chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Non-immunocompromised patient got the full third dose (0.5ml); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (Non-immunocompromised patient got the full third dose (0.5ml)) 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 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced OVERDOSE (Non-immunocompromised patient got the full third dose (0.5ml)). At the time of the report, OVERDOSE (Non-immunocompromised patient got the full third dose (0.5ml)) had resolved. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered OVERDOSE (Non-immunocompromised patient got the full third dose (0.5ml)) to be not applicable.    No concomitant medication was reported. No treatment information was provided.
On my right leg down close to the ankle I have a swelling that is showing bruising and a lump that is painful.  I am not sure if it is a clot or not. I have not been to Urgent care .  I informed people giving me vaccine I was on blood thinners.  Nobody seem to show concern about that.  I have already received 2nd shot, which I got very sick after, but symptoms seem to happen to others.  My concern is the lump on my leg if it is a clot and concern if I will get more now that I took the 2nd vaccine.
Hot, firm, itchy, red spot approx 4 inches wide on arm in injection spot
Lump in left shoulder at injection site fairly hard and about 3 inches long; Injection site was red.; Injection site was warm; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 09:45 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 27Apr2021 at 09:45 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medications included lisinopril (LISINOPRIL), acetylsalicylic acid (BABY ASPIRIN) and vitamins nos; minerals nos (CENTRUM) taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 08Apr2021, the patient experienced a lump in left shoulder at injection site which was fairly hard, about 3 inches long and was red and warm. The event resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcome of the event lump in left shoulder at injection site which was fairly hard, about 3 inches long and was red and warm was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
she received the first dose of the Pfizer covid 19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored.; she received the first dose of the Pfizer covid 19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored.; she received the first dose of the Pfizer covid 19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored.; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 (Lot number: UNKNOWN) at the age of 18 years, as a single dose for COVID-19 immunization.  Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient reported that she received the first dose of the Pfizer COVID-19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored. She received notification that Covid-19 vaccine was stored incorrectly and that the vaccine was ineffective. The patient stated they informed her she needed to be revaccinated but did not tell her when. The patient wanted to know what Pfizer says about that. She wanted to see if Pfizer would recommended that she restart the Covid-19 vaccine series and get both doses of the Covid-19 vaccine.  The patient reported that she was not getting much help on what she should do next. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
No adverse reaction. Patient was inadvertently given Bivalent booster instead of Monovalent booster. Immunization clinical team advised dose is valid and does not need repeated, but VAERS report was needed.
cough, mother also stated that patient's right arm sweeling on 4/29 after the shot on 4/28, didn't check on 4/30, but worsed today   no runy nose, + mild stuffy nose
Patient was noted to have a noticeable bright red area at injection site on left thigh with tenderness and warmth. He also to had a persistent low oral temp 95 to 97 F and became very obstinate which is out of character for him. On exam in the office he was alert and interactive. Upper left thigh had a 5-6 cm area of faint erythema extending from mid outer thigh to inner thigh with a 1 cm subcutaneous area of soft tissue swelling and moderate tenderness to palpation. There was no induration or lesions at the injection site (only erythema). The rest of the exam was normal. No lesions on the right thigh were the other vaccines were given. MMR and DTAP were given in the left thigh. No other rashes or lesions found.
5 minutes after vaccine was administered. Pt. was seen crying and complained of anxiety, chest pain/tightness, dizziness, and light headedness. Pt. was provided water, more closely observed. Pt. denied respiratory distress, nausea, diaphoresis. BP was taken: 159/114, HR: 79 at 4:05pm. BP taken at 4:14pm: 137/99, HR: 75.  EMS was contacted. EMS vital signs: O2: 100%, BP: 136/80, HR: 70. Pt. denied wanting to go to hospital. Pt. reported sx improvement. Pt. was able to stand and walk without incident.
2 nd dose Covid19 vaccine , Pfizer on 3/11 at 3 pm  She start  feeling sick on 3/12 at 3 am  : fever up to  103 F , cold sweats , body aches ,  she was in bed for 2 days  This morning fever is 102 F Since yesterday  - sore throat and blisters in her mouth and lips, feeling fatigue like running 1 mile No cough , no shortness of breath  , no dyspnea of exertion   Fine dry  rash on face ( not itchy) and at the side of  injection (  itchy)  + nausea, no vomiting  Appetite is fine  No diarrhea  Taking over the counter  - Tylenol
Mother reported a fever of 102.4 all day on Tuesday 2/18 along with nasal congestion, vomiting and a bloody nose once.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a male of unknown age. Neither medical history nor concomitant medications were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medications error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
One week after second shot (5/29/21) I developed fatigue and dull headache along with protruding golf ball size swelling on the left side of my neck. Symptoms continue into today 6/3/21. Tomorrow will be 2 weeks since the second shot.
