chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 27Mar2021 at 09:45 as a single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 at 12:30, the patient experienced vomiting, chills, cough, exhaustion, headache, ears burning, lung pain, shortness of breath and congestion. The patient went to doctor on 30Mar2021 and apparently, she has pneumonia. The patient also mentioned that she barely had a stuffy nose before taking the vaccine. The patient has a rapid response nasal swab COVID test on 29Mar2021 with a negative result and a PCR nasal swab COVID test also on 29Mar2021 with an unknown result. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Patient passed out within 5 minutes of receiving flu shot. He fell face down. Some shaking, possible seizure. He woke up within 30-45 sec. Stated he felt like he threw up. He was still dizzy. Then he became nauseous. Ambulance arrived. Patient could not walk out of store due to dizziness. Ambulance transported him to Hosp. Patient stated he went white last year when he received his flu shot.
Patient received 2nd dose 18 days after 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 18 days after 1st dose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 18 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 18 days after 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Within 27 hour developed a dry cough, by 30 hours I had a fever which stayed at about 100 degrees for 2 days, then went away. The cough slowly went away after 2 days also. Really sore in left shoulder and neck area. Entire body ached, not severe, but enough to cause discomfort.
Breakthrough case COVID-19 after fully vaccinated with 2 doses of Pfizer.
Pt noted redness and swelling difficulty lifting arm, still with slightly reddened area on inner aspect of (L) arm.
Erythematous swelling around the site (DTAP/IPV), warm to touch, but non-tender, 5 inches by 3 3/4 inches.
Constant itching. Dr. prescribed antihistamine Xyzal 5 mg - one tab daily. This has controlled my itching for the last 9 years.
dizziness; nausea / feel nauseous; tiredness; sore throat; fever; stiffness of arm; feeling "out of it."; hypersalivation; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. In July 2021, less than a week after receiving Shingrix, the patient experienced hypersalivation. On 24th July 2021, the patient experienced dizziness, nausea, tiredness, sore throat, fever, limbs stiffness and feeling abnormal. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the dizziness, nausea, tiredness and hypersalivation were not recovered/not resolved and the outcome of the sore throat, fever, limbs stiffness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the dizziness, nausea, tiredness, sore throat, fever, limbs stiffness, feeling abnormal and hypersalivation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient began to experience dizziness, nausea, tiredness, sore throat, fever, stiffness of arm and feeling out of it.  All symptoms had resolved except the dizziness, nausea and tiredness which she was still experiencing. The patient was referred to health care professional. The patient went to an urgent care on 27th July 2021 and was prescribed Zofran.  The patient was experiencing hypersalivation in less than week after vaccination and continued to feel nauseous. The reporter did not consent to follow-up.
pt recvd vax; 4 hrs later devel swollen eyes,mattered & red eyes; chest congestion, cough; swollen glands, ear ache; 24 hrs later devel diarrhea; resolved in 48 hrs;
Day 3 of Headache, chest pain, shortness of breath, heart pounding, muscle pain, and neck pain
Patient had received Moderna as a first dose and then received Pfizer as a second dose.  No AE.
Already got the 2 doses,first dose on 30Dec2020 and the second dose on 20Jan2021; Pregnant; A spontaneous report was received from a nurse, a 24-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced already got the 2 doses, first dose on 30Dec2020 and the second dose on 20Jan2021 and she is pregnant.  The patient's medical history was not reported. The patient's prior history of pregnancies is not provided. Concomitant medication is Multivitamins.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the patient received the second of the two planned doses of m-RNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  She did not report any side effects and her due date was on 27 June 2021.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, already got the 2 doses first dose on 30 Dec 2020 and the second dose on 20 Jan 2021 and vaccine exposure during pregnancy, were considered resolved on 20 Jan 2021.; Reporter's Comments: This case concerns a 24-year-old female  who reported inappropriate schedule of product administration and  maternal exposure during pregnancy. Estimated due date is 27 June 2021. Subject received 2 doses of COVID 19 vaccine( mRNA-1273) lot # 037K20A with latency of 22 days. There were no reported AEs associated with this case of Inappropriate schedule of product administration and maternal exposure during pregnancy.
