chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pneumonia; This serious case was reported by a pharmacist via call center representative and described the occurrence of pneumonia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-NOV-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant). The patient was treated with prednisone. The outcome of the pneumonia was unknown.   It was unknown if the reporter considered the pneumonia to be related to Shingrix.     It was unknown if the company considered the pneumonia to be related to Shingrix.   Additional Information: GSK receipt date: 27-APR-2023 The pharmacist reported that a patient received first dose of Shingrix and started prednisone 40 mg sometime after for pneumonia.  The patient would stop prednisone on 28th April 2023. The caller declined to provide more information. The reporter did not consent to follow up.
I had soring at the injection site which was expected. I also had chills, sore throat, body aches and a very bad headache that lasted about 5 days. In April of 2022, I had a bump that appear at the crown of my head about the size of a nickel. It did itch along with some other spots that appeared on my head as well.
Fever, chills, nausea, headache, for the 3 days following the vaccination.  No professional medical care was received, stayed home and took over the counter medications.
trunk covered w/raised red irregular plagues coalescing mouth w/buccal;white plaques;
Rash and itch on arms, stomach and back. Treatment: Dexamethasone 2 cc, Diphenhydramine 1/2 cc/prescription ATARAX.
6 days after the 2nd vaccine suddenly my  upper arm is very sore  and hurts to move it.   No pain at all until 6 days after the  2ndshot.
Cervical dystonia starting at 1am 11/8/18 clonazepam increased in frequency and not control by initial dose of clonazepam.
Under my left breast/ upper stomach area, I developed a rash about the size of a quarter. The rash is painful with small like blisters, which after sleeping on my stomach appeared to have removed any fluid. As of today, 1/22/21,  is looks like the rash attempting to heal but very sore.
Patient had a fever of 104, 5 hrs. after vaccine.  Patient had  normal temperature at time of vaccine.  Fever was sudden.  Patient had a headache described at "skull feels too tight, skin on my face feels too tight, eyes are too tight, they just want to pop free because the pressure is too great."  Patient was having seizures when brought into urgent care. Patient was given Ibuprofen by way of IV to drop temperature.  Patient was released 2.5 hours later.  Patient was advised to return to emergency if more symptoms presented, especially dizzy sign and vomiting.  6 hours later patient went to Emergency at Hospital with dizzy spells and nausea.  Patient was released.  On 8/30/15 she was admitted to Urgent Care again with feelings of weakness in her legs, spreading through her upper body.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 49 year-old female patient. On 22-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016). The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
dizzy; pain in the pelvis that goes all the way down to her leg; mainly in the pelvis back area and it's throbbing; pain in the pelvis that goes all the way down to her leg; mainly in the pelvis back area and it's throbbing; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PELVIC PAIN (pain in the pelvis that goes all the way down to her leg; mainly in the pelvis back area and it's throbbing), PAIN IN EXTREMITY (pain in the pelvis that goes all the way down to her leg; mainly in the pelvis back area and it's throbbing) and NAUSEA (nauseous) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (She  said 13 years ago she went through chemo and had pain at that time.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DIZZINESS (dizzy), PELVIC PAIN (pain in the pelvis that goes all the way down to her leg; mainly in the pelvis back area and it's throbbing), PAIN IN EXTREMITY (pain in the pelvis that goes all the way down to her leg; mainly in the pelvis back area and it's throbbing) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK, qid. At the time of the report, DIZZINESS (dizzy), PELVIC PAIN (pain in the pelvis that goes all the way down to her leg; mainly in the pelvis back area and it's throbbing), PAIN IN EXTREMITY (pain in the pelvis that goes all the way down to her leg; mainly in the pelvis back area and it's throbbing) and NAUSEA (nauseous) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received : contain Non significant information
This spontaneous report as received from a registered pharmacist refers to a 77 years old male patient with none drug reactions/allergies. The patient's medical history included hypertension. The patient was vaccinated with 0.65 ml ZOSTAVAX (SQ, left arm) (lot#1658AA) as reported, exp date:21-JAN-2013) on 17-MAY-2012. Concomitant medications included unspecified medication for hypertension. On 19-MAY-2012 two days after receiving ZOSTAVAX. The patient experienced shingles. The patient visited to unspecified physician's office and was treated with ZOVIRAX. The outcome of shingles was reported as recovered/resolved on an unspecified date. Additional information has been requested.