She is referring it as a covid arm.; A week later, her left arm was very itchy; It was red; It was hot to touch; It was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A week later, her left arm was very itchy), ERYTHEMA (It was red), HOT FLUSH (It was hot to touch), PERIPHERAL SWELLING (It was swollen) and POST-ACUTE COVID-19 SYNDROME (She is referring it as a covid arm.) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRURITUS (A week later, her left arm was very itchy), ERYTHEMA (It was red), HOT FLUSH (It was hot to touch) and PERIPHERAL SWELLING (It was swollen). On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (She is referring it as a covid arm.). At the time of the report, PRURITUS (A week later, her left arm was very itchy), ERYTHEMA (It was red), HOT FLUSH (It was hot to touch), PERIPHERAL SWELLING (It was swollen) and POST-ACUTE COVID-19 SYNDROME (She is referring it as a covid arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Anti-histamine was used for treatment.   Reporter did not allow further contact
31mm slightly raised area red and warm to touch. Advised TYLENOL or IBU PRN and cold/warm compress.
HYPOTENSION 1/5/2023 CHEST PAIN ACUTE RESPIRATORY FAILURE 1/17/2023 CHEST PAIN HYPOTENSION 1/5/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE RESPIRATORY FAILURE 1/17/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA HYPOTENSION 1/5/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE RESPIRATORY FAILURE 1/17/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Patient was seen by doctor on 03/25/02. Follow up with another doctor on 3/26/02. Patient came in with a boil to her right thigh near her injection site. Was prescribed Keflex by doctor.
Inflamed red eye, evaluated as conjunctivitis, ulcer formed in and below limbus of conjunctiva, no keratitis. Evaluated for possible use of VIG; VIG not administered because patient responded to trifluridine eye drops (Viroptic) nine times per day.
Had EXTREME abdominal pain, light blood in urine, fever of 102, nauseous, body aches, fatigue, mind fog, numb stomach, migraine, and eyes burning
My mouth and sinuses felt mentholated. It wasn't so much a flavor thing as it was the sensation. It felt like I was carry around a mentol diffuser everywhere for about 3 weeks; My mouth and sinuses felt mentholated. It wasn't so much a flavor thing as it was the sensation. It felt like I was carry around a mentol diffuser everywhere for about 3 weeks; 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 patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 09:30 (Lot number: Ew0169) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hbp" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "poor kidney/liver function" (unspecified if ongoing); "Known allergies: All nuts" (unspecified if ongoing); "Known allergies: can eat legumes" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: ORAL DISCOMFORT (non-serious), NASAL DISCOMFORT (non-serious) all with onset 16Apr2021 10:45, outcome "recovered" (2021) and all described as "My mouth and sinuses felt mentholated. It wasn't so much a flavor thing as it was the sensation. It felt like I was carry around a mentol diffuser everywhere for about 3 weeks". Therapeutic measures were not taken as a result of oral discomfort, nasal discomfort.  Additional information included: The patient age group was Adult (18-64 Years). The patient did not receive other vaccine in four weeks. The patient had no covid prior vaccination. The patient had not tested covid post vaccination. Not so much adverse, but while receiving my second dose my pharmacist was surprised that I mentioned that about an hour after my first dose my mouth and sinuses felt mentholated. It wasn't so much a flavor thing as it was the sensation. It felt like I was carry around a mentol diffuser everywhere for about 3 weeks. She said she had heard other pharmacists and doctors mention it in others, but had never encountered anyone that mentioned it until me.  No follow-up attempts are possible. No further information is expected.
tested positive for Covid/a little sinus congestion, and a minor cough; tested positive for Covid/a little sinus congestion, and a minor cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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: "colds" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "tested positive for Covid/a little sinus congestion, and a minor cough". The patient reported that after a trip to (place name), his wife and he tested positive for Covid. He thanks to Pfizer vaccinations and booster shots, they breezed through recovery. Except for a little sinus congestion, and a minor cough, they had no others symptoms. No fever, no loss of taste, no tiredness, nothing. They had had colds that were worse. Considering over a million died from this virus, they feel very fortunate. The vaccine works. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200042416 Same reporter/product, similar events in different patients;
pt recvd vax & devel hives @ the site of inject left side of neck & right ear /p recving vax; treated w/DPH;
The patient became lightheaded and showed signs of pallor. The patient also experience spotty vision, ringing in the ears, and chills. Symptoms began to improve after drinking a soda. The patient left the pharmacy 30 minutes after receiving his shot.
Nurse states vaccine leaked out the patient's left arm during ID administration; patient did not receive a full dose.  Same nurse repeated ID administration on the same arm (left arm) successfully. No patient complications noted.
administered expired vaccine to the patient after the date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient after the date of expiration) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient after the date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient after the date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Expiration Date for the lot 048C21A was reported as 09-Nov-2021 with total of 168 doses.  The date in which the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non-significant information.
Left upper arm pain that remains severe in mid upper arm where the injection was given on left since 10/20/2008 flu shot. NSAIDs nto helpful. US neg for DVT. MRI neg.
Patient developed a macular erythematous rash on head a few minutes after giving the series of shots. No difficulty breathing nor vomiting, nor other lesions noted. No wheezing on examinations. Rashes were fading after 10-15 minutes of observation without any treatment.
