chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt Horrible for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt Horrible for 3 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced MALAISE (Felt Horrible for 3 days). At the time of the report, MALAISE (Felt Horrible for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-089606, US-MODERNATX, INC.-MOD-2021-083018 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089606:Crosslinked case US-MODERNATX, INC.-MOD-2021-083018:crosslinked case
per pt got redness beneath the shingles dose with arm pain, redness injection site about a 1/4 size,   radiating in all directions about 1.5 inches below injection site as well. 12/9/2021 thursday, the pt had lump and swelling 24 hours post vaccination, recommended a benadryl dose to see if redness resolves .
Diarrhea and nausea ~ 36 hours after administration; Diarrhea and nausea ~ 36 hours afteradministration; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 14:45 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included eosinophilic asthma and chronic obstructive pulmonary disease (COPD). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included benralizumab (FASENRA) for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 03Feb2021 at 03:00 (at the age of 37-year-old), as a single dose for COVID-19 immunisation.  On 25Feb2021 at 21:00, reported as 36 hours after vaccination, the patient experienced diarrhea and nausea. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea and nausea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Positive test for COVID at end of Jul2021; Positive test for COVID at end of Jul2021; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, age at vaccination 45-year-old) as dose number unknown, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient did not receive Covid prior vaccination. The patient had positive test for Covid at end of Jul2021 and experienced symptoms similar to head cold or mild flu. AE resulted in doctor or other healthcare professional office/clinic visit. Lab data included Covid test of result positive reported in Jul2021. It was unknown if treatment received. The outcome of the event positive test for Covid at end of Jul2021 (Covid-19) was recovering.  Information about the Lot/batch number has been requested.
Painful,  hot, red rash/hive. The size of  5-6 inches in diameter. Started 8 days after injection. Has started going away after 6 days. On  feb. 13, rash has returned  again.  Have been taken my xyzal regularly fir other allergy reasons.
BODY ACHE; HOT FLUSHES; MOOD SWING; VERY FEARFUL; FEELING VERY AGITATED; DEPRESSED; MALAISE; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, Laboratory data included: Lab test (NR: not provided) negative for UTI. On 09-AUG-2021, the patient experienced body ache. On 09-AUG-2021, the patient experienced hot flushes. On 09-AUG-2021, the patient experienced mood swing. On 09-AUG-2021, the patient experienced very fearful. On 09-AUG-2021, the patient experienced feeling very agitated. On 09-AUG-2021, the patient experienced depressed. On 09-AUG-2021, the patient experienced malaise. On 09-AUG-2021, the patient experienced chills. On 09-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, body ache, hot flushes, mood swing, very fearful, feeling very agitated, depressed, and malaise. This report was non-serious.
p/vax pt had flu-like sx;later had fever;next AM (100-102) arm became very swollen w/erythematous area 3-4inch in diameter;used APAP & DPH q 4-6hr, ice packs;still remains red & tender today 2/16/99
Patient presented to Pharmacy with a mild red rash and pain in area of injection on right arm .... Rash approximately 3 inches diameter
The vaccine expired in the freezer on 6Apr2022/ Type of dose gave after expiration date and date Second booster/ Date the vial was initially stored in the refrigerator*: 28Apr2022, and 4Apr2022; administer expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022/ Type of dose gave after expiration date and date Second booster/ Date the vial was initially stored in the refrigerator*: 28Apr2022, and 4Apr2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     Patient had no allergies to medications,food and other products.Patient was neither tested nor diagnosed with COVID and had no acute and chronic illnesses at the time of vaccination.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022/ Type of dose gave after expiration date and date Second booster/ Date the vial was initially stored in the refrigerator*: 28Apr2022, and 4Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022/ Type of dose gave after expiration date and date Second booster/ Date the vial was initially stored in the refrigerator*: 28Apr2022, and 4Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown whether patient received other vaccines within 1 month prior to Modena COVID-19 vaccine. No concomitant medications were reported. The number of doses were at least 10 vials. Dose administered after 30-day Use By Date or after manufacturer date of expiry. On 28-Apr-2022 and 04-Apr-2022, the vials were stored in the refrigerator. The vials did not underwent any temperature excursions. It was unknown whether the AE caused patient to seek medical care. It was unknown whether patient experienced similar event in the past.   This case was linked to MOD-2022-593844, MOD-2022-593857 (Patient Link).
