chrisvoncsefalvay/vaers-outcomes huggingface dataset:
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.  Date of refrigeration of vial is 19-AUG-2021.   This case was linked to MOD-2021-364630 (Patient Link).
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
My daughter receiver both shots today. Once the nurse said we were good to go and my daughter stood up, she said the room was spinning and that she felt dizzy. She also said that her vision was ?fuzzy?. I immediately had her sit down and then lay down. I then grabbed a nurse who has her put her knees to her chest and gave her some juice and graham crackers. It probably took about fifteen minutes for her to feel well enough to get up. She has never had an adverse reaction to any vaccines.
This case was reported by a nurse via call center representative and described the occurrence of general body pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced general body pain, swollen joints, movement disorder and numbness. On an unknown date, the outcome of the general body pain, swollen joints and movement disorder were recovered/resolved and the outcome of the numbness was unknown. It was unknown if the reporter considered the general body pain, swollen joints, movement disorder and numbness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The nurse practitioner did not have the batch number and expiry date. Twenty four hours after vaccination, the patient experienced full body aches, joint swelling and could not close her hands. The events were lasted for 10 days. The patient had residual numbness in both hands. The reporter consented to follow up.
patient received the liquid portion of the Pentacel vaccine but not the powder, No AE; Initial information received on 28-Jul-2020 regarding an unsolicited valid non-serious case from other healthcare professional via consumer/ non-health care professional.  This case involves a sex-month-old female patient who was given only the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, [PENTACEL] (would be the third dose in the series ,batch number for Carton: UJ224AAA, Pentacel liquid vial lot: UJ314AA,Expration: 23-Apr-2020) vaccine but not the powder via an intramuscular route in an right thigh for prophylactic vaccination on 27-Jul-2020.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received concomitant medications that included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  Potential PTC:No  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow up information received on the 28-Jul-2020 from consumer/ non-health care professional  Batch number, Date of vaccination, patient's age and route and site of administration and conmeds were added.
Numbess in left hand and foot. Nerve pain in left calf and foot, pain around back of skull, pain on left side of back of neck, seeing dots of lights in left field of vision upon entering lighted area after being in dark. These occured intermittently for over 60 days. After that time period, intermittent episodes of dyspnea for over 8 months.
Diarrhea; Fever 100.4 F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (Fever 100.4 F) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever 100.4 F). At the time of the report, DIARRHOEA (Diarrhea) and PYREXIA (Fever 100.4 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications was not reported. the treatment history was not provided.
Shingrix vaccine patient has extreme arm soreness in left arm. Pheumovax patient developed a rash in the right arm and complaining of moderate arm soreness.
Moderna Covid Vaccine given at left arm on January 4, 2021 at 8am. First onset of pain, swelling and tenderness noted on January 4 in the afternoon. Pain resolved on January 6, 2021 but swelling still noted, no tenderness. January 11, 2021: pain, increased swelling on Lt upper arm, left upper arm felt heavy and tight with limited movement on left arm noted. Upon assessment by PCP on same day 1/11/21, left deltoid is noted to be swollen, red and warm to touch. That?s why she prescribed me with antibiotics and lab works. Her diagnosis is cellulitis with swelling of left arm.
The evening of 3/3 I started to feel very tired.  I went to sleep early.  During the night I started to have chills and aches.  By the time I woke up on Thursday, 3-4 I had a fever of 100 degrees, a runny nose, chills, aching body, headache, and fatigue.  I just slept all day and took Tylenol.  By Friday morning the only symptom I had was a headache and fatigue.
Achy arm feeling heavy and weak from day 3 after the shot for the next 10 days. Site of injection spot on my arm is hot. For 2 weeks following the shot I was EXHAUSTED daily with a random burst of INTENSE energy lasting 2 to 3 hours daily and usually between 3 and 8 pm. Increased headaches daily. Stomach upset. I called my doctor and was prescribed Prednisone. It helped for 1 week. The same 2 symptoms of a throbbing arm, and being hot at the injection site returned. It has been 6 weeks. I want my arm to stop throbbing in pain.
