chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTRATION SITE  SWELLING  OF SIZE OF A GOLF BALL; REDNESS ALMOST LIKE A SUNBURN; PAIN, HURTS WHEN TOUCHED; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included consumer had covid-19 on may 10, 2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and  expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced redness almost like a sunburn. On 09-APR-2021, the subject experienced pain, hurts when touched. On 11-APR-2021, the subject experienced administration site swelling of size of a golf ball. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from administration site swelling of size of a golf ball, redness almost like a sunburn, and pain, hurts when touched. This report was non-serious.
Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Drug allergy (Benadryl), Drug allergy (Requip), Drug allergy (Statins), Supraventricular tachycardia, CVA and Chronic kidney disease. Concomitant products included AMLODIPINE, WARFARIN, METOPROLOL and GABAPENTIN for an unknown indication.    On 18-Nov-2021 at 10:47 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment information were provided.  The via was first punctured on 17-NOV-2021 at 9 am. No temperature excursions were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow-up received includes updated reporter address, patient demographics (Height, weight, race, ethnicity), allergies, medical history, concomitant medications, time and site of vaccine administration.
No adverse event, but was given an invalid dose as it was repeated within the same season. Patient got flu vaccine on 10/01/22 and then again on 4/05/23.
About five hours after having the injection my chest felt very tight so I took my blood pressure at home my first reading was 187/98 heart rate 69 I continue to drink as much water as I could try to flush the stuff out of me as instructed my blood pressure readings stayed  relatively high for the next three hours settling down to 161/78 heart rate 62 bpm during this period I took another dose of my blood pressure medicine two pills one of me that is listed in my medication
Fever 102 degrees F; lethargy/exhaustion, 4 days of arm soreness/pain.
Patient developed COVID-19 symptoms and subsequently tested positive by PCR test.; Patient developed COVID-19 symptoms and subsequently tested positive by PCR test.; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an intramuscular route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. It was unknown, if patient received any vaccine in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient medical history and concomitant medications were not reported. It was reported that patient developed covid-19 symptoms and subsequently tested positive by pcr test. on 21Aug2021. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 21Aug2021. It was unknown if patient received any treatment. The clinical outcome for the event was recovering.  Information on the lot/batch number has been requested.
Per patient: a lump developed at the injection site after the injection and was sore. Administration site per patient was at the lower end of the left arm deltoid muscle and was painful. The following days swelling occurred  down the arm to the elbow. The swelling subsided of several days, but left a visible palpable lump about 3cm X 2cm just above the elbow on the posterior side of the elbow under the dermal layers. I recommended to the patient to have a doctor look at it to determine the nature of the lump. (ie. subcutaneous thrombus from bleeding after the vaccination, lipoma or sarcoma), Patient will make appointment and report findings back to me.
Admitted 7/26 from ED with COVID, PNA, sepsis. Patient removed BiPAP and dev. hypoxia & bradycardia. Went into PEA when intubating. Symptoms: weakness, CXR noted for PNA, exhausted with minor activity, hypoxic, respiratory distress Non-LTCF. (+)  PCR 7/10/2021. Dx: PNA due to COVID, ARF with hypoxia, sepsis without acute organ dysfunction, enlarged thyroid. S/S: cough, wheezing, weakness, develop PNA, SOA, tachycardia. C/M: A. fib with RVR, HTN, HLD.           Pfizer: 2/27/2021 & 3/16/2021.
Seizure activity, lower paralysis, exhaustion, nausea and vomiting, brain fog, difficulty concetrating, low blood pressure, Painful periods and off cycle, chest pain, joint pain, muscle pain and weakness, blurred vision, tremors, weight loss, personality change, dizziness, difficuly breathing, oxygen deprived, hair loss, Skin pale.  2/25/09 Received PCP medical records of 10/25/07-12/24/2008. FINAL DX: none provided Records reveal patient experienced good health on 10/25/07.  RTC 11/15 w/sore throat, left ear pain & nausea x 1 wk.  Dx w/viral URI.  RTC 11/23/07 w/left knee pain/swelling x 5 yrs.  Dx w/patellofemoral syndrome, tx w/meds & referred to PT.  RTC 1/8/08 w/neck & throat discomfort.  Dx w/voice weakness, probable strained cricopharyngial nerve.  Tx w/meds & referred to ENT who dx w/dysphonia following likely vocal misuse.  RTC 2/8/08 w/fatigue, upset stomach, weight loss, polydipsia & nausea x 1 wk.  RTC 2/12/08 s/p fainting in school, lightheaded x 1 wk.  Dx w/syncopal episode & possible dehydration, weight loss & fatigue.  Tx w/IVF & meds.  DM w/u neg.  RTC 2/28 s/p ER visit for generalized pain.  Had been hospitalized previous wk, dx w/pseudoseizure & followed by neuro.  3/27/09 Received Neuro consult medical records of 2/25-3/7/2008. FINAL DX: none provided.  Consult states excessive tiredness, nausea & weight loss likely secondary to viral illness; intermittent weakness of legs posssibly due to dehydration vs presyncope; & recent onset of nonepileptic shaking events. Records reveal patient experienced fatigue during vacation out of state approx 3 wks prior to eval.  Saw PCP after vacation for nausea, weakness.  Hospitalized x 3 days.  Eval by peds neuro at that time & dx w/syncope vs near syncope.  Improved & d/c to home.  Was able to return to school f/t & traveled out of state.  Collapsed & had to be brought back home w/trembling of extremities.  Admitted to hospital for further neuro eval.  Exam & testing all WNL.  D/C to home.  Seen in ER x 2 for recurrence of shaking & aggressive behavior.  Seen in Neuro clinic 3/7/08 where exam WNL.  Dx spells of nonepileptic events.  Referred to psych.