Chest pain (substernal burning), shortness of breath, nausea, and dizziness
Started having chest pain almost immediately the same day.   The pain in my heart has become more frequent.   The Pain feels deep within my heart.   I also feel discomfort in my chest almost all day like my chest is too small for my heart.   Breathless.  It feels like having a heart attack 3 - 4 times in a week.
Day 7 got red patch and hardening 2.5? circumference around injection site, comes and goes with occasional itching. Hardening and redness still here after 4 days
Left eye puffy and swollen and tingling in her face. Took antihistamine last night and has improved today but still present.
Patient received first dose of Moderna COVID vaccine at 1645.  At 1650 patient fell face down out of chair in observation area. Patient was rolled over on side by unknown patient (later identified as a doctor, not affiliated with clinic) and legs raised on chair. Patient was responsive , speaking in full and complete sentences and AAOx3. Patient was confused, did not remember events after falling forward. Patient states that he is lightheaded, nauseous and bilateral tingling in hands. Unknown if patient hit head, no visible injuries or abrasions noted. Patient diaphoretic, lips and face pale. Patient placed on cardiac monitor in sinus bradycardia. BP 100/77, P31, O2 91% RA, R16 . Pupils PERRLA, +weak radial pulse, peripheral pulses thready, lungs clear on auscultation, abdomen soft, non-tender and non-distended.  At 1649, patients pulse increased to 82. EMS applied O2 at 4LNC, patient at 100%. 1650 Patient secured in neck collar and transferred to stretcher and transported to medical center by EMS.
01Oct90 pt vax;  exp gen achiness, & sore arm.  02Oct90 stayed in bed all day.
COVID + 10/25/22 - Vaccination Status - Moderna x4, including bivalent BRIEF OVERVIEW: Discharge Provider:  Primary Care Provider: DO Admission Date: 10/24/2022 Discharge Date: Oct 26, 2022     DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute CVA (cerebrovascular accident) [I63.9] Cerebrovascular accident (CVA), unspecified mechanism [I63.9] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: 68 y.o. old female with hx of COPD, tobacco abuse, HLD, and anxiety/depression who was admitted for 4 day history of LUE numbness/tingling and episode of dysarthria with imaging showing early/subacute ischemic CVA in the right central sulcus.  Neurology was consulted.  An MRI of the brain was done.  There was findings of congenital venous malformations.  Neurosurgery was consulted.  They did not feel there was anything to be done in patient emergently.  They recommended follow-up with their team in 2-4 weeks.  This information was placed in her discharge paperwork. Pt also with ongoing cough and recent viral URI symptoms with most recent symptom onset about 10 days prior to admission with patient found to be COVID-19 positive. Pt initially maintaining her saturations on room air, but developed acute hypoxic respiratory insufficiency with O2 sats down to 85% on room air. Pt started on supplemental O2 via NC with quick improvement with initiation of dexamethasone and remdesivir. PT OT evaluated the patient and patient felt she was at baseline and did not require Sar placement.  Patient required a small amount of O2 with ambulation and this was arranged prior to discharge.  Patient felt ready to go home and was medically stable for discharge.
Patient experienced a rash described as located on right flank; Rash as little red bumps; Rash as little red bumps; This case was reported by a nurse via call center representative and described the occurrence of rash in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2022, the patient received Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced rash, red rash and papular rash. On an unknown date, the outcome of the rash, red rash and papular rash were unknown.   It was unknown if the reporter considered the rash, red rash and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The nurse reported that the patient experienced a rash after a dose of Shingrix. HCP was also the patient.  The rash was described as located on right flank and as little red bumps. No lot number or expiration date provided.  The reporter was Consented to follow up.
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. The patient had pain which was manageable but could be better. It was unknown if the patient was enrolled in a COVID-19 vaccine trail. The reporter's causality for the event of pain and suspect Rinvoq (Upadacitinib) was no reasonable possibility. No treatment medications were reported.
This spontaneous report was received from a office manager referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of PNEUMOVAX 23 lot# N001007, expiration date 19-SEP-2017 (dose number, route of administration and anatomical location were not reported) were administered to the patients. The doses were stored in temperatures from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 5 minutes. Digital data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. Additional information has been requested.
High fever (102), chills that lasted several hours, hard shakes, about 13 hours after took FLU shot, 400 mg Ibuprofen.
local reaction of swelling, erythema, induration, and pain for 72 hours post administration
No adverse reaction as of 3:40PM Patient given Nasal H1N1 instead of injectable.
