chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills /shivering; Fatigue; sleepy; muscle spasms; headache; stomach doesn't feel well; This case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix .5 ml. On 16th January 2020, less than a day after receiving Shingrix, the patient experienced chills, tiredness, sleepiness, muscle spasm, headache and abdominal discomfort. On an unknown date, the outcome of the chills, tiredness, sleepiness, muscle spasm, headache and abdominal discomfort were recovering/resolving.   It was unknown if the reporter considered the chills, tiredness, sleepiness, muscle spasm, headache and abdominal discomfort to be related to Shingrix.  Additional details were reported as follows: The patient got the first dose of Shingrix and experienced chills, tired, sleepy, muscle spams, headache, shivering and stomach did not feel great. The patient did not consent to follow up.
Information has been received from a female consumer who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced swelling and bruising at the injection site. It was unspecified if medical attention was sought. No outcome was reported. No product quality complaint was involved. No further information is available.
Severe nausea, cold sweats, and severe dizziness which caused inability to comprehend or understand what was going on around me and almost loss of consciousness.  I was laid on the pharmacy floor immediately after reactions with a cold pack under my neck and my feet elevated. Within 5 minutes I was able to open my eyes and able to stand. I left with some dizziness and a headache that remained for a few days. I also had severe body aches for a couple of days and fatigue. Only thing is the arm pain and a little tiredness today.
Headaches described as migraine; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Headaches described as migraine) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 14-Feb-2021, the patient experienced MIGRAINE (Headaches described as migraine). At the time of the report, MIGRAINE (Headaches described as migraine) had not resolved and PYREXIA (Fever) outcome was unknown.            No concomitant medication reported.  no treatment drugs included  Patient mentioned that his headaches have not gone away and it's been more than 3 months.   This case was linked to US-MODERNATX, INC.-MOD-2021-073520 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Clinical information and outcome of the event updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073520:
foster parent states 30 mins past vax pt stated was sick to stomach; pt skin was flushed & warm to the touch; pt slept 2 hrs & awoke than feeling much better;
Numbeness started in LUA, traveled up to skull to chin/cheek feeing like a Novocain shot
Anemia; 3 bruises in total (2 in upper right hand, 1 in arm) and there is one underneath wrist of the left arm after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (3 bruises in total (2 in upper right hand, 1 in arm) and there is one underneath wrist of the left arm after receiving 2nd dose) and ANAEMIA (Anemia) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination.     Concomitant products included CLOBETASOL for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONTUSION (3 bruises in total (2 in upper right hand, 1 in arm) and there is one underneath wrist of the left arm after receiving 2nd dose). On an unknown date, the patient experienced ANAEMIA (Anemia). At the time of the report, CONTUSION (3 bruises in total (2 in upper right hand, 1 in arm) and there is one underneath wrist of the left arm after receiving 2nd dose) had not resolved and ANAEMIA (Anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Haemoglobin: 11 (Low) dropped from 13 to 11, reported as "erythrocytes" by reporter (wife) who is concerned about possible anemia. In 2021, Haemoglobin: 11.4 (Inconclusive) 11.4 and. In June 2021, Haemoglobin 12 (Inconclusive) 12. In 2021, Red blood cell count: (Low) low erythrocyte levels that had not returned to normal.         Concomitant medications included unspecified thyroid medication, blood pressure medication, and cholesterol medication. The patient was seeing a hematologist. Specific treatment for the events was not provided by the reporter.   This case was linked to MOD-2021-205644 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Additional event was added. Laboratory data was updated.
patient reports developing a rash on her right breast on the same side that she received her second dose of the COVID vaccine occurring approximately 8 days after the 2nd dose of the COVID vaccine.  she reports that she developed a rash on her left arm after her 1st moderna covid vaccine at the site of injection.  she denies any shortness of breath or anaphylaxis.  both rashes spontaneously resolved.
He had a slight fever. He had cold symptoms and a cough. He was also really tired. The doctor put us on Paxlovid. He was one of the ones that tested positive again 7 days later.