About 15 minutes after injection patient complained of itching in her mouth and throat.  50mg Benadryl given.
pt recv vax 20NOV96 & 21NOV96 pt devel a 4-5 chickenpox-like rash;27NOV96 pt devel a pimple-like rash consisting of300 small clusters;MD felt the rash may have been viral, but there were no vesicles;3DEC96 rash was dry;
ADMINISTERED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced administered expired vaccine, and off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the administered expired vaccine and off label use was not reported. This report was non-serious.
Dermatographia started roughly 9 months after second dose of Moderna vaccine. Rash wide spread across body, comes and goes. Sometimes was raised (hive-like) in nature. Especially worse after getting out of shower and drying off with towel. Rash would appear minutes after contact. Rash could be traced with contact (i.e. could write letters on forehead with a q-tip). No major complaints of itching (rated 2/10). Rash would go away after 20 minutes of being left alone.   Kenalog injection was given 11/24/21 in clinic. No response after a couple weeks. Some improvement is starting to be seen by patient, but not completely resolved. Seen by dermatologist, was instructed to increase cetirizine to  three times daily and Pepcid 20mg twice daily.
CLIENT WITH STATED HISTORY OF VASO-VAGAL REACTIONS TO "STRESS" .  RECEIVED VACCINE- IMMEDIATE NO REACTION- TO OBSERVATION AREA- 5 MIN. LATER, BECOMING DIZZY, NAUSEATED, PALE. MOMENTARILY LOSS OF CONSCIOUSNESS. DIAPHORESIS. BP 120/60.  PLACED ON COT WITH LEGS ELEVATED.   COLOR RETURNED OVER 30-40 MIN.  NAUSEA LESSENING; 12/30/2020- AGAIN SPOKE WITH CLIENT- OCCATIONAL WEAKNESS, SWEATY , VERY MINIMAL DIZZINESS WITH EXERTION. MILD LETHARGY- ALL STAYING SAME.  REPORTING ON CDC-VSAFE SITE.
INJECTION RECEIVED 1/15/21 FEW DAYS LATER ABDOMINAL PAIN AND NAUSEA. CONTINUING NAUSEA HERE AND THERE. HEADACHES ALMOST EVERY OTHER DAY. TODAY 1/25/2021 RED LOCAL BIG SPOT ON INJECTION SITE ITCHY NOT PAINFUL
Phlebitis Arm is red, swollen and has a hard nodule , warm to touch Narrative:
pt recvd vax; on 3nov95 exp pharyngitis & fatigue;blood drawn at that time revealed inc liver enzymes;to discontinue zocor;better as of 9nov95;
Bilateral red rash to legs, itchy not painful. Dx modified varicella - treatment soap and gently lotion, hydrocortisone. Sx improved 6 days later.
Within 2 hours of vaccine I experienced complete exhaustion, fatigue and was more like a zombie state, couldn't even open my eyes from the tired feeling that came over me.  I was in the state of a coma, no eye contact, non responsive, couldn't function, complete bedrest, couldn't eat or even communicate with anyone, out of it.  12/02/09 Vaccine record received for DOS 11/18/09 and 11/19/09. Impression: Chronic sinus infection unresolved  Pt c/o sleepiness, Pt's Dr considered chronic sinusitis. Sinus examination: crusting in R and underlying purulent material in R maxillary sinus. Tx: steroids, mupirocin, tobramycin.  12/2/09 Medical records received for date 11/16/09. recurrent sinusitis. presenting w/ chronic sinus infection. Assessment: thick green mucous from nasopharynx and oropharynx.  12/2/09 Medical records received for date 12/2/09. DX: Left hip pain. OV c/o left hip pain x several months. mild chest pain, vomiting
couldn't get up; couldn't walk; Weak; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (couldn't get up), GAIT INABILITY (couldn't walk) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced HYPOKINESIA (couldn't get up), GAIT INABILITY (couldn't walk) and ASTHENIA (Weak). On 26-Feb-2021, HYPOKINESIA (couldn't get up), GAIT INABILITY (couldn't walk) and ASTHENIA (Weak) had resolved.            Concomitant medications were not reported. Treatment information not provided. About 1 hour after receiving the second dose of the vaccine, he experienced a similar whole body weakness that prevented him from walking or lifting himself. On 29MAR2021 an ambulance was called and the patient was taken to the emergency room. He was admitted to the hospital for 3 days then was transferred to a rehab facility. He still currently resides in the rehab facility. He usually walks with a walker, but is not this bad. The contact is not sure of what treatments were provided to her husband. Consented to follow up by safety.  Very limited information regarding this events has been provided at this time.  Further information has been requested.Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-081291 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had been hospitalized 3-4 times between 2007 and 2009 for cellulitis on my face originating from my outer ears. No particular cause was found at those times. I was just hospitalized for the same problem (first time since those previous episodes) on April 14, 2021. Condition has been diagnosed as Relapsing Polychondritis, a rare autoimmune disease affecting the cartilage of the body. Now, the question is: Is it just coincidence this flare occurred after getting the COVID vaccines, or did the vaccine somehow stir up my immune system causing it to bring on this latest episode?