chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: Patient wanted to know if she can take over the counter medications such as pain killers.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient describes having arm pain for 16 days after administration.  sometimes the pain extends into his neck and down his arm to his wrist.
Fever at 38 centigrade; Swollen lymph node in neck; Continuous moderate headache; Strong pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Apr2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy (poultry). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks, prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 22:00, 8 hours after the vaccination, the patient experienced fever at 38 centigrade, swollen lymph nodes in neck, continuous moderate headache and strong pain in arm. On the same day the patient underwent body temperature test and the result was found to be 38 centigrade. The events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever at 38 centigrade, swollen lymph nodes in neck, continuous moderate headache and strong pain in arm were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Resident developed fever, aches and diarrhea on the evening of 2/7/21. Tylenol administered for fever and pain. Imodium administered for diarrhea. As of the afternoon of 2/8/21 the resident is without any further symptoms.
p/vax inj pt let the clinic area & went to the office to pay bill & while standing @ counter fell to the floor;pt was alert in a few seconds & not hurt;VS were nl;
Swelling of face; itchiness of face and hands; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: NDC # 59267-1000-02) via an unspecified route of administration in the left arm on 26Apr2021 at 13:00 (at the age of 47-years-old)  as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); both taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Apr2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 00:00, the patient experienced swelling of face and itchiness of face and hands. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling of face and itchiness of face and hands was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
sore arm for a week; headache for 1.5 days; This is a spontaneous report from a contactable other hcp (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number; unknown), dose 1 via an unspecified route of administration on an unspecified as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included meloxicam (MELOXICAM) and metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. Caller stated he received both doses of the Pfizer-BIONTECH COVID-19 vaccine while being on Meloxicam and Metformin. He explained yesterday, he read on Medical News Today that taking anti-inflammatory drugs interferes with the body's immune response to the COVID-19 vaccine. Caller then stated he had a headache for 1.5 days after the first injection of the vaccine, along with a sore arm for a week. He compared his arm as being hit by a baseball bat. He also mentioned being wiped out for 3 days following the second dose. He also described it as being exhausted. The outcome of the event headache was recovered and outcome for sore arm for a week was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Pfizer Bivalent LOT GL0087 placed in the freezer upon receiving in clinic 12/7/22. Vaccine thawed and administered to patient 2/23/23. No signs or symptoms of reaction or issues from patient.
Patient c/o of left arm redness and itchiness after PREVNAR 13 shot. Had fever 102 degrees F few hours, then had redness and itchiness. Redness and warm to touch, at the site of PREVNAR injection, concerned for cellulitis. Gave KEFLEX qid x 7 days.
Improvements in Rheumatory Arthritis after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Improvements in Rheumatory Arthritis after the first dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Previously administered products included for RA: Methotrexate (The patient stopped Methotrexate in 2018 because she had cancer) in 2018 and Leflunomide (The patient stopped Leflunomide prior to vaccination) until August 2020. Past adverse reactions to the above products included Cancer with Methotrexate; and No adverse event with Leflunomide. Concurrent medical conditions included Rheumatoid arthritis (The patient was diagnosed with RA in 2014) since 2014 and Cancer.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Improvements in Rheumatory Arthritis after the first dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Improvements in Rheumatory Arthritis after the first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Rheumatological examination: zero positive ra (normal) zero positive RA. The IL6 driven autoimmune disease improve after Moderna COVID-19 vaccine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. Patient stated that COVID-19 vaccine caused a Leukotriene storm. The IL6 driven autoimmune disease improve after Moderna COVID-19 vaccine. Patient stated that after vaccination all positive rheumatoid arthritis numbers went down. All rheumatoid arthritis manifestations went away. Lab test Predictors of rheumatoid arthritis were completely gone. The patient had minimal arthritis symptoms from time to time and it goes away without using any medications. No information on treatment medications was reported.   This case was linked to MOD-2022-564648, MOD-2022-564658, MOD-2022-564650 (Patient Link).