Adverse reaction to vaccination. Hyperglycemia, Paraesthesia (Neuropathy), Weakness.
Sick; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional.   This case involves a male patient (age unspecified) who got sick (illness), while patient received INFLUENZA VACCINE [flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) for 5 days (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
This spontaneous report was received from a 90 years old female patient with hypothyroidism, "high blood", and allergy to erythromycin, regarding her own experience. The patient was vaccinated with ZOSTAVAX on 19-JUL-2012 in her upper right arm. Concomitant medications included SYNTHROID and losartan potassium. On 26-JUL-2012, about a week after received her ZOSTAVAX, the patient noticed a big red spot about 3 inches in diameter where the shot was administered. She stated that it itched very badly. The patient applied hydrocortisone cream topically in infected area. She did not sought medical attention. Patient outcome was not reported. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a female patient (reported as wife of pharmacist) of unknown age. The patients concurrent condition included similar reaction (as reported) to Yellow fever vaccine and IGA issues (details unspecified). On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date the patient experienced red rash over the entire arm (same arm as injection) and the rash was described as being "hot to the touch". The time between administration and development of rash was unspecified. It was reported that the pharmacy does not require follow up VZP mailing. No treatment was given for the events. The patient had not sought medical attention. The outcome of the events was reported as recovered/resolved (reported as after approximately three weeks). The causality for the events was not reported. Additional information has been requested.
I had, on the 21st, at about 6:00 pm or so I had left arm pain (upper). On the 22nd, at 5:00 am, I woke up with chills, body aches and fever of 99.1 and then I took Tylenol. I had taken the  morning off and I waited until 9:00 to see how I was feeling and I still wasn't feeling good. I ate breakfast and took another Tylenol and I was still having body aches, chills, fever was still 99.1. Had a little bit of headache also. So I called in work to cancel afternoon patients. At 1:00, I took two Tylenols because I had increased symptoms -about 99.3 or so fever. I went to sleep and woke up at 6:30 or so and was feeling better. After that I didn't have to use Tylenol. Arm pain was less stronger than the first dose on the second day (taken on the same arm).
About 20 hrs after second dose, I experienced low grade fever (100.4 degree f).; chills; fogginess; This is a spontaneous report from a contactable consumer.   A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: En6201) on 16Feb2021 at 16:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient didn't have medical history. Concomitant drug included metformin and melatonin. The patient received first dose of BNT162B2 on 22Jan2021 at 04:00 pm on left arm. On 17Feb2021 at 13:00 about 20 hours after second dose, patient experienced low grade fever (100.4 degree f). The patient recovered from the events on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Swollen Lymphnodes on upper area of my body (neck, shoulder and lungs). I have also suffered muscular pain for 5 months or so. Have had to perform multiple test, including Biopsy, Pet Scan, Sonogram, etc.
Distorted vision, muscle weakness, unable to walk unaided, low blood pressure, low respiration rate, low body temperature, cold sweat, vomiting and loss of consciousness.  Extreme fatigue.  Vertigo and loss of balance.
Arm swelling and pain immediately after injection. Patient states this has happened before at first dose and with other vaccines.
Patient c/o (L) arm soreness, tender to touch for 1mos - since injection. Not swelling, on exam -> Full ROM - pt has 1cm area of faint erythema and mild thickening, non tender. Tx = ibuprofen, stretching and ice.
Headache started afternoon after getting shot.  Flu-like symptoms including fever, chills, and pain started the next day.  Temperature unknown - thermometer showed 95°F but I raised the thermostat in house to 78°F, went to bed with electric blanket set on high, and ice packs on forehead and neck. Pain was so bad, I couldn't move even my fingers.  Red rash developed at site of injection that spread downward to elbow.  Headache and flu-like symptoms lasted through Thursday. Arm pain lasted through Saturday.
