chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient states she woke up with arm soreness next day, but as day went on, soreness spread to her left breast, and a lump formed near nipple on left breast, present with shooting pains from the nipple. Felt like a pimple very tender to the touch, and has to take tylenol to control the pain.
Pt recvd Pneumovax 3JAN92 & devel redness, swelling & a pimple @ site subsequent to the shot; pt recvd Pneumovax shot previously, but has not had splenectomy; Pt states MD advised previously to get boosters q 4-5 yrs;
swelling of tongue and generalized itching approximately 3-5 minutes after administration of 1st dose. Epi-pen administered, 911 called and patient sent to Hospital.
Pain in large muscles and joints on left side of body, mild headache, weakness, tiredness not resolved by sleep. Lasted 4 days.
Initial case was received from the healthcare professional on 29 October 2013. This cluster case of 50 patients (demographic details not reported) whose medical history and concomitant medication was not reported had received an intramuscular FLUZONE vaccine, (batch number UH889AA, dose and anatomical site of administration not reported) on an unknown date. On an unspecified date, the patients notified the reporter the symptoms of body ache, fever, indigestion and upper respiratory symptoms such as cough, wheezing and difficulty in breathing. These symptoms were short lived lasting from 12-24 hours. No laboratory details were reported. No corrective treatment was reported. The outcome of the event was recovered. List of documents held by sender: None.
No fever. Lt vastus lateralis red, swollen, warm, site: 15 x 21 cm induration 4 cm x 4 cm Circum (L) 36 cm (R) 34.5 cm. Follow uo recommendations.
Mother reported that four hours after the vaccines were given patient began complaining of headache and dizziness. Mother then states that patient woke the mother up at 0600 the next morning with complaints of abdominal pain, nausea, vomiting, and diarrhea. Mother contacted the pediatric clinic and is pending an appointment with a pediatrician.
Body aches, chills, low-grade fever, and malaise began about eighteen hours after the vaccination.  Ibuprofen 400mg alleviated the symptoms earlier in the day. However, ibuprofen 400mg was retaken about 1800, twenty-seven hours after the injection, without relief of the symptoms.
From initial information received on 11/08/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 40 year old female patient received a dose of TD ADS Adult, lot number U1281AA, administered in the left deltoid at 12:00PM on 11/06/2004.  The route of administration was not reported.  Later that same day, the patient developed a temperature ranging between 99 to 102 degrees and a local reaction of redness and swelling at the site of injection.  The patient did not require medical attention and she recovered from these events.
Customer called and reported that the STERILE DILUENT for MMR-II was expired. A consumer missed a dose of MMR-II as a result.; Product expiration date issue; no adverse event; This spontaneous report was received from a pharmacist and referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  It was reported that the sterile diluent (strength, lot #, expiry date were not provided) for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was expired (product expiration date issue). On an unknown date, the patient missed a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose description, lot #, expiry date, and route of administration were not provided) as a result (product dose omission issue). No additional adverse event was reported (no adverse event).
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date approximately in 2016 (also reported as unspecified dates since 01-FEB-2016) the patient was vaccinated with RECOMBIVAX HB (lot # L027733, expiry date 13-MAR-2017) (Lot # L033343, expiry date 13-SEP-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the vaccines were exposed to a temperature of 33.4 degrees Fahrenheit for 2 hours and 51.4 degrees Fahrenheit for 1.5 hours (incorrect product storage). No adverse effects were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. It was reported that the vaccines that underwent temperature excursion were administered. It was reported that there was no previous temperature excursion. It was also reported that this case was being reported due to a data logger. This case is linked to case numbers 1603USA002167, 1603USA007490, 1603USA007491 via same reporter link. Additional information has been requested.
Reports onset of "return of Covid symptoms" almost immediately (fever, chills, diarrhea, shortness of breath, loss of taste and smell, jaundice). Followed by extreme symptoms as of May 7th including fever above 104 degrees Fahrenheit. Pt first seen by medical professional on May 11. Patient was hospitalized May 15 and remained hospitalized until June 1 and was treated for multiple infections and sepsis during hospital stay.
