chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from non health care professional. This case involves an 86 years old male patient who was vaccinated with a dose of Flu shot in September of 2018 and also a 0.5 mL dose of FLUZONE HIGH DOSE (lot number: UA994AA and expiry date: 09-Apr-2019) via intramuscular route in the left arm on 03-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
It was reported that a patient  received a TD Adult vaccination. The pt experienced swelling and bruising. No specifics were provided. Further info is being requested.
Information has been received from a registered nurse concerning a patient who in approximately 2000 "over 10 years" was vaccinated with a dose of RECOMBIVAX HB (lot # unknown). The nurse stated that on 04-OCT-2010 the patient had a negative antibody titer. No adverse effect was reported. It was unknown if the patient sought medical attention. No further information is available. This is an amended report. Upon review of the file, the code was changed from antibody test negative to Anti-HBs antibody negative.
I started getting symptoms on 5/11/2022 of fatigue, headache, chest congestion, cough, and low grade fever. I received a positive COVID-19 test that was positive and also went to my doctor and did a rapid COVID-19 test that was also positive. I was prescribed Paxlovid. I did not take it. My symptoms lasted intensely for 4 days. Then the chest congestion, fatigue, and cough is still lingering.
PATIENT RECEIVED INJ. ON 11/20/2017 AND ON 11/21/2017 STARTED TO HAVE BRUISING, SWELLING AND PAIN. WAS TOLD TO USE WARM PACKS AND TAKE IBUPROFEN, CONTINUED THIS OFF AND ON BUT STILL HAS PAIN AND SOME BRUISING ON 12/30/2017.  WILL BE SEEING DOCTOR SOON.
Discomfort in my gums they kind of like swollen; Discomfort in my gums they kind of like swollen; Its still painful, its still hard to chew and eat; Its still painful, its still hard to chew and eat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced discomfort in my gums they kind of like swollen. Its still painful, its still hard to chew and eat. It was reported that got my Pfizer shot last Wednesday and may be Thursday, Friday, started feeling like discomfort in my gums they kind of like swollen. So thats why calling you up. So, they got swollen and its still painful, its not as painful as it was Saturday but its still hard to chew and eat so I dont know if that was the side effect of the vaccine or something I need to check out with my dentist to do something because its on both sides. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild.
Patient administered 0.5mL dose instead of the correct 0.25mL booster dose for their fourth dose of  Moderna.
I had a viral upper respiratory infection. I consulted my physician who prescribed me a nebulizer and inhaler. They performed a COVID-19 test on me to ensure it wasn't COVID-19 or pneumonia. I was using the nebulizer every 3 hours as well as some other medication. I'm still having some slight complications, but now to where I only use the nebulizer once a day especially when needed.
Right arm erythematous, edematous, warm - no drainage, no loss of motion, minimal pain, some itching.
This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient is not on any medication and has no known drug allergy. The patient received COVID-19 vaccine AD26.COV2.2 (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021. No concomitant medications were reported. Patient got the Janssen COVID shot on March 9th Tuesday and then experienced headache started same day and Wednesday 10th March, took TYLENOL and headache recovered, then seizure on 11th Mar, went to the ER and spoke to the doctor on reporting day. Consumer also started patient experiencing rash and extreme pain on both arms and hands on reporting day 12th Mar and getting worse. On 09-MAR-2021, the subject experienced headache Treatment medications (dates unspecified) included: paracetamol. The action taken with COVID-19 vaccine AD26.COV2.S was not applicable. The patient recovered from seizure, and headache, and had not recovered from rash on arms and hands, and extreme pain in both hands and arms. This report was serious (Other Medically Important Condition).
About an hour after the shot, I began hearing a faint ringing in my right ear.  It is very low volume, but it is there.  It now occurs about every 2 hours and the ringing lasts for only about 15 seconds before going away again.   This does not happen in my left ear.   The tone of the ringing is equivalent to a C4 on a piano.  It is not harsh, and sounds like a synthesizer tone.
Received both vaccines on Friday 10/21/22, felt bad on Saturday shortness of breath and cough with worsening symptoms with exertion and felt dizzy. O2 saturations 84% and improved to 88% after 2L of nasal cannula at urgent care. In the ER, patient's O2 saturations was 84% on room air there, placed on 3L O2 nasal cannula and improved to 95%. Denies headache or focal neurological symptoms but stated that she sees halos.  No chest pain but a little tightness.  No palpitation.  No abdominal pain little nausea.  Yesterday she vomited after coughing fits.  No history of heart problems.  Former smoker but no history of asthma or COPD.
