chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt a mild itching on his legs; he noticed that he had hives on his back, arms, and chins.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 61-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Mar2021, the patient experienced felt a mild itching on his legs, he noticed that he had hives on his back, arms, and chins. It was further reported that patient was 61-year-old male patient who received that vaccine earlier today. He mentioned that he was fine during the 30 minutes he was made to wait before leaving. On his way home, he felt a mild itching on his legs which he paid no mind to. About an hour and 40 minutes ago, he noticed that he had hives on his back, arms, and chins. He mentioned that there no to slight itching. He is not itching as of the moment. His main concern was if her could take the 2nd dose or not after experiencing these side effects. He stated that, well I have a question. I got the 1st dose of Covid-19 vaccine earlier today. I was at the location and they had me stayed there for 30 minutes and I was feeling fine. About 15 minutes later, on the way home I started noticing some mild itching. So when I got home I still have little itching and about an hour ago, I started noticing hives not the lower, the my upper extremities on my right arm, actually my right forearm on my chin and on my back I am seeing hives. Now they are not, when I say hives, I do not mean all over my body it is just like one here and there, one or two and my arm there was only one, on my upper back I see one and it was not all over, it is just one here and there and there was barely any itching at all but I was concerned about the reaction. Is it safe for me to have the second shot? He stated, let me call you back because I am working on finding what is happening to me right now. He stated that I have a PID number. No I do not see an expiration date. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
received vaccine while pregnant; sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received vaccine while pregnant) and PAIN IN EXTREMITY (sore arm) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FISH OIL and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 11-Feb-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 04-Jun-2021. On 11-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (received vaccine while pregnant) and PAIN IN EXTREMITY (sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 11-Feb-2021, EXPOSURE DURING PREGNANCY (received vaccine while pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2020, Ultrasound foetal: normal (normal) Good. On 24-Sep-2020, Pregnancy test: positive (Positive) Positive. On 23-Oct-2020, Ultrasound foetal: normal (normal) Good.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient previously had live birth on 16-JUL-2016  On 24-SEP-2020, the patient had positive pregnancy test. The estimated date of conception was SEP-2020. No treatment information was provided.
she feels funny; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "she feels funny". The event "she feels funny" required physician office visit.  Additional information: The patient reported that she would like to schedule her booster shot. Patient reported that she went to the doctor's office and she feels funny.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, fever(101.2), chills, muscle aches and stiffness hot flashes(night sweats)for about 30 hours.
After, approximately 8-12 hrs, immunization admin, irritation, redness and itching at site developed. Right forearm only.
pt recvd vax & 48hrs later devel itching on chest, abd, neck & arms;some redness sl rash chlorstrinta x 2 no relief-will try longer time
101.3 fever; Severe muscle aches (left arm, lower back, pelvic muscles, thighs); Headache; This is a spontaneous report from a non-contactable physician, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170) via an unspecified route of administration in the  left arm on 27Apr2021 at 14:30, (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included contraception. It was unknown if the patient had known allergies. Concomitant medications included ethinylestradiol,gestodene (MANUFACTURER UNKNOWN) for an indication of contraception received within 2 weeks of vaccination. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the  left arm on 06Apr2021 at 13:30, (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 06:00 the patient experienced severe muscle aches (left arm, lower back, pelvic muscles, thighs),headache and at 18:30 the patient experienced 101.3 fever. Therapeutic measures were taken as a result of events and included treatment with Acetaminophen 2x500 mg. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events were muscle aches (left arm, lower back, pelvic muscles, thighs),headache and 101.3 fever were recovered on 29Apr2021.  No follow-up attempts are possible. No further information is expected.
I had fever, body ache and head ache 12 hours after receiving vaccine; lasted for 48 hours.  Accompanied pain in injection site. Miscarried in 09/13/2022.
