chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Perhaps my immune system still weak; still tired; sinus symptoms; Cellulitis due to Lymphedema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Uterine cancer", start date: 14Sep2011, stop date: 14Sep2011; "Surgery", start date: 14Sep2011, stop date: 14Sep2011, notes: Surgery only, No other treatment, uterine cancer surgery in 2011; "Lymphedema", start date: 2014 (ongoing); "13 Lymph nodes in pelvic region removed" (unspecified if ongoing), notes: 13 Lymph nodes in pelvic region removed; "hysterectomy", start date: 14Sep2011 (unspecified if ongoing), notes: Complete hysterectomy lumpectomy of 13 lymph nodes 14Sep2011; "hysterectomy", start date: 14Sep2011 (unspecified if ongoing), notes: Complete hysterectomy lumpectomy of 13 lymph nodes 14Sep2011. There were no concomitant medications. Vaccination history included: Moderna (Dose: 1st Moderna), for COVID-19 immunization; Moderna (Dose: 2nd Moderna), for COVID-19 immunization; Moderna (Dose: 3rd Moderna), for COVID-19 immunization; Covid-19 vaccine (4th Dose, Manufacturer unknown), for COVID-19 immunization. The following information was reported: CELLULITIS (medically significant) with onset 18Jan2023, outcome "recovered" (25Jan2023), described as "Cellulitis due to Lymphedema"; SINUS DISORDER (non-serious) with onset 02Mar2023, outcome "not recovered", described as "sinus symptoms"; FATIGUE (non-serious) with onset 02Mar2023, outcome "not recovered", described as "still tired"; IMMUNE SYSTEM DISORDER (non-serious), outcome "not recovered", described as "Perhaps my immune system still weak". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Positive, notes: Positive covid home test. Therapeutic measures were taken as a result of cellulitis.  Clinical course: It was reported that the patient had issue after use of a Pfizer product. On 23Sep2022 the patient received fifth dose of bivalent vaccine and on 18Jan2023 the patient experienced Cellulitis due to Lymphedema for which the patient received the treatment with antibiotics and was recovered on 25Jan2023. No relevant tests. The patient further stated that she didn't have any other acute illness at the time she got covid but did have a cellulitis infection on 18Jan2023 and was put on antibiotics for 7 days. She get cellulitis. Sometime due to lymphedema in legs from uterine cancer surgery in 2011. Perhaps her immune system still weak from cellulitis. 02Mar2023 still tired and some sinus symptoms.  No follow-up attempts are possible. No further information is expected.
headache; This is a spontaneous report from a contactable consumer (reporting for herself).  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  Medical history included headache during menses.  The patient's concomitant medications were not reported.  The patient experienced headache on an unspecified date.  During the time of vaccination, the patient was on her menses.  Therapeutic measures were taken as a result of headache and included over the counter (OTC) medication.  The clinical outcome of headache was recovered on an unspecified date.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Intractable headache beginning 3/13/21, double vision in right eye, blurry vision in left eye, severe pain in right eye, right temple, right side neck, severely elevated blood pressure
Swelling and pain at the injection site of the Shingrex vaccine. The morning following the vaccine I rolled over in bed and felt like someone had spun me. I experienced dizziness off and on for most of day. If I reached down or looked down the dizziness was more extreme. Experienced dizziness for the next couple of days but less severe,
Vaccine received 13Sep2022. I suffered a stroke on 30Sep2022; Additional Vaccines Administered on Same Date of the Pfizer Suspect: Flu Vaccine; Additional Vaccines Administered on Same Date of the Pfizer Suspect: Flu Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 18:30 as dose 1 (booster), single (Lot number: GH9702 CUS4521) at the age of 62 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Sep2022 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "gerd" (unspecified if ongoing), notes: gerd. Concomitant medication(s) included: SYNTHROID; PANTOPRAZOLE. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 13Sep2022, outcome "unknown" and all described as "Additional Vaccines Administered on Same Date of the Pfizer Suspect: Flu Vaccine"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant, life threatening) with onset 30Sep2022, outcome "recovering", described as "Vaccine received 13Sep2022. I suffered a stroke on 30Sep2022". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 4 day(s)). The event "vaccine received 13sep2022. i suffered a stroke on 30sep2022" required emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: Patient was treated received tPA clot buster medicine to treat event. Patient did not receive other vaccines in four weeks. Prior to vaccination the patient did not diagnose with COVID-19. If patient tested for Covid-19 post vaccination was reported as unknown.  No follow-up attempts are required. No further information is expected.
Per parent patient had fever of 103F and vomited 2 times on 12/12/2016 night.
pt recvd vax; pt was crying > 3 hrs; MD stated for pt to only have dt from now on;
4-5 after injection left arm from shoulder to elbow red, hot, swollen, painful to touch. Treatment: Zithromax 11/7 for cellulitis by PCP.
