chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight pain leading into left pectoral; armpit has swollen; lymph glands are tender; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 11th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain, local swelling and lymph node tenderness. On an unknown date, the outcome of the pain, local swelling and lymph node tenderness were unknown.   It was unknown if the reporter considered the pain, local swelling and lymph node tenderness to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose on 6th August 2019. The patient received the second shot in the left arm.  The patient's armpit had swollen, the lymph glands were tender and there was a slight pain leading into the left Pectoral. Sonogram was done in 2020 to see if the swelling had become cancerous but the result was no.
2nd dose energy really bad for 3-4weeks and still not back to normal and still don't have smell and taste. Memory problems/ brain fog, MRI. Had COVID-19 in Jul2021 after my 1st dose in Jun22. Loss of taste and smell, bad headache and I thought it was a reaction to the shot I got it possibly a day or two before the 1st dose. The cough was so bad and nearly went to ER but didn't want to go. Over a week in bed and not coherent. Long haul and still have fatigue, headache and memory loss. Had a flu shot and went into metabolic problems.
I went for a regular mammogram on August 18, 2021 got a breast cancer diagnosis in left breast with the DCIS 9 mm. I had surgery on December 10, 2021 no lymph node involvement. I'm scheduled to have radiation and get hormone medication. I'm going to decline the hormone medication. I still have no symptoms.
Stape throat temperature 101-102; prescribed amoxicillin for ten days. Sore throat remained 01/10/2023 went urgent care and began to get better.
Menactra given 3/21/06 at 9:15. Youth vomited x 2 3/21/06 in evening and reported to medical clinic on 3/22/06 at 11:00 am with T 102 degrees, nausea and vomiting.
after the 1st dose of the Pfizer Covid19 vaccine, patient come up with Covid; after the 1st dose of the Pfizer Covid19 vaccine, patient come up with Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single 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), outcome "unknown" and all described as "after the 1st dose of the Pfizer Covid19 vaccine, patient come up with Covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out.
This spontaneous report was received from a registered nurse and refers to a 5 year old male patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 08-JUN-2018, the patient was vaccinated with improperly stored dose of PROQUAD, first dose, subcutaneously in left arm for prophylaxis, lot# N002916, expiration date 24-JUL-2018. The vaccine was reconstituted with properly stored sterile diluent (lot# reported as M041813, expiration date 27-MAY-2019). The vaccine underwent a temperature from 6°F to 14°F (14.3 °F) for 5 minutes, and from 15 °F to 46°F (20.7 °F) for 15 minutes. The patient had no illness at the time of the vaccination. There was no adverse event reported. The call was because of digital data logger.
Right arm celluitis with itching, pain and area very hot to touch.  Overall muscle aches and severe irritablity.  Broken sleep noted due to pressure on site during position change. Site approximately 3inches in circumference of injection site.
suspected vaccination failure; had the Shingrix / two years ago / got Shingles; had the Shingrix / two years ago / I got COVID; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. Two years ago, from the date of reporting the patient received Shingrix. The patient experienced COVID and Shingles.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Hospitalization due to acute respiratory failure with hypoxia 2/2 to COVID-19 PNA
Case PHEH2016US028860 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to a adult female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscular in left deltoid on 13 Sep 2016. On an unspecified date, the patient experienced temperature excursion prior administration (minus 2.7 Celsius for 6 hours and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The patient had been notified will be revaccinated. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse.
patient fully vaccinated.  returned home after out of state travel on 5/30/21, started having symptoms while on the plane (sinus/nasal congestion, fatigue).
Patient received a 3rd dose of Moderna. 1st dose on 2/3/21, 2nd dose on 3/4/21, and 3rd dose on 5/13/21.
