chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shoulder pain as like being shot in the back, on the shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder pain as like being shot in the back, on the shoulder blade) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (shoulder pain as like being shot in the back, on the shoulder blade). At the time of the report, ARTHRALGIA (shoulder pain as like being shot in the back, on the shoulder blade) outcome was unknown. Not Provided      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 product was not provided by the reporter  Treatment information was not provided   This case was linked to MOD-2021-017375 (Patient Link).
Patient received Pfizer bivalent booster dose instead of Pfizer primary series 2nd dose.  Patient did not display any ill effects from vaccine after 30 minutes and was released to self-care.
Began with tingling of feet then swelling of feet, then swelling of both legs. Medical tests. .. echo cardio gram, vascular ultrasound, MRI of pelvis, neurological exam of nerves, rheumatologist and immune system. Multiple blood samples all of which were negative with exception of one that showed inflammation somewhere. After all the above test there is no conclusion or diagnosis to the continued swelling . Have never had adverse event following any previous vaccines
PT RECIEVED PFIZER GREY TOP FOR 12+ AS A BOOSTER DOSE INSTEAD OF ORANGE TOP AGES 5-11  NO TREATMENT GIVEN AND NO HARM TO PATIENT
Fever, dizziness and nausea from around 6pm the day of vaccine. This persisted through the following day.  The dizziness has persisted through the entire week
felt warm in forehead; forehead was red; rash in forehead/elbow and chest; little bumps in forehead; itch in forehead/elbows and chest; This is a spontaneous report received from a contactable consumer, the patient. A 28 years-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route administration in left arm on 19Mar2021 at 11:00, (at the age of 28-years-old) as a single dose, for COVID-19 immunisation. There was no medical history and no known allergies. The concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) that started on an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 19Mar2021 at 11:30 (30-45 minutes after getting the vaccine), the patient started to get a rash in his forehead; At first, it felt warm and he did not notice it, until his wife pointed out that his forehead was red. After an hour, his forehead started to itch and after scratching it, little bumps started to emerged on his forehead. Later that night, the patient began to feel itchy in his elbows and chest. It was also reported, that the rash on the elbow and chest was smaller compared to the one in patients forehead. On 20Mar2021, (today, was the day after) the patient still had the rash in his forehead, elbow and chest. No treatment was received for the events. The clinical outcome of events rash in forehead/elbow and chest, felt warm in forehead, forehead was red, little bumps in forehead, itch in forehead/elbows and chest were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
My daughter had a reaction at each injection site and within 6 months, had lost her intelligibility. She has been diagnosed with a speech delay and apraxia. We are doing speech therapy and trying to get her to 50% intelligibility.
33 y.o. male with a significant past medical history of insomnia presenting with chest pain to ED on 11/26/21.  He reports that he received his Covid?19 booster vaccine 5 days earlier on Sunday 11/21 and since then has felt fatigued, chills, sweats, severe joint pain, and as of this morning at 3 AM woke up with severe chest pain, nausea, and vomiting.  The chest pain was located in the center of his chest described as substernal, not radiating, not associated with position, not associated with exertion, and no known inciting or relieving factors.  He describes it as a dull ache that was initially 7 out of 10 until arriving in the ED where he received nitroglycerin, aspirin, and morphine.  He received these medications all at the same time and reported relief of chest pain approximately 15 to 20 minutes after being given.
Information has been received from a woman in a doctor's office concerning a 6 year old male with no known drug allergies who on 08/07/97 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on the same day included a dose of MMRII. The reporter indicated that a rash was noted on 06/02/03.  The reporter noted "reported/seen in our office 06/04/03." The pt had itching and less than 50 lesions on the neck, chest, leg and groin. The pt subsequently recovered. No further information is expected.
Telephone call to undersigned today at 10am stating child had red, swollen, inflamed area at injection site left arm; area itchy, child scratching frequently.
