chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received first dose of Moderna vaccine on 1/29/21. Client presented for a second dose on 3/12/21 and reported that he had 'blood clots in the lungs' on 3/7/21 and was hospitalized. The cause of the blood clots is unknown. Client has since recovered and spoke to his doctors and they advised that he receive the second dose of Moderna as scheduled on 3/12/21.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 3-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969:
Red, swollen area around injection site that same night. Next day fever 103 --> went to ER. Got TAMIFLU. That night spiked 105 degrees went to ER next day Sat. Spent 2 days in hospital. Diagnosis cellulitis. Pt concerned of RPh sterilization technique.
Sever diarrhea. Extreme headache. So week my granddaughter had to help me walk. Passed out. Broke my tailbone from a fall  Went to my doctor. No treatment
Swelling, erythema, bulla, R thigh, knee; with secondary reticular pattern down leg and foot.
broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear pressure; Sinus and ear pressure; Generalized aching; break out in canker sores all over my mouth; sore muscles all over; joint pain; mild itching to upper torso, breasts and under arms; low grade fever; chills; face became pink and warm; felt burning sensation throughout my body; This is a spontaneous report from a contactable nurse (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid left on 03Feb2021 12:00 (Batch/Lot number was not reported) as 1st dose, single at age of 40-years-old for covid-19 immunization. Medical history included Asthma, 3 herniated discs in neck, hx of pneumonia, hypertension (HTN). Known allergies included: Ceclor, PCN, Doxycycline, Bactrim DS, Codiene, berries and anaphylaxis to Latex. Concomitant medications the patient received within 2 weeks of vaccination included: lisinopril; hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Adverse event started on 03Feb2021 14:00 PM, within first 24 hours the patient experienced mild itching to upper torso, breasts and under arms, also had low grade fever and chills in this time. Within first 24 hours, face became pink and warm, and felt burning sensation throughout her body. At this point the patient took Pepcid and Benedryl and it seemed to control symptoms. On 09Feb2021, the patient begun to break out in canker sores all over her mouth, total of 5 (the patient did not have a canker sore since high school), began to develop sore muscles all over and joint pain that progressed to severe by 12Feb2021. Worse in mornings. Got a flu and covid test (Nasal Swab). They were negative. 17Feb-20Feb2021 severe fatigue and cont. Joint pain. Slept 17 hours q day. Sinus and ear pressure. Generalized aching. The patient did not get 2nd vaccine. 01Mar2021 broke out in canker sores all over mouth again. Took 4 days to resolve. The patient was still having significant joint pain throughout her body, worse in mornings. The patient never had this before vaccine. Events resulted in disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event canker sores was recovered, of other events was not recovered.  Follow up needed, further information has been requested.; Sender's Comments: "Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events and suspect drug BNT162B2 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.
approx 22days p/vax pt exp chickenpox all over body w/rash consisting of approx 70 lesions, pt also exp itching.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL (route, dose, lot# and expiration were not reported) on 18-JUN-2010 and today, on 17-JUL-2012, the patient was in the office to receive the second dose and no adverse effects reported. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. Additional information has been requested.
Shingles Rash on left side of body by Rib- cage and Itching; Itching on left side of body by Rib Cage; Small Rash on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles Rash on left side of body by Rib- cage and Itching), PRURITUS (Itching on left side of body by Rib Cage) and VACCINATION SITE RASH (Small Rash on the Injection Site) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for an unknown indication.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced HERPES ZOSTER (Shingles Rash on left side of body by Rib- cage and Itching), PRURITUS (Itching on left side of body by Rib Cage) and VACCINATION SITE RASH (Small Rash on the Injection Site). At the time of the report, HERPES ZOSTER (Shingles Rash on left side of body by Rib- cage and Itching), PRURITUS (Itching on left side of body by Rib Cage) and VACCINATION SITE RASH (Small Rash on the Injection Site) outcome was unknown.            Treatment included as Tylenol per oral.
Seen in clinic about 9am on 4/14/05 and given immunizations. Developed fever that evening that was relieved by Tylenol but later developed 103 temperature rectally again so was taken to ER on 4/15/05 at which time was only given Motrin suspension. Fever resolved next day according to Mom. According to mother no redness or swelling at injection sites.