Thrombocytopenia  Rectal Bleeding Gastrointestinal hemorrhage Dehydration Pancreatic cancer (CMS/HCC)  Lower GI bleed Current use of long term anticoagulation Recurrent epistaxis Neutropenia (CMS/HCC)
Fever (101.6 degrees was highest temperature); Chills; Headache; Fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 at 08:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic rhabdomyolysis. The patient previously took Erythromycin (MANUFACTURER UNKNOWN) on unknown date for unknown indication and experienced allergy. Concomitant medications included calcium (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D), biotin (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN), all from unknown date, for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 08:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 02:00, the patient experienced fever (101.6 degrees was highest temperature, units not reported), chills, headache and fatigue. On 26Mar2021 at 02:00 the body temperature of the patient was measured and the result was 101.6 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events fever, chills, headache and fatigue was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
I woke at 2:30  am  freezing and shivering.  I checked my temperature and it was 100.9.  I had a massive headache and body aches.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness, fatigue, chills, headache, nausea, fever), ABDOMINAL DISCOMFORT (upset stomach and couldn't eat, had no appetite), DECREASED APPETITE (upset stomach and couldn't eat, had no appetite), RASH (she woke up with a rash that covers her entire upper arm) and FATIGUE (fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE for an unknown indication. On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ASTHENIA (weakness, fatigue, chills, headache, nausea, fever), ABDOMINAL DISCOMFORT (upset stomach and couldn't eat, had no appetite), DECREASED APPETITE (upset stomach and couldn't eat, had no appetite), FATIGUE (fatigue), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). On 10-Apr-2021, the patient experienced RASH (she woke up with a rash that covers her entire upper arm). On 09-Apr-2021, ASTHENIA (weakness, fatigue, chills, headache, nausea, fever), DECREASED APPETITE (upset stomach and couldn't eat, had no appetite), FATIGUE (fatigue), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, RASH (she woke up with a rash that covers her entire upper arm) outcome was unknown. Treatment was unknown.
Patient was given the vaccine 10/25 and walked into clinic this am , urgently holding her nose asking to be seen by a provider. Pt was triaged by RN first , then placed on the provider schedule as a same day urgent/walk-in appointment. X3 episodes of epistaxis w/ clots lasting >30 min each in last two days. In clinic Pt is 3 days s/p receiving her first dose of Johnson and Johnson covid-19 vaccine. She endorses PMH of at least X1 episode of epistaxsis per year, not w/ clots.
Patient did not receive Pfizer Bivalent Booster vaccine as it was not available in clinic at the time.
NO ADVERSE INCIDENT. ONLY HALF OF PRESCRIBED DOSE WAS GIVEN (0.15MG INSTEAD OF 0.3MG ).  PREDILUTED VACCINE WAS DILUTED WITH NORMAL SALINE.
patient said she experienced redness and swelling at the injection site that did not resolve in a week. She also said she felt fatigue, body aches, shivers and had a headache. Recommended pain to use tylenol and to visit urgent care clinic. Patient stated she will see how she feels before going to urgent care.
Week after receiving COVID  vaccine booster I started experiencing headaches and blurred vision. Eventually checked BP and was having very high recordings (ie 200/100). I have had to be put on 2 more BP medications to control B/P that had previously been controlled for many years with Cavedilol and Dyazide.
Developed hives and rash over entire body, hours later had angioedema of the hands and feet. Symptoms lasted over a week, angioedema was only resolved after steroids and antihistamines. Dermatographia developed after hives and swelling were managed.
Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with VARIVAX lot # N020015 and expiration date of 17-JUL-2019, (anatomical location was not reported) for prophylaxis, which was stored in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees for 1 hour and 33 minutes. Previous temperature excursion was reported as 15 Fahrenheit degrees to 46 Fahrenheit degrees for 1 hour and 9 minutes. The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. Digital data logger was not involved.
Patient was sitting in the observation area. Patient stated that she was feeling "off" and we helped lower her to the ground into a sitting position. She stated that she felt dizzy and we lowered her onto her back and raised her legs onto a chair. 911 was contacted. Patient remained responsive and was able to answer questions throughout. Patient stated that her shoulder felt like it was burning where she received the injection. She also stated that her face felt numb and her lips felt funny (tingling).  Patient was still able to breathe and respond appropriately to all questions. Care was taken over by Ambulance service. After speaking with patients mother later in the day, it was determined patient had a vasovagal episode.
