chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 10/18/23, I developed very severe chest pain, chest pressure, dyspnea, diaphoresis, low grade fever, and all over body aches. Chest pain caused me to be unable to work and I had to leave work.
Pt ran a fever red, hot, swollen about 3cm at injection site, no treatment given, just watch.
Outbreak of right face/scalp dermatomal blistering rash that improved after prednisone and valtrex.
pt recvd vax & 2 wks later exp polyarthralgia w/pos ANA & anti-DNA;
Patient attempted to get up after 10 minutes of receiving the Moderna vaccine. Apparently patient got dizzy and fell to the ground hitting his head on the floor resulting in head laceration. The paramedics were called. Attended to him and took him to the ER.
Unknown Covid vaccine; no known side effects; postmortem Covid-19 test negative  Date of death:   02/22/2021
Information has been received from a registered nurse concerning a 9 year old patient with a history of premature puberty and asthma and a drug reaction/allergies that included an unknown reaction to flu vaccine, who on 09-APR-2008 was vaccinated IM with a dose of VARIVAX (Merck) (lot number:  659610/1654U).  Suspect therapy included GARDASIL.  On 10-APR-2008 the patient developed local swelling, redness and a lump under the skin at the injection site.  Recommended treatment was ice and MOTRIN.  There were no lab diagnostic studies performed.  Unspecified medical attention was sought, via phone call to the office.  The outcome was reported as recovering.  There was no product quality complaint.  Follow-up information from the reporting medical assistant (also reported as registered nurse) indicated that the 9 year old female who on 09-APR-2008 at 12:00 was vaccinated IM with her second dose of VARIVAX (Merck) (lot# 659610/1654U).  After vaccination the patient developed redness and swelling.  Additional information has been requested.
itchy eyes; asthma; severe itchy skin; random hives; blotchy sunburn type rash on ifferent parts of the body including face; blotchy sunburn type rash on ifferent parts of the body including face; severe aggravation of allergy type symptoms congestion; severe aggravation of allergy type symptoms congestion; This is a spontaneous report from a contactable consumer (patient). A 42-year-old patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number: not provided, expiry date not provided) via an unknown route of administration, administered in Arm Left on 12Feb2021 16:00 as DOSE 2, SINGLE (at the age of 42-year-old) for covid-19 immunisation. Medical history included asthma, Autoimmune neutropenia, idiopathic thrombocytopenic purpura (ITP), allergy to animal dander, Allergies to dust, food allergy, kiwi, known allergies: sulfa from an unknown date and unknown if ongoing. Historical vaccine included first dose of bnt162b2(BNT162B2) administered on 22Jan2021 as DOSE 1, SINGLE (at the age of 42-year-old) for covid-19 immunisation and experienced slight aggravation of allergy sneezing, congestion and Itchy eyes 2 days after vaccine was given. The patient previously took Rocephine, Ciproflaxin and experienced allergy. Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received unknown concomitant medications in two weeks. On an unknown date after second dose of vaccination, the patient experienced severe aggravation of allergy type symptoms: congestion, severe itchy eyes, blotchy sunburn type rash on different parts of the body including face, severe itchy skin, random hives, asthma felt as though rolled in fiberglass and snuggled a kitten simultaneously in 2021. The patient received allergy eye drops for itchy eyes and inhaler for asthma for treatment. Outcome of events itchy eyes and asthma was recovering, and other events was unknown.  Follow-up attempts completed. No further information expected.
FLUZONE QUADRIVALENT MDVS at a high of 52F for an unknown length of time and a low of 31F for an unknown time with no reported adverse event; the patient was vaccinated with the FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who was vaccinated with the fluzone quadrivalent with no reported adverse event and fluzone quadrivalent mdvs (INFLUENZA QUADRIVAL A-B VACCINE) at a high of 52f for an unknown length of time and a low of 31f for an unknown time with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the fluzone quadrivalent mdvs at a high of 52f for an unknown length of time and a low of 31f for an unknown time with no reported adverse event (product storage error)   On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UJ899AA, expiration DATE: 30-Jun-2023, in unknown administration site as Immunization.  On 22-SEP-2022 the patient was vaccinated with the fluzone quadrivalent with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was unknown whether products had experienced an excursion at the time of administration. This situation was reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.This case is for 1 patient, 30 patients were vaccinated.  The vaccine had an excursion last weekend due to a power outage, caller also reporting for the past 8 months their products have not been stored properly. Caller reporting using an improper thermometer and the temperatures were either not recorded or not recorded accurately. Caller reporting they have periods of unknown temperatures and periods of recording temperatures too high or too low.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (the patient was vaccinated with the FLUZONE QUADRIVALENT with no reported adverse event, FLUZONE QUADRIVALENT MDVS at a high of 52F for an unknown length of time and a low of 31F for an unknown time with no reported adverse event).  At time of reporting, the outcome was Unknown for all.  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 the 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.