Pain and tingling in arm of injection from neck down to hand. Localized swelling and rash at injection site.
wrong dose inadvertently was given to a child with the dose for 12-17 yrs old. Pt with no adverse reaction afterwards not at the time of vaccination nor one day later
Narrative: 83M w/ PMH of ILD (not on home O2) Afib/flutter, CAD s/p CABG (4/2013 SVG-LAD), descending thoracic aortic aneurysm with dissection s/p L CVA (3/4/11) and (9/2019), vascular dementia, HTN and DM2 who was initially admitted to Facility on 3/25/21 for fall w/subacute C1 fracture transferred to ICU 3/26 for hypoxemic respiratory failure s/p emergent intubation with prolonged ICU course significant for prolonged ventilator needs 2/2 to ARDS from aspiration Klebsiella PNA and pulmonary edema, extubated to nasal cannula and stepped down to acute care ward. His course on the floor was stable for a bit but complicated by 2+ episodes of desaturations of unclear source, likely from recurrent aspiration vs. volume overload, requiring transfer to the ICU for high flow nasal cannula. While in the ICU, he had agitated delirium, refused oral medications, and ultimately required IM haloperidol to maintain safety, which helped significantly. Per 4/21/21 Palliative care note, family meeting held with the clear decision to change plan of care to comfort focused. Patient passed on 4/25/21 from hypoxic respiratory failure secondary to sequelae of aspiration pneumonia with ARDS like picture, also some contribution from volume overload. 4/25/21 Death Note lists immediate cause of death as, "Acute hypoxic respiratory failure." Report submitted because patient received a total of 3 COVID-19 Pfizer vaccinations. Two doses were received prior to Facility admission from a non facility source on 2/8/21 & 3/1/21. The 3rd COVID-19 vaccine dose was ordered by the Facility Medicine Team and administered on 4/14/21. (Of note, the 3/25/21 ED attending note and H&P Admission both note that patient "s/p COVID vaccine.") No suspected correlation between patient's passing and 3rd COVID-19 vaccination.
This spontaneous report was received from a nurse, concerning a 39 year old female patient. The patient's medical history was not reported. Her concurrent conditions included asthma and an allergy to eggs and eggs derivative. The patient did not have any concomitant medications to report. On 02-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 as vaccine, intramuscularly, in her left arm, lot #R006466 (strength, dose, frequency and expiration date were not reported). On 03-AUG-2018, the patient experienced redness, swelling and warmth down her left arm and torso. The patient went to an unspecified emergency room and received BENADRYL on an unspecified date. At the time of reporting, the patient was recovering from redness, swelling and warmth down her left arm and torso. The causal relationship between the vaccination with PNEUMOVAX 23 and the events was not provided by the reporter.
w/in 24 hrs of vax pt devel hives, eye swelling, hands swollen, fever-seen in office & recommendations included aveeno or Nutrasoothe oatmeal baths, aclovale cream;
Patient was checked 15 minutes post-vaccination and became unconscious. After one minute, patient was a/o, blood sugar was 119, BP 136/86, RR 18, temp 97.2, Sp02 98%. Patient denied pain. O2 was started  at 1.5L. EMS was called and arrived at 1455. Patient declined to go to hospital.
On November 10 pt received Flu vaccine. At 9:30 am. After the vaccine he went to the dentist who prescribed an antibiotic for the tooth infection. On the 12 of November (Thursday) at midnight patient started to feel pain in his hip, right leg, left leg, and the elbow. While he was at home he took over the counter head ache pills. At the ER at the Hospital was prescribed oxycodone. He started losing hearing and also lost memory while he was taking this medication at home. Gradually, also had vomiting, prescribed COMPAZINE. Right hand began shaky, could not hold anything. Excess of sleeping. Slept during 15 hours a day. Patient did not eat during 3 weeks lost 30 pounds. He drank more water and fruit juice while he was at home. After all these episodes pt. went to the ER Hospital twice, where he had cat scans. After pt was discharged on the 4 of December, gradually hearing began to come back as well as appetite.   2/2/09 MR received fro ER visit 11/28/2008 with DX: depression.  Neuro consult Impression:  Increased Anxiety from baseline.  30 lb weight loss-r/o metastasis vs depression.  Hand tremor.   Pt presented with c/o increased anxiety, difficulty concentrating, 30lb wt loss in 3 weeks, headaches and hearing loss. Pt had felt ill since 2 days s/p Flu shot on 11/11/08 with fever, flu-like sx, nausea, H/A and confusion. Saw dentist for tooth infection. Rx: abx. PE (+) for visual apraxia, L flapping tremor, (+) intention tremor, (+) Romberg. Referred for psych consult due to recent losses.  DX:  MDD, Anxiety, Adjustment reactions. Referred for outpt f/u.
pt in ER for suicide attempt; was given Tetanus toxoid booster; BP dropped (no recording) & devel rash; was given DPHH;
Noticed rash on feet yesterday. Rash on arms and legs after shower this morning. Patient to treat symptoms with Claritin. Will monitor for worsening symptoms then to f/u with MD.
