chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her arm was sore; This is a spontaneous report received by Pfizer from (Case Number: 01838253) from a contactable consumer (patient). This consumer reported same event for two patients. This is the 1st of the two reports.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date in 2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient received the first dose of the vaccine before Christmas, no exact date provided, and her arm was sore for 3 days. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021079796 same reporter/drug/AE and different patients
Case number PHEH2014US024985, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 51-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 30 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Pt recvd 1st dose of HEP B vax 15MAR92 & 30 min later exp frontal h/a, slurred speech, dizziness, dyspnea w/chest heaviness, abd pain, weakness, & incoordination; Pt seen by ER MD for dyspnea; 18MAR91 abd pain, nausea, shakiness cont;
swelling got worst.; constant urge to itch; white hive; arm at the inject site has a bump, and it's like a bee sting; chills in lower back; Body ache; fever 100.5°F; little bit of pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of pain in the arm), VACCINATION SITE MASS (arm at the inject site has a bump, and it's like a bee sting), PERIPHERAL SWELLING (swelling got worst.), PRURITUS (constant urge to itch) and URTICARIA (white hive) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (little bit of pain in the arm). On 28-Jan-2021, the patient experienced CHILLS (chills in lower back), MYALGIA (Body ache) and PYREXIA (fever 100.5°F). On 04-Feb-2021, the patient experienced VACCINATION SITE MASS (arm at the inject site has a bump, and it's like a bee sting), PRURITUS (constant urge to itch) and URTICARIA (white hive). On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling got worst.). At the time of the report, PAIN IN EXTREMITY (little bit of pain in the arm), VACCINATION SITE MASS (arm at the inject site has a bump, and it's like a bee sting), PERIPHERAL SWELLING (swelling got worst.), PRURITUS (constant urge to itch), URTICARIA (white hive), CHILLS (chills in lower back) and MYALGIA (Body ache) outcome was unknown and PYREXIA (fever 100.5°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 100.5 (High) fever 100.5°F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Pt states that the morning after her vaccination she had throat swelling which she took benadryl for. She also states she had extreme nausea and vomiting and blood pressure issues.
Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 045J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson Covid-19 Vaccine on 18-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson Covid-19 Vaccine.   On 23-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart) outcome was unknown.            No concomitant medications reported.  Patient states that he got a first dose of the Johnson & Johnson Covid-19 Vaccine on 18-Mar-2021. No treatment information was provided.
Pericarditis Tx'd with high dose aspirin for 1 wk. Echocardiogram normal. Troponins negative, slight high in ckmb 6.3/ck 148.
This spontaneous report as received from a Licensed Vocational Nurse (L.V.N), refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were reported. On an unknown date in 2008, the patient was vaccinated with the first dose of with GARDASIL (dose, route and lot number were not provided). No co-suspect or concomitant therapies were reported. On 07-FEB-2014, the patient was to receive the second dose of GARDASIL. No adverse effect was reported. Additional information has been requested.
A non-serious spontaneous event of "a woman received H1N1 Mist and then was pregnant" was received from a nurse, concerning a 22-year-old female patient. The patient history included one full term delivery. The concomitant medications includes norethindrone tablets once daily. The patient was five weeks pregnant at the time of vaccination. On 21-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 23-Oct-2009, the patient found out that she was pregnant. Her last menstrual period was on 02-Sep-2009. The patient terminated the pregnancy in Oct-2009. There was no adverse event associated with this vaccine exposure during pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of the event "vaccine exposure during pregnancy" was considered as resolved. Additional information was received on 03-Aug-2010 and incorporated into the narrative: Pregnancy outcome.
High blood pressure.  BP went from 146/84 before immunization to 185/90 post immunization.  The day after BP is 193/106 and requires medical evaluation.
Pt receive BIOTHRAX on 3 Dec 08. Pt stated he felt itchy. It's left hand is swollen.
devel itching/hives 48 hrs p/vax; improved p/DPH;
Patient noticed slight itching on body, slight swelling in through, no trouble breathing, resolved on own without treatment
SEVER RIGORS FOLLOWED BY NAUSEA AND VOMITING (VOMITING EVERY 30 MINUTES ALL NIGHT LONG).  FEVER UP TO 101.0 DEGREES.
Large local reaction at right thigh area--red and swollen, difficulty walking on first day. Seen on 9/6/02; 5 days of Orapred  1 tsp. BID & Zyrtec 1 tsp daily.