Pt called suspecting the shot may have given her a stiff neck and back 2-3 days after the shot.  Her neck is especially stiff and her lymph nodes are swollen. She got check with her Dr and it is at 2cm/0.5cm.  She said her labs of her WBC are off.  They are still trying to find out if the symptoms are related to the shot.  She also felt fatigue after the shot
Triggered severe migraine the day after getting the vaccine. The first day I had extreme fatigue and slight headache
On or about 12/01/21, developed flu-like symptoms including nasal discharge of mayonnaise-like thick fluid and related non-bronchial cough. Spouse developed similar symptoms two days later. Called primary physician and arranged Covid test at hospital testing site on 12/04. Results of AN swab (qRT-PCR assay) were NEGATIVE for both myself and my spouse. Symptoms including fatigue and low fever continued for about three weeks until roughly 12/22/21. Did not take any medication. Now both self and spouse are fully recovered.
No additional adverse event; the patient was inadvertently administered a dose of VAQTA that was expired; This spontaneous report was received from a licensed nurse practitioner and refers to a 18-month-old female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-JUN-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S002505 (lot number was verified to be valid for formulation vial), expiration date 04-APR-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. No additional adverse event was reported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:57 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Concomitant products were not provided.  On 27-Oct-2021, Excursion time was 09 AM and 10 AM, with temperature as 32, and 32 respectively. Total doses given for the day was 116 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM vaccine was moved to fridge on 29-sep-2021 and. Vial was moved to clinic on 27-oct-2021. 2 vials from 9 AM and 4 vials from 10 AM were sent to clinic. Vaccine BUD date was 29-oct-2021 for 9AM,and 04-Nov-2022 for 10 AM respectively.  On 27-oct-2021, no hourly temperature recordings available The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Information has been received from a health professional concerning a 5 year old male with no drug allergies, and a vaccination history of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3 (MSD), Oka/Merck) (MSD) on 11-JUL-2003 with no other pertinent medical history, who on 27-APR-2007 was vaccinated with his first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657034/0232U) into the left thigh.  There was no illness at the time of vaccination.  On 30-APR-2007 the patient developed injection site swelling, warmth, redness, and tenderness to the touch.  No medical attention was sought.  No diagnostic tests or labs were performed.  The patient was treated with AUGMENTIN ES 600mg and cool compresses.  The area was improved.  It was noted that injection site warmth and swelling took 3 to 4 days to go down.  There was no product quality complaint.  Additional information has been requested.
arm soreness then on 1/22 fever of 100.7 and headache.
This spontaneous report as received from the certified medical assistant (healthcare worker) refers to a patient of unknown age and gender. On 26-NPV-2014 improperly stored PEDVAXHIB (lot # K002746, dose, frequency and expiration date not reported) was administered to the patient. No adverse events were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Patient complained of redness, swelling, acute pain left deltoid and into scapula.  Developed weakness in left arm the next day and became progressively worse.  Seen in emergency department on 02/27/2006 for pain in scapula and weakness in left arm.  Diagnosed with Neuritis/Myelitis.  Improving no redness now.
Redness & edema 2 inject site measuring 2.5 x 1.5 warm to touch; Painful to light pressure;
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick to her stomach), DISCOMFORT (Uncomfortable), ALOPECIA (Hair loss), PAIN IN EXTREMITY (Arm started to hurt across the back and to the other arm) and PYREXIA (Fever of 101-102 degrees Fahrenheit) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013N20A and 013N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, VITAMIN C [ASCORBIC ACID], ZINC, COLECALCIFEROL (VITAMIN D3) and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced ALOPECIA (Hair loss). On 16-Apr-2021, the patient experienced MALAISE (Feeling sick to her stomach), DISCOMFORT (Uncomfortable) and PYREXIA (Fever of 101-102 degrees Fahrenheit). 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm started to hurt across the back and to the other arm) and FATIGUE (In bed for 24 hours). 16-Apr-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 17-Apr-2021, FATIGUE (In bed for 24 hours) and CHILLS (Chills) had resolved. At the time of the report, MALAISE (Feeling sick to her stomach), DISCOMFORT (Uncomfortable), ALOPECIA (Hair loss), PAIN IN EXTREMITY (Arm started to hurt across the back and to the other arm) and PYREXIA (Fever of 101-102 degrees Fahrenheit) outcome was unknown. Action taken with the drug in response to events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-143038, US-MODERNATX, INC.-MOD-2021-142994 (E2B Linked Report). This case was linked to MOD-2021-142282 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-143038:crosslinked; husband dose 2. US-MODERNATX, INC.-MOD-2021-142994:crosslinked; husband dose 1.
symptoms: dizziness, muscle/joint pain, flu-like symptoms, swelling/inflammation at injection site of left arm; symptoms started in the middle of the night on the day of administration
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion. Total of 168 doses/vials were given for LOT  048C21A.  Date the vial was initially stored in the refrigerator was reported as unknown.~  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document contain non-significant information was updated.