The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (MI) (Reference number- 00358657) and transmitted to Sanofi on 15-Nov-2020.  This case is linked to cases 2020SA324634, 2020SA324620, 2020SA324531, 2020SA324307, 2020SA324116, 2020SA323899, 2020SA323872, 2020SA323795, 2020SA323787, 2020SA323616, 2020SA323614 and 2020SA323597 (same reporter).  This case involves a 33 year old female patient who was administered 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ552AA, expiry: 30-Jun-2021, form: Prefilled syringe) once via intramuscular route in the left arm for prophylactic vaccination on 06-Nov-2020 instead of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (wrong product administered, product administered to patient of inappropriate age and accidental overdose).  Medical history, medical treatment(s), past vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose accidental (latency same day).  A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days. No adverse events (AE's) were noted and no treatments were administered to any of the patients.  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.
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix 1440) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 21st June 2022, the patient received Havrix 1440. On 21st June 2022, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: The patient received expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix 1440 which led to expired vaccine used.
This case was reported by a healthcare professional and described the occurrence of HEPATITIS B antibody negative in a 63-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  On 30 October 2007, the subject received 3rd dose of ENGERIX B (20 mcg/ml, intramuscularly) in the right deltoid to complete the three dose series.  The 2nd dose of ENGERIX B (20 mcg/ml, intramuscularly) was given on 30 May 2007 in the left deltoid and the 1st dose (20 mcg/ml, intramuscularly) was given on 27 April 2007 in the right deltoid.  On 27 March 2008, 5 months after the 3rd vaccination with ENGERIX B, the subject had a titer drawn that was HEPATITIS B antibody negative.  At the time of reporting the outcome of the event was unspecified.  The healthcare professional considered the event was possibly related to vaccination with ENGERIX B.
severe pain in chest; deep redness on chest; Rash on arm; Arm swelling; Rash under Breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under Breast), CHEST PAIN (severe pain in chest), ERYTHEMA (deep redness on chest), VACCINATION SITE RASH (Rash on arm) and VACCINATION SITE SWELLING (Arm swelling) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced RASH (Rash under Breast), VACCINATION SITE RASH (Rash on arm) and VACCINATION SITE SWELLING (Arm swelling). On an unknown date, the patient experienced CHEST PAIN (severe pain in chest) and ERYTHEMA (deep redness on chest). At the time of the report, RASH (Rash under Breast), CHEST PAIN (severe pain in chest), ERYTHEMA (deep redness on chest), VACCINATION SITE RASH (Rash on arm) and VACCINATION SITE SWELLING (Arm swelling) 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.   Concomitant medication was not provided.  Treatment medications: Anti allergic medication.  It was reported that, the patient did not have rash on arm or any swelling. It was strictly a severe pain in chest and then a deep redness on chest, in between breast, and abdomen, which left my skin as if it was severely burnt. Later the skin peeled. she was still experiencing side effects after the first shot and am never getting the second shot.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: New events chest pain and erythema were added. The patient would not get second shot.
Patient's mother called PHO on 11/24/15 to report her daughter had signs and symptoms of Bell's palsy after receiving influenza injection on 11/20/2015. Mother states on 11/21/15 her daughter felt sick in the morning, c/o of Pain around the jaw (R) side and pain behind her ear on the right side of face, stuffy nose and headache. On 11/22/15 patient c/o eye twitching which was getting progressively worse throughout the day. On 11/23/15, when patient woke up her mother noticed facial droop and difficulty making facial expressions on the right side of her face. Patient had difficulty smiling on the right side of face. On 11/24/15, patient's mother took her to PCP, and she was told these symptoms were not r/t influenza injection. Patient was referred to EENT. Patient was given steroids, eye re-wetting drops for right eye, and instructions for facial and massage exercises. Patient will f/u with Dr. next week. PHN spoke with mother on 12/1/15 and symptoms have not improved.
experienced body aches and chills the 1st 24hr and now the injection site is hot, red and swollen. A knot under the skin got a little bit bigger than silver dollar, felt like a huge knot. She feels nurse was administering vaccine while pushing in needle. The initial vaccine the nurse did not push in dose until needle was in arm.