01/02/2022: Event occurred after 2nd vaccine. a 44-year-old female started having mild symptoms Thursday tested today positive Covid.  She states that has had little bit of a cough body aches mostly nausea and vomiting for a couple of days.  the patient is on insulin pump for her diabetes sugar has been under good control. no significant shortness of breath.  denies:  Diarrhea, fever, urinary symptoms, blurred vision, sore throat, back pain, palpitations, dizziness, rash.  01/06/2022: admitted to covid icu and dka was hammered with iv fluids insulin drip, electrolyte repletion.
It was reported that a 19 year old male pt received a Menomune vaccination in August 2000. Reportedly the pt experienced itching of the legs two days post immunization. One week later, the pt experienced difficulty swallowing, shortness of breath and abdominal discomfort. His symptoms were slowly resolving as of 11/09/2000. From additional correspondence received on 01/29/2001, it describes the occurrence of difficulty swallowing in a 19 year old male who received hep B for prophylaxis. This report was received from the pt's mother and has not been verified by a physician or other health care professional." "Concurrent medical conditions include asthma. Concurrent medications include meningococcal polysaccharide vaccine and albuterol as needed. The pt received an injection of Engerix-B in August 2000. Two days later, he experienced itching of his legs. His mother treated him with Benadryl. Approx 1 week later, he developed difficulty swallowing, shortness of breath, and abdominal discomfort. He was not seen by a physician. His symptoms were slowly resolving as of 11/09/2000."
Patient presented with new onset dvt 5 wks post covid 19 vaccination. 36 yr old female with solitary risk factor of previous history of DVT. Of note, pt had dvt in 2002 which occurred while on birth control (and pt became pregnant).
4:16pm vaccine administered.  After walking away from getting flu shot at 4:20pm patient started to feel faint and passed out.  His mother caught him, he sat down for 20 minutes and felt fine, walking out of the store on his own.  Pharmacy did not get involved and was unaware of patient incident until later that evening.
Red mottled Chest rash and all over itchiness 3 days post vaccine.
Flu; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 09-Nov-2020.  This case involves a patient with unknown demographics who experienced flu, when received vaccine INFLUENZA VACCINE (flu shot).  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced flu, unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective medications.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
Developed about 50 vesicles over a period of 12 hours. Complained of itching.
Severe stomach pain Severe stomach and intestinal cramping Dizzy, nausea, vertigo, problems moving and standing Headache, weakness Prescribed Zofran anti nausea, took motrin for nerve swelling 14 days stomach pain, nausea, vertigo 3-4 days headache. Fully resolved 2 weeks
Alopecia- started as a small hair loss the size of  dime and is not two inches in diameter
Within 2-3 weeks of immunization, pt. began experiencing several illnesses, one following the other.  First, approx 11/7/07 bronchitis and laryngitis, 3 weeks later, laryngitis with symptoms of strep throat, 3-4 weeks later bronchitis, 3 weeks later severe coughing and repeated laryngitis, 2 weeks later double ear infection and double sinus infection with accompanying cough and post nasal drip.  2 weeks later continued sinusitis accompanied with severe cough and strep throat.  10 days later pt. still has sore throat and severe cough accompanied by laryngitis.
Patient required hospitalization due to breakthrough infection. She received Pfizer vaccine on 02/01/21 (2nd dose in series) . Hospitalized from 7/24/21 to 7/29/21. Below is copied from discharge summary:  Hospital Course:  Patient is a 75 y.o. female  with H/o CAD (s/p CABG) in 2006, HTN, HLD, obesity, and COPD not on home O2 who presented via EMS c/o SOB x 5 days. Patient reported gradually worsening flu-like symptoms over 5 days. Per EMS, patient O2 saturation in the 70s on arrival and improved to 88% on a nonrebreather.   In the emergency department on arrival, pt febrile to 102. Pt states multiple family members tested positive for Covid-19 this week. Of note, she is fully vaccinated for Covid-19 with Pfizer. Endorses associated myalgias and productive cough.     Admitted for COVID 19 and acute hypoxemic respiratory failure. Completed 5 days of Remdesivir and azithromycin/rocephin. Initial blood cx with coag negative staph and pt received IV Vancomycin x 3 days. Repeat blood cultures negative and per ID the positive set likely contaminant. Pt was weaned off oxygen and passed a walking desaturation study. Of note, echo was done showing enlarged heart and EF 45%, pt was advised to follow-up with PCP.    Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction.
