chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lip swelling; Extreme tiredness; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on the left upper arm on 25Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history seafood allergy. There were no family medical history and concomitant medications. The patient previously received flu shots in Sep2020 (Has had 100's of vaccines while in the army and never had a reaction to any of them). The patient experienced extreme tiredness on 25Jan2021; was noticed at 6pm when he fell asleep on the phone. Right now, he is fine, stating later he was just a little tired. Lip swelling- this was noticed about 11pm on 25Jan2021 the day he received the shot, when he woke to go to the bathroom. Both lips were swollen but he wasn't worried as he knew this was a possible side effect. He reported that he was back to normal other than being a little tired. He just slept. Patient reported that he couldn't stay awake for a more than 5 minutes but he is still very glad he got it. The second dose is due 15Feb2021. The events did not require a visit to physician office or emergency room. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. Outcome of the event lip swelling was recovered on 26Jan2021 while the event extreme tiredness was recovering.
pt devel hives w/in 30min of vax;took PDH & Chlor-trimeton @ home & hives disappeared
significant swelling, erythema, decreased range of motion at left upper extremity. erythema and swelling spanned approx. 9 cm in length and 5 cm in width
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician).  A 57-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dyslipidaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE(medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of Drug ineffective covid-19 with Paxlovid from 30Oct2023 to 03Nov2023. Clinical course: Patient had no known allergies.  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: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely.,Linked Report(s) : US-PFIZER INC-202300360307 Same patient, different product, different dose/event;
Duplicate flu vaccine given. A flu shot already had been administered on  9/19/2021. The patient only reports that her "face is more broken out" since she received the second flu shot. No other reactions reported.
Received Pneumonia and Flu shots at 11:00am on 10-06-06: one in each deltoid. Appx. 2 hours later severe pain, muscle aches, stiffness, and tenderness developed in the left arm where Pneumonia shot was administered. Condition worsened all day and spread to top of shoulder, arm-pit, and neck area. The pain became so intense that the left arm could not be moved or touched. Took a Tylenol before bedtime, which did relieve the pain some. Spent most of the night without sleep. Could not lay on or move left arm. The next morning same symptons but somewhat less severe. Can't raise arm outward (away from body) or overhead. Now 10:00am and pain still intense!
DISCOMFORT; I FELL JUST AS SICK THE FOLLOWING DAYS.; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown. No concomitant products were reported.    The patient started treatment with Flumist (influenza virus vaccine live, intranasal), nasal, on an unknown date.     On an unknown date, the patient experienced discomfort (preferred term: Discomfort). On an unknown date, the patient experienced i fell just as sick the following days. (preferred term: Malaise).     The outcome of the event(s) of discomfort and i fell just as sick the following days. was unknown.     The events were considered non-serious.
dizziness; Fatigue; Chills; Joint pains; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (Fatigue), CHILLS (Chills), ARTHRALGIA (Joint pains) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (Fatigue), CHILLS (Chills), ARTHRALGIA (Joint pains), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), FATIGUE (Fatigue), CHILLS (Chills), ARTHRALGIA (Joint pains), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Information has been received from a registered nurse, concerning a child patient who may have been vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck) and no adverse event was reported. The reporter stated that she was not certain who the patient was but they have a missing ZOSTAVAX (Merck) dose and only children have been in their office recently. Additional information has been requested.
Chronic severe head ache (uncommon), rigidity of neck,  earache, dizziness , fullness of the head,  tinnitus both ears more loud left side like very loud crickets sound. As time progressed now May 6, 2021 I am  experiencing the same symptoms plus vertigo at night and loss of hearing  in both ears.  My insurance does not cover the big copay for doctor's visit
He got arm soreness from the day he got the shot; he feels nauseous and terrible headache; he feels nauseous and terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He got arm soreness from the day he got the shot), NAUSEA (he feels nauseous and terrible headache) and HEADACHE (he feels nauseous and terrible headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-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 PAIN IN EXTREMITY (He got arm soreness from the day he got the shot), NAUSEA (he feels nauseous and terrible headache) and HEADACHE (he feels nauseous and terrible headache). At the time of the report, PAIN IN EXTREMITY (He got arm soreness from the day he got the shot), NAUSEA (he feels nauseous and terrible headache) and HEADACHE (he feels nauseous and terrible headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was provided as Ibuprofen.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Massaged his hands all night), FATIGUE (Fatigue), ARTHRALGIA (Severe pain in every joint of his body from the top of his head to his toes except his spinal, Ankes hurt, Hips hurt, Toes hurt), HEADACHE (Headache) and CHILLS (Chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (Massaged his hands all night), FATIGUE (Fatigue), ARTHRALGIA (Severe pain in every joint of his body from the top of his head to his toes except his spinal, Ankes hurt, Hips hurt, Toes hurt), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle pain), VACCINATION SITE PAIN (Site tenderness/ injection site hurt) and OFF LABEL USE (off label use). At the time of the report, PAIN IN EXTREMITY (Massaged his hands all night), FATIGUE (Fatigue), ARTHRALGIA (Severe pain in every joint of his body from the top of his head to his toes except his spinal, Ankes hurt, Hips hurt, Toes hurt), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle pain), VACCINATION SITE PAIN (Site tenderness/ injection site hurt) and OFF LABEL USE (off label use) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
I gave the child 4 IZ's. He stood up, walked to the clinic room door and fell to the floor in a faint.
