chrisvoncsefalvay/vaers-outcomes huggingface dataset:
56 adults patients received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and MI agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
SEVERE CHILLS FEVER 100.9 FATIGUE LASTING 24 HOURS
pesonality change; brain not working like it used to; clear; weak; not herself; brain not working as usual; Confused; Can not see clearly; slept all day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confused), VISION BLURRED (Can not see clearly), SOMNOLENCE (slept all day), PERSONALITY CHANGE (pesonality change) and FEELING ABNORMAL (brain not working like it used to) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CONFUSIONAL STATE (Confused), VISION BLURRED (Can not see clearly) and SOMNOLENCE (slept all day). On an unknown date, the patient experienced PERSONALITY CHANGE (pesonality change), FEELING ABNORMAL (brain not working like it used to), FEELING ABNORMAL (clear), ASTHENIA (weak), DISSOCIATION (not herself) and FEELING ABNORMAL (brain not working as usual). At the time of the report, CONFUSIONAL STATE (Confused), VISION BLURRED (Can not see clearly), SOMNOLENCE (slept all day), PERSONALITY CHANGE (pesonality change), FEELING ABNORMAL (brain not working like it used to), FEELING ABNORMAL (clear), ASTHENIA (weak), DISSOCIATION (not herself) and FEELING ABNORMAL (brain not working as usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Information has been received from a female consumer who on 02-MAR-2007 was vaccinated with a dose of Zostavax. A few hours after vaccination the patient developed redness at the injection site. Medical attention was not sought. There were no lab studies performed. The redness was reported to be resolving without treatment. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Headache, fever, pain around site (although shot was totally painless, then a day or two later sore throat, cough, itchy eyes, tiredness.  I still do not feel well today 10/16/2011 but getting better, still tired, cough, some asthmatic symptoms still (cough, some light wheezing).
Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Additional Details: Patient present today for MMR Vaccine due to low blood MMR Titer recommended by patient's PCP. MMR vaccine given per Clinic guidelines, and patient starts to feel dizziness and have headaches ten minutes after vaccine was given. Patient denies any shortness of breathe, difficulty breathing, chest pain or discomfort, and chest tightness at this time. EMS Called, patient was assessed by EMS. Patient refuse to go to ER with EMS.
Admin-Tet/Dip 0.5cc L deltoid on 3/6/03. Presents 3/7/03 g/c L upper arm swollen and painful. C/O sore throat.
Resident developed skin rash on her face.  She receives Loratadine 100 mg tab daily    Betamethasone cream x 10 days.
Flu vaccine on 9.26.13. Developed local injection rash -  papulovesicular - hx of egg allergies.
Site: Pain at Injection Site-Mild, Systemic: pain under breast-Medium, Additional Details: Patient complained about having pain under breast after third dose of moderna. Patients reports that the pain goes to the back area but more in the front. patient is currently consulting with doctor. Patient will be getting a X-ray and PET to investigate further.
A couple of weeks after my second COVID vaccine I started to have a high pitched ringing in my right ear. Was quiet at onset, but got extremely loud over next few weeks. Then a month or so later started in my left ear.  I have never had tinnitus before. It came on all of a sudden after vaccine where nothing else ever happened that would normally cause this condition. It is debilitating! Affects my hearing, gives me a headache, drives me crazy and affects my ability to fall asleep and stay asleep. It still to this day has not gone away or gotten any better.
12/5/2022 I had a runny nose, coughing, a lot of junky stuff in the chest. I tested positive for COVID with an at home test and I also had a PCR test which was positive. By 12/7/22 I was getting better. My doctor told me even though I was getting better that I should take PAXLOVID. I took it and finished the course. 12/21/22, I had the majority of all the symptoms again, but did not test positive for COVID. The illness was much worse and lasted longer. I had green junk from my chest and symptoms of a cold. All my symptoms were in my head and chest. The uncontrollable coughing was the worst. I was treated with MUCINEX and a Z PAK. This illness was really bad and was not COVID. It lasted into January, 2023. I recovered for a period of time until 3/7/2023. I got another respiratory infection, different from the previous one. I had uncontrollable coughing fits the mucous was thin from my sinuses and a lot of postnasal drip. I sounded so bad with my cough, I went to the doctor and was diagnosed with Bronchitis. I am taking albuterol inhaler which seems to help. I have not recovered, but am on the mend.
pt recv vax 23SEP97 & 25SEP97 pt exp a febrile sz;
Pain at the injection site <24 hours, fever<24 hours, malaise and fatigue lasting >18 days now Treatment: None Outcome: Pain at site resolved, fever resolved, malaise/fatigue ongoing
similar complaints of cornea issues; This spontaneous case was reported by a consumer and describes the occurrence of CORNEAL DEFECT (similar complaints of cornea issues) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CORNEAL DEFECT (similar complaints of cornea issues). At the time of the report, CORNEAL DEFECT (similar complaints of cornea issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information reported.