Burning sensation in arm, within 3-5 minutes a pain shot up the left of his spine reaching skull causing him to lean forward, left ear pain started mild then ear begin to get worse, it lasted a few seconds.  Right ear did the same.    Pain behind the neck, ringing of the ear
pt. ears started to turn red approx. 4 mins after injection approx. 2 mins later pt. stated that his throat was closing. Epi 0.15 mg administered at 1026 a.m. patients blood pressure and oxygen levels was assesed every 15 mins. until patient was cleared to leave. Patient left approx. 45 minutes later with normal vitals.
Dizziness/ dizzy; Weakness/ very weak; Seizures; Fainted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizures), SYNCOPE (Fainted), DIZZINESS (Dizziness/ dizzy) and ASTHENIA (Weakness/ very weak) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization and medically significant) and SYNCOPE (Fainted) (seriousness criteria hospitalization and medically significant). On 16-May-2021, the patient experienced DIZZINESS (Dizziness/ dizzy) (seriousness criterion hospitalization) and ASTHENIA (Weakness/ very weak) (seriousness criterion hospitalization). The patient was hospitalized on 07-May-2021 due to SEIZURE and SYNCOPE, then on 16-May-2021 due to ASTHENIA and DIZZINESS. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SEIZURE (Seizures) and SYNCOPE (Fainted) outcome was unknown and DIZZINESS (Dizziness/ dizzy) and ASTHENIA (Weakness/ very weak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Description: During the day of the injection, at 5 to 10 minutes, the patient fainted and had seizures that required hospitalization. Also, on 16 May 2021 the patient required hospitalization again because of the dizziness and weakness. The patient was still dizzy and was very weak. The patient had a consult with a neurologist and who told that the symptoms were probably becasue of the vaccine.  Other treatment information included unspecified pill for dizziness at the hospital.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received vaccine and was sent to observation area. She began having altered mental status, slight aphasia, and confusion. Snack was offered and patient was assessed. She had difficulty answering questions and complained of chest feeling abnormal. B/P taken 230/140. 911 services called. Transported to hospital at 12:52
Diffuse inflammation of right hemisphere of the brain resulting in left hemiparesis. Symptoms began within 12 hours of vaccine admin. Multiple seizures.
J96.00 ACUTE RESPIRATORY FAILURE 11/26/2022 COGNITIVE DISORDER
VACCINES EXPOSED TO TEMP OUT OF REC. STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER
This consumer report (initial receipt 27-Feb-2014) concerns a female patient whose past medical history included a cold which developed after receiving the flu vaccine on an unspecified date (see 2014041012). For the next two years on unspecified dates, the patient received a flu shot (manufacturer and batch number not reported). Each time after receiving the flu shot, she developed some type of flu or cold or pneumonia afterwards. Outcome was not reported.
Headache, Myalgia, Fever, CHILLS, FATIGUE Narrative:
I was driving and had double vision/ blurred vision in the evening; Swelling of throat; This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 19Feb2021 as DOSE 1, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Feb2021 the patient experienced swelling of throat. On an unspecified date the patient was driving and had double vision/ blurred vision in the evening. The outcome of event swelling of throat was recovering while outcome of event was driving and had double vision/ blurred vision in the evening was unknown.   No follow-up attempts are possible. No further information is expected.