Headache, Blisters on head, arms and hands that developed through the night, dizziness that developed on the morning of 10/15/2011.
3 year old received Quadracel Vaccine / no adverse event; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient who vaccinated with 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C55532AA (Expiry date 09-Oct-2020) via intramuscular route in the left thigh.  It was a actual medication error case due to Inappropriate age at vaccine administration. It was reported that 3 year old received Quadracel Vaccine  At the time of reporting no adverse reactions were reported.  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.
sore arm; rash; itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (rash) and PRURITUS (itchy) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), RASH (rash) and PRURITUS (itchy). At the time of the report, PAIN IN EXTREMITY (sore arm), RASH (rash) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Narrative: 63 year old male admitted on July 31 2022 with cough, clear sputum, low graede fever and nasal congestion. He had received Moderna vaccine x 4 on December 28 2020, January 25 2021, October 29 2021, June 9 2022. He was treated with remdesivie 200 mg IV x 1 then 100 mg daily x 2 days and dexamethamethasone 6 mg daily x 5 days. He rapidly improved and transferred from acute care unit on 8/2/22.
Vaccine kept in refrigerator on 15-Mar-2022/administered on 18-Apr-2022; administer vaccine to one patient three days after the use by date expired; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer vaccine to one patient three days after the use by date expired) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 15-Mar-2022/administered on 18-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer vaccine to one patient three days after the use by date expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 15-Mar-2022/administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer vaccine to one patient three days after the use by date expired) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 15-Mar-2022/administered on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The frequency of Spikevax reported was times per. HCP called because they left box of Moderna vaccine in the refrigerator, and the use by date was on the 15-Apr-2022.  On 18-Apr-2022 vaccine was administered to one patient, three days after the use by date was expired. HCP could not provide patient information.The vial was initially stored on refrigerator on 15-Mar-2022 and the vial did not undergo any temperature excursions. The healthcare professional stated that, total 150 vials were expired but only one expired dose administered to one patient. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow-up document received includes: I-narrative updated. On 18-Apr-2022: Follow-up document received includes: contact details updated
On evening of 3/8 sneezing, irritated throat, scratchy throat. By sleeping time nose running, sore throat. Temp normal. On 3/9 temp normal voice husky.
pt states that her left arm and chest were sore for a couple of days after getting her covid vax.  About 8 days later she developed severe headaches that make her nauseated.  These symptoms would come and go.  She still has these symptoms at this time and will contact her PCP.
p/vax pt exp chickenpox;the reporting MD noted that pt had 12 lesions on scalp & 4 lesions on trunk;pt afeb;on an unspecified date pt recovered;
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's medical history and current condition are not reported. It was reported that on 18-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (Lot # and expiry date not reported) of unknown dose and frequency which was stored improperly. No adverse events are reported. Product quality complaint is not reported. The outcome of the event is unknown. Additional information has been requested.
Bad rash all over my body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Bad rash all over my body) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced RASH (Bad rash all over my body). At the time of the report, RASH (Bad rash all over my body) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.  Company comment: 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. There's no evidence of seriousness from a clinical or regulatory standpoint.; Sender'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. There's no evidence of seriousness from a clinical or regulatory standpoint.
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (Lot # not reported), injection, single standard dose (dose not reported0 for prevention of shingles. No other co suspects were reported. No concomitant therapy was reported. The patient reported that shortly after the administration of ZOSTAVAX and the following day, the patient experienced a low-grade fever, body aches and chills. By the second morning following administration, these symptoms had resolved. No rash or blisters occurred. Treatment was not given for the events. The patient sought medical attention, she saw the physician. The outcome of the patient experienced chills, the patient experienced low grade fever and body aches was reported as recovered/resolved. Additional information has been requested.
Extreme pain starting at injection site, extending from hand to neck (temprorary loss of use of that arm); joint pain/weakness; fever with a delta of 4F; extreme fatigue; headache; sore throat. Treatment was similar to that of flu.  Recovery began ~18 hours from onset, but remains incomplete; function at appx. 80% of normality.
