneumonia about 12 years ago and heart palpitations. Her gastroenterologist wanted her to get the flu and pneumonia shot. Concomitant medication included ongoing atenolol since 1998 for heart palpitations. The patient had no family history. The patient previously received FLUZONE for immunization, which she gets every year, and after having double pneumonia she had the first pneumonia shot, but not PREVNAR 13. The patient also had a shingle vaccine that was hard. This was 4 or five years ago. She had redness and stuff. The patient did not have the current symptoms and did not last as long for the shingle vaccine. The patient reported that she got the the pneumonia shot last Tuesday and began to have some problems a little bit after and is still having some. Two days after on 01Nov2017 around 14:00, she got the chills and almost a 103 degree fever clarified as she got the chills and her fever was at 102.5 degrees Fahrenheit. In the late afternoon on 02Nov2017, reported as about 48 hours later it was so swollen, she had redness and swelling that was about 6 inches long from the injection site and 5 inches wide and itching. It is no longer all hard, but it was still red and had all the itchy bumps. She clarified that she had itchy bumps to the injection site area but that the itching is getting worse and has spread to her whole right arm and lower part of arm, top of her neck area, and back on an unspecified date. The itchy bumps are just to the injection site area that is red and swollen. The itching has been more in the last few days.  It is still red, but the mobility is better than it was, the swelling is not as intense. She stated that she can raise her arm up but it was so swollen and painful to raise it up or lay on it on an unspecified date. This has improved, she can lift it. Neck stiffness happened, Friday, 03Nov2017, around 12:30. It was further reported that maybe on Saturday she had a 100 degrees Fahrenheit fever, but has not had a fever since. The patient did not undergo any relevant tests. The patient wanted to know how much longer could the reaction be. The events did not require emergency room or physician office visit. The outcome of the fever was recovered on 04Nov2017 while the itching/itchy bumps at injection site was not recovered. The outcome of itching getting worse and has spread to her whole right arm and lower part of arm, top of her neck area, and back was unknown, while the outcome of the remaining events was recovering.
48 hrs after receiving DTaP- left upper arm swelled & reddened, Tender to touch
Test: Covid-19, Result: Positive; Test: Covid-19, Result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 14:45 (Batch/Lot number: unknown) at the age of 21 years as dose 2, single and administered in arm left, administration date 07Apr2021 14:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history: Depression; "anxiety" (unspecified if ongoing), notes: other medical history: anxiety; "IUD" (unspecified if ongoing), notes: other medical history: IUD; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "known allergies: any cillins" (unspecified if ongoing), notes: known allergies: any cillins. Concomitant medication(s) included: PAXIL [PAROXETINE HYDROCHLORIDE]; BUSPAR; ACETAMINOPHEN; TYLENOL. Past drug history included: Amoxicillin, reaction(s): "Allergy: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "unknown" and all described as "Test: Covid-19, Result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive, notes: Nasal Swab. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient has been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from an other health professional refers to a currently 15 year old patient. On an unknown date, the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. On an unknown date, the patient experienced inappropriate schedule of drug administration. No adverse effects were reported. The outcome of inappropriate schedule of drug administration and no adverse event was unknown.
PATIENT REPORTING SORENESS AND ARM PAIN IN LEFT VACCINATED ARM SINCE GETTING VACCINATED
Felt nauseous, a minute later, dizziness and lightheaded, the result ending in fainting.
W/in several hrs of vax, pt woke up from nap, crying & had several episodes of vomiting; Felt warm, unusual crying episodes occurred that day; "eyes looked glassy"; sx improved p/24 hrs;
As expected, I was sore after the first injection, but waited until bedtime to take Tylenol. I did that in order to sleep better.  I did have a lot of stool prior to bedtime, but didn?t think much of it, as I had a lot of water, and thought it might be due to nerves and eating a larger dinner than typical. I went to work, had lunch, and shortly after had explosive diarrhea. I went to clock out, felt weak, and had another episode. I took immodium so I could drive home, had 2 more bouts, took one more immodium, and have not had more. I do feel tender, but am not running a fever. I presume this is not related to the vaccine, but was advised to let you know.
This spontaneous report as received from a healthcare professional refers to 2 unspecified patients. On 11-MAY-2015, the patients were vaccinated with doses of improperly stored (Oka-Merck) PROQUAD (lot # L002419, expiration date 27-JUL-2016, dose, route and site of administration were not reported). The temperature excursion was supported with in-house instability data. No adverse symptoms were reported. Additional information has been requested.
Immunizer may have hit bone and retracted needle which caused most of the volume of the liquid to be squirted out of patients arm
SEVERAL HOURS AFTER ADMINISTRATION, CLIENT BEGAN TO DEVELOP SWELLING OF RIGHT ARM WITH REDNESS AND WARMTH; SWELLING OF FACE PARTICULARLY EYES; NAUSEA WITH VOMITING,  CLIENT WAS TAKEN TO ER AROUND 8:00PM. CLIENT WAS GIVEN IBUPROFEN AND BENADRYL AND WAS TOLD BY ER MD THAT SHE HAD HAD AN ALLERGIC REACTION TO THE (MEN B) VACCINATION.