Patient received her 1st dose of the Moderna  vaccine on 1/15/21. She developed a rash later in the day but failed to mention this prior to receiving her 2nd dose today (2/12/21).  After today's dose (given at around 10:00 am), she developed difficulty breathing and was rushed to the emergency department. She was treated with epinephrine 0.5 mg IM,  albuterol nebulized solution,  racemic epinephrine nebulized solution,  diphenydramine IV, famotidine IV, and methylprednisolone IV  She was also treated using supplemental oxygen  She responded well to treatment  and is currently still being monitored as of 12:21 PM
Sore arm for 5 days, bad headache, fever, chills, body aches, congestion, flu-like symptoms, fatigue
Patient's left arm area surrounding the site of Varivax administration is red, raised, and swollen. Her primary care doctor prescribed Cephalexin 500mg 1 capsule by mouth twice daily for 5 days.
COVID-19; COVID-19; right shoulder sore; This is a solicited report from a marketing program (FACILITATED COLLECT) based on information received by Pfizer from Regulatory Authority (manufacturer control number: 20K-163-3693021-00). A non-contactable consumer (patient) reported that a 65 year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 18Feb2021 (Batch/Lot number was not reported) as single dose, intramuscular on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation, age at vaccination was 66 years old; Methotrexate Sodium, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate Free for Moderate to severe rheumatoid arthritis.  Medical history and concomitant medications were not reported. On an unknown date, the patient experienced COVID-19. In 2020, the patient experienced right shoulder sore. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of Covid-19 and right Shoulder sore, with Humira (Adalimumab) was no reasonable possibility, with bnt162b2 was Possible (as reported). The action taken in response to the events for methotrexate was unknown, for adalimumab was permanently withdrawn on unknown date. The outcome of the events was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product Methotrexate Sodium was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on an implausible temporal association (right shoulder sore occurred in 2020 while administration of BNT162B2 vaccine was on 18Feb2021 (first dose and in Mar2021 second dose) arthralgia is considered unrelated to BNT162B2. Assuming  a plausible temporal association, the mentioned COVID-19 infection may be related to BNT162B2 as manifestation of lack of effect. Conversely, there are no elements supporting a causative role of methotrexate sodium for COVID-19 and arthralgia, being this latter a probable symptom of known rheumatoid arthritis.
Local reaction at the Injection site, skin is red; Injection site rash; Tender at the center; Was just a welt; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Local reaction at the Injection site, skin is red), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE PAIN (Tender at the center) and VACCINATION SITE URTICARIA (Was just a welt) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. G25L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Local reaction at the Injection site, skin is red), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE PAIN (Tender at the center) and VACCINATION SITE URTICARIA (Was just a welt). At the time of the report, VACCINATION SITE ERYTHEMA (Local reaction at the Injection site, skin is red), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE PAIN (Tender at the center) and VACCINATION SITE URTICARIA (Was just a welt) outcome was unknown. Not Provided      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 medications were not provided. Treatment details were not provided.    This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Reporter's co-worker
a vaccine expired on 22-Jan-2023 was administered to patient on 26-Jan-2023 with no reported AE; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown age and gender who was administered expired vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] on 26-jan-2023 with expiry date 22-jan-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jan-2023, the patient received an unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (expiry date: 22-jan-2023) (Suspension for injection) (lot number; strength not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 26-Jan-2023 the patient was administered expired vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with expiry date 22-jan-2023 with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Patient received 1st dose on 2/19/2021 and was scheduled to come back on 3/16/2021 for 2nd dose.  The vaccine administrator confirmed that he received Moderna last time.  The vaccine was administered without checking to see when the last dose was given.  It was only after administration that the documenter noticed the date of the first dose.  The patient was made aware of the fact.  The medical director was immediately notified and nursing administration will follow up with the patient on Monday (3/8/2021).
Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenza vax; On f/u, reporter stated pt had a gastrointestinal virus that was not related to the vax;