chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt stated that 5 minutes after receiving the vaccine her chest and neck became itchy. Pt presented with redness and no hives. Pt denied any difficulty breathing or swallowing. Pt was given 50mg of Benadryl orally. Pt was monitor for an hour and a half. Pts vitals remained stable. Pt stated she is no longer feeling itchy. Pt no longer has any rash on her chest or around her throat. Pt refused transport to hospital.
Based on follow-up information received on 15-Jan-2019, the case was assessed as non-case previously has become valid upon follow-up. Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 31 years old female patient who experienced urticaria on arms and legs, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 18-Sep-2012, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot UH7321AB via intramuscular route in upper extremities. On 18-Sep-2012, the patient developed a non-serious urticaria on arms and legs 1-4 hours following the administration of INFLUENZA VACCINE. No other associated symptoms observed. No lab test reported. Final diagnosis was urticaria on arms and legs. Patient received antihistamines as corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for urticaria on arms and legs (lasted for 1 week).
Hospitalized 9/6/22-9/8/22 nausea, body aches, fatigue, weakness, decreased appetite, UTI, pyelonephritis, kidney stone, flank pain, vomiting, cough,
extreme tiredness - couldn't stay away; extreme tiredness - couldn't stay away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 15:00 as dose 1, single (Lot number: EL9267) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Bleeding peptic ulcer" (unspecified if ongoing); "lactose intolerant" (unspecified if ongoing); "C-Diff" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: FATIGUE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown" and all described as "extreme tiredness - couldn't stay away". Therapeutic measures were taken as a result of fatigue, loss of personal independence in daily activities. Additional information: No Other medication in 2weeks.
Pt was seen at MD office on 6/10/03 in AM. According to nurse, the pt had a large local reaction of the left arm - 11 x 6cm - red, warm and swollen, elevated temp. Mother stated to MD's nurse that child had a temp at home of 103 - temp at MD office ax. 99.7 - no other symptoms reported.
musculoskeletal pain; itching at injection site; Fever; Nauseating feeling; soreness around injection site; Nerve pain; Delayed allergic reaction; Red itchy wheel; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (musculoskeletal pain), NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel) and FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (musculoskeletal pain), VACCINATION SITE PRURITUS (itching at injection site), PYREXIA (Fever), NAUSEA (Nauseating feeling) and VACCINATION SITE PAIN (soreness around injection site). At the time of the report, MUSCULOSKELETAL PAIN (musculoskeletal pain), NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (itching at injection site), PYREXIA (Fever), NAUSEA (Nauseating feeling) and VACCINATION SITE PAIN (soreness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included ibuprofen 200mg, acetaminophen 350mg and fexofenadine 60mg.  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.   Reporter did not allow further contact; 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.
Shingles after the first dose; This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. No patients or vaccine data was available. The pharmacist did not want provide the patient's data. The reporter did not consent to follow-up. This case has been linked to US2020AMR062616, reported by the same reporter.
First time recipient of flu shot. Employee monitored for 15 mins after vaccine - an appeared to be O.K - but anxious about the wait and possible side effects. Employee  returned to see nurse 60 min  later, extremely anxious - "I think  I am having a reaction: Increase BP and pulse, c/o extreme (R) arm wrist pain - within visible " thumb print like  "bruise noted. (R) ear red and itchy - and  8 small redden spots visible on her throat. Breathing rate increase, lung clear. C/o tingling and itchy all over"
Breakthrough case: I developed symptoms on 09/06/2021. The symptoms went away on 09/08/2021. Then the symptoms came back on 09/11/2021. My symptoms included: Fever Sinus infection Echo sensation in ear Cough Headache Fatigue Body soreness  I was prescribed Prednisone. The majority of my symptoms have went away, but I am still dealing with the cough.
syncopal episode approximately 7 minute after initial COVID 19 vaccine, Moderna Lot number 030L20A Exp: 7/16/202. Patient became unresponsive, gasping for air. Wearing KN95 mask, removed mask, called for assistance, applied 3L Oxygen via non rebreather face mask. Once oxygen was applied patient was able to respond to commands. Blood pressure was checked at 1545, 110/70. EMS was called at 1545, arrived on seen at 1546. Patient was assessed by EMS, vitals stable, transferred to Hospital at 1600.
THROWING UP; TOOK VIVOTIF WITH DINNER; This spontaneous case (PVX2019-1539) was received from a consumer on 13-Jun-2019. It describes a 22-year-old adult female consumer who was "throwing up", after the intake of Vivotif (lot number: 3003275) for an unknown indication. She "took Vivotif with dinner".  Case report: The consumer took the first dose of Vivotif on 09-Jun-2019 with dinner around 9 pm. Then, around 5 or 5:30 am, she violently threw up for 5 hours. It was reported that she had a normal dinner and she was fine after taking the second dose.  Action taken with Vivotif with respect to the event "throwing up" was dosage maintained while with respect to the event "took Vivotif with dinner" was not applicable.  The consumer had recovered from the event "throwing up", while the clinical outcome of the event "took Vivotif with dinner" was unknown.  Company's Comment: In this case, it was reported that female consumer was "throwing up" after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took Vivotif with dinner" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that female consumer was "throwing up" after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took Vivotif with dinner" was considered as not applicable.
