chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a patient family member or friend, describes the occurrence of chest discomfort (pressure on her chest and upper back), musculoskeletal discomfort (pressure on her chest and upper back) and headache in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 14, 2021, patient experienced chest discomfort (pressure on her chest and upper back), musculoskeletal discomfort (pressure on her chest and upper back) and headache. At the time of the report, chest discomfort (pressure on her chest and upper back), musculoskeletal discomfort (pressure on her chest and upper back) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications and treatment information not provided. Reporter did not allow further contact.
Pentacel was given after vaccine had expired. Vaccine expired 1-28-23 & was given 2-9-23. Mother notified. Patient reported to be doing well at this time.
Swollen lower left eyelid. Patient is a lifeguard parent agreed eye infection was possible. Advised doctor visit, mom never returned my follow-up calls.
Patient was administered a flu shot on Friday afternoon, October 13, 2017. Patient reported that he noticed a bruise on his arm about 3 inches below the injection site on Monday 10/16/17. He said the bruise started from the outside muscle to the inside muscle of his arm. He said he had seen his dermatologist, during a follow up appointment for another matter and the dermatologist said the bruise was caused by the flu shot. There was no pain and no tenderness. He stated that he did have some soreness a day or so after the vaccination.
Patient received expired medication. Confirmed with manufacturer that dose maintained its efficacy. No follow-up needed. no adverse outcome.
Pt c/o sore arm on 8/18, but later in the evening went to a cyclic fever with chills & shivering throughout the night. On 8/18/11 by 9pm whole body ached, joints hurt, couldn't walk very far, some nausea. Ended up in ER department; Dr tested for different infections and all negative. Concluded adverse rxn.
PATIENT STATED SHE HAD FLU LIKE SYMPTOMS WITH FEVER AND CONGESTION AND ALSO HAD A RASH ON HER CHEST
Patient mom came in to report a nerve injury from the injections. She said the pharmacist hit a nerve.
Sinus disorder; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus disorder) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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) (Subcutaneous) UNK Citrate free. On an unknown date, the patient experienced SINUS DISORDER (Sinus disorder) and FATIGUE (Fatigue). At the time of the report, SINUS DISORDER (Sinus disorder) was resolving and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On unknown dates, the patient experienced sinus issues and fatigue due to COVID vaccine and humira. on an unknown date, fatigue due to covid vaccine and humira resolved. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 26-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot number K021487 (dose and route were not reported) and dose of improperly stored M-M-R lot number reported as 014833 (dose and route not reported). Concomitant medications were not reported. No adverse effects were reported. Lot number 014833 is not valid lot number for M-M-R II.This is one of several reports from the same reporter source. Additional information has been requested.
After receiving Pfizer booster on December 28, 2021, client  started with right low back pain on 1/1/2022.  Pain increased over the next several days with blistering rash on lower back and eventually pain radiating to right abdomen with blistering.  Client was seen on  Jan 7, 2022 by her primary care physician and diagnosed with SHINGLES.  Client continues to experience shingles outbreak.
Diverticulitis; A-Fib/ heart rhythm problem; This spontaneous case was reported by a nurse and describes the occurrence of DIVERTICULITIS (Diverticulitis) and ATRIAL FIBRILLATION (A-Fib/ heart rhythm problem) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (not severely).   On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criteria hospitalization and medically significant) and ATRIAL FIBRILLATION (A-Fib/ heart rhythm problem) (seriousness criteria hospitalization and medically significant). The patient was treated with DILTIAZEM (CARDIZEM [DILTIAZEM]) for Atrial fibrillation, at an unspecified dose and frequency; APIXABAN (ELIQUIS) for Atrial fibrillation, at an unspecified dose and frequency; METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) (intravenous) for Diverticulitis, at an unspecified dose and frequency; CEFTRIAXONE SODIUM (ROCEPHIN) (intravenous) for Diverticulitis, at an unspecified dose and frequency and AMOXICILLIN SODIUM, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANIC ACID]) (intravenous) for Diverticulitis, at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis) and ATRIAL FIBRILLATION (A-Fib/ heart rhythm problem) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Computerised tomogram: abnormal (abnormal) saw A-Fib.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. Patient had some more tests done at hospital and the results were not provided.  Company Comment: This case concerns a 64-year-old male patient with medical history of immunocompromise, who experienced the unexpected and serious events of diverticulitis and atrial fibrillation. Time to onset from vaccination was not reported. The rechallenge was unknown, as the patient reports that he might get a third dose. The medical history of immunocompromise remains as a confounder.  The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 64-year-old male patient with medical history of immunocompromise, who experienced the unexpected and serious events of diverticulitis and atrial fibrillation. Time to onset from vaccination was not reported. The rechallenge was unknown, as the patient reports that he might get a third dose. The medical history of immunocompromise remains as a confounder.  The benefit-risk relationship of Spikevax is not affected by this report.