Presents to employee health with possible vaccine reaction. She indicates that she received second Covid vaccine (Pfizer) last Thursday. Approximately 2 days following this she had onset of SOB, sore throat, body aches, conjunctivitis, abdominal pain, fatigue, and dysphagia to both solid and liquids. She endorses that she has to take breaks when walking and when talking due to the dyspnea. Denies any cardiopulmonary disease. PMH significant for prediabetes not medicated. Brief history of vaccination: Had Covid in 2021, received dose 1 of Pfizer and subsequently received monoclonal antibody infusions, also had Covid a few weeks ago (July 4-8) and received 2nd dose of Pfizer on July 21st. She endorses that food gets "stuck". She denies lymphadenopathy. No N/V/D. O: VSS, O2 100% on Room Air. A/P: Potential vaccine reaction. Stable for transport by ambassador services to hospital. Report given to Private.
Case number PHEH2014US025377, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 64 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 16 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this maladministration.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 045C21A, 001C21A and 020B21A) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Nov-2021 at 11:11 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 11:47 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 11:47 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered dose after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered dose after expiration date) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022). No concomitant medications were reported. Patient had not been diagnosed with tested positive for COVID-19. The patient had any acute illness at the time of vaccination and up to 1 month before was unknown. Chronic or long-standing health conditions was Unknown. It was unknown patient had taken any prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination The patient had not experienced similar adverse event in the past and there were not any other potential causes for the event. The event does not cause the patient to seek medical care. On 26-May-2022, the used vials were placed in the refrigerator on the same day of administration. Number of doses or vials was reported as 5 vials. The vial did not undergo any temperature excursions. No treatment medications were reported. This case was linked to MODERNATX, INC.-MOD-2022-586783 (E2B Linked Report). Sender's Comments: MODERNATX, INC.-MOD-2022-586783:Master Case.
Pt received vaccine and was standing outside of immunization room with her parents waiting for her brother to receive vaccine. She felt dizzy and fainted. She hit her head and collapsed. She was seizing/ shaking on the floor. She was conscious with no visible bleeding. She was able to say her name and DOB correctly. Mother reported no history of epilepsy or seizure.  Called emergency services and pt was taken to Clinic for further evaluation. A 1.5cm laceration was noted behind her left ear. Pt received 2 staples in the lacerated area.
Large pericardial effusion who had to be admitted to the ICU and a pericardiocentethesis was performed.
Pt received COVID19 vaccine at 1044. At 1059 pt c/o dizziness. Escorted pt to observation area. Pt sat in chair HR 100. C/O increasing dizziness so transported patient to cart. 1100 126/76 RArm, 98% SPO2 on RA, 66 HR. Pt requested to have cart lowered so head was lowered.  1104 Pt requested head up due to nausea, BP 90/57, HR 61 SPO2 99% RA. 1105 EMS notified. 1107 Pt vomited and stating I don't feel well. Patient pale, cool to touch. AED applied. BP 152/136 HR 54 SPO2 98% RA. 1110 BP 110/67, 75 HR, 97% RA. 1112 EMS arrived. 1114 BP 102/63, HR 74, 98% RA. 1117 Patient transported by EMS to ED with belongings. Family with patient.
Pt vaccinated with DTP experienced excessive irritability >3hrs, shrill, high-pitched cry. Full resolution by 24hrs.
Patient admitted to hospital and tested for COVID 8/24/21. Discharged 8/28/21. Deceased 9/7/21
Chest pain; Very much sourness of breath; Cold like from inside out it was very weird; No energy at all.; Headache, started like at temples and went up to like my forehead and I really have a headache at all; Twinkling my toes; Feet were very swollen; This is a spontaneous report from a contactable consumer (patient). A 60 years old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 16Apr2021 (at the age of 59 years old) (Batch/Lot Number: EN6199) as dose 1, single for covid-19 immunisation.  Medical history included ongoing smoker (I done smoke). The patient's concomitant medications were not reported. Date of administration of first shot: 16Apr2021. Consumer stated, "Side effects, I had chest pain, very much sourness of breath and , I've never had this problem before ever, I done smoke, I am not over weight, I had cold like from inside out it was very weird, no energy at all, headache and it started like at temples and went up to like my forehead and I really have a headache at all, twinkling my toes and I still have that and my feet were very swollen." Product details (Expiration date, NDC#, UPC#): Consumer stated, "I have a paper for this vaccination so it says, so it has a LOT#, so if you want me to go and get the vaccination card well it will take me a couple of minutes, you want me to get it, I have to go stairs and get it". No therapeutic measures were taken as a result of events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Full body rash that itches. We were told by the doctor?s office to stay home until rash goes away.