"Woke Monday morning at 9:00 a.m. with EXTREME pain in my ankles. I could not stand or walk at all for about 2 hors having taken Tylenol Extra strength 2 x 500 mg. I had pain all day, but less in the left. Took the Tylenol every 4 hours."
Patient is not immune compromised and received a 5th covid-19 vaccine of Moderna. Patient had no adverse reaction onsite and was monitored for 15 minutes after the vaccine was administered.
After going to be developed headache, indigestion, and feeling very jittery within.  Got up and took some Tums (antacid).  Did not sleep very good thru night, Wednesday morning took a Tylenol-it dulled headache, still had the jittery feeling.  Still has headache, and still has the jittery feeling within, Thursday 1/21/2010.
6 days after the first shot, the area that got the shot was swollen and red again; on day 7, it starts itching.
Pain 9/10 in arm.  Under/inner arm is swollen, red and hot to touch.  No fever reported.  No visible injection site reaction.
pt recvd 1 dose of Engerix-B & the same day exp aching bones, nausea & dizziness;
10MAY94 730AM fever, nauseated, APAP slept restless; jaw tightened; noon joints knees, elbow, hips, achy pain; 11MAY fever, sore throat, joint pain;
My lips and outer mouth area were very numb for about an hour after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08May2021 as dose 2, single (Lot number: EW0170) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs allergy" (unspecified if ongoing), notes: Known allergies: Yes, Amoxicillin, Sulfa drugs and Codeine; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; "HRT" (unspecified if ongoing), notes: other medications the patient received within 2 weeks of vaccination:HRT & Thyroid Medications; "Thyroid" (unspecified if ongoing), notes: other medications the patient received within 2 weeks of vaccination:HRT & Thyroid Medications. The patient took concomitant medications. Past drug history included: Known allergies: amoxicillin, reaction(s): "Drug Allergy", notes: Known allergies: Yes, Amoxicillin, Sulfa drugs and Codeine; Known allergies: codeine, reaction(s): "Drug Allergy", notes: Known allergies: Yes, Amoxicillin, Sulfa drugs and Codeine. The following information was reported: HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "recovering", described as "My lips and outer mouth area were very numb for about an hour after receiving the vaccine". Therapeutic measures were not taken as a result of hypoaesthesia oral.   Additional information: Patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Other medications in two weeks included HRT [hormone replacement therapy] and thyroid medications. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
5 - 10 minutes in receipt of vaccine, pt started N/V, cool clammy skin, light headed/vertigo. Tx Benadryl 25mg and Ondausetion 4g 4 one time 1000ml sodium chloride.
Narrative: Historical ADE - pt. received first dose of Moderna vaccine on 2/1/2021 and went into anaphylactic shock. Further information not available concerning lot number, etc. as pt. not administered first dose at Agency. ADR documented for informational purposes.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: The patient took Paxlovid from 23Apr2023 to 28Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The contributory role of the suspect product to the reported  event drug ineffective and COVID-19 cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. ,Linked Report(s) : US-PFIZER INC-202300181837 Same reporter/patient, different suspect/event;
Localized erythema at site of varicella vaccine. moderate edema, pain at site
no initial reactions, slight soreness 3 days. 9 days later had increased joint pain. Woke up 10th day with blotches on injection sight. As day progressed felt discomfort, site began to get itchy. In evening checked and blotches became one mass, swollen, very warm to touch. Called pharmacy, they never heard of delayed reaction said take benedryl and call primary dr in morning. Went to pharmacy, the pharmacist looked at it and felt it, also never saw delayed reaction, gave same instructions. Sent picture to primary, did video call today, 99.7 temp, elevated BP and pulse. She saw picture, close up on screen, concerned one spot darker might be cellulitis, need to watch, take benedryl, call if changes, report to CDC
pt recv vax 11MAR96 & 13MAR96 pt exp chicken-pox rash & SOB;no further details were provided;
evaluated heart rate, flushed/hot, nausea. Evaluated by EMS-Cleared
Patient experienced fever, body aches and chills the same day the vaccine was given. Then on Sunday 1/2/2022 she started getting a rash all over whole body. Rash was diagnosed as Hives.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 at 12:00 as dose 3 (booster), single (Lot number: Ff2587) at the age of 59 years, in right arm for covid-19 immunisation. The patient did not have any known allergies. The patient's relevant medical history included: "Thyroid cancer", start date: 2009 (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 05Nov2009, stop date: 07May2022. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Apr2022 at 08:00, outcome "recovered" (02May2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested negative 3 days with an antigen test and then tested positive for the following 12 days until finally testing negative with a rapid antigen test; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that from 09Apr2022 to13Apr2022, the patient was given treatment for COVID-19.  Clinical course: After completing 5 days of paxlovid, I tested negative 3 days with an antigen test and then tested positive for the following 12 days until finally testing negative with a rapid antigen test.   No follow-up attempts are possible. No further information is expected.