This case was reported in a literature article and described the occurrence of uveitis in a 36-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent medications included LEVOTHYROXINE. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced uveitis, arthritis and optic neuritis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. (B0662267 till B0662297A). It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis b antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
swollen lips; Has not gotten her 2nd dose; hive was pretty swollen on her tongue/swollen tongue; soreness in her arm; hives on tongue, lip, arm/severe hives for 4 and a half months "having hives on and off, somewhere everyday."; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (hive was pretty swollen on her tongue/swollen tongue), LIP SWELLING (swollen lips), PRODUCT DOSE OMISSION ISSUE (Has not gotten her 2nd dose), PAIN IN EXTREMITY (soreness in her arm) and URTICARIA (hives on tongue, lip, arm/severe hives for 4 and a half months "having hives on and off, somewhere everyday.") in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination.     The patient's past medical history included Hives.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm) and URTICARIA (hives on tongue, lip, arm/severe hives for 4 and a half months "having hives on and off, somewhere everyday."). On 24-Feb-2021, the patient experienced SWOLLEN TONGUE (hive was pretty swollen on her tongue/swollen tongue). On an unknown date, the patient experienced LIP SWELLING (swollen lips) and PRODUCT DOSE OMISSION ISSUE (Has not gotten her 2nd dose). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Hives, at an unspecified dose and frequency. In February 2021, PAIN IN EXTREMITY (soreness in her arm) had resolved. At the time of the report, SWOLLEN TONGUE (hive was pretty swollen on her tongue/swollen tongue), LIP SWELLING (swollen lips), PRODUCT DOSE OMISSION ISSUE (Has not gotten her 2nd dose) and URTICARIA (hives on tongue, lip, arm/severe hives for 4 and a half months "having hives on and off, somewhere everyday.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Sig followup  Event details updated.
Initial Information and follow up has been received from a pharmacist and nurse for the Pregnancy Registry of GARDASIL concerning a 24 year old female with a history of 0 pregnancies and 0 live births who on 01-NOV-2007 was vaccinated with her first dose of GARDASIL (lot # not reported).  On 27-DEC-2007 the patient was vaccinated with her second dose of GARDASIL (lot # not reported).  Concomitant therapy included methyldopa, 500 mg BID for hypertension.  The patient is now pregnant with an LMP date of 11-MAR-2008 and a delivery due date of 16-DEC-2008.  No problems were reported.  The patient is also taking 40mg daily of PROTONIX for gastrooesophageal reflux disease (GERD).  The patient sought medical attention by contacting her physician on an unspecified date.  Follow-up information was received from an RN for the Pregnancy Registry for GARDASIL.  On 28-JUL-2008 and 12-SEP-2008, ultrasounds were performed for the evaluation of growth and date, and the results were within the normal limit.  On 09-DEC-2008, the patient with chronic hypertension (CHTN) and gastrooesophageal reflux disease (GERD) gave birth to a 7 pounds 0 ounce male infant.  The labor was forced for arrested descent.  Apgar score was 8/9.  The infant was normal without congenital anomalies.  There was no infections or illnesses during pregnancy.  No further information is available. Follow up informatin was received from a registered nurse for GARDASIL vaccine. On 28-JUL-2008 and 12-SEP-2008, ultrasounds were performed for the evaluation of growth and date, and the results were within the normal limit. On 09-DEC-2008, the patient had chronic hypertension and gastrooesophageal reflux disease. Forceps vaginal delivery was performed for arrested descent. On 09-DEC-2008, she delivered a 7 pound 0 ounces normal male infant. APGAR score of 8/9. The infant was normal without congenital anomalies. There was no infections or illnesses during pregnancy. Follow up information was received from an RN for the Pregnancy registry for GARDASIL. The delivery date was 18 weeks and 6 days from LMP. The infants length was reported as 20.5 inches. Complication during labor/pregnancy was forcep vaginal delivery. No further information is available.
Hospitalized for COVID-19. Patient initially admitted with hypoxemia, likely suggesting a COVID pneumonia. CT scan without infiltrates. Patient now on room air. Likely could discharged home with no further pharmacological management of COVID.
cough; patient felt dizzy; weak; pulse of 121 bpm; blood pressure of 168/121; 101-degree F fever; body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (cough), DIZZINESS (patient felt dizzy), ASTHENIA (weak), HEART RATE INCREASED (pulse of 121 bpm) and BLOOD PRESSURE INCREASED (blood pressure of 168/121) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced COUGH (cough), DIZZINESS (patient felt dizzy), ASTHENIA (weak), HEART RATE INCREASED (pulse of 121 bpm), BLOOD PRESSURE INCREASED (blood pressure of 168/121), PYREXIA (101-degree F fever) and MYALGIA (body aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 27-Oct-2022 at an unspecified dose and frequency. At the time of the report, COUGH (cough), DIZZINESS (patient felt dizzy), ASTHENIA (weak), HEART RATE INCREASED (pulse of 121 bpm), PYREXIA (101-degree F fever) and MYALGIA (body aches) had not resolved and BLOOD PRESSURE INCREASED (blood pressure of 168/121) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2022, Blood pressure measurement: 168/121. On 27-Oct-2022, Body temperature: 101 degree F. On 27-Oct-2022, Heart rate: 121 bpm.         It was unknown if patient was under any concomitant or regular medication. Patient received First, second and booster dose on an unknown date. Patient stated he wanted to report a really severe reaction that his wife was experiencing after getting Moderna COVID-19 Vaccine Bivalent. Caller stated his wife got the bivalent on 27-Oct-2022 and during the night she experienced 101-degree F fever, blood pressure of 168/121, pulse of 121 bpm, cough, body aches, felt dizzy and weak, and took aspirin, helping for the blood pressure to drop. On 28-Oct-2022 around 6:00 AM patient needed to go to ER because of these symptoms. Caller mentioned he was running out of time because his wife was still in the hospital, and he had to attend calls from doctors and was not able to provide additional details about the AE.  It was unknown if patient was under any concomitant or regular medication. It was unknown if patient ever had COVID positive test or diagnosis. It was unknown if patient had Acute and Chronic illnesses at the time of vaccination. It was unknown if patient experienced a similar event in the past.
itchiness; found a cluster of hives in the upper left arm at the injection site; feel under the weather; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel under the weather), PRURITUS (itchiness) and INJECTION SITE URTICARIA (found a cluster of hives in the upper left arm at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced MALAISE (feel under the weather). On 30-Mar-2021, the patient experienced PRURITUS (itchiness) and INJECTION SITE URTICARIA (found a cluster of hives in the upper left arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (feel under the weather), PRURITUS (itchiness) and INJECTION SITE URTICARIA (found a cluster of hives in the upper left arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.
Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil.  Per the reporter, "a patient experienced a cold after receiving her second dose of Gardasil."  The patient sought unspecified medical attention.  The lot number was not available and no further information was given.  The physician does not want to be contacted.  Additional information is not expected.
Patient was given a Varivax in addition to a Pro Quad which contained Varicella
I had "flu like sx" the following day & since that time I have awakened almost daily w/painful & swollen joints. The joints include hands/fingers, elbows, wrists, shoulders, knees, ankles & my entire back aches. Some days are worse than others but this has been almost constant & new since rec'd this vaccine. I am experiencing ongoing fatigue, malaise & a general feeling of poor health. I have req'd large amounts of Ibuprofen to keep the discomfort somewhat diminished.
Patient received 0.5mL dose instead of the correct 0.25mL dose for their fourth dose booster in the series.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, Fever 101.3, chills, fatigue
This spontaneous report was received from a medical assistant and refers to 11 patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored GARDASIL (dose, route of administration, lot number and expiration date were not reported, it was confirmed that it was not GARDASIL 9). Concomitant therapy was not reported. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.