chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen/hard lymph node in armpit; A spontaneous report was received from consumer concerning female patient who was in late 20s who received Moderna's covid-19 vaccine (mRNA-1273) swollen/hard lymph node in armpit.  The patient's medical history and concomitant medication was not provided.  On 12 Jan 2021, the patient received first dose of mRNA-1273 for prophylaxis of covid-19 infection.  On an unknown date the patient developed swollen/hard lymph node in armpit (axillary lymph nodes enlarged).  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event axillary lymph nodes enlarged was unknown.; Sender's Comments: 26 Feb 2021: As per fact sheet lymphadenopathy, and axillary mass, kept as listed kindly reassess.
Patient states that he feels anxious .He was observed for 30 minutes before leaving the vaccination site.
Patient reported felt fatigued on 5/22/18. On 5/23/18- noticed a red area that enlarged to 3 inches X 3 inches skin redness, inches below the injection site, closer to elbow rather not the deltiod that was the site of injection. A second quarter size red area was developing along side the larger one. Cool compresses 15 minutes on and 15 minutes off was recommended by physician with office follow up if no improvement noted.
All hair has fallen out; Heartburn; Nausea feeling; Passed out; Wasn't feeling right after dose; Face was tingling; Burning feeling in head; A spontaneous report was received from a Consumer regarding  a  63Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like passed out, Wasn't feeling right after dose, face was tingling,bBurning feeling in head, devastated about hair loss after 1st dose, Heartburn  and Nausea.   The patient's medical history was not reported.  Relevant concomitant medications were reported like amitriptyline, duloxetine, gabapentin, metformin, Nexium, hydrocodone, potassium, Proair, ropinrole, simvastatin, spironolactone, Topamax, vitamin d, vitamin b12.  On 12- Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:030m20a) intramuscularly  for prophylaxis of COVID-19 infection.    On 12- Feb-2021, the patient experienced the event like Passed out.  On an unknown, date the patient experienced events like Wasn't feeling right after dose, Face was tingling, Burning feeling in head, Devastated about hair loss after 1st dose, Heartburn nausea feeling and Nausea.  Laboratory details not provided.      No treatment information was provided.      Action taken with mRNA-1273 in response to the events was not reported.       The outcome of the events Passed out, Face was tingling  is resolved. The outcome of the events Devastated about hair loss after 1st dose is Recovering/Resolving. The outcome of the events like Wasn't feeling right after dose, Burning feeling in head, Heartburn nausea feeling and Nausea are unkown; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Nausea is consistent with the known safety profile of the vaccine.
Acute hypoxemic respiratory failure due to COVID-19; shortness of breath; hyperkalemia; pneumonia due to COVID-19 virus
Flushing within 4 hours, 4 hours duration  Headache within 4 hours, duration 6 hours Chills within 4 hours, duration 4 hours Site soreness, lump and heat within 4 hours, still experiencing after 40 hours Extreme tiredness and sleepiness with 24 hours, still experiencing at 40 hours
Pt recvd 2 doses of Engerix-B DEC91, 21JAN92 & the evening of 21JAN92 pt exp a rash across the upper trunk that became very itchy; Reporter indicated that rash was full blown by that noc; pt went to ER for tx;
Administered a vaccination (7/27/22) that was 2 days expired (7/25/22), no s/e reported.
flu-like symptoms; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication of the patient was not reported.   The patient reported those events as normal side effects, and all the events were resolved within 3-4 days.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-436372, MOD-2021-436373 (E2B Linked Report).; Sender's Comments:  MOD-2021-436372:Dose-2 MOD-2021-436373:Dose 3
which caused a general feeling of being unwell; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: which caused a general feeling of being unwell). The outcome of the feeling unwell was resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAY-2023 The reporter was the patient. The patient reported that of having a slight reaction to his second dose of Shingrix, which had caused a general feeling of being unwell. The reporter had denied consent to follow-up.
Information has been received from an RN concerning a 47 year old female who on 2/25/00 was vaccinated IM with the 1st dose of pneumococcal vaccine 23 polyvalent. On 2/26/00, the pt developed a red, hot  and swollen arm "all the way to the elbow". The pt sought unspecified medical attention. Follow-up information received from the physician indicated that on 2/26/00, the pt developed a 6cm X 8cm macule on the left deltoid at the injection site with tenderness. On an unspecified date, the pt recovered. No further information is available.
had a headache; pain all over her body/pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-JUN-2023, the patient received Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: had a headache) and general body pain (Verbatim: pain all over her body/pain). The outcome of the headache and general body pain were unknown.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.   It was unknown if the company considered the headache and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUN-2023 The reporter was a patient's friend. The reporter wished to remain anonymous and provided limited details.  The reporter stated that the patient received Shingrix.  The reporter stated that the patient reported to her that she was in pain all over her body and had a headache.  The reporter did not consent to follow-up.
