chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an 84 year old female with no known drug allergies who on 01-NOV-2006 at 4:00 PM was vaccinated with a second dose of Pneumovax 23, in the left deltoid. There was no illness at the time of vaccination. The patient reported onset of pain two hours after injection. The patient had pain in the left shoulder, left tricep radiating into finger. The patient continued to worsen. The patient had office visit on 04-NOV-2006. There was no inflammation noted at the time of exam. The patient had stated that she had applied heat to injection site at onset of pain. The patient was given CELEBREX 400 mg PO daily, then 200 mg daily x 4 days. On 07-NOV-2006 the patient reported "greatly improved slight shoulder pain." The patient recovered. The patient received a first dose of Pneumovax 23 on 15-NOV-2001. Additional information is not expected.
pt was vaxed @ noon 31AUG95; 1AM 1SEP95 began w/sxs of croup & sinusitis; began tx for sxs 3AM 1SEP95 include steam; nebulizer w/saline, ventolin & nasalide humidifier; recvd inj of decadron on 1SEP95 10AM & begn taking Cephzil, Atrohist
Area immediately adjacent to injection site was slightly raised (about 1 - 2 mm), cherry red - pink, and had color. Not painful per patient. Size of area that shows inflammation is approx 5 1/2 inches x 3 inches.
i was perfectly fine the day of. Next day had some soreness in upper arm, little dizziness for a couple of hours  & a headache. Everything subsided except the headaches all week until Friday my arm got a hot spot and small lump and started aching. it's progressed rapidly...lump is grown a lot, arm & shoulder are very sore, it's very itchy and warm. I still have headaches
I caught it once from the flu shoot and my brother did too; Initial information was received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patients brother) via social media.  This case involves a male patient (unknown demographics) who reported that I caught it once from the flu shoot and my brother did too (influenza), while received INFLUENZA VACCINE.  This case was cross referenced with 2020SA347211 (same reporter).  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, patient had flu (influenza), (unknown latency), following the administration of INFLUENZA VACCINE.  It was reported that the patients brother also had flu from the flu shoot and did catch the flu by taking a flu shoot. It was also reported that if took the COVID 19 (corona virus disease) flu shot, would catch COVID 19, No debate.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.  Additional information has been requested.
had a nodule under his armpit for 3 months now/he has had a nodule under his arm for over two months. He had the first one two months ago and then the second one; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 21 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NODULE (non-serious) with onset 2021, outcome "not recovered", described as "had a nodule under his armpit for 3 months now/he has had a nodule under his arm for over two months. He had the first one two months ago and then the second one".  Additional information: Reporter stated her 21 year old son received the Pfizer COVID vaccine and had a nodule under his armpit for 3 months now. He proceeded to receive the second dose in which the second shot also resulted in a nodule under his armpit, but not as big. Both arms under armpits have the nodules, they are not painful, but they are just there and the first one that he got, it didn't has not gone away yet..  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 16 year old male who on unspecified date was vaccinated with the first dose of GARDASIL (lot# and route not provided), within 48 hours of the vaccination child developed a pneumothorax. On unspecified date, the patient was vaccinated with the second dose of GARDASIL (lot# and route not provided), and within 48 hours of the vaccination child developed a pneumothorax again. Patient sought for medical attention by contacted the physician. Follow-up information was received from the physician who confirmed that the patient was hospitalized in an unspecified hospital for an unspecified duration. The patient had a chest tube placed in him while in the hospital. At the reporting time, the outcome of pneumothorax was unknown. The doctor seemed to think the patient would be ok. Additional information has been requested.