Shaking; lack of energy; feel freezing "to death"; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ASTHENIA (lack of energy), CHILLS (feel freezing "to death"), MYALGIA (body aches) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced TREMOR (Shaking), ASTHENIA (lack of energy), CHILLS (feel freezing "to death"), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, TREMOR (Shaking), ASTHENIA (lack of energy), CHILLS (feel freezing "to death"), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Information has been received from a physician concerning an 18 year old female who on 10-MAR-1993 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported).  On 27-NOV-1995, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported).  On 25-NOV-2009, the patient experienced mumps (diagnosed date reported as 11-NOV-2009).  On 11-NOV-2009, the first blood work was negative for IgM, the IgG was 4.49 and serum amylase was 184 (lab units not reported).  The patient was afebrile and had parotitis.  The outcome of the mumps was not reported.  Follow up information has been received from the physician concerning the 18 year old female patient who on 15-NOV-2009 experienced mumps (diagnosed date reported as 17-NOV-2009).  The patient was afebrile and developed parotitis on both sides.  At the time of the report, the outcome of the patient was unknown.  Follow up information has been received from the physician who indicated that on 17-NOV-2009 an IgM test was performed with a negative result, an IgG test with a result of 2.94 and a serum amylase test with a result of 478.  This is one of several reports received from the same source.  No further information is available.
Within several hours of receiving flu shot started having hives on face, back, tops of arms and legs. Also has severe itching/discomfort of both eyes. Self medicating with Benadryl PO and Visine, strongly encouraged on 11/19 to see PMD ASAP! Still has hives.
Itchy hives on anterior & posterior trunk & face. Swelling, redness, pain, and warmth at injection site.
This spontaneous report was received from a female patient of unknown age, who was also a Nurse, reporting on herself. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in 2015 (reported as "3 years ago"), the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). After the administration of PNEUMOVAX 23 the patient experienced a very large, warm, red knot on her arm. On an unspecified date, the patient was evaluated by her physician. The patient fully recovered from the event on an unknown date. The reporter did not assess the causal relationship between vaccination with PNEUMOVAX 23 and the event.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was inadvertently vaccinated with 0.5 ml GARDASIL (lot # 666595/0096Z, expire date 14-OCT-2012) intramuscularly on 16-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information is not expected. This is one of several reports received from the same source.
Patient states that she is having soreness in left arm that started with the first dose of Pfizer in Jan 2021. She also received second dose in left arm and second dose seemed to make pain worse. Rates pain 7/10 when using arm but does not bother her at rest. Received third dose in right arm and is also experiencing pain in that arm since dose. Rates pain 4/10. Has not tried anything to relieve the pain at this time but is going to try "muscle rub." States pain seems to be getting worse rather than better.
My legs and body felt a burning and itching sensation took one Benadryl tablet felt a little better but Still not normal
Information has been received from a registered nurse concerning a patient who on 12-MAY-1999 was vaccinated with a dose of Varivax. Subsequently on 08-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
sore arm; "little red" on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA ("little red" on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA ("little red" on the injection site). At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA ("little red" on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported. It was reported after getting the 1st dose of the Moderna Covid-19 vaccine in Oct-2021 had a sore arm and a little red on the injection site.   This case was linked to MOD-2022-461199 (Patient Link).
Local doctor diagnosed patient with cellulitis. Warm, red patches on left arm. Patient says that patches were on her deltoid a few days before. On presentation the deltoid was clear but the redness was on the tricep and sides of shoulder.
Pt received first dose of vaccine and three days later reported itching all over body and red splotchy rash covering entire body
A non-serious spontaneous report of nose bleeds has been received from a non-healthcare professional concerning a patient, subsequent to FLUMIST. Neither medical history no concomitant medication was reported for this patient. On an unknown date, the patient received FLUMIST. The patient experienced nose bleeds after receiving FLUMIST. The outcome of the event of nose bleeds was unknown.
patient received her 2nd dose of SHINGRIX vaccine on 7/2/19 and stated on 7/4/19 she was in the shower in the morning and felt dizzy, had heart palpitations and had to sit in the shower. She came out wet and decided to go lay down because she was feeling nauseous. Next thing she remembers is waking up on floor. She had passed out. She slept for the past 20 hours on and off but mainly sleeping. She reported extreme diarrhea, black tarry stools but is starting to feel better today (7/5/19). She is tired, her bowel movements are more 'normal' but they are still dark in color.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Tingling (specify: facial area, extremities)-Mild, Additional Details: Pt experienced tingling in left hand, then later right hand, while still with pharmacist after passing out.
Fever of 101.9 after aspirin, muscle aches, headache, throwing up, fatigue for 48 hours after vaccination
Pt completed Engerix-B series 16AUG90, 14SEP90, 6FEB91 & titers tested w/in last month (?APR92) & were found to be neg;
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N002720, with expiration date on 12-MAY-2019 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 192 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.