chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case was received from a physician on 07 and 08 October 2009. A six-year-old male patient experienced blistering and cellulitis of the vaccinated arm after receiving an intramuscular, right deltoid injection of FLUZONE SV 2009-2010 (lot number U3210AA) on 05 October 2009. The patient had a history of asthma, obesity, and pre-diabetes, and was taking Albuterol concomitantly as needed. on 06 October 2009, the day after vaccination, the patient developed three blisters, five inches from the injection site on the right deltoid. By the next day, he presented with 75 blisters below the injection site; the largest was described as being the size of a 50 cent piece. The blisters ruptured, and the skin subsequently sloughed off. An area of cellulitis developed, described as hot, red, and swollen, in an area approximately 6 inches long by 4-5 inches wide. The reaction was most prominent on the medial aspect of the upper arm, where the patient's arm rubbed against his chest, but had also spread circumferentially. The patient had no systemic symptoms, and felt well otherwise. The reporter felt that contact dermatitis was unlikely, as the patient had been wearing clothing which covered the area. He was admitted to the pediatric unit of the hospital, and was treated with Clindamycin and Benadryl. As of 08 October 2009, the patient was reported to be improving. Documents held by sender: None.
Headache on my left side for a few weeks, Left arm still aches, sharp nerve issue
Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-DEC-2015, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
parents state rt arm sore soon p/vax;large area redness began around inj site late next day;large area redness still viable & warm to touch;today w/sl swelling;advised use cool compress & APAP;
Pt reports since receiving vaccine area first pruritic, then pruritic rash (no redness/bumps) developed on face, ear, neck and back that spread. No redness nor swelling.
Generalized hives from 4mm to 1.5 cm in size.  Started 10 days after vaccines given.
not sure what caused what appears to be transient creatinine elevation, to cover bases getting urine microalbumin and prot/creat, also reporting to VAERS in case moderna vax caused...
01/06/22 presents to ED for "recurrent falls". PMHx of "HTN, HLD, COPD and recent COVID pneumonia on home o2 therapy"
I started to get dizzy. The next morning when I woke up I was extremely dizzy; I start vomiting and nausea from the dizziness; I start vomiting and nausea from the dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Prediabetic" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster), Single), for COVID-19 immunization, reaction(s): "I guess is 03Mar I started to get dizzy". The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "I started to get dizzy. The next morning when I woke up I was extremely dizzy"; VOMITING (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "I start vomiting and nausea from the dizziness". The events "i started to get dizzy. the next morning when i woke up i was extremely dizzy" and "i start vomiting and nausea from the dizziness" required physician office visit. Therapeutic measures were taken as a result of dizziness, vomiting, nausea.  Additional information: The report was not related to a study or programme. The patient had other conditions. There were no investigations conducted. Consumer stated that she had her second booster shot which was a Pfizer shot. All her shots the first two in the beginning and then the booster and the second booster were all Pfizer shots, and she had her second booster on 29Apr which was the Friday. Sunday night which she guessed was 03Mar she started to get dizzy. The next morning when she woke up she was extremely dizzy then started vomiting and nausea from the dizziness. She had her 'PCP' who sent her to PT, physical therapy and till this day they were still working on her and she still don't have all of the dizziness gone and she reported this to the people who gave her the shot. Starting date of adverse event: Consumer stated, "01May, the evening of 01May. It got really bad when I woke up the next day on 02May." Treatment in response to adverse event (dizziness and vomiting): Consumer stated, "I went to a physical therapy." Consumer stated, "Help me get rid of the dizziness. It's slowly going away but I still have it. The physical therapist have been trying to help that to get this go away but for some reason it won't go anywhere."
The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    Concomitant product use was not provider by the reporter. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case ID
At the time of the vaccination both patient and patient guardian consented to patient being 16 and being eligible for the vaccination. However, patient ineligible because she is 15. Patient and patient guardian believed it would be ok to have vaccine administered since the patient was close to turning 16 years of age. Patient guardian signed consent.
Shortness of breath, racing heart beat, dizzy, headache, vomiting. At ER elevated D-Dimer.
received booster shot at 0715 and around 1615 started to have soreness at injection site and abdominal cramping
Pt vaccinated /w DTP developed fever of 104 x 48 hrs /p 2nd DTP was "not herself".  Wt. 13 lbs 10 oz.
Painful and delayed menstruation; Painful and delayed menstruation; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 25Mar2021 at 07:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021, the patient experienced painful and delayed menstruation. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful and delayed menstruation was resolved on an unknown date in 2021.
Got a shot of Pediarix / after the expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th June 2021, the patient received Pediarix (intramuscular) and Pediarix Pre-Filled Syringe Device. On 17th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: On 17th June 2021, patient received Pediarix, which was expired on 14th June 2021. The reporter did not have information about the patient. The reporter consented to follow up.
extreme soreness of arm down to hand day of Tdap vaccine and 2 more days. unable to use arm as normal. treated with ibuprofen. a little better 4th day and 90% better 5th day. Nausea upset stomach and diarrhea 1st day.
Redness/edema to left upper arm onset x1 day. Pt says the injection site was very sore that night-> so bad it interfered with his sleep. Saturday pain was not that bad but on Sunday the arm started to feel like it was burning and he noticed redness distal to where he got the shot and that has seemed to spread further down the arm in the past 24 hours. Burns less on day of presentation in fact barely hurts at all unless touched. Pt thinks it is less bright red than yesterday as well. Prednisone 10 mg every day.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrived at facility. On 06-Oct-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C. No treatment medications were reported.