On 7/26/05 client received 5 vaccines at approx 8:45AM, left arm. On 7/27/05 mother noticed his arm starting to swell, get red and warm to touch, child stated it did not hurt he also did not run any fever, that evening she gave him, Benadryl put a cold compress on and off 7/28/05 arm still red, warm and swollen, gave Tylenol and took to daycare, pain. Mom told to call private MD or go to ER if worsens or has further problems mom told to cont cold compresses and Tylenol.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On an unspecified dates in February 2016 (reported as between 15-FEB-2016 and 23-FEB-2016), the patients were vaccinated with doses of improperly stored ROTATEQ (dose, lot# and expiration date were not reported) orally. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt given the wrong formulation.  Staff thought she was giving the Pfizer for 12 y/o and over but actually gave the Pfizer 6 month-4 y/o undiluted.  Patient notified, no adverse reactions reported
This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 23-year-old female patient who received HAVRIX (batch number TB995, expiry date 25th October 2020). On 20th April 2018 09:30, the patient received HAVRIX 1 ml. On 20th April 2018, less than a day after receiving HAVRIX, the patient experienced dizziness and feeling abnormal. On an unknown date, the patient experienced pharmaceutical product complaint. In April 2018, the outcome of the dizziness and feeling abnormal were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the dizziness and feeling abnormal to be related to HAVRIX. Additional details were provided as follows: Concomitant medications included birth control pill. After receiving the vaccine, the patient became dizzy but did not pass out. The patient also experienced a significant head rush. The reporter insisted that the adverse event experienced was related to the lot of the HAVRIX product and insisted that a quality assurance (QA) report be filed. The reporter related QA reported to quality.
Information has been received from a nurse concerning a female who on approximately 27 Dec 2006 was vaccinated with a second dose of Gardasil. On approximately 27 Dec 2006 the patient developed swelling in the arm. The patient was treated with Benadryl. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Confused/blurriness/head pain/nausea.  Another student at his school had immunizations yesterday also, and was sent home from school with similar symptoms.
I started feeling like I had the flu. I felt very achy with an earache. It felt like I got COVID. As it progressed, I was sore and tired with nausea and an earache. It was intense allergies that went on for 2 weeks. On the 15th day, I woke up with a fever and was vomiting. Fever was 102.4. I was so sick, I felt like I had the flu. My family told me to get tested for COVID so I went on Monday and I was diagnosed with COVID. I have been quarantined since then but I have not gotten any better. Its all in my head, my ears, throat and sinuses.  I was supposed to be off quarantine today but I am still highly symptomatic. I no longer have fever, intense body aches or throwing up but I am still feeling the symptoms with my head. I also got a rash on my hand like eczema and a ring appeared around the area where I got the shot.
A few hours after receiving the first booster all of joints were hurting extremely bad. I developed an extremely bad headache and shortness of breath. I am now being tested for COPD. My joints have stopped hurting it is just the breathing problem that I have that I now have to see a Pulmonologist.
Pain all over my  arm ever since I vaccinated my left shoulder until now. The pain continuous since February 2021. The pain gradually speeded all over my leg to my toes from the same side of my body (left). No rest and less attention to concentrate on my job. I could not travel as I used to in order to do or perform my field work. My family Dr. wrote to my agency I work for to limit long driving and follow with pain control management. I can send you the letter from the Doctor if needed. Let me know.
Administered a 5-11 pfizer vaccine to a 3y.o. on left deltoid at 14:50 on 7/22/22. Patient was monitored for 30 minutes and presenting  with no adverse reactions. Physician assessed patient and informed guardians about possible side effects. After observation period, patient was assessed for any allergic reactions. Patient reported "feeling  fine" and guardian confirmed patient was doing well after observation period.
Swollen area where H1N1 vaccine was administered/some red strawberry-like patches 2 1/2 - 3 cm.
Left armpit lump and pain. Started next day after COVID-19 Booster injection shot.
Patient reportedly received, in his own words, "Johnson-Johnson vaccine" on 5/12/21. Believe he meant Janssen. Patient presented for worsening dyspnea and shortness of breath with relative hypoxia recorded on home pulse oximeter; at 94%. He has had progressive worsening dyspnea for over two-weeks attributed to asthma, but unsuccessfully treated with current home-regimen. CTA showed sub-segmental pulmonary embolism in right upper lobe and left lower lobe.  Prior to 2-weeks ago, he had reported to rheumatologist and complained of lower extremity edema, which was attributed to diclofenac treatment, per patient, at that time; and he was started on diuretic HCTZ/Triamterene.    - Ultrasound of lower extremity is pending. Patient denies travel, decreased activity or prolonged inactivity. Denies history or family history of clotting or pulmonary embolism . Med list was reviewed and no obvious instigating medications are identified.  B-symptoms for potential neoplasia were denied on ROS.  Additionally patient denied any recent trauma to extremities.