I was covid-19 positive; I felt a little weird at first it felt like I had covid; when I woke up my nose was runny then went to work and I felt well enough to work; I wore a mask then at nigh I took a test and I was positive; The next day I spoke to my nurse  and I was prescribed paxlovid
This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (transient myopericarditis) in a 44-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. LITERATURE REFERENCE: Transient myopericarditis following vaccination for COVID-19. Med Cases; 13(2): 80. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (transient myopericarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (transient myopericarditis) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (transient myopericarditis) to be related. No concomitant and treatment medication were reported. An autoimmune mechanism as the cause of cardiac injury, augmented by the increased vaccine reactogenicity seen in younger patients was suspected. Company comment: This literature non-study case concerns a 44 year old male patient with no reported medical history, who experienced the expected serious (important medical event) AESI of Myocarditis, about 48 hours after receiving the second dose of mRNA-1273 vaccine. An autoimmune mechanism as the cause of cardiac injury, augmented by increased vaccine reactogenicity was suspected. No further information on clinical course and management of the event was available in the report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This literature non-study case concerns a 44 year old male patient with no reported medical history, who experienced the expected serious (important medical event) AESI of Myocarditis, about 48 hours after receiving the second dose of mRNA-1273 vaccine. An autoimmune mechanism as the cause of cardiac injury, augmented by increased vaccine reactogenicity was suspected. No further information on clinical course and management of the event was available in the report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to case 2018SA256372 (same reporter). This case involves a four years old female patient who was vaccinated with FLUBLOK QIV (lot number QFAA1814) via unknown route in the left thigh on 10 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No Concomitants therapies received. It was an actual medication error due to drug administered to patient of inappropriate age. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
expired dose of Daptacel was inadvertently administered to a patient/no adverse event; Initial information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 18 months old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) on unknown date.  On 07-May-2019, the patient received a 0.5 ml single fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5169AA (expiry date: 16-Mar-2019) via intramuscular route in the left thigh.  It was of actual medication error case due to  expired vaccine used.  No adverse event was experienced by patient.  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.
Erythema multiforme rash on cheeks, neck, ear lobes, elbows, fingers, abdomen; symmetrical. Questionable target lesion.
This spontaneous report as received from a Nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients might have received ZOSTAVAX, reconstituted with expired dose of sterile diluent (lot number reported as H006212 with expiration 20-JUN-2014). No adverse effects were reported. This is one of three reports from the same source. Per memo received on 01-OCT-2014 lot number H006212 is valid for sterile diluent with expiration date of 30-JUN-2014, previously reported as 20-JUN-2014). Additional information has been requested.
Patient has first vaccination with Moderna Lot 047A21A on 3/15/2021.  Following vaccination, patient had complaints of Headache, Nasal Congestion, and Body Aches.  Patient also had a bloody nose.  She did not take any medication for her symptoms  but complained of symptoms lasting three days.   Patient was encouraged to receive the second dose of the vaccination on 4/12 and to use Tylenol and Advil to minimize symptoms.  Patient had similar symptoms as after the first vaccination.  Patient did take Tylenol and Advil - severity remained about the same.
rash; This case was reported by a consumer and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as the patient self reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and experienced since than had persistent rash. When the patient get to went away, then it pops up somewhere else. The reporter said It was terrible but still better than shingles. No contact details were reported. Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR180470, Same patient, different dose.
Soreness; redness on arm where the vaccine was given. Injection site was swollen and patient stated that it was very painful. Patient had a headache, bone ache and a high temperature when she went to the hospital on 4-27-13.
Cold/flu symptoms and rundown for a few days. BRUISING on my RIGHT THIGH for 4-5 days. Got my 2nd dose on April 28th at 4:30 pm. Noticed bruising on my right thigh on April 29th AM. Went to the emergency room on April 29th, 2021... doctor ran a full workup - blood, ultrasounds on both legs, CT-Scan on lungs with contrast, and CT- Scan on the brain. Was told everything looked okay and that there were no signs of clotting or hemorrhaging.