pt recv vax several hr p/vax & exp nausea, dizziness, tingling in lt arm; pt was doing a student rotation;
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 58-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# and manufacturer unknown), at the age of 58, in 2021, single dose, for COVID-19 immunisation. The patient did not have any medical history to report. The patient took unspecified concomitant medications. The patient experienced immunisation/booster shot, onset an unknown date in 2021, with outcome of unknown; and tinnitus/ringing in one or maybe both ears, the ringing started shortly after the COVID-19 shot, onset Dec 14, 2021, with outcome of not recovered. No therapeutic measures taken as a result of tinnitus. Additional information: The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, patient has not tested for COVID-19. The lot number for BNT162B2 not provided and will be requested during follow-up.
Injections given on 12/14/2020. Severe redness and swelling around both injection sites started around 8:00AM on 12/15/2020. Skin warm to touch at that area. Patient seen in our office and placed on Keflex and Bactroban.
C/o upper back/shoulder pain, headache and "pinched nerve" following vaccine. Said felt sharp pinch across upper back with injection. Has not seen the doctor and is taking Advil, Excedrin and aleeve for back and head pain.
Client learned she was pregnant 4 days after receiving Varivax vaccination, EDD January 09, 2021, presence of adverse effects unknown at this time.
Recipient reported to Employee Health Nurse:  Pain at injection site, severe fatigue, headache, muscle pain, severe chills, joint pain, fever exceeding 101.0 for 2 days, increased heart rate, rash, dizziness, weakness, tightness in throat, difficulty breathing, nausea, swelling of face/lips.
Temperature excursion - CDC recommend Re-vax. Pt revaccinated on 11/09/2021.
extreme sore arm severe back and neck pain   I do have cervical arthritis and lower back pain due to herniated discs
SLIGHTLY DIZZY; LEFT SIDE OF THE BODY FELT TINGLY; LEFT SIDE OF THE BODY FELT NUMB; TINGLING IN LIPS; NUMBNESS IN LIPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced slightly dizzy. On 08-APR-2021, the subject experienced left side of the body felt tingly. On 08-APR-2021, the subject experienced left side of the body felt numb. On 08-APR-2021, the subject experienced tingling in lips. On 08-APR-2021, the subject experienced numbness in lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly dizzy on APR-2021, was recovering from left side of the body felt tingly, and left side of the body felt numb, and had not recovered from tingling in lips, and numbness in lips. This report was non-serious.
On the first dose I smoked weed and it made my lungs feel strange.; This is a spontaneous report from a contactable other hcp (Patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via intramuscular route of administration (age at vaccination 30-year) in Left Arm on 27Jan2021 at 05:00 PM as dose 1, single for COVID-19 immunization. Reported medical history was none. Concomitant medication includes other medications received in two weeks; medicines were unspecified. The patient received no other vaccine in four weeks. Reported facility type vaccine was Nursing Home/Senior Living Facility. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On an unspecified date the patient experienced on the first dose he smoked weed and it made his lungs feel strange. The clinical outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Patient called the pharmacy the day after and stated woke up from bad sleep with numbness in imminization arm, leg, flushed face and feeling not right.   There was no redness at the site of injection.
Abd pain, itching all over body, feeling as though it's hard to swallow only happened 1-29-13 night 1-30-13 morning tx EPIPEN, ORAPRED, hydroxyzine, diphenhydramine.
This spontaneous report as received from a pharmacy manager via company representative refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications and medical history were not reported. On an unknown date, the pharmacist had administered ZOSTAVAX intramuscularly (dose, lot # and expiration date were not reported) to the patient. The patient, who was a registered nurse, was told on the phone call that a better immune response occurred, when the vaccine is given intramuscularly. Then, the patient went a step further and got revaccinated with ZOSTAVAX about one month later (exact date and route of administration not reported). The patient was concerned that the vaccine was given intramuscularly. No adverse event reported.
cannot sit due to back pain and his kidneys; cannot sit due to back pain and his kidneys; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (cannot sit due to back pain and his kidneys) and RENAL PAIN (cannot sit due to back pain and his kidneys) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (cannot sit due to back pain and his kidneys) and RENAL PAIN (cannot sit due to back pain and his kidneys). At the time of the report, BACK PAIN (cannot sit due to back pain and his kidneys) and RENAL PAIN (cannot sit due to back pain and his kidneys) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.  Patient had both doses and had side effects such as he cannot sit due to back pain and his kidneys.
