chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of IPOL was inadvertently administered/No AE; Initial information regarding an unsolicited valid non-serious case was received on 26-Apr-2021 from a health care professional  This case involves a 13 year-old female patient who was inadvertently vaccinated with expired dose of IPV (VERO) [IPOL] (Expired product administered).   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE for prophylactic vaccination.  On 26-Apr-2021, the patient received third dose of suspect IPV (VERO) (Strength: standard; lot R1B251M and expiry date 13-Mar-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  It was also reported that "caller with question on whether dose needed repetition. Caller also with question on any safety concern with administering expired dose".  At the time of report, no adverse event 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.
Patient received vaccine that had been drawn up the day prior to vaccination. Vaccine expired at 6pm on 7/29/21 and was given at 9:40 on 7/30/21
First dose / on Dec 2020, then she got Shingles disease; This case was reported by a other health professional via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received vaccine and then had shingles disease. The patient was wondering how soon could she inject the 2nd dose or dose the whole schedule reset. No other information was provided. The information regarding consent to follow up was not reported.
Lightheadedness/whooziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness/whooziness) 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.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheadedness/whooziness). At the time of the report, DIZZINESS (Lightheadedness/whooziness) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided.
aching in her arm/inoculation my left arm started aching; her arm started to throb; By last night arm was very painful.; her arm was swollen; tingling in her tongue and lips; tingling in her tongue and lips; feeling heavy; waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face; waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face; waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face; minor chills; This is a spontaneous report from a contactable consumer or other non hcp.    A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in arm left on 27Jan2021 at 11:30 as single dose for COVID-19 immunisation.The patient medical history included hypersensitivity from an unknown date and unknown if ongoing and concomitant medications were not reported. The patient experienced feeling heavy, waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face, chills on 06Feb2021. It was reported that the patient had experienced aching in her arm/inoculation her left arm started aching, her arm started to throb, by last night arm was very painful, her arm was swollen, tingling in her tongue and lips on unknown date. Clinical course was given as 10 days after the inoculation her left arm started aching, feeling heavy, waves of pain which then by day 13 had spread to her shoulder and neck on the left side of her face.On Saturday her arm started to throb and it hasn't stopped. She is not really using her arms. By last night arm was very painful. The throbbing and pain spread from her shoulder to her neck.When she put her night on gown her husband noticed that her arm was swollen. The are was 6x4 inches on her arm.Also, tongue and lips were tingling now (not previously) and minor chills. It was reported that patient did not have treatment. The seriousness of events was reported as non-serious.The outcome of events aching in her arm/inoculation her left arm started aching, her arm started to throb, by last night arm was very painful, her arm was swollen, tingling in her tongue and lips were unknown. The outcome of events feeling heavy, waves of pain which then by day 13 has spread to her shoulder and neck on the left side her face, minor chills was not recovered.  Follow-up attempts completed. No further information expected.
Patient presented to ED for generalized weakness and was found to have a fever upon admission. No clear onset date.
I had flu like symptoms, diarrheas with the chills and throwing up. Then later, I had severe itching on both my legs, and it got worse. I waited a few days, but the itching got worse, so I went to the urgent care and I was referred to an allergist.
The reporter determined that the symptoms were related to receipt of FluMist. A nurse at a military clinic reported that an adult patient received FluMist in January 2005. A few hours later, the patient experienced flu like symptoms. The reporter felt that the symptoms were related to FluMist but she did not think that it should be reported because it was an expected reaction. The patients demographic information was not recorded. It is also unknown if the patient recovered from the reported symptoms.
FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Case previously recorded as MA2009-3293. Initial case report received from health care professional via MedCom on 26 OCT 2009. The patient, age and gender unknown, was vaccinated i.m. with S-OIV FLUVIRIN (batch no. unknown) on 23 OCT 2009. The patient, under 4 years, was inadvertently given Novartis H1N1 vaccine. No adverse event was reported. Reference no.: NA09-007031.
Client report receiving COVID vaccination on 01/28 at 11:40, adverse reaction on left index /pointer finger having moderate swelling.  Has pain with bending it, and it is warm to the touch.  Has not contacted a medical provider or had any treatment.  Per client her mother is a nurse and told her to continue to monitor her finger.  At this time, client believes the swelling is worse but not to the need to see a medical provider.