Difficulty breathing, nausea, weakness, mouth and tongue numb, lightheaded, hematoma and redness to injection site, fatigue. Received EpiPen and liquid Benadryl. All symptoms have resolved except for the fatigue.
5 to 7 days p/ vax, pt devel a rash described as very pruritic;the rash was considered to have resulted in a persistent or significant disability or incapacity;approx 15 days p/onset pt recovered;
my wrists red, inflamed, itching running rash; my wrists red, inflamed, itching running rash; eyelids started flaking/peeling; eyelids started flaking, itching; my wrists red, inflamed, itching running rash; Made worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An elderly patient received BNT162b2 (BNT162B2), on 16May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient never had allergic reaction to vaccine or anything. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER)), administration date: 23Sep2021, for COVID-19 immunization, reaction(s): "my wrists red, inflamed, itching running rash", "my wrists red, inflamed, itching running rash", "eyelids started flaking, itching,peeling", "eyelids started flaking, itching,peeling", "my wrists red, inflamed, itching running rash"; Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The patient believed in the Pfizer Covid Vaccine. The following information was reported: CONDITION AGGRAVATED (medically significant) with onset 2022, outcome "unknown", described as "Made worse"; EYELIDS PRURITUS (medically significant) with onset 2022, outcome "unknown", described as "eyelids started flaking, itching"; EYELID EXFOLIATION (medically significant) with onset 2022, outcome "unknown", described as "eyelids started flaking/peeling"; RASH (medically significant), ARTHRITIS (medically significant), ERYTHEMA (medically significant) all with onset 2022, outcome "unknown" and all described as "my wrists red, inflamed, itching running rash". The events "my wrists red, inflamed, itching running rash", "eyelids started flaking/peeling", "eyelids started flaking, itching" and "made worse" required physician office visit as over the last 16 months, the patient went to 3 dermatologists and had multiple doctor visits. No help. The patient underwent the following laboratory tests and procedures: Allergy test: Unknown results. Therapeutic measures were taken as a result of rash, arthritis, eyelid exfoliation, eyelids pruritus, erythema, condition aggravated which included three steroid shots which helped for about a week and multiple cortisone topicals.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300037618 Same patient/ AE, different drug dose;US-PFIZER INC-202300092269 Same patient/ AE, different drug dose;
Pfizer BioNTech Covid 19 vaccine = treatment under Emergency Use Authorization(EUA): Patient presented to Covid Vaccine Clinic. Appointment time was 0925. Patient indicated she did have allergies on her screening sheet. Pfizer- BioNTech Covid-19 vaccine (0.3ml) was administered per protocol (Lot # EL3246, exp. date 04/30/21). At 0947 I was asked to come assess patient by the monitor. Patient reported her tongue felt thick and the roof of her mouth felt weird. I asked if her throat felt tight, if she had any shortness of breath or chest tightness. She denied any other symptoms. I asked if she had any allergies. Patient reported having a reaction in the past to adhesive from EKG leads, codeine, and contrast dye. I asked patient to pull her mask down. No swelling was observed around her mouth, lips, or tongue at that time. No hives were observed on her arms, chest or back. Patient than started to complain of feeling worse and had some tightness in her chest. At that time I escorted patient to a cot and advised I was going to administer an epi-pen. Patient verbalized understanding. I advised staff to call 911. At 0955 0.3 mg of epinephrine was administered into her left anteriolateral thigh. HR was 88 bpm at this time. Patient reported feeling shaky and felt like her heart was racing. I advised her that was a normal reaction to the epinephrine. Symptoms at this time did not progress. Patient reported her chest felt less tight at 10:05. EMS arrived and reported on 02 sat of 97% on room air. Patient was transported to the ED without further incident on location. Husband was present at all times and informed on all action taken.
8/31/21 to 9/2/21 : Burning tingling sensation on left back, abdomen and chest. Sensation worsened daily. 9/3/21: Presence of rash development on left chest with worsening burning sensation and sensitivity to touch. 9/4/21: Saught medical attention due to worsening symptoms. At this visit, symptoms were identified as shingles. Anti-viral medication, Valacyclovir was prescribed. 9/5/21 to current: Worsening of all symptoms listed above with rash spread to under arm and back.