Shakiness, nausea, vomiting, dizziness, weird feeling in my head and then a headache.
Twenty-four hours after receiving both the season flu vaccine and the H1N1 vaccine, the patient experienced an outbreak of herpes simplex (HSV-1) on the skin surrounding and inside the mouth.
STOMACH PAIN; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; SWOLLEN GLANDS; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; FEVER; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; SORE THROAT; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; VOMITING; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; HEADACHE; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; A spontaneous report has been received from a consumer via the regulatory authority concerning a 11 year old male patient with height of 145 centimetres and with weight of 43 kilograms.    The patient's past and current medical history included allergy to nuts (ongoing). No concomitant products were reported.    On 30-Oct-2020, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal) 1 dosage form, nasal.     On 30-Oct-2020, the patient experienced stomach pain (preferred term: Abdominal pain upper), swollen glands (preferred term: Lymphadenopathy), fever (preferred term: Pyrexia), sore throat (preferred term: Oropharyngeal pain), vomiting (preferred term: Vomiting) and headache (preferred term: Headache).     At the time of reporting, the event of stomach pain, swollen glands, fever, sore throat, vomiting and headache was improving.     The events were considered serious (important medical event) by the reporter.; Sender's Comments: Abdominal pain upper, lymphadenopathy, oropharyngeal pain and vomiting are not listed in the company core data sheet of Q/LAIV (Fluenz). Pyrexia has been associated with use of LAIV in children but not in adults. The events could be in connection. Due to limited information on indication of the suspect drug, onset date and outcome of the event, possible risk factors, circumstances surrounding the event, aetiological and diagnostic workup, concurrent diseases, concomitant medications and medical history, it is not possible to make a conclusive assessment of the causal relationship of the events and suspect drug
Autoimmune response, itching, hives, hypersensitiviy to many beauty products, allergens, and food. Joint pain, swelling, rash, allergic reactions, allergy to deodorants with aluminum, unspecified inflammatory polyarthropathy, unspecified mixed connective tissue disease, unspecified diffuse connective tissue disease, Raynaud's Phenomenon, erythema, myelopathy, neuropathy, carpel tunnel, tremors, muscle pain, myalgia, fever, numerous bacteria and parasitic infections, skin ulcerations, cough, massive GI bleed.
28nov89 pt vax hepta B. pt ex. pain at inject site . 28dec89 pt vax 2nd hepta B. pt ex prolonged pain and tenderness at inject site which lasted 2 days to 1 week .pt recovered.
STATES HIVES ALL OVER TORSO AND LEGS AND IN HAIR STARTING FRIDAY 10/30/2009.  HAD H1N1 NASAL 10/28/2009 FEELS SOB.  BP 166/86 T98.4 P67. TOOK BENADRYL PO AND SPRAY DIDN'T HELP.  SAW HER DOCTOR.  STEROID INJECTION GIVEN.  GOT BETTER 4-5 DAYS.