History of present illness: patientt is a 73 y.o. year old female with a history of hypothyroidism, hypertension, history of breast cancer status post bilateral mastectomies who presented with complaints of bruising, petechial rash and gum bleeds.  She noticed that when she was brushing her teeth this morning, her gums were bleeding and found a pea size hematoma in the bottom of her lip.  Denies recent injury or trauma.  Denies fevers chills nausea vomiting chest pain shortness of breath cough weakness dizziness lightheadedness.  Denies hematuria or blood in stools or dark stools.  Patient reports she received her first dose of Covid vaccine on March 2.  She noticed a large bruise in her injection site this morning.  Denies pain.  She reports that her lower extremity started itching last week and she began scratching and knows it is small red dots diffusely distributed in her bilateral lower extremities.  Denies starting any new medications.  Denies history of HIV or hep C.  She reports starting a new topical medication given to her by a dermatologist for dry skin but does not know the name.  Denies history of blood disorders. 3/18: Patient diagnosed with idiopathic thrombocytopenia and admitted to medical floor. History of present illness as above. Plt <2; WBC 9.2; Hgb/Hct 13.2/38 3/19: Oncology provider consulted and recommended oral prednisone 100 mg daily, transfusing for any evidence of significant bleeding and considering IVIG if no improvement in platelets after 2 days. After further discussion plan was changed to dexamethasone 40 mg dailys x 4 days and rechecking CBC, transfusing platelets if <2 with a goal of >10. Labs showed plt <2, transfused 1 units, plt increased to 9, transfused additional unit. Plt <2, <2, transfused 1 unit plt, increased to 9, transfused additional unit of plt. WBC 94.6, 10.1, 13.4 (no s/s infection, monitored); Hgb/Hct 13.1/38, 12.8/37, 11.7/33 (decreased throughout day). 3/20: Provider consulted hematology who recommended rechecking platelets in 24 hours and considering IVIG on 3/21. Continued dexamethasone. Platelets increased to 11 after additional plt transfusion on 3/19. WBC 15 (no s/s infection, monitored); Hgb/Hct 11.3/32. 3/21: Platelets found to be <2 with morning labs. Transfused 1 unit of platelets, IVIG ordered by hematologist, and dexamethasone was continued. Plt <2, transfused 1 unit plt, plt increased to 21. WBC 14.2, 17.5 (no s/s infection, monitored); Hgb/Hct 11.3/34, 13.2/38 3/22: Patient feels more comfortable this morning denying any new bleeding symptoms. ITP refractory to treatment with prenisone, high-dose dexamethasone and is status post 1 dose of IVIG. Patient to receive her last dose of dexamethasone today and reassess tomorrow. Additional dose of IVIG planned for 3/22. Plt 2 in the am, increased to 43 in the afternoon. WBC 11.5, 13.7 (no s/s infection, monitored); Hgb/Hct 11.2/33, 12.8/37  Patient is still currently admitted.
I noticed on April 3rd at 5pm that I  had a rash on my both legs I went to the hospital and they just treated with a topical lotion and I was also having  SOB. and was given albuterol and that helped.
mild joint pains; rash on injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE RASH (rash on injection site) and ARTHRALGIA (mild joint pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on injection site) and ARTHRALGIA (mild joint pains). At the time of the report, VACCINATION SITE RASH (rash on injection site) had resolved and ARTHRALGIA (mild joint pains) had not resolved.            No concomitant and treatment medication was provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-020514 (Patient Link).
flu like symphtoms; injection site pain; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Registered Nurses (RN). The age at vaccination was not reported. The patient experienced flu like symptoms for a 1/2 day and injection site pain. The RN did not agree to be followed up. This case has been linked with cases US2019AMR113762, US2019AMR113752, reported by the same reporter.
This case was reported by a physician via sales rep and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX (batch number 524S7, expiry date unknown) for prophylaxis. On 14th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were unknown. It was unknown if the reporter considered the fever and myalgia to be related to SHINGRIX. Additional details were reported as follows: The patient experienced fever of 103 degree F. The physician gave consent for follow up contact. Lab Comments: On an unknown date, the patient's body temperature was performed.
Sore arm; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR189657   Additional Information: GSK Receipt Date: 19-DEC-2022 Reporter's Comment: The patient self-reported this case and she was worked in administration for the program. The patient reported that she received Shingrix vaccine. The patient stated that after Shingrix vaccine she experienced sore arm. The reporter did not consent to follow up. Additional supportive information: For the tolerance of the 2nd dose, refer linked case US2022AMR189657 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR189657:Same reporter
This is a spontaneous report from a cont actable office assistant (other HCP) via a sale representative. A patient of unspecified age, ethnicity, and gender received PREVNAR13, intramuscular on an unspecified date at 0.5 ml single. The patient medical history and concomitant medications were not reported. The patient experienced local injection site reaction on an unspecified date with outcome of not recovered.