This spontaneous report as received from register nurse refers to a 6 month old patient gender unknown. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose and route were not reported). Concomitant therapy was not reported. The patient was administered PNEUMOVAX23 instead of PREVNAR on an unspecified date. No adverse effects were reported. Additional information is not expected.
Patient complains of headaches since day of Twinrix.  Noted onset of global HA, not relieved with Aleve 500mg.  Denies N/V, photophobia, neck stiffness, fever.  Bruising and swelling at site of vaccine noted.  Continues with soreness and swelling.
mom states pt had t101;APAP given temp came down;mom found pt coughing-jerking in crib called 911;pt gasping;tonic-clonic movements looked postictal;fussier;dx sz, febrile;
could not use his arm; This is spontaneous report from a contactable consumer. A 90-year-old male patient received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) (Solution for injection in pre-filled syringe) via an unspecified route of administration on an unspecified date, at single dose for Immunization. Patient medical history included ongoing Congestive heart failure. Concomitant medications were not reported. It was reported that, reaction with pneumonia vaccine, could not use his arm for a few days on an unspecified date and they told him that was normal. She does not know the name of the vaccine she thinks it was the pneumococcal and does not have lot, ndc, or expiration. Outcome of event was unknown.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Per patient, she had a rash on both legs with welts. She is not sure, wether this is due to vaccine, but she got rash the next day after receiving vaccine and show would like it reported.
Vaccine given 11/10/04 @ about 10AM, noted a tender knot on the left side of her neck when she arose on 11/11/04.
itchiness all over body evening of the next day. Whole body rash the following morning. Resolved after 1 week
I received a spikevax injection ( moderna ) on 10/3/2023 at 1330 hours I became tired, dizzy and achey and also developed a red rash on my abdomen and trunk this morning I saw the dermatologist to confirm it was not shingles. ( the rash is on both sides of midline so unlikely ) The rash has receded without treatment this evening.
TTP: decreased platelets, increased creat. and decreased kidney function, fever, hemolytic anemia, seizure requiring ICU stay and plasma pheresis.
HUGE pockets/pouches of fluid under both eye. (roughly 1 inch long; 1/2 inch thick); Pt got the Fluzone HD and Arexvy at the same time.  Pt has had the Fluzone HD for at least the last few years (4/2/20; 9/2/21; 10/17/22) and has had no issues.  Vaccines given 9/15/23 @ about 11:15am. No issues until Saturday morning, but it was mild fluid up under the eyes. It was the same on Sunday. Patient woke up at 6am on Monday (9/18/23) and had the severe pockets of fluid. pt said he felt a little "woozie". pt was going to go home and take some benadryl. pt said he has never had any problems with a vaccine before.
Second Dose of BEXSERO given in appropriate time frame and no prior reaction to previous dose of BEXSERO. Mother states child developed fever and chills about 1 hour after receiving vaccine. Mother then proceeded to say another hours passed and patient started to have vomiting. Fever went to 102 and mother called the Nurse Advice line who told her to take child to the emergency room. Mother complied and was sent to Hospital ER--Was given IV Fluids and ZOFRAN. Mother states was told this is an Allergy to the vaccine. Patient was discharged in approximately 2.5 hours later.
This spontaneous report was received from a medical assistant and refers to a patient of and unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored M-M-R II lot # L038612 with expiration date: 07-OCT-2017, lot# L035674 with expiration date 17-SEP-2017 or lot# L023386 with expiration date: 25-JUN-2017 (dose and route of administration were not reported). Administered dose of M-M-R II underwent temperature excursion at 30.128 Fahrenheit degrees, for 2 hours. Previous excursion was at 14.6 Fahrenheit degrees, for 3. 72 minutes. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 20 year old female patient who on 07-JAN-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) route intramuscular (lot# 654539/0890F), on 12-MAR-2008, was vaccinated with the second dose of GARDASIL vaccine (yeast) route intramuscular (lot# 655604/0052X). Concomitant therapy included hormonal contraceptives (unspecified). On 21-APR-2008, the patient experienced dizziness, lightheadedness and clumsiness. She had blood work for a Complete Blood Count, Thyroid and glucose, which were all normal. On 23-JUL-2008, the patient called the office and stated her symptoms were continuing. She was referred to an otolaryngologist and a neurologist. The patient sought medical attention in the office. Additional information has been requested.  9/30/08 Reviewed PCP medical records of 3/12-9/23/08. FINAL DX: none provided Records reveal patient experienced vaginitis on 3/12/08.  Dizziness 7/23 & referred to ENT & Neuro.  9/23/08 doing well w/occasional dizziness.  Office does not have ENT/Neuro consult contact info.  Unable to reach patient or parent despite multiple attempts.