The smallpox vaccine area becomes really itchy, and the scar area rises. Happened about 3-4 times, and lasts about a day.
about 10 days after the shot, I slowly developed pain in LLE, then ultimately swelling which led be to getting a LLE venous US on 1/16/21 that showed acute DVT in the gastrocnemius and popliteal veins.  Was put on Eliquis 5mg bid for 6 mo.  Saw a vascular surgeon.  Repeat US at 6 mo was fine, no more acute DVT.  Eliquis stopped,  no issues,  never had PE.   Of note, drove 10 hrs on 12.26.20 and same return trip on 1.3.21 in a motor vehicle with minimal stops, 2 each way, but some walking around.  No prior or family hx of DVT.   Have made that trip many times in my lifetime without issues.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 72 years of age, the patient was administered the ZOSTAVAX by a healthcare provider at a county health department. On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
The vaccinator reported:  He administered the vaccine to the patient and as he withdrew the needle from patient's arm, there appeared to be liquid "running down" the patient's arm  the vaccinator believed was vaccine.  The patient reported this is very normal for her and confirmed this happens every time she receives a vaccination.  Clinic staff were unsure if immediate re-does was appropriate.  Staff did not immediately re-dose and contacted Moderna via phone for further instruction/recommendation.  Initial Moderna representative indicated he would be unable to answer question regarding re-dose, and stated he would advance the question/situation to company patient safety division.  Representative did explain it would most likely be some time before patient safety division returned contact.  As of the time of this report, staff still has not heard back yet from Moderna.  Staff explained the situation to the patient, advised her to monitor for any adverse reactions, and recommended contacting her PCP and staff is things worsened.  Decision was made to maintain the patient's schedule for her 2nd dose until Moderna contacts staff to advise them of any other best next steps.  Staff follow up with patient several times via phone call to inquire about any adverse reactions.  The patient describes redness/soreness/warm to the touch at injection site, however states this is also normal following any vaccination administration.  The patient did confirm she will follow up with her PCP after staff's last check-in phone call.
FATHER CAME TO CLINIC WITH USED MEDS STATING CHILD HAD BECOME ILL.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). Concurrent medical conditions included pain. Concomitant products included OXYCONTIN. On 21st August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced feeling unwell and feeling abnormal. On an unknown date, the outcome of the feeling unwell and feeling abnormal were unknown. It was unknown if the reporter considered the feeling unwell and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she was not the healthiest person in the world. She lived in pain and took a low dose of oxycodone to eliminate pain. The patient had her SHINGRIX shot a day before date of reporting and she felt sicker than a dog. She felt drugged. The patient wanted to know if this was known side effect. If yes how long would this dead feeling last. This case was linked with A0807245A, reported for the same reporter.
I have the second dose on 25Feb and this made my arm sore; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Epileptic seizure" (unspecified if ongoing), notes: She had it since she was born. She had a lot of seizures but haven't had any since 18Feb2020. Concomitant medications included: LEVETIRACETAM; GABAPENTIN, start date: Mar2019. Vaccination history included: BNT162B2 (Dose 1, single (Lot Number: EL9264)), administration date: 04Feb2021, when the patient was 74 years old, for covid-19 immunisation, reactions: "rash", "itching". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "I have the second dose on 25Feb and this made my arm sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient stated that the lot number of second dose was "EH or N 6202". She had a laboratory test and did not know for sure but they probably did a complete blood count (CBC).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335204 Same patient and drug; Different dose and events
First developed rash (blisters) across face, which spread over body.  Chest, abdomen and back, shoulders, neck, face.  Some along arms and legs.  This occurred approximately 2 days later, accompanied by a fever (101F) extreme body aches and chills.  Day 3, the 26th of January, the rash has intensified and spread more along neck, scalp.  No fever noticed, but moderate aches and chills are noticed.
second day of taking the COVID -19 Moderna vaccine, my lips started getting  dry, itchy to the point where my lips start cracking, these symptoms have lasted for 5 days, last night my face, eyelids, neck, and upper torso started itchy, i couldnt fall asleep because i kept scratching these parts of my boday  (4/24/2020 ) this morning ( 4/25/2021) these symptoms have improved a little bit
Elevated Blood Pressure:  In the weeks following the shot my blood pressure increased to hypertension 2 with readings going up to 170/118 occasionally. This reduced to readings up to 150s/100s over time, before I started taking blood pressure medication.   This was accompanied by fatigue, brain fog, muscle loss, etc.  I have been on blood pressure medication (Olmesartan) ever since to keep it under control
Pregnancy - I was about 5 weeks pregnant at the time of my second vaccine dose. I started bleeding one week later which resulted in miscarriage. Conceived again in April 2021, which miscarried in June 2021 at 11 weeks requiring D&C. One previous successful pregnancy conceived naturally with no complications.
25 April - body aches and chills, no fever, these symptoms lasted for about 36 hours followed by general soreness throughout my entire body; 1 May - I woke up in the morning and was unable to urinate, I went to the ER and was given a catheter and sent home, I kept the catheter in place until Friday, 7 May when a urologist at hospital removed the catheter.  I was able to urinate over the weekend but the symptoms returned 10 May.  I returned to the urology clinic at hospital and I was given another catheter with instructions to follow up and conduct a hydroanalysis study with the urology clinic; Tuesday 11 May - I woke up with numbness and tingling in my hands, abdomen, and feet and pain throughout my entire body, scratching my chest made a burning sensation.  I went to the ER and was admitted to the Neurology department at the same hospital.  I stayed there for three nights and started to improve after receiving three daily doses of steroids, two days of IV steroids (1gram each), and one day of oral steroids (1 gram).  I was discharged on Friday, 14 May and still had significant pain throughout my body and numbness and tingling in my feet, hands, and torso.  I began to improve around 18 May with pain fading and numbness and tingling decreasing.  As of 2 June, I still have some numbness and tingling in my hands, feet, and abdomen.  It seems to slowly improve but not as quickly as it was in the aftermath of the high-dose steroids.