Sometime after the vaccinations the pt experienced seizures and strokes. The pt is currently hospitalized with intracranial bleeding and retinal bleeding. No specifics were provided. Further information is being requested. Follow-up received on 3/1/01 noted "No problems until 11/00" by MD. Additional info regarding pt, vaccine administrator, responsible physician, reporter, date of vax and vaccines given were provided. As you know, the pt was hospitalized for a reported acute head injury on 12/29/00 and I first examined him and followed his medical care there for a little more than a week or so. I have interviewed and spoken with the parents on numerous occasions since and seen and examined the pt several times. I have reviewed all tests and exams and an exhaustive medical evaluation is now complete. After many MRI's and exams, the mother disclosed that the infant had fallen off of a couch. The baby was discharged on low-dose baby aspirin (1/4), Zantac and seizure free on phenobarbital to be mixed into 2 bottles per day. The type of stroke injury seen on the scans is 'non-hemorrhagic' or ischemic. After the fall, the pt was unresponsive and EMS was called. In PICU the areas of pre-existing permanent brain damage were again seen in the pt's brain, but also a large right subdural hematoma and bilateral retinal hemorrhages were first discovered. These were not present in November. A new skeletal survey was still nml. The pt required neurosurgery on 1/2/01, to release the pressure on his brain. At surgery, the right subdural was seen to be made of blood, fluid and membranes, which is in agreement with the CT scans prior to surgery that documented new, subacute and older blood in the right subdural. This subdural hemorrhage(s) of various ages likely explains the history of intermittent vomiting during the 10 or so days prior to 12/29/00, which then became accompanied by recurrent seizures in spite of phenobarbital prior to the neurosurgery and the improvement in both the vomiting and the seizures after the subdural was evacuated. He has now been in foster care without known new events. This baby has suffered abusive head trauma or 'Shaken Baby Syndrome'. There were bilateral retinal hemorrhages and also a large retinal hemorrhage in the right macula that is usually seen in severe infant head trauma cases. A low-height fall from a couch to a carpeted floor cannot cause these and there is no other dx for this combination of medical findings than violent head trauma. I have considered aspirin as a complicating factor in the case. His PT and PTT were normal. While aspirin cannot be 100% ruled out as at least a contributor to continued bleeding after intial head trauma, it could have caused the subdural to become larger than it otherwise might have become, physical forces must have 1st injured the blood vessels to allow the blood to leak into the space in the 1st place. These same physical forces must also have caused the retinal hemorrhages at the back of both eyes and the same violent physical forces are certainly the cause of the retinoschisis.
incredibly nauseous; throwing up; had a terrible migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 11:30 (Lot number: EN6199) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Loeys Dietz Syndrome" (unspecified if ongoing); "heart surgery" (unspecified if ongoing), notes: heart surgery 4 years ago; "blind in one eye" (unspecified if ongoing), notes: blind in one eye. Concomitant medication(s) included: MIRTAZAPINE; GUANFACINE; LOSARTAN; LOESTRIN. The following information was reported: NAUSEA (non-serious) with onset 11Mar2021, outcome "unknown", described as "incredibly nauseous"; VOMITING (non-serious) with onset 11Mar2021, outcome "unknown", described as "throwing up"; MIGRAINE (non-serious) with onset 11Mar2021, outcome "unknown", described as "had a terrible migraine". Therapeutic measures were not taken as a result of nausea, vomiting, migraine.  Additional information: Facility type vaccine was reported as other. Patient had not received any other vaccine in four weeks. Treatment AE was given as no. Covid prior vaccination reported as no and patient was not tested covid post vaccination. Other medical history: Loeys Dietz Syndrome, heart surgery 4 years ago, blind in one eye.  No follow-up attempts are possible. No further information is expected.
Injection site soreness; Vaccine administered by IN route; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered by IN route) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Food allergy (yeast), Drug allergy (Clindamycin), Drug allergy (Codeine), Drug allergy (Morphine) and Drug allergy (Zofran).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intranodal) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered by IN route). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness). On 26-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered by IN route) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intranodal), the reporter did not provide any causality assessments.   No concomitant medication listed.  No treatment information provided.   This case was linked to MOD-2021-344343, MOD-2021-336776 (Patient Link).
Arm has been painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included the relevant medical history or any additional safety information was unknown.   On 26th October 2022, the patient received Shingles vaccine. On 27th October 2022, 1 days after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the Shingles vaccine before the day of reporting and stated it was not painful but had pain in arm, but it was very tolerable. The patient stated did not think twice.  Additional Supportive Information: The follow up would not possible as no contact details were available.
I have numbness & pain in hands & feet. Face became paralyzed also. Acquired Guillain-Barre around Sept. 2012.