After I took the first dose of the shingles vaccine three days ago at Center, I had all day fever on the first day, muscle soreness and severe floaters on the second day and many dark spots and clouds in both eyes (but no flash). Today is the third day, the fever and muscle soreness disappeared, but severe floaters still exist.
Upon receiving the vaccination the patient went limp and passed out. She was carefully moved to the ground. She came to after 10-15 second and never stopped breathing. She indicated afterwards that she had fainted before (after indicating on her paperwork that she had not). After 30 min. she left with a family member.
off label use; Had J&J and your booster; Had J&J and your booster; Fainted; Dizzy; Falling; Bruising my wrist and hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant), outcome "unknown" and all described as "Had J&J and your booster"; SYNCOPE (medically significant), outcome "unknown", described as "Fainted"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FALL (non-serious), outcome "unknown", described as "Falling"; CONTUSION (non-serious), CONTUSION (non-serious), outcome "unknown" and all described as "Bruising my wrist and hand".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Date of refrigeration was 11/1/21. Product was used past 31 days.
Headache, Body pain all over, increased heart rate, vomiting, chills, lethargy.  Experienced for 1 month and still only feels 90%
Weak  left Arm after second vaccine; Sore left Arm after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weak  left Arm after second vaccine) and MYALGIA (Sore left Arm after second vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 030M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weak  left Arm after second vaccine) and MYALGIA (Sore left Arm after second vaccine). At the time of the report, MUSCULAR WEAKNESS (Weak  left Arm after second vaccine) and MYALGIA (Sore left Arm after second vaccine) outcome was unknown.            No concomitant medications were provided by reporter. No treatment details were provided by reporter.
soreness; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness). At the time of the report, MYALGIA (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on 1/11/2021 was seen in the ED for bilateral eye swelling, right side greater than left.
On 10/28/2021 I received the first dose of the Pfizer Vaccine mandated by (privacy). On 11/13/2021 I lost complete consciousness while suiting up for work. No prior incidents. I have been under the Care of Cardiologist and Neurologist as well as Primary Physician and I have been diagnosed with Cardiomyopathy .
had a stroke 12/27. went to rehabilitation. then found to be (+) 1/2/2022. Sent back to hospital and is currently admitted as of 1/05/2022.
Patient experienced severe pain 10 minutes after vaccine administration. The site of action (the arm) was warm and swollen about 3 inches in diameter and the muscle around it was hard and tender. Patient also experienced locked jaw the next morning on her left jaw, and took her about 10 minutes to feel normal again. The swelling and redness lasted 2 weeks.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   No adverse effects noted or voiced by patient.
I noticed in June 2021 that 2 of my fingers stated swelling up. I had stiffness in the hand, but now 2 particular fingers were swollen. Towards the end of the summer, I reached out to a Rheumatologist and he put me on methotrexate. It was in December before I saw the doctor. We are trying to see if I am on the right track. I have not responded, so far, to the medication. Additionally, the medication that this would treat is either rheumatoid arthritis or psoriatic arthritis, but the symptoms are not consistent with either.
Moderna vaccine was administered - reported by patient  J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2022 SEIZURE, UNSPECIFIED
Patient claimed to have breathing problems and felt generally ill. She described it as flu-like and went to an urgent care. She said she was ill for 5 days since getting the vaccine.
Primary vaccination site enlarged with multiple satellite lesions. Fever and chills. Diffuse macular rash to trunk and face. Sent to local emergency room with diagnosis or acne.
This spontaneous report was received from a pharmacist refers to a adult patient of unknown demography. On an unknown date, the patient who was intended to vaccinate with M-M-R II was inadvertently vaccinated with PROQUAD (dose, route and frequency was not reported). No adverse effects reported. Additional information is not expected.
After receiving Vaccines on 7/20/2018 client told PHN that when she woke up she had a huge, swollen & red arm on her Left side where SHINGRIX was given. She denies any fever and any other symptoms aside from Moderate soreness. Client mention she notice today her swollen arm is getting better.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (strength, does, lot# and route not provided) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: Patient presented to ED on 09/07/2022 with chief complaint of pain with deep breathing. No fever. Relevant past medical history includes asthma. Admitted and started on dexamethasone 6mg IV daily and remdesivir 200mg followed by 100mg IV daily.