chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered from vial over 12 hours after vial puncture.; temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from vial over 12 hours after vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from vial over 12 hours after vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered from vial over 12 hours after vial puncture.) had resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  Concomitant medications were provided. No Treatment medications were provided.
she received the first dose of the vaccine on the 22nd of December and tested positive on the 28th; she received the first dose of the vaccine on the 22nd of December and tested positive on the 28th; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer(patient) reported that a female patient of an unspecified age received first dose BNT162B2, via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on the 22nd of December and tested positive on the 28Dec2020, she was scheduled to get the 2nd dose on Jan 12th. The reporter wanted to know if it was safe for her to take the 2nd dose. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Information has been received from a 42 year old female consumer allergic to penicillin and many pain medications who was vaccinated (route and site not reported) on 09-OCT-2007 with PNEUMOVAX 23 (lot # 655766/0038U) and FLUVIRIN (Novartis). Concomitant therapy included ZYRTEC, EFFEXOR, and hormonal contraceptives (unspecified). On the evening of 09-OCT-2007, post vaccination, the caller stated she had developed an allergic reaction. Per the patient, her arm swelled up and began getting real red, 2 days later she could barely use the arm because it was very painful. The swelling and redness lasted about 1 week to 10 days. The caller stated that there was still "a knot" at the injection site. The caller stated she had received pneumonia vaccine in the past with no adverse effect. The caller sought unspecified medial attention and stated that her symptoms had improved since they started. Additional information has been requested.
Alopecia, fibromyalgia, chronic fatigue, thyroiditis, vasculitis. Other vaccines given were Hep B 6/99 and Tetanus 5/99 unknown manufacturer/lot number. Per 1 year follow up: Pt did not recover. Symptoms all described in earlier VAERS submission.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Lot number: FH8027) and on 21May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ; CETIRIZINE HYDROCHLORIDE; IBUPROFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Sep2022) Positive, notes: antigen test; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 30Aug2022 to 04Sep2022 for COVID 19 Treatment. Experienced COVID rebound with symptoms and positive antigen test. Adverse event start date: 10Sep2022, 03: 30, recovering. No treatment received. The patient had no allergy.
Initial unsolicited report received from an office person medical assistant on 23-May-2018. This case involves a child patient (age and gender was not reported) who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to inappropriate reconstitution technique. It was explained that this was not a valid dose since the child was given ACTHIB mixed with sterile water. No adverse event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
LUMP IN ELBOW; CHILLS; JOINT PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included patient had no known allergies or drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: 01-JUL-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine. On 16-MAY-2021, the subject experienced lump in elbow. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced joint pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 17-MAY-2021, was recovering from joint pain, and had not recovered from lump in elbow. This report was non-serious.
Rash for 1 month and continuing presently on arms, hands, feet, burns and itches
Patient experienced Swelling, Bruising, Warm to the Touch, Very Painful at site of injection. The symptoms started about 5 hours after the vaccine was administered and lasted about 48 hours. Still sensitive 3 days later. Patient took liquid BENADRYL and it helped.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild
Attended a wedding on 01/01/2022, On 1/05/2022  had a headache, cough, sore throat, went night of 01/05/2022 had a PCR test through the Medical Center then on evening 01/06/2022 home test while waiting for PCR results and both came back positive. The following week on 01/14/2022 receive call in prescription of Inhaler and cough medicine. Still recovering with cough.