8x8cm erythema surrounding vaccination site lt deltoid;temp 100;pt eval 4 days p/vax;no pain, itching;
Started experiencing slight loose stool, headache, dizziness. fatigue 11-12 days after receiving vaccine but did not correlate it with vaccine and was still able to function. Then I received an epidural injection in the C spine 2 weeks after the vaccine on 08/03/2021. Then 2 days later I had diarrhea felt more dizzy, headache, fatigue, then got short of breath with profuse sweating with any slight exertion and went to hospital and was diagnosed and admitted with COVID 19  pneumonia.  Since then I am experiencing streme fatigue, brain fog, still needing oxygen on and off, bronchospasms, insomnia PTSD depressed feeling, anxiety, panic atacks, dizziness, light headed, worsened tinnitus, dyspnea, easily out of breath, chest discomfort, palpitations, low blood pressure, worsened pain syndrome, leg cramps, more stiffness in the joints, pain behind eyes, sicca symptoms of dry mouth dry eyes, tongue stinging sensation, urgeny and frequency of urination with dribbling and incontinence periodically, uncontrollable bowel habits needing to wear a pad or diaper as needed, changes in appetite, altered taste
Pt.called to report numbness and tingling in her mouth and over-all itching.Advised to see HCP,and went right away. Was RX'd Zyrtec. On 10/29/02 reports no symptoms.
Redness that became swollen and itched.  Today 3/17) is day 2. It looks worse than yesterday.  I had the same reaction to the first shot and it was diagnosed as cellulitis. Now I see it wasn?t.
Patient received J&J at a different facility and then received 2 Pfizer doses from another on 6/29/21 and 7/21/21. System was not checked prior to Pfizer administration
Erythema and induration left thigh 8 x 8 cm, some pain.
Vision loss; Multiple outbreaks of herpes zoster; Multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information has been received regarding the pt.'s past medical history, concurrent conditions, or concomitant medication.  On an unknown date,  the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (dose, route of administration lot number and expiry date were not provided) for routine health maintenance and prophylaxis.  After receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster (herpes zoster and herpes zoster reactivation) and loss of vision. As a result of these symptoms, the pt was seen and treated by medical providers and was still under care. As a direct and proximate result of the  vaccine, the pt symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of pt condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of the vaccine the pt sustained severe and permanent personal injuries and  serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Also the pt  had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.The outcome of blindness and herpes zoster reactivation was reported as not recovered/not resolved.   The reporter considered blindness and herpes zoster reactivation to be related to Zoster Vaccine Live(ZOSTAVAX).  The event blindness was consider to be medically significant.
her arm was sore and tender to the touch; tiredness; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (her arm was sore and tender to the touch) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 014M20A and 032F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (her arm was sore and tender to the touch) and FATIGUE (tiredness). At the time of the report, TENDERNESS (her arm was sore and tender to the touch) and FATIGUE (tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient received fourth dose on 19-Oct-2022 and lot number was AS7164B. Patient doesn't remember with which of the 4 shots but stated that at most her arm was sore and tender to the touch, and maybe she felt some tiredness. However, these side effects never interfered with her daily functioning the following day. No treatment information was provided.
Information has been received from a 51 year old female with no known medical history or allergies who on 07/2003 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg(yeast). Concomitant therapy included cimifuga(Remifemin). She reported that she experienced elevated liver enzyme levels after her last injection in 07/2003 and that "either AST or ALT is elevated slightly. Unspecified medical attention was sought and diagnostic lab tests were all negative. At the time of the report, the patient was recovering . There were no product quality complaint involved. Additional information has been requested.
fainted; cannot drive; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2022, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fainting (Verbatim: fainted) (serious criteria GSK medically significant) and driving ability disturbed (Verbatim: cannot drive).  The outcome of the fainting and driving ability disturbed were not resolved.   It was unknown if the reporter considered the fainting and driving ability disturbed to be related to Shingrix.     It was unknown if the company considered the fainting and driving ability disturbed to be related to Shingrix.   Additional Information: GSK Receipt date: 08-SEP-2023 The reporter reported that since he received his Shingrix vaccine he had fainted five times in the past year. The reporter reported that he did not faint at the time the Shingrix was administer. Reporter reported the fainting was random with no warning. Patient had his heart checked by a cardiologist, stress test and they can find no reason for his fainting. The reporter called GSK because the TV commercial for Shingrix stated that it could cause fainting. Relayed to the reporter that was when the vaccine was administer usually. Reporter was trying anything to find an answer because he could not drive until he was fainting-free. Reporter had not received his second dose Shingrix because of his concern with fainting. The reporter consented to follow up.
FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to .
Diarrhea started 5 days post injection, duration 5 days. Red, itchy rash started 8 days post injection, still it red and itches.  Headache on days 5-7.
pt recvd vax; w/in 1.5 wks in ER w/ bleeding thru skin; hematomas baseball size/covered w/ petechiae; tx w/ gamma glob, plt ct 30000-60000; dx w/ thrombocytopenia & URI; hosp off & on x3 months.
Underage recipient received dose 1 in two dose series. (15 at time of administration)
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 60-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
Patients received an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult patient who experienced received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA. It was a case of actual medication error due to Product storage error. First cooler contained DAPTACEL, PENTACEL, QUADRACEL, ACT HIB, IPOL (opened), MENACTRA and ADACEL. Lowest temp was -2.2 degrees C for 45 min and a 2nd temp excursion lowest temp was -1.9 degrees C for 1 hour. Second cooler contained DAPTACEL, PENTACEL, QUADRACEL, IPOL (opened), MENACTRA, TENIVAC and ADACEL. Lowest temp was -1 degree C for 30 min and a 2nd excursion lowest temp was -4.1 degrees C for 1 hour and 30 min. It was unknown whether patient experienced 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.
Pt recvd 3 doses of Engerix-B 31JAN90, 1MAR90, 1AUG90 & 5MAR91 it was determined that pt was a non-responder; Reporter indicated that a booster dose would be given;
Arm is in pain. She feels like a not in the area where vaccine was administered. Nees other hand to left her arm where vaccine was given 9/29/14. Went to Dr. Dr said probably a nerve hit.
High fever (102.5) within 12 hours of vaccination.  Fever of 100.5-101.5 for the next 36 hours.  Irritable.  Treated with children's motrin.
No adverse event; She states that the MA gave a dose (0.25 ml) today 3Aug2023 of the Moderna bivalent (lot number 215K22A) for babies with pink cap, but it was the one that was supposed to be given for dose 3; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states that the MA gave a dose (0.25 ml) today 3Aug2023 of the Moderna bivalent (lot number 215K22A) for babies with pink cap, but it was the one that was supposed to be given for dose 3) and NO ADVERSE EVENT (No adverse event) in a 19-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product HEPATITIS A VACCINE (HEPATITIS A) for an unknown indication.    The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient had  no COVID19 vaccination history.    On 03-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter and dose of HEPATITIS A VACCINE (HEPATITIS A) (unknown route) 1 dosage form. On 03-Aug-2023, the patient experienced WRONG PRODUCT ADMINISTERED (She states that the MA gave a dose (0.25 ml) today 3Aug2023 of the Moderna bivalent (lot number 215K22A) for babies with pink cap, but it was the one that was supposed to be given for dose 3). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states that the MA gave a dose (0.25 ml) today 3Aug2023 of the Moderna bivalent (lot number 215K22A) for babies with pink cap, but it was the one that was supposed to be given for dose 3) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (She states that the MA gave a dose (0.25 ml) today 3Aug2023 of the Moderna bivalent (lot number 215K22A) for babies with pink cap, but it was the one that was supposed to be given for dose 3).    No concomitant medication was reported. No treatment medication was reported.
Had reaction both times (broke out in hives) but did not realize they were the result of vaccines until the second dose. Started on inner thigh, looked like ringworms. Then it started turning into welts. Also had white bumps. The rashes started moving to the elbows on 5/31/21. Eyes started getting very itchy this morning (6/1/21) and looks like she has bug bites on eyelids. Hydrocortisone did not work well, tried using antihistamine but did not work well either. Has been using ice packs and minimize physical activity.