Continued through day 13 (at least)....  a well demarcated rash around the area of the injection site (L upper arm) that approximates 3 inches wide and 6 inches in length.  The rash is not itchy, nor is it raised.  The rash is red.
Pt states that few hours after 2nd dose of Shingrix she experienced - fever, asthma attack, - mild case of shingle. Pt was prescribed Valtrex and prednisone
Received second dose of Moderna Vaccine on 2/3.  On 2/4 developed headache, fever, chills, fatigue, and abdominal cramps.  Missed work on 2/5.
LEG CRAMPS; LOT OF PAIN; FEVER; VERY TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up request for batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced leg cramps, lot of pain, fever, and very tired. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg cramps, lot of pain and fever was not reported. This report was non-serious.  Additional information was received on 28/Mar/2021.The following information was updated and incorporated into the case. Reporter full name and patient initials.
Chest Pain; Nasal Congestion; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), NASAL CONGESTION (Nasal Congestion) and FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest Pain), NASAL CONGESTION (Nasal Congestion) and FATIGUE (Tiredness). At the time of the report, CHEST PAIN (Chest Pain), NASAL CONGESTION (Nasal Congestion) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
day after cannot move lt arm, sore & red around needle mark;T102, body ahces, nausea lasted 2 days;arm is still sore;shot was given 27AUG:
Swelling of lips and eyes, treated in emergency room with Benadryl with no further treatment needed.
My arm around the vaccination site is very red and swollen and sore. And where I got my shot it is badly bruised.
Client received Prevnar 20 vaccination on 6/3/22, data base was not updated, and client was given a second dose of Prevnar 20 on 11/2/22.
Suspected Bell's palsy; Facial drooping right/upper chin; Mild swelling to right eye and chin; Abnormal feelings on literal right upper ileus and the region of his chin; Tangling; A spontaneous report was received from a healthcare professional concerning a 31-years-old, male patient who developed suspected Bell's palsy/facial paralysis, facial drooping right/upper chin/facial paresis, mild swelling to right eye and chin/swelling face, abnormal feelings on literal right upper ileus and the region of his chin/feeling abnormal, tangling/paraesthesia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 23 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (lot number 022M20A) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date,  the patient developed abnormal feelings on his lateral right upper ileus, his chin bone, tangling, facial dropping right upper chin, mild welling to his right eye and chin. He can't open his right eye. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, suspected Bell's palsy/facial paralysis, facial drooping right/upper chin/facial paresis, mild swelling to right eye and chin/swelling face, abnormal feelings on literal right upper ileus and the region of his chin/feeling abnormal, tangling/paraesthesia, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Observed pt. sitting in a wheel chair with mom and EMT.  Pt. awake, alert, verbal, complaining of feeling flush after taking 1st dose of Pfizer vaccine@12:43pm.  Vitals taken by site EMT.  Vitals within normal range.  BP 114/72, O2Sat 100%.  12:55 pt. stated, "I'm feeling better now."  Pt. observed by staff for 30 min. before leaving to go home.  1:20pm pt. left vaccine site to go home with mom with no signs of acute distress.  Patient and parent educated by staff about Pfizer vaccine.  Verbalized understanding.
Pt was  seen at ED 01/23/2022 for UTI and concerns about would healing. Pt presented at ED, 01/24/2022, with fever, and SOB. Admitted. Pt died 02/02/2022. Submitter does not have access to further medical records. If you need more details please contact admitting hospital.
superficial arm pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose BNT162B2 (Comirnaty, Formulation: solution for injection), dose 2 via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunisation. The patient medical history included historical vaccine BNT162B2 at the time of her first dose she was just starting increasing her amantadine dosage for neurological tremor control, per physician instructions, at that time of increase from two to three tablets a day, she accidentally took a fourth dose, at that time at which the COVID vaccination and increase in amantadine dosage occurred together, she quickly developed dramatic instability and fell four or five times, subsequently (about 2 weeks later), she commenced weaning off of amantadine. she is just now down to one tablet a day, and her condition is steadily improving. physician attributes this to weaning off of amantadine, and all of us believe that the pfizer vaccination had nothing to do with the dizziness and falling, and that amantadine was the cause and also had an asymptomatic UTI for which she took a round of Cipro. UTI's can, we are told, cause instability and apparently more so in older people. So this is another conceivable cause. Notably, the second Pfizer vaccination occurred while these other conditions were being addressed and the vaccination did nothing to exacerbate or reinvigorate the dizziness symptoms. The concomitant medication were not reported. The patient experienced superficial arm pain on an unspecified date with outcome of recovered on an unspecified date.  Information on the lot/batch number has been requested.
Tender, erythematous lesion right thigh 7 1/2 cm x 10 cm width outer circle, 5 cm x 4 cm inner bright red.  Reaction to Varicella.