8/31/21 hx of HTN, HLD, GERD, who presented to BHS-RO ED w/ complaints of chest pain, N/V. Pt w/ +COVID exposure and subsequently tested positive at urgent care.
Information has been received from a physician assistant concerning a female who on 17-AUG-2009 was vaccinated with her first dose 0.5 mL of GARDASIL (Lot # was not provided). On 19-AUG-2009 the patient experienced gum swelling. The outcome of the patient's gum swelling was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Arm tender and difficult to lift/turn, swelling and redness around injection site (10 x 12 diameter), fever X 4 days (up to 104.6), drooping and swollen left eye.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 18-JUN-2015, the patient was inadvertently administered with improperly stored MMR II vaccine, lot # K002816, expire date: 25-FEB-2016 (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
Shingles; This spontaneous report was received from a lawyer referring to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 23-JUN-2010, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result, the patient had suffered and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. The outcome of herpes zoster was not recovered, and the reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Fever lasting 24 hours with chills; severe headache and full body pain (severe pain lasting about 14 hours, dull pain continuing for an additional 24 hours), extreme fatigue and weakness, dizziness, loss of appetite, pain and swelling at injection site
24JUN92 pt devel a fever never higher than 101; 28JUN devel a rash temp @ that time nl;
2 febrile seizures (generalized tonic-clonic, short). Temp of 39.6C around 12:00PM. First seizure at 3:00PM. Second seizure at 6:00pm. According to ED note, patient was very tired after second seizure, prompting father to take him to Emergency Department.
Patient came in for first dose of Pfizer vaccine, accompanied by her father, who drove her there. After vaccine, during her observation period, her father alerted staff that she had passed out. As soon as I got there She was able to talk, A&Ox4. I checked her vitals. HR 44, O2 100% on RA, BP 60/33. She reported that she hadn't eaten breakfast or drank much for fluids and had worked out this morning. Her blood pressure and HR came up with subsequent checks and she was 105/66, HR 57 and felt better. We encouraged her to seek medical care if she felt that way again. Patient seemed to have fainted, witnessed by her father and he felt comfortable taking her home and monitoring her.
This spontaneous report as received from a nurse via a company representative refers to a 11 year old female patient. Patient did not specify specific medical history. No drug reactions/allergies were reported. On 12-AUG-2015 patient was vaccinated with GARDASIL 9 (strength, dose, route were unspecified by the reporter). Concomitant therapies included meningococcal vaccine (unspecified). On 12-AUG-2015, patient experienced syncope after receiving treatment with GARDASIL 9. Also reported patient experienced fell and received a minor cut on her lip during her syncope experience. Reporter stated that patient did not receive any treatment for the events. On 12-AUG-2015 patient recovered during the office visit from lip injury and syncope. There was no product quality complaint involved. Reporter's causality statement was not reported at the time of the report. This is one of the two reports received from the same reporter (MARRS # 1508USA008232). Additional information has been requested.
sore arm; Muscle and joint pain all over the body; Muscle and joint pain all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (Muscle and joint pain all over the body) and ARTHRALGIA (Muscle and joint pain all over the body) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (Muscle and joint pain all over the body) and ARTHRALGIA (Muscle and joint pain all over the body). At the time of the report, PAIN IN EXTREMITY (sore arm), MYALGIA (Muscle and joint pain all over the body) and ARTHRALGIA (Muscle and joint pain all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
endocarditis; This is a spontaneous report from a Contactable Other HCP. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 23Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient received the first dose of bnt162b2 on unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced endocarditis on 23Aug2021 with outcome of unknown. Patient was hospitalized for 20 days. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient had Nasal Swab on 03Sep2021 with negative result.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of endocarditis cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
patient  received Moderna vaccine which had been frozen,refrozen and rethawed.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (patient  received Moderna vaccine which had been frozen,refrozen and rethawed.) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient  received Moderna vaccine which had been frozen,refrozen and rethawed.). At the time of the report, PRODUCT STORAGE ERROR (patient  received Moderna vaccine which had been frozen,refrozen and rethawed.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported No Treatment medications reported   This case was linked to MOD-2021-381132 (Patient Link).