02/01/2022 - 57-year-old woman with history of diabetes, hypertension, hyperlipidemia, stage  III CKD presents with shortness of breath.  Initial vital signs significant for  exertional oxygen saturation 88%, improved to mid 90s at rest.  High suspicion  for Covid infection given multiple close positive contacts.  Covid swab today is  positive. Chest x-ray with bronchial thickening consistent with viral syndrome.  D-dimer elevated to 0.98.  Decision made to defer CT angiography at this time  given higher suspicion that this is due to Covid, and when weighing the risk  given patient's chronic kidney disease.  Admitted with plan for remdesivir and  respiratory monitoring.  02/01/2022 - This patient meets inpatient level of care because Covid-19 with exertional hypoxia   02/03/2022 - Patient discharged following COVID 19  hypoxia
Extreme sensitivity / intolerance to  loud sounds.  During the cleaning of  my house by people who have been doing it for years I found that the sounds of a vacuum cleaner working and normal conversations between the cleaners and my wife and daughter became almost intolerable.  I was unable to concentrate on work I was doing and had to go to a room where those sounds were significantly less.  I have never before experience this intolerance to customary sound levels.  The intolerance passed within about three hours of when I noticed it.
Caller reports that they had a temperature excursion 3/31/2023 which they called into the Facility. The vaccines were "short dated" and a new expiration date of 6/30/2023 was given. She states that the products were labeled but still accidentally adminis; Expired product administered; This spontaneous report was received from an office manager regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-JUL-2023, the patient was vaccinated with an expired and improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #W031816, expiration date: 30-JUN-2023, administered as prophylaxis (strength, and route of administration were not provided). The vaccine suffered a temperature excursion at 6 up to 14 Fahrenheit degrees for 4 hours, 14 to 46 Fahrenheit degrees for 4 hours, 47 to 77 Fahrenheit degrees for 3 hours and 57 minutes on 31-MAR-2023.
After administering the Pfizer vaccine, Immunizer realized patient was given moderna as her second shot. Patient was given Pfizer as her second shot 21 days after her first moderna shot.
skin rash, headache, body aches, injection site pain; skin rash, headache, body aches, injection site pain; skin rash, headache, body aches, injection site pain; skin rash, headache, body aches, injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (skin rash, headache, body aches, injection site pain), RASH (skin rash, headache, body aches, injection site pain), HEADACHE (skin rash, headache, body aches, injection site pain) and INJECTION SITE PAIN (skin rash, headache, body aches, injection site pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     same reaction to Neosporin ointment, but not to the cream, so I believe it is a nonactive ingredient in the ointment.  Concurrent medical conditions included Drug allergy (Reports allergy to Neosporin ointment bur not to the cream, believes it is a nonactive ingredient in the ointment that causes the reaction.).    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 29-May-2021, the patient experienced PAIN (skin rash, headache, body aches, injection site pain), RASH (skin rash, headache, body aches, injection site pain), HEADACHE (skin rash, headache, body aches, injection site pain) and INJECTION SITE PAIN (skin rash, headache, body aches, injection site pain). At the time of the report, PAIN (skin rash, headache, body aches, injection site pain), RASH (skin rash, headache, body aches, injection site pain), HEADACHE (skin rash, headache, body aches, injection site pain) and INJECTION SITE PAIN (skin rash, headache, body aches, injection site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       No concomitant or treatment medications provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Pt states he felt very hot and sweaty. Pt presented as pale and diaphoretic. Pt was moved to the exam area and monitored. Pts vitals are stable. Pt states he?s feeling better and wants to leave. Pt didn?t require transport to hospital.
Redness to/at injection site, mild pain, and feeling of warmth. No fever or chills.