chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 07 Feb 2022 and date of administration of vaccine was on 10 Mar 2022; A single dose of Moderna Covid-19 vaccine was given to a patient on the 31st day in the refrigerator. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was given to a patient on the 31st day in the refrigerator.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07 Feb 2022 and date of administration of vaccine was on 10 Mar 2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022 at 5:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was given to a patient on the 31st day in the refrigerator.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07 Feb 2022 and date of administration of vaccine was on 10 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was given to a patient on the 31st day in the refrigerator.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07 Feb 2022 and date of administration of vaccine was on 10 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  A single dose of Moderna Covid-19 vaccine was given to a patient on the 31st day in the refrigerator. Date the vial was initially stored in the refrigerator on 07 Feb 2022 at 10:31am. The vial did not undergo any temperature excursion.  Treatment information was not provided.
I have fever, fatigue, nausea, and diarrhea. These symptoms lasted for about 6 days. I tested positive for COVID-19.
red raised rash all over body less than 24 hrs p/flu shot not itchy remains on Antihistamine;
Started feeling ill 4/4/2023.  Moved to feeling like a really bad cold on 4/5/2023.  Communicated via email with my primary care physician on 4/6/2023 and received a prescription for Paxlovid on 4/7/2023.  Started taking the prescription that evening, having stopped taking my Lovastatin and Tamsulosin prescriptitons prior.  By the evening of 4/9/2023 was feeling infinitely better.  Completed the Paxlovid prescription.  Restarting the Lovastatin and Tamsulosin on 4/19/2023.  I don't seem to have any lasting symptoms except a cough, which may also be due to seasonal allergie.
Information has been received from a health professional concerning a patient who on 04-JAN-2007 was vaccinated with Zostavax. Subsequently the patient experienced blisters which were located near her ankles. The symptoms were burning, stinging and numbness. The reporter did not think that the blisters were due to the vaccine. No additional information was provided. Additional information has been requested. Follow-up information indicated that the patient was exposed to shingles for two weeks prior to vaccination. She was the caregiver to her husband. Twenty three days after the vaccines on approximately 27-JAN-2007, the patient broke out. This lasted just a few days and the patient "seems fine". She had no pain. The reporter indicated that there was "no reaction to the vaccine". Additional inforamtion has been requested.
Parent called stating she noted Pt's Right arm with redness at both injection sites along with pain a day after receiving vaccines. Parent stated she applied cool compresses as instructed by this Nurse for relief of discomfort. Parent stated the redness has improved on today when she called in. Stated pain is also improving. Pt no longer complaining as often like day before. Parent state Pt is not disoriented or confused and is otherwise normal.  Advised Parent to continue to apply cool compress and to also administer a pain reliever to help with discomfort and seek medical assistance if Pt worsens or if she feels Pt needs to be examined. Parent verbalized understanding stating she will continue to monitor and administer pain reliever and cool compress as needed.
Case number PHHY2015US022460 is an initial spontaneous report received from a nurse via product technical complaint department (QA reference number: 1008125) on 28 Oct 2015. This report refers to a patient whose identifiers were not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P, expiry date: 30 May 2016) pre-filled syringe on 28 Oct 2015. It was reported that when received the product was packaged in a good condition and the vaccine was removed from the box by the nurse and was placed into a refrigerator. The syringe was removed from the refrigerator to administer the patient. During administration, the vaccine began to leak out from the side of the syringe body/barrel. The nurse found that the barrel was cracked when she noticed the syringe closely. The syringe was discarded (the complaint sample was hence not available) and the patient was administered only a partial dose. No adverse event were reported following the maladministration. The seriousness of the events were not reported. No further information was provided.
the last 3-4 weeks I have been experiences tightness in my chest, it's becoming hard to breathe.  I went to my doctor for my annual physical and she listened to my heart a little longer than normal but would not hear anything different.  My blood pressure is higher post vaccination as well both at doctor office and when donating blood (something I do on a regular basis).
uncomfortable feeling; have to put hand on hips; elongated inflammation; swelled up under left arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (uncomfortable feeling; have to put hand on hips), VACCINATION COMPLICATION (elongated inflammation) and VACCINATION SITE SWELLING (swelled up under left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IBUPROFEN from 08-Feb-2021 to an unknown date for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelled up under left arm). On 10-Feb-2021, the patient experienced LIMB DISCOMFORT (uncomfortable feeling; have to put hand on hips) and VACCINATION COMPLICATION (elongated inflammation). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (uncomfortable feeling; have to put hand on hips), VACCINATION COMPLICATION (elongated inflammation) and VACCINATION SITE SWELLING (swelled up under left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Ultrasound scan: Patient described findings as elongated inflammation, almost snake-like and it was an inch in diameter..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included warm compress.   Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2021: Follow up document included patient's age
Headache, fatigue, general  mild feeling of being unwell, some nasal congestion,  mild sore throat, slight upset stomach.  No treatment needed.  Symptoms cleared up in 24 hours.
