chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported on 09/30 that he had experienced pain, limited mobility in arm/shoulder, and large rash following immunizations. I am not exactly sure when adverse event first began but he was feeling better on 9/30. Patient was instructed to contact doctor and go to ER as he still had large rash on 9/30.
Administered LAIV to child w/asthma (MEDIMMUNE lot # 500796P exp. 2/17/2010). As of 11/12 no adverse reaction.
EMT found Pt in vaccine observation area, sitting in chair. At 2:12 pm (15 min after vaccination). Pt c/o scratchy, swollen throat, feeling warm, pain in neck, light headed, nausea. Vitals taken at 2:19 pm: BP 146/100, HR 112, respirations 20. Pt AxO x4, still talking, no SOB or complaints of breathing, no wheezing heard. 50 mg Benedryl liquid given PO at 2:24 pm. PHN  on scene at 2:32 pm, 9-1-1 activated, Pt c/o continued neck pain 6/10, feeling hot, worsening of swollen tongue, throat tightness and swelling, now chest tightness, EMT reports no wheezes or stridor with auscultation of lungs and larynx. EMS on scene at 2:35 pm, assumed care. Pt transported to hospital at 2: 50 pm.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # reported as L031065, expiration date 18-AUG-2017; lot # L037562, expiration date 29-SEP-2017; lot # L013824, expiration date 21-APR-2017, lot # L019127, expiration date 27-MAY-2017 (exact dose and route of administration were not reported). The nurse indicated that those vaccines were subjected to multiple defrost cycles (no more than 4 cycles per day lasting 30 minutes for each cycle and not exceeding temperatures over -14.5 degrees Celsius). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left side of my face became numb. Then my eye, tongue and throat began to swell. I stopped and purchased Benadryl.  The swelling started to diminish after about 4 hours, but tingling and slight numbness continued for about 3 days.
sore arm; This is a spontaneous report from a contactable consumer reported for her mother. A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and batch no/lot number: not reported) via an unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced very sore arm on an unspecified date. It was reported that It was reported that My mother (80 years) had a very sore arm; other than that, she was ok. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sm - pinpoint rash all over. No fever. Had cold sx earlier in week. Child not ill appearing.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 16-OCT-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. In 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report was received from a licensed vocational nurse, refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The licensed vocational nurse informed, that on an unknown date, the patients were vaccinated with MMR II (dosage, route, lot# and expiration date were not reported) which was exposed to temperature outside of the recommended range. Concomitant therapy was not reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a doctor of pharmacy who refers to a 60 years old female patient with codeine allergy. On 05-NOV-2012, the patient was vaccinated subcutaneously in left arm with a 0.65 ml dose of ZOSTAVAX (lot# reported as H013022, exp. date 09-OCT-2013). Concomitant medications included FLULAVAL given on that same day and cyanocobalamin. On approximately, reported as after vaccination, 05-NOV-2012 the patient experienced fatigue, tenderness, torso aching, headache and feeling "rundown". On 07-NOV-2012 the patient also developed a red, raised rash about the size of a half dollar with irregular borders on her left arm at the injection site. The patient sought unspecified medical attention, at the pharmacy. She did not receive any treatment for adverse event. None laboratory tests were performed. At the time of the report patient's state was reported as not recovered. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 23-MAY-2017 the patient was vaccinated with ROTATEQ lot # L048854, oral for prophylaxis. Concomitant therapies included DIPHTHERIA TOXOID (+) PERTUSSIS VACCINE (UNSPECIFIED) (+) TETANUS TOXO and PREVNAR 13. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
elevated blood pressure after injection; dizzy; foggy; rash on the left arm 7 inches long and 3 inches in diameter; extreme headache; Fatigue/brain fatigue/exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (elevated blood pressure after injection), DIZZINESS (dizzy), FEELING ABNORMAL (foggy), RASH (rash on the left arm 7 inches long and 3 inches in diameter) and HEADACHE (extreme headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (elevated blood pressure after injection), DIZZINESS (dizzy), FEELING ABNORMAL (foggy), RASH (rash on the left arm 7 inches long and 3 inches in diameter), HEADACHE (extreme headache) and FATIGUE (Fatigue/brain fatigue/exhaustion). At the time of the report, HYPERTENSION (elevated blood pressure after injection), DIZZINESS (dizzy), FEELING ABNORMAL (foggy), RASH (rash on the left arm 7 inches long and 3 inches in diameter), HEADACHE (extreme headache) and FATIGUE (Fatigue/brain fatigue/exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.