red like rash on my arm, on my left arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Jul2023 as dose number unknown, 0.5 ml, single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 05Aug2023, outcome "unknown", described as "red like rash on my arm, on my left arm". Additional information: the patient woke up with a red like rash on left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Has not received the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the second dose yet) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
March 7:  After 3-4 days or worsening dyspnea, pt requested ambulance transport to our ED.  Upon arrival, pt was very SOB so full workup ensued.  Pt was found to have elevated BTNP at 2240 pg/ml with fluid overload, and Biofire Respiratory Panel showed Coronavirus PCR positive.  At that time, his COVID markers were also elevated.  CRP 91.4 mg/L,  D-Dimer 2340 ng/mL.  Patient was admitted, diuresed, and started on inpatient COVID protocol which included Ivermectin.  March 9:  EKG was performed and patient was found to have a heart block.  All labs had improved over the past 48 hrs. BTNP reduced to 1530, D-Dimer reduced to  1700, CRP reduced to 47.9.   Due to the heart block, patient was transferred to a care center to a cardiologist.  Just prior to transfer, a follow up Biofire respiratory panel showed Coronavirus PCR NEGATIVE.  PCR positive and negative results were relayed to accepting facility - facility and they were going to refer to epidemiology for follow up.
vaccination site pain; muscle pain; tachycardia; felt strange; light headed; muscle tremors; muscle spasm; heavy breathing; Pressure in the chest and neck; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (tachycardia), FEELING ABNORMAL (felt strange), DIZZINESS (light headed), TREMOR (muscle tremors) and MUSCLE SPASMS (muscle spasm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced TACHYCARDIA (tachycardia), FEELING ABNORMAL (felt strange), DIZZINESS (light headed), TREMOR (muscle tremors), MUSCLE SPASMS (muscle spasm), DYSPNOEA (heavy breathing), CHEST DISCOMFORT (Pressure in the chest and neck) and DIZZINESS (Dizziness). On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain) and MYALGIA (muscle pain). On 01-Mar-2021, TACHYCARDIA (tachycardia), FEELING ABNORMAL (felt strange), DIZZINESS (light headed), TREMOR (muscle tremors), MUSCLE SPASMS (muscle spasm), DYSPNOEA (heavy breathing), CHEST DISCOMFORT (Pressure in the chest and neck) and DIZZINESS (Dizziness) had resolved. At the time of the report, VACCINATION SITE PAIN (vaccination site pain) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Vaccine Breakthrough   COVID + 8/1/21.  Inpatient hospitalization for dyspnea.  Inpatient telemetry unit
pt recv vax & w/in several hr post vax, pt exp fatigue, nausea, vomiting;reporter called pt 2-3 days p/vax & pt was feeling well;pt thought that may have had a virus;sx resolved by 7MAR96
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Feb2021 at 11:00 as dose 1, single (Lot number: EM9810), in left arm, on 25Sep2021 at 13:00 as dose 2, single (Lot number: EM9810), in left arm, on 04Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FF8841), in right arm and on 12Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FP4554), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: positive antigen test; (2023) Negative, notes: negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 08Sep2023 to 12Sep2023. 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: Linked Report(s) : US-PFIZER INC-202300304630 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300304631 same reporter/patient/product, different dose/AE;
I had an appointment with my doctor on February 15, 2023. I mentioned I had a dry cough all year. At the time, I was taking an ACE inhibitor. We both thought it might be the cause of my dry cough. She switched my blood pressure medication. She said if that didn't help, she would order chest x-rays. On the morning of February 21, 2023, I was in bed sleeping and was awoken by sharp stabbing pains in my right side. I had shallow breathing for about ten minutes due to the pain. I reached out to my doctor later that morning. She was unavailable. The nurse suggested I go to urgent care. When I got to urgent care, the doctor ordered chest x-rays. They showed atelectasis in both lungs. She felt that it was possibly Pneumonia as well. She prescribed a five-day course of 100mg doxycycline. I took it twice a day. The cough improved a bit after I changed my blood pressure medication. It improved a bit more after the doxycycline. I still have the cough at times. I had more instances of the pleurisy, sharp pain, and inability to breath deep after taking the doxycycline. The past two days, I've had a lot of pain in my ribs when breathing and coughing. I haven't followed up with anyone yet, but I'm scheduled to see my doctor next week. I feel better today.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 or 01-MAY-2015, the patient was vaccinated with either improperly stored VARIVAX (Merck) (strength, dosage, frequency and route unspecified) (Lot: reported as K015375 expiration date: 18-SEP-2016, Lot: reported as K018990 expiration date: 15-OCT-2016, Lot: reported as K011317 expiration date: 13-AUG-2016, Lot: reported as K016153 expiration date: 24-SEP-2016) or improperly stored M-M-R II (strength, dosage, frequency and route unspecified) (Lot: reported as K021930 expiration date: 10-NOV-2016, Lot: reported as K021487 expiration date: 03-NOV-2016, Lot: reported as L001329 expiration date: 13-JAN-2017). It was unspecified exactly which lot # of the vaccine the patient was given. No adverse effects were reported. Follow-up information has been received from the medical assistant on 24-JUN-2015 referring to a 4 year old female with one sibling. The patient's birth weight was 7 lb and 8 oz. The patient's weight was 49 (unit not provided) and height was 44.5 (unit not provided). On 01-MAY-2015 16:00, the patient received her second dose of M-M-R II (lot# K018990, expiration date and dose unspecified), subcutaneously in the right site. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested. Patient information, product, event and narrative were updated.