This spontaneous report was received from a registered nurse referring to  two patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dose and route of administration were not reported) (lot # R017642, expiry date: 20-JUN-2020 (also reported as 02-JUL-2020)) for prophylaxis (product storage error). The vaccine was stored in between -14 °C (degrees Celsius) to -10 °C for 6 hours 15 minutes and between -9 °C to 8 °C for 1 hour 45 minutes. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is a non-valid case due to lack of patient identifiers. Follow up information was received on 06-DEC-2018 from the registered nurse referring to 3 unspecified patients of unknown age and gender. The reporter stated that the temperature excursion had taken place on 08-NOV-2018. The patients received improperly stored doses of VARIVAX on unknown date in November 2018 (reported as between 09-NOV-2018 and 13-NOV-2018). Additionally, the reporter stated that a second temperature excursion took place on 13-NOV-2018 involving the same batches of VARIVAX. Follow up information was received on 10-DEC-2018 from the registered nurse. Upon receipt of follow-up information it was determined that this case is now valid because patient information were updated. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1811USA006380: US-009507513-1812USA005348:
migraine headache / she can feel like a migraine coming on; This is a spontaneous report from a contactable consumer via Pfizer sponsored program.   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No 9264, Expiry date May2021), via an unspecified route of administration on 29Jan2021 as single doe for COVID-19 immunisation. Patient medical history included migraine. Concomitant medication of the patient not provided. Patient received COVID vaccine today (reporting day, 29Jan2021), and has a question, she was looked everywhere, she didn't want to bother anyone, but she gets migraine headaches, because of all this hype, she was a little bit of a migraine, can she take Excedrin Migraine after she has had the injection? Patient stated that she can feel like a migraine coming on, this was common for her, to have a migraine, otherwise she was fine, no sore arm, no fever, she was feeling fine. If she does get a migraine, could she take it? Whoever she talked to before, she asked this and they said they would put her through to who would be able to answer it, she has been on hold over an hour, she was on the phone with them for 40 minutes and they read this whole long thing off to her, read this whole proclaimer off, and asked her a million questions, put her on hold, and said they had to transfer. At the time of this report event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse referring to a patient of unknown age and gender Information about medical history and concurrent condition was not reported. On 26-JAn-2015 the patient was vaccinated with improperly stored PNEUMOVAX23 lot # K010465 with expiration date of 23-MAR-2016; dosage and route unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
WORSENING OF FLUID IN THE LUNG (Lung edema, Pulmonary oedema) WORSENING OF LOW OXYGEN LEVEL (Oxygen saturation low, Oxygen saturation decreased) HARD TO BREATH WORSENING (Difficulty breathing, Dyspnoea) VOMITING (Vomiting, Vomiting) NAUSEA (Nausea, Nausea) PAIN IN THE HEAD (Head pain, Headache) TIRED (Tiredness, Fatigue) This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD), heart condition, neuropathy, and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the patient started symptoms and was tired. The patient had swollen face, nausea, vomiting and pain in the head. On 10-MAR-2021, the patient's symptoms got worse which included worsening of fluid in the lung, worsening of low oxygen level, hard to breath worsening and was admitted to the hospital. The patient was in hospital at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from worsening of low oxygen level, swollen face, and worsening of fluid in the lung, had not recovered from hard to breath worsening, and the outcome of nausea, vomiting, pain in the head and was tired was not reported. This report was serious (Hospitalization Caused / Prolonged).
Vaccine administered that went under temperature excursion for 15 minutes at the site; Vaccine administered that went under temperature excursion for 15 minutes at the site; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The data logger at the clinic was not set with correct parameters and temperature excursion happened with the vial.  Number of doses/vials that were administered from that lot was 2 (1 punctured and 1 not punctured).  The vial was previously stored in fridge.  The vial was moved from freezer to refrigerator on 15-Jun-2022.  The vial was first punctured on 15-Jun-2022 at 9.15 AM.  The vial was stored in portable fridge post puncture.  The vial underwent temperature excursion for about 15 minutes having minimum temperature of 1.9 degree Celsius and maximum temperature of 6.4 degree Celsius. The dose was administered to the patient within less than 12 hours post puncture.  Proposed desired use by date and time of the vial was 15-Jun-2022 (afternoon).  The vial was returned to fridge and quarantined after administration.  Treatment information was not provided.
NOTE 1: RT Breast CA-Ax dissection lumpectomy-colloid 2/1990 Radiation and Study Chemo methotrexate and 5fu completed Aug 1990. NOTE 2: Second covid19 Moderna 046B21A IM Lt arm 4/14/2021 at 2:30pm GE9. NOTE 3: I am RN BSN 1966 & Nurse/ Consultant PA DOH 30yrs.  I have written a timeline. All this information was submitted on VSAFE. I have improved enough to type this form. My ADL are improving but not my normal. MY FEARS: headaches, swelling of head-sometimes scalp feels soggy other times feels tight, b/p not well controlled, hearing returned in May my new EARGO aids due to large swelling of ears, struggle to keep lymphedema and fibromyalgia in check when body swells. somedays are very good others not. Oct 31 Since Ap 2021 I have not been able to wear bras at times - too tight Clothes too tight socks & knee high hose way too tight can't wear many of my regular everyday shoes Difficult to wear lymphedema arm sleeve (I have worn for 20 yrs) Difficult to wrap lymphedema arm - I do & I must gets tight & painful Note: till recently I had NEVER had painful lymphedema When you look at anatomical picture of lymph system - where it is * located on each side of my head is where the headaches are Nov 13 Swelling is beginning to improve for a full week. Can wear some shoes and clothes again. By end of day all gets tighter and need to change to loose fitting close SUGGESTION Please study what has happened to others with pre-existing lymphedema. Develop guidelines for what to expect and standards of care.
