chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incorrect product storage; No adverse effects reported; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On unknown date, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis (which had a lot number R014263 and expiration date on 26-MAR-2021; however, dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 33.6 F for 24 hours and 30 minutes, as recorded by data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.; Sender's Comments:  US-009507513-1904USA011405: US-009507513-1904USA012028:
FEVER, CHILLS, MYALGIA Narrative:  FEVER 102  Other Relevant History:
Injection site warm to touch; Injection site red; Injection site sore; Injection site itchy; Injection site swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warm to touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE WARMTH (Injection site warm to touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, INJECTION SITE WARMTH (Injection site warm to touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
There was  a miscommunication. The intern gave the patient the concentrated (unconstituted) vaccine of 0.3 ml. We spoke to the patient the next morning. He said he only has a sore arm so far but his wife is a nurse and will monitor him.
Information ahs been received from a woman in a doctor's office concerning a 45 month old female pt with no past medical history and no allergies who on 03/28/1999 was vaccinated with a second dose of varicella virus vaccine live (0.5ml), in the right thigh. There was no concomitant medication. On 01/15/2002, in the AM, the pt came into the doctor's office with active chicken pox with 10 to 15 lesions scattered over her body. The pt sought unspecified medical attention. It was reported that the pt recovered. No further info is expected.
blisters broke out; Getting over them and had the shot/suspected vaccination failure; getting over them; painful / Felt like an ice pick stabbing; 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.   The patient's past medical history included knee operation (First a fall, then knee surgery for msnicusi and ligament) and sepsis (then in hospital again with sepsis, sick for a year). Additional patient notes included Tansfusion- iron.   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), shingles, pain and blister.On an unknown date, the outcome of the vaccination failure and blister were unknown and the outcome of the shingles was recovering/resolving and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient mentioned that this year was bad year and a half, first fall then knee surgery for meniscus and ligament, then in hospital again with sepsis, sick for a year, then iron transfusions, then shingles. The patient stated he/she just now getting over them (shingles) and had the shingles vaccine. The patient stated they were extremely painful. The worst pain was before the blisters broke out. The patient felt like an ice pick stabbing for 3 solid days. The patient stated he/she wanted to be healthy even though he/she on a heating pad right now at the time of reporting, he/she thankful, it could be worse. 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 possible as contact details was not available.
Pt reported bilateral neck swelling 1 mo after receiving Moderna vaccine, which resolved 2 months later. Stated she saw her pcp Dr, and he did not attribute symptoms to the vaccine. However, she then reported she saw a nurse practitioner that suspected it might be a vaccine reaction. She is nervous today about having a booster, as she believes it was possibly a lymphatic vaccine reaction.
Vaccine administered to patient 16 yoa.  Moderna vaccine EUA is for age 18 and over.
ON 8/30/2017 AT 4 AM THE SITE OF INJECTION BEGAN ITCHING. THE INJECTION SITE BECAME RED AND SWOLLEN AROUND 0830. THE ITCHING BEGAN TO SPREAD AND THE SITE OF INJECTION FELT WARM TO TOUCH AROUND 1000. THE SITE OF INJECTION IS CURRENTLY SLIGHTLY PAINFUL 2/10 AT 2PM.
This spontaneous case reported by a consumer, describes the occurrence of headaches, chills and vaccination site swelling (swelling around injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 27, 2021, patient experienced headaches and chills. On Mar 29, 2021, patient experienced vaccination site swelling (swelling around injection site). At the time of the report, headaches, chills and vaccination site swelling (swelling around injection site) outcome: unknown/not provided. Treatment and concomitant information not provided. This case linked to MOD-2021-060770 (patient link).