Employee developed a rash under bra area hours after receiving the vaccine.  States the rash is warm and sensitive, but does not itch.  She has no other symptoms.
rt arm swollen, erythematous, lt arm over deltoid;pain w/movement;poss cellulitis started on ATB, ice, Ibuprofen;
Patient experienced some blurred vision, and  started to loss a bit  of consciousness. Despite the fact of losing a bit of consciousness  but alert and oriented  times 3. Blood pressure was 101/69, Oxygen sat was sitting  at 100 and the pulse rate was 78.
patient received the vaccine and died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (patient received the vaccine and died) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  Treatment information was not provided by the reporter.    Reporter did not allow further contact; Reporter's Comments: This is a spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and fatal event of death, which occurred on an unknown date after an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.
Severe allergic reaction five hours later - very tight throat, problems swallowing, itchy throat and mouth, exhaustion.  Was very nauseous for two days and then moderate nausea for five additional days. Still not feeling normal.
Tonight just have the fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, solution for injection), administration date 25Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1) for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 25Oct2021, outcome "unknown", described as "Tonight just have the fever".  Follow-up attempts completed. No further information is expected.
Red and warm swelling on deltoid of left arm that started on Monday when patient notice it after her shower. Patient took two tablets of Tylenol 500mg and feels better now. It is not itchy but patient said she will take Benadryl after work if it gets worst. If the redness grows she said she will see her doctor incase it is an infection. Patient said she will let us know how she feels in the next few days.
19yo M presents to clinic c/o chest pain since 0330 this morning. Member states that he woke up with an ''intense pressure and a sharp pain upon inhalation.'' Member denies any SOB or wheezing. He denies any trauma. Patient denies chest being induced by physical activity. Member notes that he had a small pox vaccine last Friday.
Numbness, tingling, weakness, decreased sensation and proprioception in lower extremity. Diagnosed with variant of Gullain-Barre. Treated with IVIG.
No adverse event noted. Client had taken aspirin before receiving vaccination, failed to mention it during process. Stated doing fine. October 28, 2009 52 yo male caller  received the H1N1 inactivated flu vaccine yesterday at the DOH and accidentally took his usual dose of aspirin 325 mg this afternoon around 1 PM. He didn't realize he wasn't supposed to take ASA-containing products for at least 24 hours. He is not having any symptoms currently, but he is wanting to know what to look for. Discussed association between aspirin and viral infections and Reye's syndrome. Rec holding off on using anymore aspirin products for another 24 hours. Call back prn. Pt has PMHx of HTN, COPD and cardiac disease.
Information has been received from a pharmacy student concerning a 66 year old female with herpes simplex on her back who on 08-JUN-2010 was vaccinated subcutaneously with a 0.6 ml ZOSTAVAX (Merck) (lot# 665522/1765Y). Concomitant therapy included acyclovir. On 09-JUN-2010 the patient called the pharmacy and stated that her "lesions on her back showed up today". At the time of the report, the patient had not recovered. There was no laboratory test performed. Additional information has been requested.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt has a PMH significant for t2dm, hyperlipidemia, CAD, HTN, Primary malignant neoplasm of right lung. Patient initially presented 4/8/21 to the ED.. Patient was admitted due to confusion and weakness and found to have respiratory failure. Patient was intubated in ICU and transition to hospice care.
In November of 2021, she was complaining of a rapid heartbeat. We went to see her pediatrician. The pediatrician ordered and EKG. Everything seemed to be normal. She had other rapid heartbeat events, I cannot remember when.  In late January of 2023, and March 30 of 2023 and April 14, 2023 and April 29, 2023, she had rapid heartbeat events.  In April, we saw a cardiologist who put her on a heart monitor. She was diagnosed with SVT in April. She is going in for an ablation on Friday.
The following day after the vaccination, my right knee was swollen like a football and it still doesn't feel right, It feels like I'm having muscle spasms. My knee doesn't feel right after the medicine that my doctor gave me. I went to the doctor on 01/21/2022 and she stated it was gout and gave me anti inflammatory colchicine and indomethacin 3 a day with food for 10 days, which I don't think that's what it is. I should finish this medicine by the 31st of this month. I am waiting for my doctor to call me back to see if I need a follow up appointment. Every morning is super swollen and it goes down once I take my meds.
Patient was due for Dtap vaccination and a Tdap vaccine was given in error. Patient experienced no side effects.
Warmth, Erythema and swelling to injection site Left upper arm from shoulder to approx. 2 inches above elbow. Dr 11:30 on 3/30/07 treated with Amoxicillin x 7 days and Zyrtec. Spoke with parent on 4/2/07 and stated childs arm was no longer swollen, red or warm
Patient c/o of pain and throbbing in left arm. Instructors given per take anti-inflammatory and apply heat compresses report back to clinic if no improvement.
Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking; lives with her niece and she found her in between china cabinet and fireplace and asked her how long she been there and she didn't know/going to the bathroom on herself and she doesn't recall that; This is a spontaneous report from a contactable consumer (reported for herself).  This 79-year-old female patient received her first dose of the BNT162B2 (Pfizer covid vaccine, Lot number: ER2613 expiry date: unknown) via an unspecified route at left arm as a single dose on 23Mar2021 11:00, for Covid-19 immunization. Medical history included diabetic, cholesterol, acid reflux; had a reaction to tetramycin: she had shortness of breath, sweating, and light headed-ness, 30 years prior to this report. She stated that it was a form of penicillin and they didn't have penicillin so they gave her something else. Concomitant medications included metformin(METFORMIN) for diabetic, fexofenadine hydrochloride (ALLEGRA) and ibandronate sodium (BONIVA). It was reported that she skipped Boniva, that she usually would take at the end of the month. On 25Mar2021, two days after first dose, she got covid and pneumonia . She visited emergency room and was admitted in the hospital from 26Mar2021 till 05Apr2021. The patient did not have her appetite back, felt still kind of shaky, and was trembling and shaking. She did not remember what happened on the 24Mar2021 and 25Mar2021. It was stated that she was improving but she was not back to par. she was not trembling. She stated that she was not fully recovered. She was scheduled for her second dose in 2 weeks on 13Apr2021. It was stated that she had got a list of concomitant medications she was taking (unspecified names) and she did not think any of them would have interacted with this and she was taking them way before she got the Covid shot, also stated that she did not think she had bad underlying issues. The patient had her blood sugar checked and was given her insulin because of Covid and something else. She did not receive any additional vaccines on same date of the Pfizer Suspect or prior vaccinations (within 4 weeks). The patient did not have any Antipyretic (around the date(s) of Vaccination). The patient was recovering from the event of Pneumonia. The outcome of the events of doesn't have her appetite back and shaky/was trembling and shaking was not recovered, however the outcome of the events of Covid and did not remember what happened on the 24Mar2021 and 25Mar2021 was unknown.  No further information was provided.
Information has been received from a registered nurse concerning a 7 year old pt who in January 1997, was vaccinated with varicella vaccine. In January/February the pt was "exposed to a severe breakout at school." In approximately February 2001, the pt developed greater then 100 lesions all over. Unspecified medical attention was sought. The pt's sibling had a similar experience. Addiitional info has been requested.
Fever; Aches; Chills; Feeling of a heavy weight on their chest; This is a spontaneous report from a non-contactable consumer. An adult non-pregnant female patient of an unknown age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 14Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination and was tested for COVID-19 since the vaccination. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced fever, aches, chills and a feeling of a heavy weight on the chest. It was unknown whether any therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever, aches, chills and feeling of a heavy weight on the chest were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast (0.5ml). Concomitant therapy included Dtap. The day after vaccination with HPV the pt developed a blotchy rash which lasted for three days (site of rash not specified). It was also reported that the pt experienced a fever with a temp between 99 and 103 degrees during the same three day period. Unspecified medical attention was sought. At the time of this report, the pt was recovering from the rash and fever. Additional information has been requested.
Explosive watery diarrhea, bright green color at times. Excessive gas some cramping. Frequently had little control of bowels
This spontaneous report as received from a pharmacist via a company representative refers to a 41 year old female patient. On an unknown date a pharmacist administered to the patient ZOSTAVAX, 19400 PUF, 0.65 ml (lot number no reported) subcutaneous in the abdomen. There are no adverse events reported at this time. Additional information is not expected.
Warm to the touch; Little swollen; Tender/pain; A spontaneous report was received from a consumer, concerning herself, a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced warm to the touch/ vaccination site warmth, little swollen/ vaccination site swelling, tender/pain/ vaccination site pain.    The patient's medical history was not provided.  Concomitant product use included allergy pill every day.  On 27 Dec 2020, approximately eight days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 04 Jan 2021, after receiving the vaccine, the patient reported that it was little swollen, tender, pain and warm to the touch. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events, warm to the touch, little swollen, tender/pain were not reported.; Reporter'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.
Informed by patient's wife on 8/11/16 that pt started to become paralyzed 32 days after receiving MMR vaccine from the clinic and was diagnosed with Possible Inflammatory Acute Transverse Myelitis. Pt's wife stating that reason unknown but after researching and thinking possible from MMR vaccine d/t multiple researching.
Inflammation, swollen neck and underarm of the side the vaccine was given. Fatigue sensation and headache
arm soreness is also more than he had with the flu shot / sore arm lasting 1 -1.5 days; The cotton patch had 10 drops of blood, more than he saw after his flu shot in the same (left) arm 1 month ago; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm and injection site hemorrhage. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and injection site hemorrhage were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site hemorrhage to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu shot 1 month ago and experienced the effects as sore arm lasting 1 to 1.5 days. The patient was successfully treated with Tylenol. The reporter did not consent to follow up. This case has been linked with case US2020225610, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2020225610:same patient
The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.; Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient did not have COVID-19 preceding the month of vaccination.  No allergies nor any Acute and Chronic illness was reported.     On 01-Apr-2022 at 10:59 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 10:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022. Vial did not undergo any temperature excursions. Patient did not experience any side effects yet. Concomitant drugs were not reported. Treatment details were not given.