Previously a clotter, I received emergency surgery for bleeding/ulceration of stomach and tearing of esophagus with two units of blood re-applied, intubation. four days in ICU to recover. extreme hives like skin rash for ~four weeks. appearance of brainstem arachnoid cyst at 5-6 months time (by CT scan, previous CT/MRIs a few years earlier were clean). continued fatigue and weakness. living and working presenting extreme difficulty, now.
Expired dose of Pediarix was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number J953N, expiry date 11-MAY-2023) for prophylaxis.   On 15-MAY-2023, the patient received Pediarix. On 15-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired dose of Pediarix was administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-MAY-2023 The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. The patient received an expired dose of Pediarix vaccine, which led to expired vaccine used.
lt thigh from knee to hip became very painful & edematous; fever reached 101 & pt was very irritable; mom advised to give APAP & use cool compresses & get medical attention if no improvement;
Patient is 13 and should have received an adult dose of Pfizer, but received a Pfizer dose for 12  to 5 year olds
ITCHING AND PAINFUL TO TOUCH. 2.75 " REDNESS AT AREA OF VACCINE. PT WAS TAKING IBUPROFEN AND USING A COLD COMPRESS. PT WAS ALSO USING A WARM COMPRESS. ALL SYMPMTOMS ONE HOUR AFTER THE VACCINE WAS ADMINISTERED.
Brain fog/A disconnect with my arms and legs; Arm pain; Horrible joint/lymph gland pain; Horrible joint/lymph gland pain; Feeling of small needles poking me in the head; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170), via an unspecified route of administration in right arm on 29Apr2021 at 13:15 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. Medical history included hypoglycemia from an unknown date and unknown if ongoing, splenic hemangiomas from an unknown date and unknown if ongoing, peanuts bother me from an unknown date and unknown if ongoing, hypersensitive to meds from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; Oil of oreganol taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, after first vaccination, the patient experienced some brain fog, arm pain, horrible joint/lymph gland pain, feeling of small needles poking me in the head, a disconnect with my arms and legs and fatigue. This lasted about 4 days. The seriousness of the events was reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date.  Follow-up attempts are completed. No further information is expected.
15 min after vaccine patient stated she felt lightheaded and had spotty vision. She complained of chest tightness. We laid her on a cot and gave her water. After 10 mins she stated the chest tightness and vision changes were resolved. She now states she has a headache. She got ibuprofen out of her purse and took some. She stood up and stated she was "much better."
Gardasil vaccine administered 0900am. Pt was seen in ER same day at 2120 c/o nausea, arm pain and was hyperventilating. Pt was tx'd with NS IV for dehydration and released. No temp, no other s/s.
Within one (1) after vaccination, experienced muscle pain/soreness in ankles, back of both knees, buttocks, hip, shoulder and wrists.
Severe nerve pain shooting last -3 seconds (legs) - Day 1 relieved with NEURONTIN (husband's prescription med). Sharp shooting headache (random places in head) Day 2 last 1-3 seconds not as severe as legs. Toothache/jaw ache lasting hours Day 2.
Headache and fatigue lasting 3 days, shivers lasting through the night, body aches lasting 2 days.  Treatment consisted of rest at home.
Chills; fever; mild headache; body aches; This is a spontaneous report from a contactable other-HCP (patient herself). A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 12Mar2021 11:00 as dose number unknown single (at the age of 52-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. No other vaccine was administered in four weeks. Patient had no known allergies. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19 post vaccination. Patient medical history was reported as none. The concomitant medications were not reported. On 12Mar2021 at 16:00, patient experienced chills, fever, mild headache, and body aches. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the adverse events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.