Patient said the night of receiving the vaccine, her arm went numb and then developed sharp pain, it swelled up around the injection site, and she had a severe fever the rest of the night.  The next day, the day of reporting, she says the only symptom she has left is some pain in her arm.  She did not go to the doctor.
This spontaneous report was received from a registered nurse and refers to four unspecified patients of unknown age and gender. The patients' concurrent conditions and medical histories were not reported. In approximately 2016 (reported as "on unspecified dates starting in March 2016"), the patients were each vaccinated with unspecified improperly stored doses of PEDVAXHIB which had a lot # of L030871, an expiration date of 10-JUN-2016 (concentration, dose, route and anatomical place of vaccination were not reported). Which were exposed to a temperature of 32.4 F for a time frame of 1 hour and 15 minutes, without a previous excursion. Additionally, a data logger was involved. Information regarding concomitant therapies was not reported and no product quality complaint was involved. No adverse effect was reported. This is one of two reports from the same reporter. Additional information has been requested.
Patient wanted to receive the pfizer booster, and patient was inadvertently given Moderna 0.3ml instead. Patient did not have reaction immediately after the injection.
Information has been received from a nurse at the physician's office concerning an "11 year old" female who on 08-JUN-2009 was vaccinated with her first dose of GARDASIL, and on 10-AUG-2009 the patient received her second 0.5ml dose. "Right after the second dose", the patient developed hives. It was unknown if the patient sought medical attention. At the time of the report, the patient recovered (date unspecified). It was unknown if the patient had any reactions after the first dose. "Only two doses were administered". No further information is available.
Information has been received from a physician concerning a 14 year old female who was vaccinated with a dose of GARDASIL. The patient missed her period for two months after receiving both her second and third dose of GARDASIL. Unknown medical attention was sought at the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Approximately 2 hours after receiving her second pfizer dose, the patient felt dizzy and nauseous. She did vomit a few times a while after this occurred, so she went to the emergency room. The providers in the in the emergency room ran a few tests and could not find a source of the dizziness, she was sent home with meclizine and was feeling a bit better the following day.
Patient was given Adacel instead of Boostrix. Age was miscalculated. No adverse reaction. Explained to guardian after call made to immunization board.
Elevated blood pressure 211/124; Tachycardia; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 13Feb2021 12:00 as 2nd dose, single for covid-19 immunisation . Medical history included hypertension. Patient had known allergies to seafood allergy. Patient previously took first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 24Jan202112:00 PM as single dose for covid-19 immunisation. Patient received other medications in two weeks and no other vaccine in four weeks. On 14Feb2021 01:00 AM, patient experienced tachycardia, elevated blood pressure 211/124. Patient used acetaminophen, amlodipine, metoprolol as treatment. Patient was not covid tested post vaccination and not had covid prior vaccination. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  Excursion on 03-MAY-2022.  The vaccine had been administered since the excursion occurred.; This spontaneous report was received from a nurse referring to a 13 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The reporter reported two temperature excursions on multiple refrigerated vaccines.She said it was very likely all vaccines had been administered since the excursions occurred.  As she was looking through her data, she estimated there would be around 40 patients who have been administered vaccines alone and many others who had received the other vaccine types.   After all, it was confirmed that on 03-MAY-2022, the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # U014656 with expiration date on 07-MAY-2023, had a temperature excursion at 47.3F for 5 minutes. and on 09-MAY-2022, the patient was vaccinated with tat vaccine for prophylaxis (dose and route were not reported).  No additional adverse event was reported and no product quality complaint was identified.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001594: US-009507513-2206USA001600: US-009507513-2206USA001585: US-009507513-2206USA001584: US-009507513-2206USA001583: US-009507513-2206USA001589: US-009507513-2204USA002052: US-009507513-2204USA001998: US-009507513-2204USA001952: US-009507513-2204USA001865: US-009507513-2206USA001582: US-009507513-2206USA001593: 2US-009507513-206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: 2US-009507513-206USA001600:
Headache, ErythemaMultiform, Diarrhea & NauseaVomiting Narrative:
8 days after receiving  1st vaccination  Lightheaded, dizzy , weakness in legs  Feels like Cotton  in my brain Fog brain  Lethargic, malaise
extreme pain and paralysis. Still have severe back pain in my lumbar area. Inflamation
mom came for vax on 18OCT94, stated pt had series of generalized szs lasting 5-10 mins p/vax on 10AUG94; had fever of 100-101; mom called paramedics but did not go to hosp or ER:
Significant pain began shortly after administration. Decreased ROM of left shoulder. No redness, swelling, or itching