PATIENT EXPERIENCED A LOW GRADE FEVER (101.4), HEADACHE, CHILLS, CHEST PAIN (PRESSURE), JABBING PAIN IN THE EAR AND JAW, BODY ACHES/PAINS AND STOMACH CRAMPING. ALL SYMPTOMS BEGAN AT APPROXIMATELY 11:30PM ON 1/24/22. PT ALSO REPORTED STAGGERING. SHE GOT UP IN THE MIDDLE OF THE NIGHT TO GET AN ICE PACK FOR HER NECK AND FELT OFF BALANCE. HER KNEES FELT LIKE THEY WERE GOING TO BUCKLE AND PT COULD NOT WALK STRAIGHT. PT WAS UNAWARE OF THE TIME OF THIS INCIDENT.
pt told me she had the Johnson and Johnson one covid shot and slept for 3 days afterwards and then had to be hospitalized for a blood clot
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored VARIVAX (dose, route and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
101.2 Fever, dehydration, body aches, quarter sized smallpox site, 3" erythema around site. Pt also diagnosed with acute strep pharyngitis at this time.
Migraine headache with blurred vision; Migraine headache with blurred vision; Sore arm; Fatigue; Dizzyness; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021, at 15:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), diphenhydramine (MANUFACTURER UNKNOWN) and famotidine (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 20Feb2021, at 11:00 as a single dose for COVID-19 immunisation. On 13Mar2021, at 09:00 the patient experienced migraine headache with blurred vision, sore arm, fatigue and dizziness. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine headache with blurred vision, sore arm, fatigue and dizziness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Allergic reaction, moderate throat tightening within 15 minutes of vaccination with no prior history of allergic response to vaccines or any medications. Patient treated under regional allergic reaction protocol by EMS as a mild allergic reaction, patient received IV, IV Diphenhydramine, and ambulance transport to ED for evaluation/observation.
Pt. developed Transverse Myelitis two months after getting the Shingles vaccine.  Pt. has severe right arm numbness/disability with numbness down the right side of her body.  Disease is not controlled at present.  Prognosis uncertain. Presently being treated with high dose steroids.
tested positive for covid-19; tested positive for covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthmatic" (unspecified if ongoing); "Upper respiratory infection" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient did not have medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 17Apr2022, outcome "not recovered" and all described as "tested positive for covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: I tested positive for covid-19 on 17Apr22; (24Apr2022) Negative, notes: tested negative with a home test 24Apr- 26Apr; (26Apr2022) Negative, notes: tested negative with a home test 24Apr- 26Apr; (27Apr2022) Positive, notes: It is now 27Apr and my Home test is fully positive. Therapeutic measures were taken as a result of covid-19.  Additional information: Anti viral details; product: COVID 19 Treatment, Brand Paxlovid, Treatment start date was 18Apr2022, Treatment stop date was 23Apr2022, Lot number was Not sure, Indication was Treatment of COVID-19. The patient tested positive for covid-19 on 17Apr22 and began the Paxlovid course the night of 18Apr as she was prone to asthma with respiratory illness. Felt symptoms progressing and tested negative with a home test 24Apr- 26Apr. 26Apr she developed a cough and more congestion which got progressively worse overnight. It was now 27Apr and her Home test was fully positive. Keep reading about rebound cases like her so figured she would share the data. Adverse event start date: 26Apr2022. Patient was not recovered. Ae treatment given was Antibiotics for secondary bacterial Infection.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.