PPD and Varicella administered 01/27/04.  Left tricep area inflammed with slight swelling complained of itching/pain.
Titinitis in both ears. Worse in left ear.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 28Feb2021 at 15:30 (at the age of 60-year-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 13:30, the patient experienced Titinitis in both ears, worse in left ear.  The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event titinitis in both ears, worse in left ear was not resolved at the time of this report.
on 26Jan2021 tested positive for covid; on 26Jan2021 tested positive for covid; This is a spontaneous report from a contactable consumer (one is patient herself) via Pfizer-sponsored program and via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: not reported) on 12Jan2021 via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history and concomitant medication was not reported. On 26Jan2021, the patient underwent COVID-19 (Nasal Swab) and was tested positive for covid virus. She was supposed to get the second dose on 02Feb2021, but she missed it due to contracting the virus, so she is asking does she still need to get the second vaccine. She has not called before, read social media. A Consumer calls for information about if she should be administered with the second dose of the vaccine considering that she is recovering from COVID-19 infection. The Consumer reports that she tested positive for COVID-19 on 26Jan2021 after she received the first dose of the vaccine on 12Jan2021. The outcome of the events was reported as recovering.  Information on the lot/batch number has been requested
Expired Moderna vaccines that were given to 7 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccines that were given to 7 patients) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccines that were given to 7 patients). On 09-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccines that were given to 7 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Nurse stated the Moderna vaccine was in refrigerator at 37F. Then it was moved from freezer on 6-17-2021. There was no visual impact or cloudiness and the vials were still clear with only one 10mL of the Moderna vaccine vial affected.  No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up document is received patient demographic details, anatomical location of vaccine administration is added.
Mother called office and reported: had DTaP and polio yesterday, temp 104 degrees throughout the night; next AM vomiting. Mother states legs were swollen and pt could hardly walk. Mother stated that she was calling to provide information to be put in the chart - left message with front office personnel. MD spoke with pt by phone 4/14. Mother later came into the office and reported "child was talking out of his head when he awoke during the night".
Received 1st shot on March 2  noticed only slight discomfort of Right arm.  Then 2 weeks later on March 16 I had  difficulty moving my arms above my head .  Pain in my legs getting up from chair, going up stairs.  Progress to difficulty  with getting in and out of bed, turning in bed, showering and dressing.  I had pain in both arms, hands and legs at rest.  Pain and stiffness of the neck.  Starting  taking Advil and Tylenol  with little relief.  Talk with NP at Dr. office Told to rest,  fluids and heat.  Folowed up with office visit on March 29 and Lab work, Started on Prednisone 10mg qd  March 24th..    Today  March 25 I have noticed some improvement.Ck 565
Vaccine was administered to 16 year old male. No adverse signs or symptoms. Parents were present and notified.
Patient received first dose of Moderna vaccine on left arm @ 0840 on 03/27/2021 at the vaccination pod in their vehicle. Soon after vaccination,  Patient complained of dizziness, and began to prespire. Nurse noticed and notified me. A code was called and medical attention was administered to the patient. All Vital signs were checked and found to be within normal values.
Patient presented to the ED and was subsequently hospitalized for compression fractures of scrum and thoracic spine within 6 weeks of receiving COVID vaccination.
Initial unsolicited report received from a healthcare professional  on 14 October 2015. This case involves a patient (age: unknown, gender: not provided) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series route and site of administration were not reported) on an unknown date. The patient's illness at time of vaccination; pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient went to emergency department with an adverse reaction (not severe). Laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a healthcare professional on 14 December 2015. No new information reported.
MMR Sub Q vaccine needle out of patient's leg when vaccine given due to patient twisting his body. Another MMR was given w/consent from guardian.
This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 12-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2007). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red, warm spot on right thigh noted sd after immunizations done.  Baby presented with low appetite, but no fever.  Treated with oral antibiotic, Keflex and recovered after incident.
He received the vaccine and within the first hour he broke out into hives. The only place that he doesn't have them is on the bottom of his feet.   Went to the work place clinic on 3/24/21 and they instructed him to take 50 mg. of Benadryl every 6 hours and is actually going to pick up a prescription for this reaction.