I started to have extreme muscle weakness, tremor, palpitations, shortness of breath with exertion, chest pain, fatigue, muscle pain, difficulty swallowing, dizziness, weight loss
Patient c/o feeling dizzy + lightheaded 10 minutes after receiving vaccine. Treated in ER
Product was placed in refrigerator on 19Feb2022; One of our locations give a dose of Moderna Covid-19 vaccine 2 days beyond the 30 day beyond use date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of our locations give a dose of Moderna Covid-19 vaccine 2 days beyond the 30 day beyond use date.) and PRODUCT STORAGE ERROR (Product was placed in refrigerator on 19Feb2022) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of our locations give a dose of Moderna Covid-19 vaccine 2 days beyond the 30 day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was placed in refrigerator on 19Feb2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One of our locations give a dose of Moderna Covid-19 vaccine 2 days beyond the 30 day beyond use date.) and PRODUCT STORAGE ERROR (Product was placed in refrigerator on 19Feb2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Product was placed in refrigerator on 19-Feb-2022 and Use by date was 19-Mar-2022. Reporter reported that at one of our locations give a dose of Moderna Covid-19 vaccine 2 days beyond the 30 day beyond use date.  No concomitant drug information was provided. No treatment drug information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow-up received contains no new information
Seasonal allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEASONAL ALLERGY (non-serious), outcome "unknown", described as "Seasonal allergies".  Additional information: It was reported that rhe patient received 1st dose on 15Mar2021. Started experiencing seasonal allergies. Called to know if it is safe to take allergy medicine. Unaddressed medical questions were referred or forwarded to Medical team.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
A little over a week after receiving the vaccine I have developed a rash around the injection site. It is a circular rash that is slightly raised, mildly itchy, and warm. I am not experiencing pain.
Patient states that she experienced inflammation at the site of injection about 3 hours after receiving vaccination.  She also stated that she had sweating at night and her left arm was swollen red in the morning after vaccination.
This case was reported by a healthcare professional and described an adult male subject who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On an unspecified date before 03 October 2006, the subject received 3rd dose of Engerix-B. On 03 October 2006, at an unspecified time after vaccination with Engerix-B, a  hepatitis B surface antibody titer was negative. Relevant test results included (laboratory results/hospital investigations). At the time of reporting the outcome of the event was unspecified.
breathing heavy; lightheaded and dizzy; my BP to 188/110; Within 2 minutes of vaccine my heart was pounding out of my chest; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number FC3180, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 31Aug2021 10:15 (at the age of 60 year old) as dose 1, single for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. Concomitant medication(s) included ibuprofen, calcium, vitamin d nos, fish oil, curcuma longa (TURMERIC), all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine taken in four weeks. The patient previously took duloxetine (CYMBALTA) and meloxicam (MOBIC) combined and experienced allergy. On 31Aug2021, within 2 minutes of vaccine, the patient experienced her heart was pounding out of her chest. She told the nurse who monitored her. By heart rate went to 135 and her BP to 188/110. She was lightheaded, dizzy and was breathing heavy. The Dr came and they put her in a wheelchair and took her to ER. They did an ekg and was normal but her HR spikes to 118 so they did blood work and released her a few hours later. Event onset time was reported as 10:45 AM. The patient did not receive any treatment for the events. The patient had not tested covid post vaccination. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
The vial was shook before the patient being vaccinated; A spontaneous report was received from a consumer concerning a 90-years-old, female patient who received Moderna's COVID-19 Vaccine, and the vial was shook before the patient was being vaccinated.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On unknown date, the vial was shook before the patient being vaccinated. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, the vial was shook before being vaccinated was not reported.; Reporter's Comments: This case concerns a 90 year old female patient who received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and the vial was shook before the patient being vaccinated. There were no reported adverse events after study drug was administered in this case of product use issue.
When she rcvd the vaccine she stated it felt like she could feel the medicine going through her arms. Extremely tired. About 2 1/2 to 3 weeks later she started having pounding headaches. She was taken to urgent care on April 12th because the pounding throbbing headaches got real bad. The doctor told her she was having migraine headaches which she never had before. Called her pcp and referred her to get a MRI on the brain.