The patient developed a progressive facial diplegia and quadriparesis, mostly involving the lower extremities 3 weeks after receiving Moderna Vaccination.  Initially work-up was concerning for Guillain-Barré however LP showed significant pleocytosis with high protein, more consistent with transverse myelitis.  MRI demonstrated long region of increased signal lower cervical to upper thoracic without enhancement.  She showed significant improvement on high-dose steroids.  She is able to ambulate without assistance at this time.  She was discharged after complete her fifth day of steroids. Her speech and swallowing is improving, plans to follow-up with outpatient speech therapy.
headache; feels lightheaded and as if her head is floating around; This is a spontaneous report from a contactable consumer or other non hcp.   A 78-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 2 via an unspecified route of administration on 26Feb2021 2nd dose, single for COVID-19 immunization. The patient took historical BNT162B2 on 05Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. On 27Feb2021, the patient experienced woke up this morning with a headache, feels lightheaded and as if her head is floating around. Therapeutic measure was taken with Tylenol and her headache went away. She now feels lightheaded and as if her head is floating around and she was not dizzy and her balance was not off. The patient would like to know if her lightheadedness was associated with the vaccine. The clinical outcome of the events headache was recovered and event feels lightheaded and as if her head is floating around was unknown.      No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
No c/o of SOB, c/p. Pt. states he vomited aprx. 20 minutes ago in bathroom. VSS 112/70, 84, 22, lung sounds clear.
I am a board certified physician in gastroenterology and internal medicine and work for the Medical Center.  I have no hearing or ear history.  Received Pfizer vaccine from work on 12/21/20 L arm IM, no side effects, sore arm for < 24 hours, second dose 1/11/21 L arm IM, no side effects, sore arm for < 24, however, on 1/22/21 work up with muffled hearing and bringing in the left ear only.  Called colleague Doctor who started prednisone 50 mg immediately on 1/23/21 and continued for 4 weeks without improvement.  Audiometry testing 1/25/21 demonstrated moderate high-frequency hearing loss suggestive of sudden sensorineural hearing loss (SSHL).  Emergent CT head and MRI brain and ear were unrevealing.  20 session of hyperbaric oxygen therapy from 1/21-2/21 without substantial improvement.  Vasculitis workup negative with normal ANA, CRP, ESR, ANCA, CBC, CMP.   3/21 COVID-19 antibodies test for exposure negative.  4/21 noting more public event reporting of hearing loss and tinnitus associated with vaccines. reports-grow-amid-covid-19-vaccinations/) while I understand there is not causal evidence yet linked, I feel that there is a temporal relationship and odd correlation that needs to be recorded and accounted prospectively further.  Vascular surgeon, Hematologist who are treating me for a PE and DVT post ankle fracture and surgery do not correlate the SSHL with my DVT, PE, or anticoagulation.  To date 3 audiometry tests demonstrate persistent left-sided moderate high-frequency hearing loss.
I had a stroke or TIA on 9/15/2022 similar to the one I had in 2015 I don?t believe it?s related to the vaccination.  I am being seen to rule out  APS
Fever, swollen throat, "green stuff coming out of eyes: starting 4h after shot and resolving the next morning.
patient has developed rash on 06/05/23. Seen in office on 06/07/23 and advised to give Benadryl
Mom states swelling: left arm after vaccine about 1 min after DTAP: urticarial reaction on left upper arm.
Kidney stone/Nephrolithiasis recurrent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 at 14:10 as dose 3 (booster), single (Lot number: FD8448) at the age of 68 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Percutaneous nephrolithotomy", start date: 24Aug2020 (not ongoing), notes: to remove 12mm stone; "cardiac disorder/cardiac health" (ongoing); "Blood pressure abnormal" (ongoing); "Cholesterol control" (ongoing); "Chest pain", start date: 10Oct2016 (unspecified if ongoing); "Atrial stents implanted" (not ongoing); "herniatic disk L4-L5", start date: 2014, stop date: 2019; "Micro discectomy", start date: 14Oct2019 (not ongoing); "Kidney stone", start date: 2014, stop date: 2020; "Prostate health" (ongoing); "very high blood pressure", start date: 10Oct2016 (unspecified if ongoing); "arterial sclerosis" (unspecified if ongoing); "hydrocodone allergy" (unspecified if ongoing). The patient's medical history, reported also as family history included: "Father died of heart problems at age 68/Mother died of heart attack at age 47" (unspecified if ongoing); "mother had childhood scarlet fever" (unspecified if ongoing), notes: approx. 1919-2020. Concomitant medication(s) included: LISINOPRIL oral taken for blood pressure abnormal (ongoing); METOPROLOL oral taken for cardiac disorder (ongoing); FLOMAX [MORNIFLUMATE] oral taken for prostate infection (ongoing); ATORVASTATIN oral taken for blood cholesterol abnormal (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] oral taken for cardiac disorder (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, at 14:40 , Anatomical location: right arm, Route of administration: Intramuscular , Batch/Lot number: EN5318), administration date: 28Jan2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, at 13:00, Anatomical location: right arm, Route of administration: Intramuscular , Batch/Lot number: EN6200), administration date: 23Feb2021, for COVID-19 immunisation. The following information was reported: NEPHROLITHIASIS (medically significant) with onset 02Feb2022, outcome "unknown", described as "Kidney stone/Nephrolithiasis recurrent". The patient underwent the following laboratory tests and procedures: Too many test: Unknown results. Therapeutic measures were taken as a result of nephrolithiasis. Clinical course: Patient also received BNT162B2 (BNT162B2) on 20May2022 at 14:15 as DOSE 4 (BOOSTER), SINGLE  (lot number: FM7553) intramuscular, in right arm and BNT162B2 (comirnaty bivalent BA4/5) on 16Sep2022 at 12:45 as DOSE 5 (BOOSTER), SINGLE  (lot number: GH9694) intramuscular, in right arm  for COVID-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175662 same patient/reporter, different drug/AE;US-PFIZER INC-202300176199 Same patient, same product, different dose (Dose 3), Different events;
positive for the COVID-19 Virus; positive for the COVID-19 Virus; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (Covid-19 Vaccine), via an unspecified route of administration at single dose for covid-19 immunisation. Medical history included congestion. Concomitant medications were unknown. She said she didn't realize she was asymptomatic, and tested positive for the COVID-19 Virus. She said she had already received her first COVID-19 Vaccine dose before she was told she was positive for the COVID-19 Virus. Consumer asked if she should delay getting the second dose of the COVID-19 Vaccine, or does she need to start from scratch. She asked if Pfizer has any specific COVID-19 Vaccine protocol for someone who has tested positive for the COVID-19 Virus after already receiving a COVID-19 Vaccine dose. Reported she had been experiencing some congestion, so she decided on a Monday to get tested for the COVID-19 Virus. She said her COVID-19 Virus test was negative. She said on that Friday she was still congested. She said she had her first COVID-19 Vaccine dose earlier on that Friday. She said after she had received the COVID-19 Vaccine on that Friday, someone who she had been in close contact with tested positive for the COVID-19 Virus. She said since her congestion started, she had developed other symptoms, so she retested for the COVID-19 Virus later in the day that Friday. She said she received a positive COVID-19 Virus test result on Monday. She said she was guessing that the was positive for the COVID-19 Virus at the time she received her first COVID-19 Vaccine dose on that Friday. Reported she looked at Pfizer's Medical Information website to see if she needed to repeat her first COVID-19 Vaccine dose, and didn't find any information directly related to her situation. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be requested.
Initial unsolicited report received from a pharmacist on 18 May 2016. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of YF VACCINE (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On an unspecified date post vaccination, the patient had a seizure. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event: seizure. List of documents held by sender: none. Sender's Comments: Based on the available information temporal relationship between the suspect vaccine and the reported event cannot be established, also very limited information is provided in this case, hence due to lack of information causality cannot be assessed for now.