Resident was given Pfizer bivalent. Supposed to start primary series. No adverse reaction.
dizziness, not very bad; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 69 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: ALEVE. The following information was reported: DIZZINESS (non-serious) with onset Feb2021, outcome "not recovered", described as "dizziness, not very bad". Therapeutic measures were not taken as a result of dizziness.  Additional information: The patient was also taking a vitamin. The patient reported, "After the first shot, I had little diarrhea, not diarrhea but dizziness, not very bad." Consumer stated there was no treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021318611 same reporter/patient/vaccine, different dose/event
Information has been received from a pharmacy technician concerning a 11 year old daughter of a friend who in January 2007 (exact date unknown), was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). In Jan-2007, the patient developed a red, itching vaginitis after receiving the 1st dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Per the pharmacy technician, the patient's vaginitis persisted throughout the complete HPV rL1 6 11 16 18 VLP vaccine (yeast) series. The patient did receive unspecified medical attention and tropical creams were used to treat the problem. At the time of this report the patient has not recovered. Additional information has been requested.
Patient has been experiencing pain in his left shoulder and deltoid muscle when he lifts his arm above the shoulder. He says that he has no pain when his arm is placed below the shoulder. He has had no redness or swelling. The pain got progressively worse starting the day after receiving the flu shot on 10/22, but has since gotten better. He states he still has mild pain now, but it is manageable.
huge cold sore; some arm soreness upon reaching; some redness & itching around injection site; some redness & itching around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some arm soreness upon reaching), INJECTION SITE ERYTHEMA (some redness & itching around injection site), INJECTION SITE PRURITUS (some redness & itching around injection site) and ORAL HERPES (huge cold sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20N) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfa), Iodine allergy, Drug allergy (Bacitracin), Hypothyroidism (since 1973), Psoriasis (since 1993), Paroxysmal ventricular tachycardia (since 2014), High cholesterol and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, ATORVASTATIN for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, METOPROLOL for Paroxysmal ventricular tachycardia, MELATONIN for an unknown indication.    On 15-Feb-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (some arm soreness upon reaching), INJECTION SITE ERYTHEMA (some redness & itching around injection site) and INJECTION SITE PRURITUS (some redness & itching around injection site). On 23-Feb-2021, the patient experienced ORAL HERPES (huge cold sore). The patient was treated with DOCOSANOL (ABREVA) in February 2021 for Oral herpes, at a dose of 1 dosage form. On 18-Feb-2021, PAIN IN EXTREMITY (some arm soreness upon reaching) had resolved. On 20-Feb-2021, INJECTION SITE ERYTHEMA (some redness & itching around injection site) had resolved. On 22-Feb-2021, INJECTION SITE PRURITUS (some redness & itching around injection site) had resolved. On 08-Mar-2021, ORAL HERPES (huge cold sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-080849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up report included updates on patient height, weight, race, ethnicity, medical history, batch number of vaccine, concomitant medications, event outcome, treatment medication and causality.
soreness in the arm, the right arm; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the arm, the right arm) and MYALGIA (body ache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in the arm, the right arm) and MYALGIA (body ache). At the time of the report, VACCINATION SITE PAIN (soreness in the arm, the right arm) and MYALGIA (body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient takes a blood thinner medication as regular medication. Patient did not take anything to treat his symptoms only, a hot tea.
Patient with h/o CAD, vertebrobasilar insufficiency, recent hospitalization for COVID PNA admitted to hospital on 02/20/2022 with inferior STEMI.  The patient was at rehab and acutely lost consciousness, was intubated on arrival to ED and found to have inferior STEMI.  The patient was taken to VUMC cath lab and had POBA to totally occluded RCA, also severe disease in LAD.  Post procedure the patient continued to be hypotensive requiring pressors and hypoxemic.  On 02/28 patient was noted to be more hypoxemic.  He was placed on OptiFlow.  On 03/01 the patient went into PEA arrest.  CPR was initiated immediately, and underwent multiple rounds of CPR during ROSC was obtained multiple times, however, his rhythm continued to degrade into PEA arrest.  Patient expired on 03/01/2022
My upper arm has been aching since receiving this shot one month ago.  The arm feels weak.  I can still feel exactly where the shot was administered as it is painful to press on that point.