Left arm started swelling immediately and has been warm and painful to touch.  Neck ache.
YEAST INFECTION 1 WEEK AFTER INJECTION AND MISSED 4  MENSTRUAL CYCLES
The vaccinations were administered on April 26, 2018. The patient's mother stated she noticed that the patient's right upper arm was turning red on April 28, 2018. The patient stated the area to his upper arm was itchy.
Patient was administered an 0.25ml dose instead of 0.5ml/ Recipients received lower than authorized dose of the moderna bivalent; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an 0.25ml dose instead of 0.5ml/ Recipients received lower than authorized dose of the moderna bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an 0.25ml dose instead of 0.5ml/ Recipients received lower than authorized dose of the moderna bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an 0.25ml dose instead of 0.5ml/ Recipients received lower than authorized dose of the moderna bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an 0.25ml dose instead of 0.5ml/ Recipients received lower than authorized dose of the moderna bivalent).    No concomitant product reported by reporter. It was reported that 100 patients were administered an 0.25ml dose instead of 0.5ml of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.  It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL. No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
I experienced COVID-19 after vaccine on 09/17/2022. I was with my sister on Wednesday afternoon 09-14-2022. On Friday I woke up with a tiny sore throat. On Saturday morning I felt I had a mild to moderate cold and over course of next days I felt my cold was worsening, with post nasal drip. I had no problems breathing. I felt my sense of taste diminished a bit. I did a telehealth visit and wanted to get antiviral and the doctor prescribed PAXLOVID. I did an OTC COVID-19 test and it was positive. I can say I feel fine and have felt fine for one week and a half or so.
Have had mild tinnitus for 15 years but after first vaccine increased tinnitus which has not gone away.
I am normally fairly regular in my menstrual cycle, but this one was 12 days late, and lasted for 8 days, when they normally last no more than 5 days. Additionally, the day I started my period, my mood dipped to such an extent that I was experiencing suicidal thoughts, which was not consistent with my general mood.
Fever x 24 hours, cough, vomited x3, sore throat.
Moderna COVID-19 Vaccine EUA  Extreme fatigue, chills,  some headache and a very sore arm that had a half dollar size red area around the injection and there is a bruise at the actual injection site.  The injection site was also quite itchy.  I took Tylenol and I put some lotion on the injection site.  The fatigue and chills lasted over 12 hours.  The injection site is still quite sore and bruised but the area around it has turned pink.
Parosmia Peppers & onions smell & taste musky & mold Coffee smells like a waste facility Cilantro smells and taste like mold
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 02-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
PATIENT GOT 3RD DOSE OF PFIZER THROUGH FALSE STATEMENTS (BEFORE POTENTIALLY APPROVED BY CDC/FDA). PATIENT MADE APPOINTMENT FOR 2ND PFIZER DOSE. WHEN RUNNING THROUGH INSURANCE IT SAID 2 FILLS IN 300 DAYS REJECTION. PATIENT STATED HE HAS GOTTEN HIS FIRST SHOT AT A WALGREENS IN SAN FRANCISCO, CA AND DIDNT BRING HIS CARD. HE SAID THEY MAY HAVE ACCIDENTALLY JUST RAN IT FOR A SECOND ONE SO I JUST BILLED THROUGH COVID HRSA AND TRY TO REBILL LATER TO GIVE HIM THE SHOT. WHEN REBILLING, CALLED INSURANCE AND THEY TOLD ME HE GOT HIS 1ST SHOT AT PHARMACY AND 2ND ON FEB 18TH CONTRADICTING WHAT PATIENT SAID. WATCH OUT FOR THIS IN THE FUTURE.
