chrisvoncsefalvay/vaers-outcomes huggingface dataset:
56 adults patients received doses after its expiration date Jul 13, 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 Jul 13, 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 Jul 13, 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 Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      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 Jul 13, 2022).    Concomitant medications were not reported.  Vial size was 5 ml. The vial did not undergo any temperature excursions. This case contains information for the 18th of 56 adult patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125: case (1 of 56 patient)
Patient had received Moderna for the first dose and erroneously received Pfizer for the second dose.  No AE.
A spontaneous non-serious report of administration of expired product has been received from a nurse practitioner concerning a 14 year old male patient subsequent to FLUMIST. Medical history and concomitant medication were not reported. On 23-Dec-2008, the patient received FLUMIST that expired on 21-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 31-Mar-2009: 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.
The client is experiencing pain, popping, and the inability to move her right shoulder 1 week post vaccination.
had me take a week of anti-viral medication. I am wondering whether that medication interfered with the efficacy of the vaccination; developed shingles; This is a spontaneous case is received reported from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 25Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication not reported. The patient experienced developed shingles, had me take a week of anti-viral medication. I am wondering whether that medication interfered with the efficacy of the vaccination. The outcome of event was unknown
Left Breast Pain; swollen Lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 12Apr2021 at 11:15 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHYROID) started on an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Apr2021 at 13:00 the patient experienced left breast pain with swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left breast pain with swollen lymph nodes were not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient recieved the Zostavax Vaccine 4 years ago and now has a large case of shingles on L sided chest.
Period delayed 1 week. Spotting for first 3 days then super unusually heavy Vertigo - going on for 2 weeks now
Symptoms such as fever, headache, nausea quickly died down within 2 days after the injection. However, my smell ability seems greatly reduced. I sense metallic smells (I looked it up online and it seems to be fake smells made up by the brain) at times. I can't smell my meals, although I used to be able to smell the fragrance. I can still smell burnt food, garlic, and certain unpleasant smells. My smell has not returned at the time of the report (already 6 days after injection).
Red injection site; Swollen injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Nov-2022 Reporter's comment: The reporter was the consumer. The patient asked how long injection site should be red and swollen after the shot. The patient had red and swollen injection site. Additional Supportive Information: The follow up would not possible as no contact details were available.
At first I had the same symptoms as my 2nd dose.  Fever, chills, fatigue and body aches.  I woke up this afternoon with itchy chy rash that looks like hives all over my body.
Breakthrough COVID infection. Presented to ED for fatigue on 09/11/2022. Onset of fatigue 09/10/2022.
One week after immunizations at 6 p.m. in the evening both shoulders felt like arthritis pain.  During the night the pain left the shoulders and went to both hips.  Took Ibuprofin, helped to sleep.  Pain decreases during the day, increases at night. At approx. 2 weeks after immunizations along with the traveling joint pain, started coughing, headache, and sore throat.  Lasted for 3 days, then came back about one week later.  Three weeks after immunizations went to visit MD.  Exam was done, and Vioxx was given.  Reports helped for 1-2 days then stopped.  Fourth week went back to Dr. blood tests where done no other meds given  All blodds tests results were negative.  One week after MD visit, returned to MD with continue complaint of traveling joint pain, headache, sore throat  MD did Strep test, X-rays of both hips and more blood work.  All tests were negative.  Perscription Ibup. and Zithromax was given.  Voices compliance to meds, continues to have above symptoms, startes "I'm still the same."  Today reports stiffness, pain in left hand and left ankle, sore throat.  Planning on seeing a specialist.
Day 50 and has not received second injection; Autonomic nervous system symptoms; Neurological pain in her legs making it difficult to walk; Unexplained, rapid heart rate; Pressure in her head; Ringing in her ears; Paresthesia in her tongue and throat; Paresthesia in her tongue and throat; Neurological pain all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms) in a 36-year-old female patient who received mRNA-1273 (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms) (seriousness criterion medically significant), GAIT DISTURBANCE (Neurological pain in her legs making it difficult to walk), HEART RATE INCREASED (Unexplained, rapid heart rate), HEAD DISCOMFORT (Pressure in her head), TINNITUS (Ringing in her ears), PARAESTHESIA ORAL (Paresthesia in her tongue and throat), PHARYNGEAL PARAESTHESIA (Paresthesia in her tongue and throat) and NEURALGIA (Neurological pain all over). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Day 50 and has not received second injection). At the time of the report, AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms), GAIT DISTURBANCE (Neurological pain in her legs making it difficult to walk), HEART RATE INCREASED (Unexplained, rapid heart rate), HEAD DISCOMFORT (Pressure in her head), TINNITUS (Ringing in her ears), PARAESTHESIA ORAL (Paresthesia in her tongue and throat), PHARYNGEAL PARAESTHESIA (Paresthesia in her tongue and throat) and NEURALGIA (Neurological pain all over) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Day 50 and has not received second injection) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       It was reported the patient has been to the emergency room 4 times and had a whole laundry list of tests and labs. Nothing has been successful. The symptoms began within the first 5 minutes after vaccination and had progressively gotten worse. She denies pregnancy.  Company comment: Limited information regarding the events and medical history has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and medical history has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.