Had reaction to the last oral dose of four. Dizziness and hives. Taking Benadryl.
experienced tiredness that lasted only for that day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (experienced tiredness that lasted only for that day) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concomitant products included Birth control pills and Xeralto.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced FATIGUE (experienced tiredness that lasted only for that day).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-162322 (Patient Link).   Reporter did not allow further contact
PATIENT CALLED THE PHAMRACY ON OCTOBER 28 AT AROUND NOON. SHE WAS HAVING SEVER PAIN IN HER LEFT LEG. SPECIFICALLY AROUND HER KNEE.  THE PAIN IN THE LEFT KNEE WAS VERY SEVER AND SHE COULD NOT MOVE. THE KNEE WAS STIFF AND BURSED. SHE SAID IT FELT LIKE IT WAS TURNED SIDEWAY WITH TOTAL SPASIM. SHE WAS SCARED OF MOVING BECAUSE SHE THOUGHT HER KNEE WOULD FREEZE AND HURT. HER INJECTION SITE WAS OK, SHE EXPERIANCED THE EXPECTED PAIN AND SORENESS AT THE INJECTION SITE. HER RIGHT KNEE WAS FINE AS WELL AS HER LEFT AND RIGHT ARM. WHE THE SHOT WAS ADMINSTERED THE PATIETN WAS ON CRUCHES UPON ARRIVAL AND APEARED TO HAVE SOME KIND OF LEG PAIN.
102 fever for over two days, extreme fatigue, unable tog et out of bed, incontinence, cognitive fog, extreme muscle fatigue and weakness, unsteady on feet - unable to walk without cane.  He became an old man overnight and still has not recovered.  The day before his booster vaccine my husband was able to hike 5 miles per day which he did 6 days per week.  His mind was sharper than any 30 year old.  He was physically strong doing numerous chores and gardening tasks.  Now he is very unsteady on his feet.  Can not walk without a cane.  Hiking is out of the question.  He can not even walk an easy mile with assistance.  Cognitively he is in a fog unable to do simple tasks like unbuttoning his shirt.  He is easily confused.  His blood pressure has been very high and his MD has double his medicine - still not under control  He is so sick - I can not leave him alone because he may fall.  We have MRI scheduled for first week in November.  I must say - what has happened to my strong active husband.  This happened overnight.  I took him to ER fearing that he was having a stroke.  CT showed no sign of stroke.
Mild fever with severe redness and moderate swelling of left arm. Event started approximately 15 minutes after immunization, and lasted 3 days.
pt leg was very swelled also pt cried for 4 hrs w/out any relief; pt also had a t103 to 104;
Chills, congestion, fatigue Narrative:  Employee tested positive for COVID-19 on 1/5/21
Information has been received from a licensed practical nurse (LPN) concerning a 6 month old female who on 1/30/03 was vaccinated with the second dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant. The LPN reported initially, in January 2003, the pt developed a knot at the site and a quarter size red area. Three weeks later, in February 2003, the area resembled a pimple or boil. The pt's mother, a physician, squeezed the area an pus was released (color not known). During the last week of February 2003, area was stained like a bruised red mark. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional info is not expected.
Pt. felt very dizzy for about 10 minutes. Had eyes closed for most of the time.