Breakthrough case after Covid vaccination. Dose #1 6/3/2021 Dose #2 7/1/2021. C/O fever and runny nose
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 31-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. On 20-Nov-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
1/6/21: left arm soreness and decreased range of motion around 5pm.  lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am.  Nausea  started around 6am.  Fever lasted all night till around 10am.  Blood pressure 138/85 and resting  HR 125 and fever started again around 12pm.  Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm.  Fever and headache returned around 8pm and gone by 10pm.
has a spotted skin rash all around her body; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Lot number and Expiry Date was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number and Expiry Date was not reported) as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced a spotted skin rash all around her body, occurred two weeks after the second dose. The seriousness of the events was considered as non-serious. The outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Information regarding PREVNAR 13 was received from a physician regarding a child who experienced "large swelling areas in the limbs". The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient experienced "large swelling areas in the limbs". Outcome was unknown. No additional information was available at the time of this report. See related case (s): US WYE H18212010 (adverse event, non expedited).
Patient experienced flushing of the face approximately 45 minutes after administration.  She stated that it was not an allergy type rash. Felt like a hot flash
This non-valid spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N026812, expiration date 22-JUN-2020 (exact dose, route of administration and anatomical localization were not provided). No adverse effects were reported. Data logger was involved. Administered doses of GARDASIL 9 lot # N026812 were exposed to the temperature excursion of below 32 degrees Fahrenheit for 3 hours. Previous temperature excursions of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 4 hours and 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour 30 minutes were reported. This is a non-valid case due to lack of the patients' identifiers. Follow-up was received on 22-OCT-2018. On 22-OCT-2018, a telephone call was placed to the medical assistant. The phone call went straight to voicemail. A message was left providing reason for the call, case reference number, contact number and a request for a retumed phone call. This is a non-valid report and should have been forwarded to the Non-valid workflow, instead of being distributed. Therefore, it is being sent to distribution for the last time to notify all recipients.
The pt called on 10/18/10 to report ADR. Pt felt very weak for many days after getting Flu shot. She could not even lift her arms for days. She is feeling normal now.
Patient reports her arm was hot and swollen and red for a duration of over 30 days after receiving the vaccine.  Her primary care doctor has advised her not to get the 2nd dose.
TD vaccine was administered to employee's left deltoid on 9/15/04 at 9am. Employee informed me on 9/20/04 about her reaction. For two days 9/16 and 9/17 , she had swollen and painful injection site, body ache, low grade fever (no temp taken) Did not seek medical attention. , nor informed me until 9/20/04. No fever , no body ache, site soft and normal in skin color.
DTaP and IPV on 2/08 Erythema started 2/9 with induration (r upper arm) Seen in office 2/10 and per parent, less reddness and firmness. At office, erythema 8 X 7 cm. Induration of 1 cm.
pt c/o tingling in lt arm around the inj site;site examined +tenderness, +hardness;pt instructed to put ice on it & take DPH;no hives;no diff breathing;
Hive near injection site 1-3 cm occurred about 20-25 min post injection.
Patient developed dizziness, had a vasovagal reaction where heart rate dropped to 50s and improved to 70-80s after patient had a chance to rest. She was given 25 mg of benadryl, observed for 30 minutes and recovered without incident and was discharged homed.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 19-SEP-2012, patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports from the same reporter. Additional information has been requested.
small CVA to the right side of my brain; spasms to my left leg; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). This consumer (patient) reported via follow-up letter which included that:   A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unspecified route of administration on 12Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 18Feb2021 for covid-19 immunization and on 02Mar2021 was admitted to hospital after suffering from several falls. The patient was discharged on 11Mar2021 with no definitive diagnosis but had spasms in left lower leg and foot. In order to obtain a second opinion, went to withheld in withheld, withheld again, no specific reason for the spasms and option for treatment. Patient purpose for reaching out to you was patient awareness that there are reported instances of Covina 19 vaccines causing neurological problems possibility, because of unintended auto immune responses. The patient appreciate looked into this possibility as any information available may helped me in finding a procedure my doctors can used to correct these spasms that were causing so much difficulty. On 12Mar2021, patient received second dose of injection and went to emergency room. On 02Apr2021 with spasms to left leg and to rule out TIA vs CVA. On this admission patient underwent MRI which indicated that had a small CVA to the right side of brain. Patient was transferred to hospital on 09Apr2021, for surgical evaluation. Patient has been admitted into 2 hospitals for a total of 15 days with no explication of why the patient was suffering from spasms. These spasms have limited patient's ability to ambulate, thus patient spent most of patient's time in a wheelchair. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Began with a bad stomach ache, four hours after flu shot was given, followed by vomiting eight times, headache, chills. No treatment other than going to bed.