Developed 5d later shortness of breath with exertion, running workout, less with speed walking, walking stairs in house, and some chest tightness without radiating pain in arm or jaw. It did improve about 10d after, but still felt SOB at times. Began having L rib and back discomfort and more chest discomfort with SOB 10 weeks later. 11/8/21 presented to PCP with the discomfort and D Dimer was abnormal and chest X-ray abnormal.  ER evaluation and D Dimer repeated with other tests, D Dimer cont being abnormal with CT chest abnormal for PE L lung.
hourly urination - from 11PM day of booster until 6PM next day (19 hours) severe chills- from 3AM until 7pm (16 hours) body aches- from 3am until 7pm (16 hours) painful swollen lump in left armpit (Lymph node?) started sometime next morning after shot and is still not totally gone today, May 20, 2022
I got the shot at 10 am, then at about 7 pm I got chills and achy.  I layed down and had a hard time getting up.  When I got up at 10:30 to check and see if I had a fever, I measured it at 103.5 F.  I took 2 tylenol at 10:30 and at 130 am my fever was 102.5.  I just thought this was a larger reaction than what is typical, so I thought I would report it.   Additionally, this mass vaccination site had a number of adverse reactions (within 15 minutes of injection), so I thought I should report this to someone.   Disappointingly it is near impossible to talk to anyone on the phone these days to get or give information.  I called the VAERS phone number, but was on hold for 15 minutes and gave up.
Pt's arm became swollen p/vax w/in 24hrs - taken to MD states arm red-hot-swollen-felt it was a localized reaction;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 17:30 as dose 1, single (Lot number: 4d9835) at the age of 53 years, in left arm for covid- 19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster ), single (Lot number: GJ5342), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9263), in left arm, on 14Feb2021 as dose 2, single (Lot number: EL9269), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: Fj4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Disease" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: THYROID, start date: 15Oct2019; PROGESTERONE, start date: 07Dec2020; ESTRADIOL, start date: 07Dec2020; TESTOSTERONE, start date: 15Apr2021; LEXAPRO, start date: 30May2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient took Paxlovid from 30Sep2023 to 05Oct2023.
Localized rash, on the left arm, near axils and front of shoulder, flat, small red marks, non-itchy, not warm/hot to touch
Soreness; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number and expiration date were not reported), via an unspecified route of administration on 09Apr2021 at single dose for COVID-19 immunization. Medical history included back pain. Concomitant medication included paracetamol (TYLENOL) taken for back pain. The patient experienced soreness on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Pregnant; On and off vertigo for about 3 days starting 6 hours after the first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VERTIGO (On and off vertigo for about 3 days starting 6 hours after the first dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Feb-2021 and the estimated date of delivery was 29-Nov-2021. On 18-Mar-2021, the patient experienced VERTIGO (On and off vertigo for about 3 days starting 6 hours after the first dose). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 21-Mar-2021, VERTIGO (On and off vertigo for about 3 days starting 6 hours after the first dose) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 74-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (experienced in 2000, 2015 and 2017, which were very tiny and smaller than a quarter in size). Concomitant products included amlodipine, Levothyroxine, simvastatin, Aspirin and Valsartan HCT. On 2nd May 2018, the patient received the 1st dose of SHINGRIX .5ml. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site bruising. On 3rd May 2018, the patient experienced urinary tract infection, fatigue, fever and shivering. On 4th May 2018, the patient experienced creatinine urine increased. On 16th May 2018, the patient experienced tremor. The patient was treated with MACROBID and ALEVE. On 3rs May 2018, the outcome of the fatigue and shivering were recovered/resolved. On an unknown date, the outcome of the urinary tract infection was unknown and the outcome of the injection site erythema, fever, tremor and injection site bruising were recovered/resolved and the outcome of the creatinine urine increased was not recovered/not resolved. The reporter considered the urinary tract infection, injection site erythema, fatigue, fever, shivering, creatinine urine increased, tremor and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness and bruising feeling at the injection site on her first day. Those symptoms resolved by the end of the weekend. On 3rd May 2018, 1 day after vaccination, at around 2 to 3:00 PM, the patient thought she was not able to get to her car after an event, because she experienced a wave of tiredness that came over her. She got home and stated shivering and she felt like she had a fever with exhaustion and body fatigue. This went on for a couple of hours and around 8:00 PM, the symptoms resolved. The following day on 4th May 2018, the patient had labs done. On 6th May 2018, the patient's labs came back and she had a urinary tract infection and the patient was put on MACROBED and she finished the medication on 16th May 2018. On 16th May 2018, 14 days after vaccination, the patient started to shutter and shake and could barely brush her teeth. She also had a fever of 102 degree F. She claims that her fever was more significant on 16th may 2018 and it lasted longer. She took ALEVE for her fever. On 22nd May 2018, the patient had additional lab work and they would like for her to have an ultrasound done because her lab work was screwy and her creatinine and kidney levels were elevated and worse now. The contact details of the physician was provided.