1 week at the hospital; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (1 week at the hospital) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced HOSPITALISATION (1 week at the hospital) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (1 week at the hospital) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was unknown.  It was reported that the patient stayed at hospital for 1 week. Patient received the first vaccine last month.  Company comment: Very limited information regarding the hospitalization event has been provided at this time.  Further information is required.; Sender's Comments: Very limited information regarding the hospitalization event has been provided at this time.  Further information is required.
Information has been received from a physician concerning a 12 month old patient on an unspecified date was vaccinated SC with a 0.5 ml first dose of Varivax. Subsequently, in the last year, the patient developed a breakthrough case of "mild" chickenpox. Medical attention was sought and unspecified therapy was used. Subsequently the patient recovered. No further information was available There was no product quality complaint involved. Additional information has been requested.
Reacción alergica, ronchas, comezón, mano, problemas al tragar, se me hincho la cara, hasta la fecha no se me quita el dolor de cabeza, me siento muy nervioso no puedo dormir.  Anxiety and Stress reaction.  (See attached for Box 7)
My arm has been sore for weeks now. I realize the shot makes your arms sore but it shouldn't be lasting this long. It hurts to move!
After my second shot, I had a sore arm at the shot of injection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 (Lot number: EPG955) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EL3247, administration date=08Mar2021, dose number=1, vaccine location=Right arm), administration date: 08Mar2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Mar2021, outcome "recovered" (2021), described as "After my second shot, I had a sore arm at the shot of injection.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
1st event, 3 weeks after vaccine major muscle twitch exceeding 24 hrs continuous in left  bicep, stopped after 36 hrs. 2 nd event major muscle twitch in left thigh lasted 2 hrs. 3rd event major muscle twitch in left thumb >24 hrs., stopped 28 hrs. End of month/June & July, minor muscle twitch, throughout body, visible, random , every 5 sec to 60 sec., legs, arm, stomach, back, all feet, issues with leg, arm weakness, dropping items and speech, including fatigue, numb tingling hand and feet off on. Symptoms align with ALS, MS, or other neurological disease
MUSCLE SORENESS AREAS ON BODY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bone on bone lower back, pain in upper right thigh, fullness in groin, and fullness neck lymph nodes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced muscle soreness areas on body. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle soreness areas on body. This report was non-serious.
Low grade fever (100 deg F), body ache, chills and some dry cough. Lasted for a day. Took over the counter tylenol and woke up feeling better next day.
started menstrual bleeding that lasted continually for 68 days; severe headaches; migraines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 14:30 (Lot number: EN6207) at the age of 44 years as dose 1, single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Relevant medical history included: "Breast Cancer IDC stage 1", start date: 2018 (unspecified if ongoing), notes: No lymph involvement. Concomitant medication(s) included: ZOLOFT. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 20Mar2021 12:00, outcome "recovered with sequelae", described as "started menstrual bleeding that lasted continually for 68 days"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "severe headaches"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "migraines". The events "started menstrual bleeding that lasted continually for 68 days", "severe headaches" and "migraines" were evaluated at the emergency room visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative, notes: test type Nasal Swab. Therapeutic measures were taken as a result of heavy menstrual bleeding, headache, migraine. Reported Event: With in 24 hours of the first dose of the Covid vaccine, the patient started menstrual bleeding that lasted continually for 68 days. The patient developed severe headaches and migraines that have continued presently. Adverse event start time was 20Mar2021 12:00 PM. The treatment of the event included Nurtec, Nose packed, Ibuprofen. No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experienced a gum infection and asked if he can take amoxicillin in Apr 2021. The outcome was unknown. No follow up attempts are possible; Information about lot/batch number cannot be obtained.