Information has been received from a physician assistant (P.A.) concerning a female who was vaccinated with GARDASIL (lot# not reported). Concomitant therapy included MENACTRA, administered the same day. The injections were given in the same arm. Subsequently the patient experienced considerable fever (temperature not reported) and a "welt type reaction" in her arm. It was not known if the patient required hospitalization or other treatment. Outcome was not reported. Additional information has been requested.
Patient presented to the ED via EMS for evaluation following a loss of consciousness and syncopal episode  and seizure-like activity. Bystanders performed CPR as he was noted to be pulseless and the patient was bradycardic after once ROSC was obtained. En route to the ED the patient was nonresponsive and his eyes were tracking. Per EMS the patient is now more alert, but not at baseline. At baseline the patient can communicate and answer questions. The patient is prescribed Tramadol but is not prescribed seizure medications. History is otherwise limited given the patient's altered mental status. Neuro consulted. Found to be COVID positive, placed in isolation. Pt received a course of Dexamethasone 6mg and vancomycin. Pt stable and will be discharged home.    Discharge Diagnoses: COVID - stable  Breakthrough seizure  Post-ictal  Hyperammonemia  Acute encephalopathy
p/vax pt devel swollen, tender, erythema @ tetanus inj site;seen 6/17/99 w/sx improving;pt given oruvail, instructed to ice arm;
Experiencing diarrhoea 3-4 times a day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Experiencing diarrhoea 3-4 times a day) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Experiencing diarrhoea 3-4 times a day). At the time of the report, DIARRHOEA (Experiencing diarrhoea 3-4 times a day) outcome was unknown. Not Provided          No concomitant medications were reported.  Treatment information was not provided.
This spontaneous report as received from healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received doses of VARIVAX (Merck) (dose, lot#, expiration date, route of administration were not reported) that were improperly stored. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Complaint of feeling lightheaded. Denies any other issues or distress. Color is pink, warm to touch. Alert and oriented x3. Sitting in chair. Denies taking medication today. Blood pressure 98/60, pulse 80, respirations 16, oxygen saturation 98%. Monitored for 45 minutes. No complaints of dizziness or lightheadedness at 1300. Client left clinic with no complaints.
No additional AE; 6 years of age was administered MMRII on 9/3/2021 and VARIVAX on 9/21/2021, when there should have been a minimum of 28 days between doses of live vaccines; This spontaneous report was received from a nurse and refers to a 6-year-old patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 ml, quantity: 1, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided). On 21-SEP-2021, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, quantity: 1, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided). The patient received varicella virus vaccine live (oka/merck) (VARIVAX) while there was no minimum of 28 days between doses as it should with live vaccines (inappropriate schedule of product administration).  There were no adverse events reported (no adverse event).
Fever, chills, vomiting, stomach aches, lipschitz, vaginal ulcer
Chest pain started 6 days after Pfizer shot. I was admitted to hospital on June 1 2021 with a pulmonary embolism. I was put on heparin drip and discharged on June 4. And was placed on Eliquis for approximately a year.
Vaccine administered from vial which has been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 45 year old, female patient who received Modern'a Covid-19 vaccine (mRNA-1273) from vial which has been punctured for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the event, the patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A) intramuscularly in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, administered vaccine from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns the 45-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial, which had been punctured for more than 6 hours. On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. Reported event is unlisted for COVID-19 Vaccine (mRNA-1273) and causality assessment was assessed as not applicable.
Pt exp fever 105, lethargy, h/a, abd pain, trouble breathing;
Information has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patient were vaccinated with improperly stored doses of GARDASIL 9 lot # L026602, expiry date: 19-OCT-2017. The temperature of exposure was reported as 29 degree Celsius for 3 hours. No adverse effects were reported. Additional information has been requested.
Itchy Red rash/welt around injection site 8 days after shot. Applying hydrocortisone to help alleviate itch. Had sore arm first few days after shot, but rash is new today.
I had my vaccination on 09/12/2022. I was diagnosed with Bell's Palsy 11/14/2022 on my right side. I had fell on 11/2022 and fell on my right side. I started to have dental pain on the right side. I was diagnosed with Tinnitus on the right side 12/2022. All of these events happened within a 2-month time period.  I just got back to going to an acupuncturist and a Chiropractor. These appointments are ongoing as I am in bad shape. I do go back to the audiologist in 05/2023 as I still have tinnitus.
Site of IM injection (L deltoid) became pruritic and developed a papular rash.  Symptoms resolved after self-administration of 2 "Allergy Relief" tablets (each tablet contains 325mg Acetaminophen, 2mg Chlorpheniramine Maleate, and 5mg Phenylephrine HCl).