Pt called hospital advice call center. noted no emergency s/sx. Pt stated pt got 1st covid vaccine Pfizer 4/28/2021 at facility and pt got facial redness, rashes, facial swelling, tearing after covid vaccination and those symptoms last for 3 weeks. The symptoms got better 90 % but still pt has facial rash on temporal area. Pt said pt got redness beginning from around eye area to facial, collar bone area in a few days after covid vaccination. Pt took benadryl facial cream. Noted no allergies except pollen. Pt said pollen allergy used to be gone after 4-5 days but redness, rash on face at this time last 3 weeks and still pt has 10 % of redness, rash on face. Pt said pt had pain on left arm pit and it last 2-3 days and then pain went away. Noted pt got vaccinated on left arm.  recommended pt to discuss with MD prior to covid vaccination. Pt agreed. Pt scheduled visit with urgent care MD 5/20/2021 for consultations. Pt is educated covid vaccine side effects. Pt verbalized understanding. All questions answered.
Neurological and digestive problems; Neurological and digestive problems; off label use in unapproved age group; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (Neurological and digestive problems) and DYSPEPSIA (Neurological and digestive problems) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced NEUROLOGICAL SYMPTOM (Neurological and digestive problems) (seriousness criterion hospitalization) and DYSPEPSIA (Neurological and digestive problems) (seriousness criterion hospitalization). On an unknown date, the patient experienced OFF LABEL USE (off label use in unapproved age group). At the time of the report, NEUROLOGICAL SYMPTOM (Neurological and digestive problems) and DYSPEPSIA (Neurological and digestive problems) had not resolved and OFF LABEL USE (off label use in unapproved age group) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient participated in an experiment in Pfizer or Moderna mRNA technology.  patient experienced events 12 hours after second dose.  She has been hospitalized several times and her condition to this day continues to be difficult.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 12-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization) events of neurological symptoms and dyspepsia starting 12 hours after the second dose of mRNA-1273. The report stated that it is unclear whether the patient received the "Pfizer or Moderna mRNA" vaccine. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 12-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization) events of neurological symptoms and dyspepsia starting 12 hours after the second dose of mRNA-1273. The report stated that it is unclear whether the patient received the "Pfizer or Moderna mRNA" vaccine. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a registered pharmacist refers to a 60 years old patient with no pertinent medical history and no drug reactions or allergies, who on 05-SEP-2012, was vaccinated "possibly intramuscularly" with one 0.65 ml dose of ZOSTAVAX (lot number 0422AE, Exp. Date: 27-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. On 06-SEP-2012, the patient developed bruising and redness at injection site area after possible intramuscular administration of ZOSTAVAX. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The relatedness for patient developed bruising and redness at injection was unknown for ZOSTAVAX. Additional information is not expected.
Fever 102-103, max 104, lasting ~3 weeks; onset of psoriatic arthritis.
Screamed for longer than 2 hours after receiving immunization on 7/14/03. Some swelling.
I was immediately light headed and groggy after dose was administered , within a few hours I was getting chills and fever, severe body aches, and shortness of breath. I am on day 3 and am better but still have body aches and short of breath
Arm Pain- at injection site. 7:30pm- present. Headache- throbbing. 10:15- present. Nausea- 10:30-present.
The night that she received the SHINGRIX vaccine (3/28/19) the patient developed vasculitis on bilateral lower extremities. The provider checked labs at the appointment on 3/29/19. Symptoms were resolved at follow up appointment on 4/25/19.
a 2-year old patient received second dose of Quadracel vaccine/No AE; Initial information received on 24-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 25 months old male patient (reported as 2 years) who received a 0.5 ml second dose in series of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5635AA, Expiration Date: 18-Jun-2021 via intramuscular route in the left thigh on 10-Jun-2019 .  The patient' past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  It was an actual medication error due to Inappropriate age at vaccine administration.  No adverse event none reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  The outcome of event was reported as unknown.  List of documents held by sender: none.
This case was reported by a physician and described the occurrence of autism in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates in August 2006 and in 2006 the subject received three unspecified doses of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced autism. The physician, who is also the subject's father, had inquired about the amount of Thimerosal in PEDIARIX vaccines. He reported the subject was vaccinated with PEDIARIX in 2006 and was diagnosed with autism. the subject was vaccinated with lots AC21B074CA expiration November 2008, AC21B073AA expiration November 2008 and AC21B084CA expiration February 2009. The physician declined to provide any further details but was open to follow-up. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unresolved.
pt recv vax 1993 & devel a rash for which is reported to have sought medical attention;the rash resolved;