Report received on 20.Apr.2012 from a physician and forwarded by Crucell, ref. no. CVAE-015-2012. This case concerns a female patient in her thirties who received the first dose of VIVOTIF (batch number not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. An unspecified amount of time after VIVOTIF intake, the patient developed rash on the abdomen. The outcome was not reported. The event was considered non-serious.
Initial unsolicited report received from a pharmacist on 13-Jul-2018. This case involves a 79-year-old male patient who had 0.5 ml dose of ADACEL lot number: C5541AA, expiration date: 13-Nov-2018 via unknown route in right deltoid on 09-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used and incorrect product storage as vaccine was 58.4 degrees F on July 6th at 12:00 AM until July 9th and was administered on July 9th at 8:30 AM. It was not known 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 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.
seems more confused and fatigued than usual afterward; seems more confused and fatigued than usual afterward; This is a spontaneous report received from a Pfizer-sponsored program. A non-contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 27Mar2021 at a single dose for covid-19 immunization. Patient had medical history of Alzheimer's which was prior to receiving first dose of vaccine. The patient's concomitant medications were not reported. On an unspecified date, after receiving the first dose, the patient seems more confused and fatigued than usual afterward. The outcome of events was unknown.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Situation: 55F, MRN 2798009, had an appointment for 1st dose Pfizer (Lot#: EW0187) today. Shortly after receiving the vaccine, the patient reported hives and itching at 1300.    Background: Allergies to Keytruda, Tramadol, and Opdivo. PMH include HTN, GERD, h/o melanoma with LN involvement, AA, SMA aneurysm on coumadin who was referred to surgery clinic for evaluation of a possible seroma.  Last melanoma surgery was 1/31/2020.   Assessment:  Pt reported hives and itching at 1300. She was assisted to the gurney and vital signs monitoring was initiated. Most recent BP was 153/100.  Recommendation: Physician was notified thus received telephone order with readback for Benadryl 25 mg po once. Vitals signs were monitored until 1400 after Benadryl administration. Pt reported reduced itching at 1345.Pt was advised to follow up with primary care physician prior to second dose of vaccine. Pt stable upon leaving the clinic
OVER 50 PATIENTS WITH NEW OR REOCCURRING CANCER DIAGNOSIS; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate account) concerned multiple (over 50) patients of an unspecified age, sex, race and ethnic origin. 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, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Reporter stated that, "Anyone with a brain, didn't get the vax. I begged my hubs not to get it and now has a new cancer diagnosis. Even my Dr said she has over 50 patients with new or reoccurring cancer diagnosis, since getting the vax". On an unspecified date, over 50 patients diagnosed with new or reoccurring cancer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of over 50 patients with new or reoccurring cancer diagnosis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221223452.; Sender's Comments: V0: 20221223430- over 50 patients with new or reoccurring cancer diagnosis.  Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
received a 3rd dose of shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received two doses in 2021).   On 10-MAR-2023, the patient received the 3rd dose of Shingrix (left arm). On 10-MAR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a 3rd dose of shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date:14-MAR-2023 The case was reported by the patient. The patient received another dose of Shingrix after receiving two doses of Shingrix because his doctor recommended it. The patient was unable to give lot number/expiration date of the Shingrix he received. The reporter consented to follow up. The reporter received another dose of Shingrix after receiving two doses of Shingrix, which led to extra dose administered.
Chest pain, numbness in left arm, and left leg. President headaches and fatigue for over two weeks after vaccine.
itching; joint soreness; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on 20Jan2021 as dose 1, single for COVID-19 immunisation. Medical history included a bug sting when she goes outside in her garden, she also gets a lot of itching. The patient's concomitant medications were not reported. It was reported that she got the first dose of the Covid vaccine on 20Jan and got an appointment to get the second dose the day after. She said that she was fine. On 05Feb2021, until 3 days ago, she started lot of itching and joint soreness. She said that the temperature was changing and that might also cause her joint soreness and when she goes outside in her garden and a bug stings her, she also gets a lot of itching. She wanted to know if she should be getting her second dose. Since her doctor does not know much about this, she did not get an advise. The outcome of events was unknown  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
On 12/11: pain at injection site, rash, fever, and joint pain. Tachycardic to 106, concern for sepsis, ultimately was hospitalized.
Patient suffered a central retinal vein occlusion in her left eye with symptoms beginning one day after her Covid 19 vaccination.  She has associated cystoid macular edema and required treatment today with an intravitreal aflibercept (Eylea) injection in her left eye.