no wheel created on first attempt to administer intradermal vaccine. a second attempt was made on right arm and was successful
PATIENT PRESENTED TO THE CLINIC FOR HER SECOND DOSE OF THE COVID VACCINE. SHE MENTIONED THAT SHE HAD AN ALLERGIC REAACTION TO THE FIRST DOSE ABOUT 25 MINUTES AFTER ADMINISTRATION - TONGUE SWELLING, FINGERS TINGLING, SINUS PRESSURE, SOMETHING LIKE A TRIANGLE SHAPED AREAD OF HER FACE WHERE SHE FELT THE PRESSURE, FACIAL NUMBESS - THAT LASTED FOR ABOUT 40 SECONDS THEN WENT AWAY. PATIENT STATED SHE SPOKE WIT HER HCP ABOUT IT AND WAS GIVEN PREDINSONE TO TAKE AFTER SHE RECEIVED THE SECOND DOSE. RN CONSULTED WITH ONSITE EMTS ABOUT THE SITUATION, AND THEY TALKED WITH THE PATIENT AT LENGTH. RECOMMENDATION TO HAVE BENADRYL ADMINISTRERED PRIOR TO THE DOSE WAS DISCUSSED AND AGREED UPON BY PATIENT, PATIENT STATED SHE STILL WANTED TO RECEIVE THE DOSE AND WAS NOT WORRIED ABOUT IT.  10 ML OF CHILDREN'S LIQUID BENADRYL WAS GIVEN TO PATIENT ABOUT 5 MINUTES PRIOR TO ADMINISTRATION OF THE VACCINE. EMTS IN THE ROOM WHEN DOSE WAS ADMINISTERED. PATIENT STATED THAT SHE ONLY WAS OBSERVED FOR 15 MINUTES AFTER THE 1ST DOSE, WE HAD HER WAIT FOR 30 MINUTES WITH HUSBAND PRESENT. ABOUT 25 MINUTES INTO THE OB PERIOD, THE PATIENT STATED TO ANOTHER NURSE THAT SHE FELT LIKE HER SYMPTOMS WERE RETURNING. EMTS CALLED IN TO THE CLINIC FOR EXAMINATION, TWO RNS PRESENT AS WELL AS PATIENT AND HUSBAND. PATIENT STATED HER TONGUE AND FACE FELT TINGLY, KIND OF LIKE AFTER BEING NUMBED BY A DENTIST, BUT THE SX WEREN;T AS BAD AS BEFORE.  PATIENT WAS GIVEN WATER THROUGHOUT  THROUGHT THE APPOINTMENT AS NEEDED. EMTS EXAMINED PATIENTAND DISCUSSED THE SYMPTOMS WITH HER AGAIN, ENCOURAGEMENT WAS GIVEN TO DISCUSS SITUATION WITH HCP, AND TO BUY DYE-FREE BENADRYL FOR HOME,  PATIENTE RELEASED HOME AFTER SYMPTOMS SUBSIDED.
The patient was admitted to Hospital on  5/19/2021.  Patient was having shortness of breath.  Patient was diagnosed with acute respiratory failure with hypoxia. Patient was admitted to the CCU. Patient died on 5/23/2021
2 fainting episodes the next day after receiving the vaccine. The first time I realized I was losing consciousness but the second time I fainted I didn?t know what happened.
Aches, pains, cough - sweating, congestion - M.D tx with antibiotic PHENERGAN with codeine amoxicillin 500 mg BID. 5 days post injection symptoms began.
mild fever 21SEP & 22SEP; 2OCT92 MD said pt had maculopapular rash (diffused) & GBS resulting in bilateral paralysis of lower extremities;
Patient developed rash starting  from wrist which progressed to upper arm (just below the elbow). Rash seemed to be spreading but not itchy
Migraine aura. It started the morning after the 2nd COVID vaccine dose.  Continued for 10h. Responded to ibuprofen, but it comes back.  Ongoing.