Severe headache causing him to have to cease activity and go to bed, Lasted throughout day, next  day he felt residual effects, headache subsided.
Induration and pain at injection site. 24 hours after injection. Induration approx 20 mm.
a patient received a dose of Acthib that had been resconstituted with normal saline 0.9 percent (rather than the 0.4 percent saline diluent supplied with the vials)/No AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographics patient who received HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) that had been reconstituted with normal saline 0.9 percent (rather than the 0.4 percent saline diluent supplied with the vials) (lot number and expiration date reported) via an unknown route in an unknown administration site for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.   It was an actual medication error due to wrong solution used in drug reconstitution.  At the time of report, no adverse event was 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.  Information on the lot number was requested.
I had very bad sore throat, coughing, body aches (mainly in my hands), loss of appetite, extreme fatigue, chills. No fever or shortness of breath or breathing difficulties. I called my doctor and started Paxlovid. I started it on a Monday and by Wednesday I felt completely like myself. The duration was not long at all.
I had a headache, sore throat, body aches, fatigue as well upper respiratory symptoms. I also had brain fog. I was just out of it, my vision off while driving. I tested positive on December 27, 2022 using a home test. They prescribed Paxlovid. The symptoms did get better then on January 4th, 2023 I tested negative. I started to feel sick on the 5th and was positive again on the 6th of January. I am currently out of work because I am still testing positive. As of Friday the 13th, my symptoms had improved but I still have mild symptoms with left over fatigue and brain fog.
Information has been received from a physician concerning a 70 year old female with no pertinent medical history, drug reaction or allergies who on 03-JAN-2008 was vaccinated with Zostavax (Oka/Merck). The reporting physician noted that the vaccine was administered at the pharmacy, and therefore he did not have access to the lot number and route of administration. There was no concomitant medication. On 05-JAN-2008 the patient developed shingles. The shingles rash followed the right thoracic dermatome. The patient was prescribed prednisone and VALTREX. At the time of reporting the patient had not yet recovered. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
given after being frozen at -0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 24R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter gave Pediarix after being frozen at minus 0.45 C for 15 minutes , which led to incorrect product storage. The reporter consented to follow up. This is one of 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter
20 patients total who received the shot outside of temperature range; expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients total who received the shot outside of temperature range) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients total who received the shot outside of temperature range). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients total who received the shot outside of temperature range) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided. Maximum or minimum temperatures reached, is min -59C; max -75C and Excursion duration is of  6 days.
LOCAL RASH, ITCHING, REDNESS STREAK, WARM TO TOUCH.
Inappropriate Schedule of Vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019, in an unknown arm, Intramuscularly).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16 August 2023: The patient reported that she received her first Shingrix vaccine sometime in 2019, in an unknown arm. She now finds out from the pharmacy that there was supposed to be a second Shingrix vaccine in 2 to 6 months from the first to complete the series.  The reporter did not consent to follow-up. Till the time of reporting the patient did not received 2nd dose of Shingrix which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023111557:Same reporter, different patient
About 4cm red, indurated swelling @ DTP site (given 4 days ago) pt afebrile; suspect sterile abscess but cannot r/o bacterial etiology; pt tx w/Keflex;
24 hrs after injection, right leg vaccine site developed swelling, described the size as a small egg. No heat or redness of swelling. Swelling started at injection site and move towards knee.