Inj at 11am - Approx. 230p Pt started getting joint pains, cold chills, wheezing. Spoke with her daughter at her home next day (10/20) and patient had done fine and had gone to work on 10/20 as usual.
felt bad; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), PYREXIA (fever) and MYALGIA (body aches) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 27-Jan-2021.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced FEELING ABNORMAL (felt bad), PYREXIA (fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt bad), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Treatment medication included paracetamol.
Pt had stated that she had a prior anaphylactic reaction to an injectable containing sulfa. Due to this we had pt stick around for 30 min post moderna injection (~3:50pm),  after around 10 minutes the pt alerted us to her reaction. Pt was having increasing shortness of breath and was starting to panic a bit. Pt had no visible signs of swelling of face or throat and no reaction at the injection site. Pt was given 50 mg of benadryl and a glass of water. After ~ 15 min the pt  had returned to baseline and was calm. Pt departed shortly after.
The patient presented to my pharmacy today, March 30 around 12 noon.  A blister, aprrox 3in x 2in x 1in, was located on top of the MCP joints of his right hand.. Pt stated he has been seen by the local emergency facility, his PCP and has been referred out to wound care.
administered beyond 30 day vaccine; 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 EXPIRED PRODUCT ADMINISTERED (administered beyond 30 day vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered beyond 30 day vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered beyond 30 day vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over; a lot of muscle pain; could not sleep; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 24Dec2020 09:30 at single dose for preventative. Medical history included none. There were no concomitant medications. The patient previously took influenza vaccine (FLU) for immunization and experienced sick (Flu shot if it contains egg she gets really sick). Patient reported experiencing a rash 2 weeks on 06Jan2021 after getting her first dose of the vaccine. Caller stated ''I'm concerned because I'm getting this rash on my face and everywhere and I'm due for my booster on 13Jan2021."  Caller questioned if others had reported this. She had a lot of muscle pain on 24Dec2020 and could not sleep from the pain in Dec2020. Reports the pain is gone now and lasted till 28Dec2020. She has a rash and it is breaking out her face and now it is all over. States nothing has changed and the vaccine was the only new thing. States the rash started two weeks since she got the vaccine. Vaccination facility type was Hospital. Vaccine administered at military facility was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE not require a visit to emergency room. Therapeutic measures were taken as a result of rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over (Doctor ordered steroids for her today she is a CNA). The outcome of the event a lot of muscle pain was recovered on 28Dec2020. The outcome of the event rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over was not recovered. The outcome of the event could not sleep was unknown.   Information about lot/batch has been requested.
No further AEs were reported; improperly stored, supported dose of VARlVAX was administered to a patient; This non-valid spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAR-2021, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S020464, expiration date 02-JUL-2021, 1 injection (strength, route of administration and exact dose were not reported) for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at -13.8 Celsius degrees (C) for 7 hours. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.  The report is non-valid due to lack of patient's identifiers.
Woke up 2 am on 8/20/20 with headache , fever 100.4, aches and chills, severe right knee pain and almost unable to pain, pain in left arm and unable to lay on that side of elevate arm overhead. Called in to work with adverse reaction- unable to work
Information has been received a business manager via a friend concerning the daughter of the friend (age not reported) who on an unspecified date was vaccinated with Gardasil. The patient also received another unspecified vaccine at the same time. It was reported that the daughter passed out in the care after receiving Gardasil with another vaccine. The patient recovered and received pop afterwards. No further information is available.
Extreme headache, fever for 3 days from 100.0 as high as 101.8, body aches, chills, extreme fatigue(4 days)
All over body ache like the flu; on the 24th I developed hives, I itch as though I have been rolling in fiberglass insulation.
Large red welt at injection site within 24 hours, full body itchy rash within 72 hours
There is no known adverse reactions at this time.  Patient was given 0.2ml of diluted (1.3ml diluent) Pfizer  and should have received the Pfizer pediatric 0.2ml.
Patient reports red rash that spread over left arm. arm was itchy for a day and a half then symptoms resolved. Pt reports symptoms starting 8 days after vaccination.
spots or discoloration on tongue; spots or discoloration on tongue; legs hurting or muscle pain; legs hurting or muscle pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 01Apr2021 at single dose for COVID-19 immunisation. The patient medical history included chemotherapy which stopped a few months ago. The patient's concomitant medications were not reported. The patient called in saying that she received the 1st dose of Pfizer COVID-19 vaccine last April 1, 2021 and she scheduled for the 2nd dose on April 22, 2021. The patient was currently experiencing spots or discoloration on tongue, legs hurting or muscle pain and other adverse events but claiming that it is not serious. The outcome of the events was not recovered.  No follow up attempts are possible, information about lot/batch number cannot be obtained.