The glands near right collar bone are swollen and tender; The glands near right collar bone are swollen and tender; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 20Apr2021 at 08:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to egg whites, peanuts and dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 30Mar2021 at 07:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient previously also received gentamicin sulfate (GENTAK) on an unknown date and experienced drug allergy. On 21Apr2021 at 13:00, the patient reported that the glands near right collar bone were swollen and tender. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events glands near right collar bone were swollen and tender was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt reported dizziness, low Blood Pressure, Vomiting, Behavioral changes, numbness.  NP ordered bloodwork, Medrol Dose Pack, Loratidine, topical hydrocortizone.
3x3x5 cm region of induration with eczematons patch at injection site.  Mild elevation in eosinophils on CBC 10%.  WBC 9,100; Poly 32; Lymph 52; Mono 5 Eo 10 Base 1.
Hypertension (220/110) and shortness of breath after Pfizer-BioNTech COVID-19 0.3 IM injection in the right deltoid.  Presented to ED within 6 minutes of injection for evaluation. Symptoms resolved within 10 minutes in the ED except BP remained in 160s/90s. Blood glucose, CMP, and ECG normal. No medications given. Patient asked to leave following resolution of symptoms.
Lightheaded, weak in Left arm, Itching  with fine red rash on arms and trunk.  No evidence of distress.  Vital Signs Stable.  Observed for 30 minutes and Medical Director notified.  No treatment necessary. Plan to observe for 30 minutes post dose 2.
hx cardiopulmonary disease, dyspnea, hypoxia, positive COVID test
Routine vaccination as part of welcome to insurance visit on 6/26/12. A few hours after leaving office developed severe chills, myalgias, headaches, nausea, temperature, spikes up to 102.5 F. Conservatively treated with acetaminophen & ibuprofen, not responding, admitted through ER to hospital given IV fluids 6/27-6/28/12. On 6/29/12 injection site became red, swollen, tender, treated with KELFEX, resolved by 7/3/12. Fever free x 24 hrs.
Information has been received from a registered nurse concerning a 6 year old with no known allergies who on 07/26/1996 was vaccinated with a dose of varicella vaccine. On 12/28/2001 at 8:30am the pt's mother called the doctor's office reporting that her son was exposed to chicken pox over the holiday, and "now mom said he's covered with pox this Am." The pox were described as small little water blisters (60-70) all over the body. The pt was afebrile; however, he did have itching. The pt was given Aveeno and Beandryl for itching. It was noted that the pt was prescribed hydrocortisone cream 1% on 12/18/2001. It was reported that the pt recovered on 01/04/2002. No further info is expected.
24OCT96 began w/swollen, red, inflamed, welt & heat;had diarrhea, loss of appetite, no vomiting, no h/a, no body aches;(admits to other family members being ill);Friday 25OCT96 recovered completely;
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was placed in refrigerator on 18-Nov-2021 Vial did not undergone to any temperature excursion. No adverse event was reported. No treatment medications were reported.
ADULT OBSTRUCTIVE SLEEP APNEA 8/10/2022 -- RECURRENCE OF SAME SYMPTOMS
Vaccinated in Left arm with Hep B #1 and AVA #1. Noticed 4-5 days later a rash on outside surface of rt elbow extending up to bicep area, rash on outside of left elbow with no extension, rash on 1st and 3rd knuckles of rt hand and 1st knuckle of left hand, and on both outer surfaces of the "knotty bone" on the ankle. Denied swelling but experienced extreme itching. OTC hydrocortisone provided little relief. Went to Dr. and was given ATARAX and stronger HTC cream. Rash lasted 2-3 wks before resolving. He also reported bil knee pain without swelling. Pain described like growing pains and would ease with TYLENOL. Pain intermittent x 2-3 wks, and would last approx 15 min. No other joints painful. He denied fever, headache, N/V. Never had anything like this before. Denies any new substances taken internally or extrernally. Symptoms: Rash, diffuse, Pruritus, Joint Pain, multiple joints.
patient says muscle still tender after 1 week. pt tried an aspirin and an aleve tablet. pt applied topical theragesic cream...still sore. Arm does not feel warm and no red areas seen. No heart palpitations or difficulty in breathing
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX (batch number 9779K, expiry date 24th May 2019) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved. It was unknown if the reporter considered the pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The HCP (healthcare professional) who was also the patient reported that they developed a sore arm and tiredness for four days after receiving their initial dose of SHINGRIX. No further information was reported regarding the event. This case has been linked with case US2018122189, reported by the same reporter.
Patient came into clinic for booster dose of Moderna. Pt was given 0.25ml of moderna 060h21a at 1300 on 3/29/2022.  Vaccine was expired 3/28/2022.