Perhaps 3 weeks after last vaccination (second booster, Moderna) I felt mild Covid symptoms of cough and sore throat with heavy phlegm in throat;  never had a fever (documented 97.3 F);  symptoms lasted 2 days after which I had no further apparent illness;  quarantined for 5 days after first symptoms were noted and always use a mask in public
On Friday, 8/6/21, PT received his dose of Janssen Covid-19 vaccine (LOT #: 201A21A, exp: 9/21/21) at 9:42 am on his left deltoid. During assessment questions, client stated he has history of fainting when getting vaccinations. Client was walked over to Observation Area to have vaccine administered in the anti-gravity chair and to be observed for 30 minutes after injection. At 9:50 am, while waiting in anti-gravity chair in the Observation Area, client stated to RN, he is feeling "faint and anxious." Upon observation by RNs client appeared diaphoretic and pale. Client was given emesis bag, ice pack and bottle of water. Client placed ice pack around his neck and drank the bottle of water. Vitals taken at 9:58 am: BP: 136/76, HR: 69, O2 sat: 98%, RR: 15. Client was alert and oriented to person, place, time and orientation. At 10:03 am, BP: 137/73, HR: 63, O2 sat: 98%, RR: 18. Client was offered a protein bar to which he declined and stated he did eat breakfast this morning. Client AOx4, skin dry and pink. At 9:52 am, client denied nausea, headache or dizziness and pallor was gone upon observation. Client also stated to RNs he was feeling much better and denied any nausea/vomiting. No further interventions needed. Client was educated by RNs on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site with a steady gait and driven home by his mother at approximately 10:15 am.
Had an unknown aneurysm burst (brain bleed) In my brain I was taken by ambulance to Hospital where Dr. (neurosurgeon)put in a titanium clip in my brain to stop the brain bleed... I was in ICU then approximately  three days later I had internal bleeding and had to go back into surgery where they found duodenal ulcers that had burst as well I then had to have a blood transfusion and the gastroenterologist  had to cauterize  the duodenal ulcer.
Per mother -> red, swollen, softball size local allergic reaction to right arm on 5/11 the day vaccines were given. Took BENADRYL and applied ice pack.
PRINZMETAL ANGINA 4/21/2023 ASHD NATIVE COR ART W/ANGINA PECTORIS DOC SPASM
This case was reported by a consumer and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX. Concurrent medical conditions included rheumatoid arthritis. On 16th April 2018, the patient received SHINGRIX. On 16th April 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 17th April 2018, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was hoping to talk to someone other than 2 days from now. The patient has Rheumatoid Arthritis and had to take the non virus vaccine. The patient had her my first shot yesterday of SHINGRIX and she received it under her arm, which led to vaccine administered at inappropriate site, and it was so swollen today had a huge red raised area and her arm was so sore she queried if it was common, and is she could take to help it. The patient also queried if she should really get the 2nd shot, and if she does not would she be still covered and is 2nd dose a booster.
Suspected vaccination failure; I got after the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got after the vaccine). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-JUL-2023 This case was reported by a patient via interactive digital media. The patient got it after the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Information has been received from a physician's wife concerning their daughter who was vaccinated with three doses of GARDASIL (lot #s not provided).  Subsequently the patient experienced headaches for approximately one month after receiving a dose.  This occurred after administration of one of the three doses.  It was not specified which of the three doses it was.  Subsequently, the patient recovered from the headaches.  The patient sought unspecified medical attention.  A product quality complaint was not involved.  Additional information has been requested.
trouble swallowing her saliva; About 10 minutes after administration, experienced tingling in her tongue, that started at the tip of tongue and then moved back towards middle of tongue, sensation continued to at least half way to the back of her tongue; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/ non health care professional (Reference number- 00798748).  This case involves a 73-year-old female patient who experienced about 10 minutes after administration, experienced tingling in her tongue, that started at the tip of tongue and then moved back towards middle of tongue, sensation continued to at least half way to the back of her tongue (paraesthesia oral) and trouble swallowing her saliva (dysphagia) after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 28-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date: not reported) (Frequency: once) via intramuscular route in the left arm  for prophylactic vaccination.  On 28-Sep-2021, the patient developed a non-serious about 10 minutes after administration, experienced tingling in her tongue, that started at the tip of tongue and then moved back towards middle of tongue, sensation continued to at least half way to the back of her tongue (paraesthesia oral) and trouble swallowing her saliva (dysphagia) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "The patient would like to know the difference between the ingredients from this years FLUZONE HD vaccine and the ingredients in the previous FLUZONE HD vaccine from 2019. "  Details of laboratory data not reported.  The patient was treated with 100 mg BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] (patient took this on her own).  At the time of reporting, the outcome of events were reported as unknown.  There will be no information available on the batch number for this case.