Shot received 8/27/09- 8/29- Severe sweats- Pain in lower butt. Could not sleep prone 9/1- Saw family M.D. - X-rays; Pain meds - Back to M.D. 9/4 - pain progressed to shoulders- whole back- V. severe - 9/9 ER -Bel. pressure mild/saw Spinal specialist- 9/11 -back to family DR. - 9/12 ER - admitted -to host - 9/13 kidneys scan - chem stress test -Aorta test - Neurologist called/Spinal Taps / IGIV - intravenous 5days 9/20-9/24 Diag as GUILLAIN BARRE Syn.  10/7/09 Rehab records received for dates 9/16/09 to 9/28/09. DX: Acute Demyelinating Polyneuropathy, Bells palsy, neuropathy, gait abnormality, CAD, back pain. Recently dx with GBS. Adverse event occured 8/29/09. Presenting SX: Pt c/o prior to admission pt was completely independent with ADL's now presenting with unsteady gait/ataxic gait pattern backpain after receiving influenza vaccine 2 days prior. Assessment: PE neuro (+)numbness, tingling, weakness.  ICD9 codes: 782.0, 351.0, 781.2, 357.0, 724.5, 357.0, 276.1, 401.9, 414.01, V45.82, V14.8, 781.2, 351.0, 272.4, 564.0, 780.93, V12.54, 427.31, V58.61   10/13/09:  Additional Medical Records (Cardiology Consultation) and Discharge Summary received. Date of Service 9/16/09 to 9/28/09 Dx:  Pain and weakness with AIDP/Guillian Barre. Carotid disease bilaterally less than 50%, hyponatremia, dyslipidemia, constipation. Cardiology consult:  Noted hematuria which resolved during hospital course and memory difficulty.  Pt. notes to cardiologist feeling of fatigue and chills.  Decreased breath sounds diffusely, bibasilar rales. 1+ pitting edema RLE.  Positive for focal weakness, sensory change, speech change. Parasthesia of left hand.  Worsening Bell's palsy on the right (patient is unable to close right eye). Decreased fine coordination RUE, hand.  Decreased coordination heel to shin LLE.  Decreased DTR both UE and LLE. Joint pain, myalgias and neck pain all positive.  Pt. treated with 5 doses of IVIG.  Condition at discharge afebrile, ambulating, eating, drinking, voiding and stable.
PATIENT BEGAN EXPERIENCING IMMEDIATE LIGHTHEADEDNESS, DIZZINESS, FEELING OF FAINTING AND STARTED BEADING SWEAT WITHIN MINUTES AFTER RECEIVING THE VACCINE. PATIENT WAS MONITORED WITH A COLD COMPRESS TO THE FOREHEAD AS WELL AS BOTTLES OF WATER TO ENCOURAGE HYDRATION. AFTER ABOUT 15 MINUTES PATIENT DECIDED HE WAS WELL ENOUGH THAT HE COULD STAND AND LEAVE WITH HIS SIGNIFICANT OTHER WHO THEN DROVE THE TWO HOME.
COVID Vaccine Breakthrough Case  J&J Dose 5/10/21 (lot NA) COVID Positive 12/3/2021  12/3/21: Patient is a 68-year-old male with history of peripheral neuropathy, COPD, chronic pain, present to the emergency department with a complaint of worsening shortness of breath since Tuesday.  Prior to Tuesday patient has been in his usual state of health.  Denies any fever or chills, since Tuesday he has been having some shortness of breath, reported cough, patient has been getting weaker, no fever or chills, symptoms keep getting worse hence his wife brought him to the emergency department.  He received COVID-19 vaccine Johnson Johnson in April, received flu shot, smokes half pack per day, history of COPD in uses inhaler as needed but no oxygen or. No obstructive sleep apnea.  Close contact with COVID-19 patient at home.  Patient was very tachypneic in distress, could not provide much history however his wife was present at bedside and was able to help.  He is full code.   In ED, Anion gap 20, lactic acid 3.7, proBNP 4883, troponin 0.05, fever, tachycardia, severe hypoxia requiring BiPAP.  Chest x-ray showed right upper lobe pneumonia. Patient was given 1 dose of Solu-Medrol, Rocephin and DuoNeb nebulizer treatment.  12/23/21: Patient is very comatose and noncommunicative, and respiratory distress. His wife is on bedside.  His condition has not been changing since yesterday. Patient deceased later that day.
pt recvd 1st dose of vax;on 29oct95 to MD w/ 70 varicella lesions on face, body & scalp; tx w/ dph & recovered;
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The patient received shingles shot for shingles and 3 months later patient experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Information has been received from a LPN concerning a male firefighter who on 12/02/2002 at 19:00 was vaccinated IM in the deltoid with a first dose pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  On 12/02/2002 at 19:00 concomitant therapy included an IM dose in the "opposite deltoid" of influenza virus vaccine (FLUZONE) (Batch # U0925AA).  Both doses were "given with a 25 guage, 1 " needle".  It was noted that 2 hours after receiving the vaccine, he spent the next 20 hours at a fire scene and was engaged at times in "heavy physical labor".  It was noted that the patient was unable to be contacted for a complete interview and the patient's fire department captain reported the symptoms.  On 12/03/2002 at 21:00 the patient developed pain, redness, swelling at the injection site, "induration from elbow to shoulder" and did not require medical care as result of this.  It was also noted that the nurse had suspected the "activity played a major role in their reactions".  The nurse also reported on 9 other patients that were vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (LOT #: 643251/0445M) and developed induration (WAES #'s: 0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02081).  No further information is expected.