head hurt so bad, she thought it was a stroke; had to lay around the house/weak; dizziness; not well; nausea; little bit of soreness in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (head hurt so bad, she thought it was a stroke) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (little bit of soreness in the arm). On 09-Feb-2021, the patient experienced HEADACHE (head hurt so bad, she thought it was a stroke) (seriousness criterion medically significant), ASTHENIA (had to lay around the house/weak), DIZZINESS (dizziness), MALAISE (not well) and NAUSEA (nausea).   At the time of the report, HEADACHE (head hurt so bad, she thought it was a stroke), ASTHENIA (had to lay around the house/weak), DIZZINESS (dizziness), MALAISE (not well), VACCINATION SITE PAIN (little bit of soreness in the arm) and NAUSEA (nausea) outcome was unknown.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 11:00 as dose 5 (booster), single (Lot number: 6h9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: El3249), on 09Mar2021 as dose 2, single (Lot number: En6205), on 15Oct2021 at 11:00 as dose 3 (booster), single (Lot number: Fe3590), in left arm and on 13Apr2022 at 11:00 as dose 4 (booster), single (Lot number: Fp4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Treated for high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Negative, notes: After testing negative 2 days after completion of 5 day paxlovid treatment; (11Feb2023) Positive, notes: 3 days later symptoms reappeared and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After testing negative 2 days after completion of 5 day paxlovid treatment, 3 days later symptoms reappeared and tested positive
History of Present Illness Patient states she started having cough runny nose last week approximately 9 days ago today tested positive for Covid at urgent care was sent here for general infusion, she is a little bit of shortness of breath but mostly with ambulation, still having some cough otherwise denies chest pain fever chills nausea vomiting or any other symptoms or concerns.  She is vaccinated but did not get the booster yet.  Denies any other symptoms or concerns, she is on half liter of oxygen at nighttime and that is because she had diagnosed with whooping cough in the past.  Reason for Hospitalization COVID-19  Hospital Course Fairly stable.  Requires only 1L/NC for upper 90s SpO2.  Has oxygen at home already and wears 1L/NC at NOC already.  Does not qualify for Remdesivir based on length of symptoms.  DC home on dexamethasone.  Will needs SSI Novolog x 7 days while on steroids.
Pt recvd flu vax & devel erythema @ the site of inject which persisted for 24 to 48 hrs;
Vaccine was given at 10:30am and patient waited for 30 min after receiving vaccine. Patient c/o dizziness when walking and when sitting, along with nausea. 11:05am: BP 154/96, pulse 102, O2 sat 98$ on RA.   11:20am:  BP 144/100, pulse 100, O2 sat at 98% on RA. Evaluated by Fire Department and paramedic. Patient to go home with husband. Will contact physician or call 911 if symptoms get worse.
COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). At the time of the report, COVID-19 (COVID 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter  Treatment information was not provided.
Itchy eyes; Swelling around eyes; Face tingling AFTER SECOND DOSE ONLY
After 12 hours I was awoken with painful large swelling and lymphadenopathy in left axillary area. Area swollen caused pain in lateral, external chest area and axillary area with swelling approximately 10 x 6 cm.  Area still swollen and painful 48 hours after vaccination on 29 JAN 2021 prompting report.
Patient developed tingling in fingers, shortness of breath,  pruritic rash to forehead and chest, blanched with applied pressure, associated sweating, feeling hot  and shaky within 20 minutes of vaccination.
BLOOD PRESSURE WENT CRAZY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood pressure went crazy. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure went crazy was not reported. This report was non-serious.
Diarrhea; Body aches; Body was hot and then cold; Weakness; Severe headache; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the right arm on 18Mar2021 at 12:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included Sjogren's, high blood pressure (BP), thyroid, acid reflux and chronic obstructive pulmonary disease (COPD). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included pro tonic (MANUFACTURER UNKNOWN), levothyroxine (SYNTHROID), metoprolol (MANUFACTURER UNKNOWN), atorvastatin (LIPITOR) and hydroyc (MANUFACTURER UNKNOWN) all since an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm on 25Feb2021 at 11:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 05:00, the patient experienced severe headache, body aches, weakness and the body was hot and then cold. On 20Mar2021, the patient experienced diarrhea. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events severe headache, body aches, weakness, body was hot and then cold and diarrhea. The clinical outcomes of the events severe headache, body aches, weakness and body was hot and then cold were recovered in Mar2021 while that of diarrhea was recovered on 20Mar2021.   No follow-up attempts are needed. No further information is expected.