Information has been received from a nurse concerning a 15 month old patient who on 05-MAR-2012 was vaccinated with a dose of GARDASIL (lot# 671427/1217AA). The nurse mentioned that on 06-JUN-2012 the patient had outbreak of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow-up information received from registered nurse refers to a 15 months old male patient (child) with speech delay, hearing loss, colic and no illness of vaccination. On 05-MAR-2012 at 10:00 AM, the patient was vaccinated with the first dose of VARIVAX subcutaneously in right leg (dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 06-JUN-2012, the patient was seen in clinic, a rash described as "scattered macular and papular rash with a few vesicles mostly excoriated with trace crusting, rash spares face and palms, skin turgor within normal limits (WNL); diagnosed with varicella. No treatment information was reported. No testing was done. The outcome of patient's was recovered/resolved on 03-JUL-2012 ("no rash"). The relatedness for the patient's event was not reported for VARIVAX. Additional information is not expected.
01/29/04 R thigh red, hot to touch, swollen and itching.
Severe joint pain through entire body.; Muscle fatigue; lethargic; Severe headache; Top lip swelled; left eye mild swelling; Temperature of 100°; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 14:00 (Batch/Lot number was not reported) at 61-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient was not tested for COVID post vaccination. The patient's medical history was reported as none; no allergies to medications, food, or other products. The patient did not have COVID prior to the vaccination. There were no concomitant medications.  The patient previously took bnt162b2 for COVID-19 immunization on 23Feb2021 (Dose number=1; Vaccine location=Left arm; Administration time=13:30; Lot number= Unknown), hyaluronic acid (JUVEDERM) in Jan2019 (location=under left eye), hyaluronic acid (JUVEDERM) (location= top lip) on 02Feb2021. On 23Mar2021 at 05:00, the patient experienced: severe joint pain through entire body, muscle fatigue, lethargic, severe headache, top lip swelled (where she received hyaluronic acid filler on 02Feb2021), left eye mild swelling (at the hyaluronic acid filler injection site from Jan2019), temperature of 100°; all assessed as non-serious. There was no therapeutic measures taken. The clinical outcome of the events was recovering.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
This initial spontaneous report was received on 11-SEP-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Vomiting, lack of appetite, diarrhea, dehydration, fever ranging from 100-102
Patient reported that she has excruciating pain on her arm and could not lift her arm and under arm was involved. She was asked to have the condition checked out by going to a medical facility.
Pt reported large rash on injection arm, muscle aches and hardness on the site. No SOB.
numbness facial; Headache; headache that felt like pressure; Stomach cramps; This spontaneous case was reported by a non-health professional and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps), HEAD DISCOMFORT (headache that felt like pressure), HYPOAESTHESIA (numbness facial) and HEADACHE (Headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps). On 13-Mar-2021, the patient experienced HEAD DISCOMFORT (headache that felt like pressure). On 20-Mar-2021, the patient experienced HEADACHE (Headache). On 24-Mar-2021, the patient experienced HYPOAESTHESIA (numbness facial). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Sleep difficult, at an unspecified dose and frequency. On 22-Mar-2021, ABDOMINAL PAIN UPPER (Stomach cramps) had resolved. On 24-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, HEAD DISCOMFORT (headache that felt like pressure) and HYPOAESTHESIA (numbness facial) outcome was unknown.            No concomitant drugs reported   This case was linked to MOD-2021-060788 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: F/U-1 : To confirm NNI
Received vaccine 5/2.  5/3 some erythema & pain progressive.  Seen in ER 5/4 & diagnosed with "cellulitis" & put on Bactrim.  Seen in ofc by PCP 5/5 with 4 1/2 x 5" erythema with warmth.  By less red less tender & less swollen than from 5/4/08.