Immediate swelling, redness, and a large 15cm induration to injection site (right thigh).  Inconsolable crying in an otherwise happy baby.  Red spots on forehead.  Gave 12.5mg Benadryl and 160mg Tylenol.
Redness, tenderness to area of vaccination 6 hours after vaccination. (Rt. Deltoid). Worsening symptoms 24 hours after vaccination- Fever 102 degree F, spreading redness and pain to entire Rt. limb. Weakness to Rt. limb 36 hours after vaccination.
Pt admitted to Hospital on 15 Dec 2021 for pancreatitis. After investigation, no obvious etiology to explain the pancreatitis. Still pending autoimmune labs. Pt did receive J&J COVID booster 5 days prior and so possible that may be a AR, but cannot prove it.
FEVER OF 101.5. CHILLS. DIZINESS AND FEELING FAINT--HAD TO STOP WHILE SHOWERING TO SIT AND LOWER HEAD 2 DIFFERENT TIME FOR 15 MINUTES. EXTREME FATIGUE. SORE MOUTH, PALATE, GUMS, AND THROAT AS OF DAY 5 AFTER SHOT. CONTINUED FOR 4 TO 5 DAYS....THROAT WAS EXTREMELY PAINFUL. PAIN AT INJECTION SITE AND TINGLING IN LEFT ARM.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX. Concurrent medical conditions included hypertension. Concomitant products included Estradiol Patch. On 14th May 2018, the patient received SHINGRIX. On 16th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The healthcare professional did not have access to the batch number or expiry date or the patient's exact date of birth but did say the patient was in her late 60's to 70's. The patient was taking blood pressure medications daily. The healthcare professional reported that the patient developed a rash from her elbow to her shoulder, after receiving a SHINGRIX vaccine.
It started that Saturday the week after the vaccine. He woke up and said his leg started hurting and didn?t want to walk on it. When he did walk on it, he was limping. Later in the day, he started walking on it and was eventually just fine. Several days passed, and he reported the same symptoms another day when he woke up. There was leg pain, and he didn?t want to walk on it. The 2nd day was July 6, 2022 and continued on into the 7th. Since it persisted, we decided to make a doctor?s appointment which is later today. He?s still complaining of leg pain and there?s still a limp, but not as bad as it was. I didn?t notice any redness or swelling as well.
29MAY94 pt sharp lower, back pain, tightening of chest w/pain 30MAY94; felt faint-tightness in chest cont; 3JUN94 seen in ER-no problem found dx minor anxiety attack;
four earlier Pfizer COVID vaccines, I had fevers the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing), notes: she just takes an unspecified thyroid medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1,, Lot/Batch Number: EP6955,, Anatomical Location: Unknown), administration date: 18Mar2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "Fever". The following information was reported: PYREXIA (non-serious) with onset 16Apr2021, outcome "unknown", described as "four earlier Pfizer COVID vaccines, I had fevers the next day". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Fever: Experienced this on the day after her second dose of the vaccine; 16Apr2021. Second Dose of the Pfizer Covid 19 Vaccinee: Received by the caller on 15Apr2021; NDC and Expiry Date: Unknown; Lot Number: Reported by the caller as being either CRM29 or LRM29; Anatomical Location: Unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a medical assistant, via a company representative, refers to a patient of unknown age and gender. On 31-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J000492 (was reported as "J0000492") expiry date 19-JAN-2014, 0.65 ml, subcutaneous. The patient was vaccinated with expired vaccine. No adverse effect was reported. Additional information has been requested.