I received the vaccine on 3/29/2018. Within 8 hours I had a headache, fever and chills that lasted for approximately 36 hours. The injection site was sore, but no redness or swelling. Approximately 72 hours (4/1/2018) after the vaccine I developed a maculopapular rash on the right buttock that was extremely pruritic; the blisters weeped for approximately one week. The rash continued to spread to my lower abdomen, hips, left left, the tops of both of my feet and both shoulders. The rash persists to this date (4/18/2018). I went to urgent care on 4/8/2018 because the rash continued to spread. I was given acycolvir 800 mg for 7 days (I completed the meds). I returned to my primary care on 4/11/2018 because the rash continued to spread. I continue to apply calamine and take claritin or benadryl.
really sick like the flu; Abdominal cramping; Bloated stomach; Gassy; Diarrhe; Felt tired; fever over 100°F; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu) and DIARRHOEA (Diarrhe) in a 62-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 was  reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu), DIARRHOEA (Diarrhe), ABDOMINAL PAIN (Abdominal cramping), ABDOMINAL DISTENSION (Bloated stomach), FLATULENCE (Gassy), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu), DIARRHOEA (Diarrhe), ABDOMINAL PAIN (Abdominal cramping), ABDOMINAL DISTENSION (Bloated stomach), FLATULENCE (Gassy), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 100f High. On an unknown date, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: 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.
several patients were administered doses of Hepatitis A vaccine less than 6 months apart; Information has been received from a physician assistant via a company representative, referring to several children patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with hepatitis a vaccine, inactivated(manufacturer unknown) (trade name, dose, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis.       On an unspecified date, less than 6 months apart the unspecified patients were vaccinated with another dose of hepatitis a vaccine, inactivated(manufacturer unknown) (trade name, dose, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis.
Four hours post vaccine: muscle/joint pain, low grade fever, extreme soreness at injection site.  Overnight: Fever, extreme muscle/joint pain (unable to sleep due to pain), eye pain 2 and 3 days post vaccine: Muscle / joint pain, extreme eye pain, extreme headache (not helped by Tylenol), fever, vomiting, extreme nausea, unable to continue daily activities (spent most of the day in bed), elevated heart rate, chest pain (improved when lying down)
Constant Tinnitus in left side of head above ear.  It never stops.  Sleeping is very difficult.  Have to use benadryl and melatonin every night to get any sleep.
Intense lower back pain and not so intense in neack area. Pain was extreme for 2 weeks, (DNIF 2 weeks). Still minor now, not as to prevent flying. Pt notes same symptoms after shot #5 for about 1 month, but did not report at that time as he thought it may have been exercise induced.
Had SHINGRIX Zoster shot on 9/11/18. On 9/12/18 suffered from diarrhea, chills, and severe rigors.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/08/21 pfizer,Lot#EL3248 2nd dose: 01/29/21,Pfizer,Lot# EN5318 Diagnosed covid positive:07/22/21 sumptoms started:07/21/21 Exposure:Unknown Symptoms:Runny nose, sore throat.
Two weeks post receiving the Moderna bivalent booster I started developing burny, itchy welts and hives on my body, mainly my torso. Seems that it is dermatographia and I have been taking Allegra or Claritin to help with the symptoms. Both of these antihistamines relive the itching and burning but the hives/welts still appear anywhere on my skin where it is touched with moderate pressure, scratching for example. Without antihistamines it is pretty unbearable and quite painful.
awakened the AM of 5/20/99 w/face burning & blotchy red, esp around crease of nose on both sides, above eye & brows & around lips;lips were sl swollen & for a brief time felt nauseous;
Total head/body aches; Total head/body aches; Skin very sensitive/tender; Skin very sensitive/tender; Chills; Injection site extremely tender; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 (Lot number: EL9263) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; "High cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing), notes: High BP. Concomitant medication(s) included: METOPROLOL SUCCINATE; CANDESARTAN; VIIBRYD; ESTRADIOL; AMLODIPINE BESYLATE; BUPROPION; HCTZ; ATORVASTATIN; JUICE PLUS; OMEGA 3 [FISH OIL]; PREVAGEN [APOAEQUORIN]; VIT B 12. The following information was reported: HEADACHE (non-serious), PAIN (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "Total head/body aches"; SENSITIVE SKIN (non-serious), PAIN OF SKIN (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "Skin very sensitive/tender"; CHILLS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Injection site extremely tender". Additional information:  The patient did not have any known allergies to food, medication or other products. Prior to the vaccination, the patient was 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 vaccine.   No follow-up attempts are possible. No further information is expected.
Patient came in to our pharmacy today stating that his left arm was still having a dull ache once to twice a day.  Patient states that the initial soreness of the injection never went away.  He stated that he never had trouble with his left arm until he was administered the flu shot.  The arm soreness does not affect his daily activity but is of concern to the patient.  Consulted patient to see MD.
Headache, Myalgia, NauseaVomiting, nausea, body aches, h/a second dose Narrative: