chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; shingles on left eye; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she got the shot for shingles and at the time of reporting had shingles on his/her left eye, it was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Blurred vision; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VISION BLURRED (Blurred vision). At the time of the report, VISION BLURRED (Blurred vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported Treatment information was not provided   Reporter did not allow further contact
She already took Tylenol yesterday because of headache and high hernia and high hernia is swelling; I got headache; I have a higher hernia and after the Tylenol it made my high hernia to swell, it made my stomach open up and I got sick; stomach open up; I got sick; high hernia is swelling; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (patient, self-reported). A 59-year-old female patient (age at vaccination: 59 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 02Jun2021 at 13:05 PM, as a single dose for COVID-19 immunization; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she already took Tylenol (Captured as suspect) yesterday because of headache and high hernia and high hernia was swelling; she got headache. She had a higher hernia and after the Tylenol it made her high hernia to swell, it made her stomach open up and she got sick on 02Jun2021. The patient stated, she wanted to find out if it was okay for her to take the Ibuprofen (captured as suspect) because she was told that we are taking the shot, she already had her second shot, this was her second, she had it was second, but they told her to take Tylenol and she had a higher hernia and after the Tylenol it made her high hernia to swell, it made her stomach open up and she got sick. She got headache like so and all and she mean she just, she was for bed off. So, she wanted to find out if it was okay to take as Ibuprofen and two doses of the Tylenol. The action taken in response to the events for Tylenol and Ibuprofen was unknown. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/12/2021 and 3/12/2021. Presented to ED 12/27/2021 from nursing home for positive COVID-19 infection and sepsis with urinary tract infection. PMHx a-fib, mitral valve replacement, aortic stenosis and dementia. TX'D w/pressors, IVF, vancomycin and Aztreonam. DNR upon admission, expired 12/30/2021.
Initially well circumscribed patch of erythema approximately 5 cm in diameter.  This progressed to malaise, generalize weakness, enlarged lymph nodes b/l axillae and groin, b/l muscle pain and weakness in shoulder and hip girdle.  Diffuse urticaria.
Dose administered out a vial which was left in refrigerator for more than 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered out a vial which was left in refrigerator for more than 30 days.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered out a vial which was left in refrigerator for more than 30 days.). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered out a vial which was left in refrigerator for more than 30 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-355908, MOD-2021-355908 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Significant followup appended on 18-Oct-2021,Gender of patient confirmed by Pharmacist reported as Female.
Bad reaction; Low back pain; This case was reported by a other health professional via interactive digital media and described the occurrence of ill-defined disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced ill-defined disorder and low back pain. On an unknown date, the outcome of the ill-defined disorder and low back pain were unknown.   It was unknown if the reporter considered the ill-defined disorder and low back pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. HCP reported that he received the 2nd dose of shingrix on last thursday and experienced bad reaction and also low back pain with that. Patient was asking about if that was the concern or it will resolve.
Patient presented to ED on 9/2/21 from a rehab facility with fever and cough and found to be covid positive. Patient is fully vaccinated. Patient was appropriately treated for his covid 19 infection. On 9/14, patient developed a new fever and acute hyposia requiring high flow nasal cannula and was started on broad spectrum antibiotic due to suspicion for aspiration pneumonia. Chest x ray confirmed development of a new consolidation along with a rising procalcitonin. Despite antibiotics, patient was unable to be weaned from HFNC with high FiO2 and flow requirement. Given worsening work of breathing and inability to tolerate HFNC, patient's family transitioned him  and patient passed away peacefully on 9/19.
Influenza vaccine given 10/11/07 at 8am to left upper arm.  At 8pm on 10/11/07 developed a bruise and rash to left upper arm.  The rash spread to neck and chest area. Rash was itching and lasted until Sunday 10/14/07 morning
Shortness of breath; Headache; Diarrhea; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever) and NAUSEA (Nausea). On 30-Sep-2021, the patient experienced DYSPNOEA (Shortness of breath) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: The followup contains No new information
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives, itchiness on arms, olecranals. Itichinees between fingers internal ichiness.
Pt was seen in urgent care with diagnosis of herpes secondary to varicella given 5 days prior to onset of rash. Rash was noted to be on right side of chest around to mid back-red and blistery "only hurts in the sunlight". 07/22/2003 left message for parents to call clinic RE: update on condition
Received Pfizer vaccines on 5/1/21, 5/22/21; tested positive for COVID 19 by PCR on 10/26/21. Admitted to Hospital on 10/31/21 for fever and septic right ankle.
Sensation of bilateral lower eye swelling without obvious signs of swelling. Sensation resolved without intervention. Resolved the following day, about 10 hours?
Fever of 100 degrees; Not feeling too good; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100 degrees) and FEELING ABNORMAL (Not feeling too good) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (Fever of 100 degrees) and FEELING ABNORMAL (Not feeling too good). On 26-Feb-2021, PYREXIA (Fever of 100 degrees) had resolved. On 28-Feb-2021, FEELING ABNORMAL (Not feeling too good) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Pyrexia: 100 degree.         Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not Applicable.
Woke up on 10/9 with raised hives across both upper arms, elbows, shoulders, and upper back, with some small clusters on both thighs and stomach. Contacted doctor via secure messenger who advised taking an antihistamine and come in if there was no improvement or if the spots began to resemble Monkeypox lesions. Took standard doses of Benadryl tablets to relieve itching every 4 hours. Tapered off to taking Benadryl once a day by 10/14.  Hives were no longer raised by 10/14. Red spots still remain on right arm where hives were the worst cluster, with some faded spots in other places.
Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 035B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.            No concomitant medications reported. No treatment information was reported by reporter
Felt warm/flushed after vaccine.   HR 128/68, HR 90.  Given water. Reports having similar reaction with other vaccines - assumes anxiety related per patient. felt better and released after 30 minute observation.
Flu like symptoms; Low grade fever; Chills; body aches; sweating; fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old male patient received BNT162B2 (lot ej1685) intramuscular on 29Dec2020 07:15 AM at a single dose on the left arm as COVID-19 vaccine. Medical history and concomitant medications were not reported. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA). The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He did not receive other vaccines within four weeks prior to the COVID vaccine. The patient experienced flu like symptoms, low grade fever, chills, body aches, sweating, fatigue, all on 30Dec2020 12:00. The events were non-serious which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the events. He was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 30Dec2020.
Case number PHEH2016US029456 is an initial spontaneous report received from consumer on 20 Oct 2016. This report refers to 67 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN at a dose of 0.5 ml intramuscular on 19 Oct 2016. On 20 Oct 2016 the patient experienced flu-like symptoms. The patient states that it was not an anaphylactic reaction and on the same day, the patient had begun feeling warm, dizziness, sweaty, feverish, with a sore throat, cough, pain in upper abdomen, weakness, itchy/watery eyes, runny nose, loss of appetite, joint pain in wrist and fingers. These symptoms lasted one week. The patient cough and achy/feverish feeling left after 1st week. The second week, patient still had a runny nose, itchy eyes, and dizziness. It was reported that the customer states that she had not had any new medications and this was the first flu vaccine she had received in years. The outcome of the events was reported as watery eyes, itchy eyes and dizziness condition unchanged, warmness, weakness, flu-like symptoms were condition improving and sweaty, fever, sore throat, cough, abdominal pain, runny nose, appetite absent and joint pain were reported as complete recovery. The seriousness of the events was reported as serious disability. The causality of the events was not reported.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in Aug-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On Tuesday, 09-Nov-2021, the patient experienced headache and did COVID-19 rapid POC test (NR: not provided) which came negative. The Patient lost her sense of taste and smell and had chills, headache, nasal congestion and cough. On 12-Nov-2021, the Patient had (Home Rapid test) Laboratory data included: COVID-19 rapid POC test (NR: not provided) which was Positive. On 13-NOV-2021, the patient went to her PCP (Primacy care physician) and had COVID-19 PCR test (NR: not provided), the report of test came positive on 15-Nov-2021 (confirmed clinical vaccination failure and confirmed covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000202316.; Sender's Comments: V0: 20211133893- COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATION
Sudden onset of fever with strong chills, muscle aches, and fatigue. Fever typically stayed around 101-102, with highest temp recorded of 102.6.  This lasted from about 7pm the night of the vaccine until around 3:30 in the morning, despite alternating Tylenol and ibuprofen.  The chills and muscle soreness alone were debilitating.   I filled vsafe today when I signed up but it did not give me the option to add yesterday?s symptoms so I am reporting them here. Today symptoms have been milder, mostly fatigue and no fever.
Pt received the nasal flu vaccine at school on the 11th. About a week or two later, his mother became ill with a URI. On 10/29 pt became ill with URI sx and some wheezing. Seen for this at my office on 11/1/2010; URI severe but wheezing not bad at all.
Patient returned to clinic for PPD reading on 1-10-2020. Patient C/O (L) arm pain & swelling and took off bandaid it was a 5mm blister that had been broken. Mom concerned about Blister & upper arm redness. Physician looked at arm & blister under bandaid approx. 4mm from inj site. Patient did not return Monday to re-evaluate. Given ABX ointment & wrap.
WHERE GOT THE SHOT IT HAS BEEN SUCH A LENGTHY PERIOD OF TIME BUT IT HAS GRADUALLY GOTTEN WORSE INSTEAD OF THE INJECTION SITE GETTING BETTER; 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced where got the shot it has been such a lengthy period of time but it has gradually gotten worse instead of the injection site getting better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from where got the shot it has been such a lengthy period of time but it has gradually gotten worse instead of the injection site getting better. This report was non-serious.
Patient reported having fever and generalized reaction in the two days immediately following the injection. However, a localized redness and swelling were persistent afterwards. She contacted us again on the fifth day after injection complaining of the area still being red and swollen and was advised to contact her physician for evaluation and follow up.
Booster dose was given 7 days before due date, patient waited 15 minutes for observation and had no issues or reaction to vaccine. Medical director was notified of event.
Hospitalized 09/25/2021; COVID-19 positive 09/25/2021; fully vaccinated  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness, somnolence.  New oxygen requirement and See H&P from 09/25/2021 for full details.   HOSPITAL COURSE: Patient was admitted to the Hospital with COVID 19 pneumonia.  He was initially requiring 2 L of oxygen, required between 2-3 L oxygen during the hospital stay.  He was put on Decadron, received 3 days of this.  He was not a candidate for remdesivir given the onset of his symptoms 09/17/2021.  He was stable on 2 L oxygen and was anxious for discharge, he will be prescribed home oxygen, with home health care services.    His blood sugars were elevated while in the hospital, per chart review his A1c is 12.1%.  He was recently restarted on long-acting insulin by his PCP; he should resume this at discharge he can increase to 30u daily while on steroids and needs to check his blood sugar more frequently.
2 days following vaccine, slu like symptoms developed in the a.m.  After noon, redness and heat in face developed.  Early evening, swelling in face and under eyes developed.  No fever.  3 days following vaccine, eye lids swollen; eyes swollen shut.  Treated self with Benadryl.  Did not seek medical attention.  Day 4-5, swelling subsided.
Narrative:  A 45yo female with PMH if Chronic Periodontitis, Migraine, Optic Neuritis (2008), Mechanical Low Back Pain,, Lumbar Radiculopathy, Allergic Rhinitis On September 30.2021 a PCC physician reported the patient had a historical ADR of Influenza vaccine induced eye pain (Bilateral Optic Neuritis) in October or 2012 - vaccine received at a different facility No additional information regarding the vaccine (Type of Influenza vaccine, Manufacturer Lot # and where administered) were included in the report