Hospitalized 1/12/2022; COVID-19 positive 01/05/2022; fully vaccinated plus booster  BRIEF OVERVIEW: Discharge Provider:  Primary Care Provider:  Admission Date: 1/12/2022 Discharge Date: Jan 16, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: HAP (hospital-acquired pneumonia) [J18.9, Y95] Pneumonia of left lower lobe due to infectious organism [J18.9] COVID-19 [U07.1] Pneumonia [J18.9]   HOSPITAL COURSE: Patient with pertinent past medical history for renal transplant in 2009, stroke, type 2 diabetes, hypertension, hyperlipidemia, gastroesophageal reflux disease who presented for headache, fatigue, shortness of breath, and chest pain.  Patient had recently been treated for COVID-19 pneumonia 01/05/2022 as well as adrenal insufficient and adrenal crisis.  The patient been discharged on a steroid taper however had not taken this in instead transition back to her normal 5 mg of prednisone daily.  On arrival there was concern that the patient may have developed bacterial pneumonia, however procalcitonin was negative so bacterial pneumonia antimicrobial therapy was discontinued.  Infectious disease also weight in and recommended restarting remdesivir.  The patient was not hypoxic, however blood pressure started to dip so steroids were restarted with concern that this may represent adrenal crisis.  The patient was restarted on stress dose steroids which were tapered down to 50 mg every 8 hours hydrocortisone.  By the 4th day of admission the patient was once again hemodynamically stable, respiratory complaints and resolved.  The patient was discharged in stable condition with instructions to take her steroid taper starting with a 40 mg dose which is approximately equal to her hydrocortisone dosing.  The patient was instructed to follow up with her transplant nephrologist regarding repeat testing for her tacrolimus level and restarting cellcept and a follow-up with her primary care physician. All questions were answered the patient was discharged in stable condition
Patient experienced fever, headache, nausea, and muscle pain that started the day of the vaccine on 2-13-19. She was in bed for 7 days and feeling very unstable while walking and tremors. Patient reported these side effects and also reported that she was trying to "keep moving" and tried her best to continue her workout routine, moving her arm around to help with pain. Patient we to the doctor after blisters started to appear over her body and had thought a spider/bug was in the bed that had bitten her.   Patient saw her MD 12 days after the injection and the md stated, per the patient, "that this was a toxic reaction".
Client came in for 2nd dose of Pfizer client reports dizziness and nausea after 5 minutes. Both lasted 10 minutes. Client was approved for dose #2 of Pfizer and had no reactions.
Patient seen by clinican at clinic on 3/6/14 reporting soreness to site since vaccine was administered. Pain improved initially then worsened. Hurts to lie on R side, pain is 3-5/10. Pain is not constant just with activity.
Delayed cutaneous hypersensitivity - approximately 3 cm diameter rash around injection site.
A nurse reported the occurrence of a rash in a 15 month old male who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On 8/23/02, the subject received an injection of Infanrix. Later that day, an unspecified time post-immunization, the subject experienced a rash and an injection site reaction characterized by swelling and warmth. The subject was seen by a physician. The events persisted as of 8/26/02.
caused muscles to twitch; nerves fired up; This case was reported by a consumer and described the occurrence of muscle twitching in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix 50 mcg at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced muscle twitching and nerve pain. On an unknown date, the outcome of the muscle twitching and nerve pain were recovered/resolved.   It was unknown if the reporter considered the muscle twitching and nerve pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, received Shingrix vaccine early in the morining and experienced side effect by super time. The reporter stated that, after vaccination, the patient experienced nerve fired up which causesed muscle to twitch. The reporter stated that, side effects gone by lunch next day.
Headache, Myalgia, fatigue Narrative: missed work following second dose due to the above symptoms
First nausea and headache at around 6:00pm until days later. Then shortness of breathe once around 10:30. Near 11:00pm I started getting fever, chills, trouble staying asleep for more than 30 minutes. Loss of appetite for the following days. Felt like worst case of flu ever.  Symptoms stayed from that Friday up until about 6:00pm on Sunday night the 25th.
Severe inflammation/flare-up of arthritis, carpel tunnel syndrome and planter's fasciitis.
Patient is too young to receive the Shingrx shot, she is not immunocompromised & under 50 years old.