Moderna COVID-19 Vaccine EUA 1/23/21: in the night, experied: fever; chills; fatigue; ;muscle pain; body aches; diarrhea; dizziness; headache, and passed out twice. 1/24/21: chills, muscle pain, weak, fatigue, light headed 1/25/21: unable to go to work (teacher): ongoing fatigue, feeling wrung from intensity of reaction; 11:00 pm - heart racing; chills 1/26/21: back to work; stablizing; arm still very sore
Hives on left knee and face and given 1/4 tsp of Benadryl
pt c/o trouble breathing & of feeling hot;mom had pt take slow deep breaths;1hr p/vax pt stated going to pass out;@ this time eyes rolled back, stiffened & then did a short amount of shaking;passed out;c/o stomache & h/a;
Pt well.  REceived ZOSTAVAX 5/23 - on 6/1/08 developed multiple joint pain and swelling,  arthralgia, high fever (101.3) and headache.  O2 sat 88% ran air.  06/20/2008 MR received for DOS 06/7-10/2008 with D/C DX: Polyarthragia, arthritis resolving on steroids.  Possible serum sickness reaction to recent varicella zoster vaccine. Fever, headache, neck pain-all resolved.  Bronchospasm, resolved.  Hypertension.  Hypercholerolemia. Anxiety Disorder.  GERD exacerbated by steroid use. Pt developed L thumb and hand swelling 1 week after receiving Zostavax.  Swelling spead to L knee, wrist, ankle and great toe. Joint swelling and tenderness noted on PE.  Pt then developed fever and rash was instructed to be evaluated in ER.  IN ER pt's O2 sat dropped from 98% to 88% and was noted to be wheezing and was admitted.   Improvement of all sx noted with IV steroids.
Received MMR on 10/23/2003.  Developed increased temperature (max 103 F), conjunctivitis, pharyngitis and erythematous maculo-papular multiple ? eruptions difficulty and generalized accompanied with poor appetite.
Headache, Myalgia, Arthralgia, Fever, Localized pain; fatigue, chills Narrative:  Other Relevant History:
pt recv vax & exp stretchy pain in legs by 7AM, severe by 11PM;took APAP got partial relief allowing sleep;slept till noon;afeb, malaise, h/a, joint pain, somnolence in afternoon;called clinic MD advised ASA;
Pt became dizzy and had a syncopal episode when she stood up. EMS called  and patient declined and went home because she was feeling better
CLARIFICATION FOR KINRIX (There was not room to put this info: DTAP DOSE #5, IPV DOSE #4  Vaccines administered on 6/2/20. Patient's mother called on 6/4/20 and left a message for the nurse to call her back. The nurse called her back but was unable to reach the mother. On 6/9/20, patient's mother sent pictures via digital media. The message (with pictures) was forwarded to our NP for recommendation. NP recommended an in person visit for the following day. NP responded to mother's digital media message with this recommendation. (Mother's initial description of symptoms/reaction was "red, hard, itchy, swollen & warm to the touch".  On 6/4/20 patient's mother stated the patient had a rash on his arm. Mother had him seen at her PCP. She was told it was a reaction to the vaccines. On 6/8/20 the rash spread to his legs, "looked like hives" per mother. "Not itchy, he's not bothered by the rash", per mother. On 6/9/20 patient's mother called to inform our office that the patient's symptoms seemed to worsen on 6/8/20. The nurse instructed the patient's mother to bring the patient in on 6/10/20. On 6/10/20 the patient was seen in our office. Dx for visit: (1) skin eruption (2) immunization reaction (3) insect bite. An RX for Bactroban was written for insect bites. Swelling of injection sites noted to be "resolved" . Mother informed to continue to monitor the patient's symptoms and call us with any other questions/concerns.
Mother explained when child woke up 4-3-07 a day after immunization she noticed her skin was pale, weak and has fever.
Pruritis of face started 1/28 with facial edema and erythema. No tongue swelling, throat swelling or breathing difficulties. Pt seen in office on 1/29 and given Benadryl and instructed to continue Allegra.
red right arm; swollen right arm; sore right arm; felt sick for 12-15 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick for 12-15 hours), VACCINATION SITE ERYTHEMA (red right arm), VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE PAIN (sore right arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was hospitalized for 52 days due to severe Covid-19 infection. She was discharged on 22Dec2020.) on 03-Nov-2020. Concurrent medical conditions included Acid reflux (esophageal), Hypercholesteraemia, Hypothyroidism, Rheumatoid arthritis and Drug allergy (morphine allergy). Concomitant products included POTASSIUM, PANTOPRAZOLE, LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN, AZATHIOPRINE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), MULTIVITAMIN [VITAMINS NOS] and RITUXIMAB (RITUXAN) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ILLNESS (felt sick for 12-15 hours). On 19-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red right arm), VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE PAIN (sore right arm). On 16-Apr-2021, ILLNESS (felt sick for 12-15 hours) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red right arm), VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE PAIN (sore right arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Called to say: swelling from elbow to wrist. Disappeared following days. (Animal Control officer) pre-exposure. Primary medical doctor prescribed Steroid. Recommend discontinue Rabies series.
After receiving the H1N1 injection in my right shoulder on 10/29/2009 the pain has continued everyday. I was seen by an orthopedic physician who ordered physical therapy. I had 10 sessions with the physical therapist and continue to have discomfort everyday depending on certain movements of my right shoulder.