Memory Impaired; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MEMORY IMPAIRMENT (Memory Impaired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 642L20A and 029A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concomitant products included SIMVASTATIN for Cholesterol, METOPROLOL for product use for unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram. In May 2021, the patient experienced MEMORY IMPAIRMENT (Memory Impaired). At the time of the report, MEMORY IMPAIRMENT (Memory Impaired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MEMORY IMPAIRMENT (Memory Impaired) to be not related.    Treatment information was not provided.
Having mild fever; Flu like symptoms since last night and slept for almost 16 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms since last night and slept for almost 16 hours) and PYREXIA (Having mild fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms since last night and slept for almost 16 hours). On 08-Apr-2021, the patient experienced PYREXIA (Having mild fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms since last night and slept for almost 16 hours) was resolving and PYREXIA (Having mild fever) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Child was given a 2nd dose of FluMist, and only should had received 1 dose, due to age. Child is 9 years of age. No treatment. Per mother , no signs or symptoms noted after adverse event. Adverse event was reported to doctor.
~2 days after receiving smallpox and anthrax vaccine, patient developed fever and chills which resolved overnight.  Patient went running the next day and experienced chest pain that resolved with walking, but returned when she resumed running.  Other symptoms included dyspnea and a sensation of a pounding regular heartbeat.  Patient presented to the acute care clinic where an ECG was significant for an incomplete right bundle branch block.  Patient was then sent to the emergency department for further evaluation. ESR, cardiac troponin, and D-dimer drawn in the ED were normal.  Patient also seen for follow-up in the cardiology clinic and had a normal graded exercise treadmill test.
Increasing swelling in feet/ankles / increasing swelling in hands; increasing swelling in feet/ankles; Increasing swelling in face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Increasing swelling in feet/ankles / increasing swelling in hands), JOINT SWELLING (increasing swelling in feet/ankles) and SWELLING FACE (Increasing swelling in face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Increasing swelling in feet/ankles / increasing swelling in hands), JOINT SWELLING (increasing swelling in feet/ankles) and SWELLING FACE (Increasing swelling in face). At the time of the report, PERIPHERAL SWELLING (Increasing swelling in feet/ankles / increasing swelling in hands), JOINT SWELLING (increasing swelling in feet/ankles) and SWELLING FACE (Increasing swelling in face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter
VERTIGO Narrative:  Pt called to report vertigo episode after getting his first COVID-19 (Moderna) vaccine dose earlier that day. No intervention or f/u treatment noted.
patient was administered two doses of VAXENUVANCE less than 6 months, second administration was accidental; No additional AE information reported; This spontaneous report has been received from a nurse practitioner via a company employee referring to a 62-year-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with one dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (first dose; strength, exact dose, lot #, expiration date and route of administration were not provided) for prophylaxis. On an unknown date less than 6 months apart, the patient was vaccinated with another dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (second dose; strength, exact dose, lot #, expiration date and route of administration were not provided) for prophylaxis (extra dose administered). It was reported that the second administration was accidental that provider was unaware patient had already received one dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). No additional adverse event (AE) information or product quality complaint (PQC) was reported.
Developed red rash at injection site day after administration. Subsequently developed widespread maculopapular rash.
Patient experienced stroke like symptoms. Lethargic, confused, light sensitivity, slurred speech, off balance and unable to respond to commands or stimuli. Next day- patient experienced swelling in the neck.
DID NOT TAKE DOSES ON TIME; A spontaneous case report was received from a nurse on 17-Oct-2019 for four consumers.  Based on the information obtained from the nurse four individual case safety report PVX201910-000804 (PVX2019-2599; first consumer), PVX201910-000805 (PVX2019-2600; second consumer), PVX201910-000806 (PVX2019-2601; third consumer), and PVX201910-000807 (PVX2019-2602; fourth consumer) were created and cross-linked in the database.  This case (PVX2019-2602) described a consumer who "did not take doses on time" (PT: Product dose omission), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif, then did not take the remaining doses for several days.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take doses on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take doses on time" was considered as not applicable. US-PaxVax Berna GmbH-PVX201910-000804:
Inflamed rash originating at injection site and radiating down arm following the lines of the tricep.  Rash is uniformly raised and hot to touch.  Rash is very painful to touch.