Two weeks after the 1st vaccine I started having severe muscle and joint pain in my shoulder and pelvic Areas. Within 24 hours of my second vaccine I experienced four hours of chills and malaise. This lasted four hours.  My second vaccine was on April 16, 2021 in my left arm. the Vaccine was Moderna, lot number 043 B21A. two days after my second vaccine, my left knee became swollen to the point of being unable to bear weight. The shoulder and pelvic area pain continued to worsen and I began experiencing profound fatigue. I felt as though I had full body inflammation. The acute pain then  extended into my right-hand where I experienced a sudden and spontaneous rupture of my thumb tendon which required surgery to repair.  The rapture occurred why was sitting quietly doing nothing strenuous. I am being followed by a rheumatologist with a new diagnosis of polymyalgia rheumatica. My symptoms have been going on for over two months and they're quite debilitating.
Pediatric patients might have received adult Moderna COVID-19 vaccine (Red Cap Vial); This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Pediatric patients might have received adult Moderna COVID-19 vaccine (Red Cap Vial)) in a 9-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Pediatric patients might have received adult Moderna COVID-19 vaccine (Red Cap Vial)). At the time of the report, INCORRECT DOSE ADMINISTERED (Pediatric patients might have received adult Moderna COVID-19 vaccine (Red Cap Vial)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to INC.-MOD-2022-607276 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2022-607276:MOD-2022-607283(9 year old patient)same reporter
Patient developed cold symptoms with heavy drainage on 4/15/21. Patient took a whole package as directed but continued to get worse. Used Vicks Vapor Rub and took a couple doses of sinus medication after the Coriidin was gone.  Started severely hurting  with difficulty breathing and chest pain on 4/27/21.  Went to The Hospital on 4/28/21.  Was diagnosed with pneumonia, pulmonary embolism in left lower lobe pulmonary arterial branches. Patient was admitted.  Patient placed on Rocephin 1 gram IVPB daily and azithromycin 500 mg IVPB daily. Patient was started on therapeutic dosing of Lovenox and then transitioned to Eliquis 10 mg BID for 7 days then 5 mg BID. See hos.
Fever 101F x48hrs  Headache chills Right axillary lymphadenopathy x1week
Eye twitching; Fast stabbing/sharp pain behind ear (on skull bone); Extreme fever; Chills; Brain fog; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the left arm on 30Sep2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, spinal cord injury and autoimmune disorder. Patient has known latex allergy and fruit allergy (tomatoes). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported.  The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and clarithromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 07Sep2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021, next day of vaccination, the patient experienced extreme fever, chills, brain fog that lasted for approximately 24 hours. On 03Oct2021, 3 days after vaccination the patient experienced eye twitching on and off all day, fast stabbing/sharp pain behind ear (on skull bone) that happened multiple times a day. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. 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 extreme fever, chills and brain fog were resolved within approximately 24 hours of duration on an unknown date of Oct2021. The clinical outcome of the events eye twitching and fast stabbing/sharp pain behind ear (on skull bone) was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
n/v, lethargy, achy muscles;progressed & feeling of burning-severe on both thighs & upper arms;both knees & both elbows ache;hurts to climb stairs,feels dizzy, equilibrium compromises, causes h/a, fatigue, moody;