No adverse event; 26Jan2021: 1st dose of Moderna Covid-19 vaccine, 10Mar2021: 2nd dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (26Jan2021: 1st dose of Moderna Covid-19 vaccine, 10Mar2021: 2nd dose of Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014520A and 029L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (26Jan2021: 1st dose of Moderna Covid-19 vaccine, 10Mar2021: 2nd dose of Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (26Jan2021: 1st dose of Moderna Covid-19 vaccine, 10Mar2021: 2nd dose of Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were not reported.  Patient received full dose for first and second dose.  No treatment medications were reported.   This case was linked to MOD-2022-647010 (Patient Link).
20 weeks and 3 days pregnant with a girl at time of COVID vaccine, due date July 14th 2021. Anatomy scan on 2/26/21 and everything was normal. Two prior pregnancies both healthy and carried full term in 2017 and 2019. Spontaneous preterm labor on March 6th, 2021. Resulted in baby being born and dying about an hour and a half later due to how early she was. Labs came back normal, no signs of infection, placenta pathology came back normal. Baby was healthy as of 2/26/21 and was born alive.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (dose and route were not reported) lot # K025760 expiration date 08-JUN-2016, lot # K023862 expiration date 25-MAY-2016 and lot # L009208 expiration date 17-SEP-2016. No symptoms reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Throat swelling/trouble breathing, hives on neck, throat, and shoulder, and inflammation and rash at injection site beginning approx. 45-60 minutes after injection. Treated with Benadryl. Throat swelling reduced by following day. Hives on neck, throat, and shoulder, and rash at injection site  have not resolved. Continue to take Benadryl. Severe arm pain and shoulder pain at injection site. Began within 1 hour of injection. Treated with ice and Aleve. Shoulder pain has not resolved. Continue to treat with ice and Aleve.
neurologist by phone 1SEP92 16AUG92 rt focal sz not related to vax; hosp rx c/meds 1 day but then d/c & readmitted w/metabolic acidosis; acidosis & hypoglycemia; MD said no pertussis vax in the future;
vomiting; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): UNT-2022-031105 (regulatory authority).  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; treprostinil sodium (TYVASO), first regimen since 29Oct2020 (Batch/Lot number: unknown) and second regimen (Lot number: 2102219, Expiration Date: 30Nov2023) at 54 ug 4x/day (54 microgram (9 breaths), four times a day) for pulmonary arterial hypertension; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Secondary pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: OPSUMIT; SILDENAFIL CITRATE. The following information was reported: DIARRHOEA (non-serious) with onset 17Nov2022, outcome "unknown", described as "Diarrhea"; VOMITING (non-serious) with onset 17Nov2022, outcome "unknown". The events "vomiting" and "diarrhea" required emergency room visit. The action taken for treprostinil sodium was unknown.  Additional information: The patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 29Oct2020 for secondary pulmonary arterial hypertension. The current dose was reported as 54 microgram (9 breaths), four times a day (QID) via inhalation (IH) route. On 17Nov2022, 2 years and 20 days after initiating Tyvaso, the patient went to emergency room after receiving COVID [coronavirus disease] and flu shot as she had vomiting (vomiting) and diarrhea. Action taken with Tyvaso was not reported for the events of vomiting and diarrhoea. At the time of reporting, the outcome of vomiting and diarrhoea was unknown. The reporter did not provide causality for the events of vomiting and diarrhoea. The reporter's causality for the events of vomiting and diarrhoea with COVID-19 vaccine and influenza vaccine was considered to be possibly related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache; myalgia; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVEL) at an unspecified dose and frequency. On 27-Apr-2021, HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Body temperature: 99.6 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was given.
Night of vaccines pt broke out in hives, lg itchy red welts --> both arm, back and chest. Benadryl given and change to Zyrtec.
Developed Blood clot in right leg; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. This is the 1st case out of 2 cases.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 13Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. On 14Sep2021, the patient developed blood clot in right leg. The outcome of the event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383187 same reporter/drug/AE, different patient
Narrative:  96yo male pt who does only receives specific care for hearing aids got 2 covid vaccines (moderna) from facility on 1/11/21 & 2/8/21. Pt died on 12/22/2021, place & cause of death unknown. This death is likely not related to the vaccinations due to patient's advanced age and length of time from vaccine administration.