chills; Reaction to the Flu shot; High heart rate; Initial information was received on 21-Oct-2020 regarding an unsolicited valid serious case from a consumer or non-healthcare professional via pharmacy.  This case involves a 75 years old male patient (89.3 kg) who experienced chills, reaction to the flu shot (vaccination complication) and high heart rate (heart rate increased) while he received INFLUENZA VACCINE and was treated with TREPROSTINIL SODIUM [TYVASO].  At the time of the event, the patient had ongoing medical history of pulmonary arterial hypertension.  Concomitant medications included SILDENAFIL CITRATE.  Past medical treatments, vaccinations and family history were not provided.  On 21-Jan-2020, the patient started taking TREPROSTINIL SODIUM dosage inhalation use (batch number- 2101833, expiration date: 30-Jun-2021) concentration of 0.6 mg/ml delivered by Tyvaso Inhalation Device (TD-300/A) (device only for Pulmonary arterial hypertension. The current dose was prescribed was 60-120 µg (10-20 breaths), four times a day (QID)  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 27-Sep-2020, the patient developed a serious chills, reaction to the flu shot (vaccination complication), high heart rate (heart rate increased), eight months six days following the first dose intake TREPROSTINIL SODIUM and unknown latency following the administration of INFLUENZA VACCINE. The patient was hospitalized for three days after this event occurred.   The patient was discharged on 30-Sep-2020.  Relevant laboratory test results included: Heart rate - On 27-Sep-2020:  [high].  No action was taken for TREPROSTINIL SODIUM as it was continued.  It was not reported if the patient received any corrective treatment or not.  The reporter did not provide causality for the events of vaccination complication, chills and heart rate increased.  The outcome of the events chills, reaction to the flu shot and high heart rate was unknown.  Senders comment: The company has assessed the serious adverse event of vaccination complication, chills and heart rate increased as not related to IH (inhalation) treprostinil and TD-300/A device. Vaccination complication was likely a reaction to the flu vaccine and chills and heart rate increased were likely clinical cascade from vaccination complication.  There will be no information on the batch number for this case.; Sender's Comments: This case concerns a 75 years old male patient who experienced chills, reaction to the flu shot, high heart rate after vaccination with INFLUENZA VACCINE (unknown manufacturer) and while treated with TREPROSTINIL SODIUM. The history of patient includes pulmonary arterial hypertension. There is, however, no information regarding lab tests to rule out alternate etiologies. Based upon the reported information, the role of both the suspect products cannot be individually assessed.
Still itchy, faint pink rash; Itching,burning rash back on both sides; faint pink patches, no itching(almost normal); Swollen nodes on left side,also red itchy; Swollen nodes on left side,also red itchy; Swollen nodes on left side,also red itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Swollen nodes on left side,also red itchy), ERYTHEMA (Swollen nodes on left side,also red itchy), RASH PRURITIC (Itching,burning rash back on both sides), RASH PRURITIC (Still itchy, faint pink rash) and RASH (faint pink patches, no itching(almost normal)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives. Concurrent medical conditions included Allergy, Drug allergy (Amoxicillin allergy-patient experienced rash on torso, loss of sense of smell, burning feeling on soles of feet.) since 10-Mar-2013 and Hypothyroidism post ablative since 31-May-2018. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 05-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (Swollen nodes on left side,also red itchy), ERYTHEMA (Swollen nodes on left side,also red itchy) and LYMPHADENOPATHY (Swollen nodes on left side,also red itchy). On 21-Aug-2021, the patient experienced RASH (faint pink patches, no itching(almost normal)). On 14-Sep-2021, the patient experienced RASH PRURITIC (Itching,burning rash back on both sides). On 28-Sep-2021, the patient experienced RASH PRURITIC (Still itchy, faint pink rash). The patient was treated with HYDROCORTISONE (PROCTOZONE HC) from 06-Sep-2021 to 17-Sep-2021 for Itching, at a dose of UNK, qd. On 19-Mar-2021, PRURITUS (Swollen nodes on left side,also red itchy) was resolving, ERYTHEMA (Swollen nodes on left side,also red itchy) and LYMPHADENOPATHY (Swollen nodes on left side,also red itchy) had resolved. At the time of the report, RASH PRURITIC (Itching,burning rash back on both sides), RASH PRURITIC (Still itchy, faint pink rash) and RASH (faint pink patches, no itching(almost normal)) had not resolved.            This case was linked to MOD-2021-314641 (Patient Link).
Myalgia, Arthralgia & Rash Narrative:  DEVELOP RED ARM NOW FINGER JOINT PAIN RED AND SWOLLEN