chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hib portion that was not given/not reconstituted with the Hib powder portion with no reported adverse event; Liquid portion DTaP-IPV of pentacel that was not reconstituted with the Hib powder portion with no reported adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 2 months old female patient who experienced hib portion that was not given/not reconstituted with the hib powder portion with no reported adverse event and liquid portion dtap-ipv of pentacel that was not reconstituted with the hib powder portion with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine for Prophylactic vaccination; and pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for Prophylactic vaccination.  On 29-Apr-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at a dose of 0.5 ml; lot U6985AA and expiry date: 10-Jul-2022, lot UJ543AA and expiry date: 10-Jul-2022 and lot UJ543AAA, expiry date: 10-Jul-2022 via intramuscular route in the left vastus lateralis for Immunization.  On 29-Apr-2022 (latency: same day) the patient developed a non-serious hib portion that was not given/not reconstituted with the hib powder portion with no reported adverse event (incorrect dose administered) and also liquid portion dtap-ipv of pentacel that was not reconstituted with the hib powder portion with no reported adverse event (product preparation issue) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken: not applicable.  Outcome: unknown for both the events  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 the 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.
10/1/12 AM KINRIX given (L) arm. 10/3/12 AM mom brought child in - arm erythematous, hard, swollen - 6 3/4 inches - 4 1/2 inches form shoulder to above elbow. 10/4/12 PMD Rx'd prednisone & cephalexin. 10/11/12 arm back to normal.
Wife reporting this information, her husband is in prison.  He informed her that he did not have a choice to take the vaccines.  He does have a heart condition.  He feels that he was coerced to get the vaccine, and informed that if he did not take it that he would be moved to an area where he would not have privileges for visitors, etc., and then found out a week later that was not the truth.     He got his vaccine, he has more shortness of breath, bad pain in his joints, lots of confusion with his brain, blood blisters on his hands that are oozing on his fingers.  Sick for 2 days on the 2nd vaccine, but he continues with joint pain, oozing, and brain fog.   He has an injury to his knee and he cannot get to the infirmary and cannot buy Tylenol in the canteen.
Got shot between 9:30 and 10:00 by 3pm my tongue started swelling, then I had trouble swallowing even water, I felt like my throat was swelling shut, at 7:30 my lip started swelling and by 8pm I was at the ER,  I told them about my throat and showed them my lip, I waited  for some time in the waiting room, they were so busy.  They put on my chart that I was having chest pains, not once did I tell them I was having chest pain.  They did an EKG and gave me 2 shots of something and I went home.  I don't think I was having an allergic reaction to the booster shot.  A few days later I had a rash and swelling on my right hand and arm , went to walk in clinic, put on steroids pills and allergy pills, doctor did not think it was the shot. a few days later my left hand swelled up, rash, hot and itching almost up to my elbow.  Then a few days later my tongue swelled so big, I could barely stick my tongue out and lip and face swollen, went to walk in clinic by 8pm saw doctor at 10:15 by then the swelling had gone down.   So far no more problems but I would never get another shot.
Fever- normal fever for several days after booster, then on 12/24 the fever was 104° and developed facial rash and rash on leg. 12/29- dr visit prescribed cephalexin. 1/2/22- ED visit and admitted to hospital. Fever, facial rash, headache, lightheaded.. Discharged 1/4/22.  1/12/22 ED- admitted to hospital. Chest pressure, SOB, nausea, lightheaded, headache, extreme fatigue   facial rash. Released 1/13/22. Follow up with PCP weekly, ophthalmology, rheumatology, dermatology, endocrinology   I still suffer from brain fog, LE neuropathy, extreme fatigue, anxiety, hair loss, nausea, dizziness
Patient appeared to have a vasovagal response after having the vaccine. He became nauseous and clammy and pale. He began to seize and passed out. EMT evaluated him and found his vitals were stable, as well as, his blood sugar. He felt better and refused transport for further evaluation. No other incidents occurred.
FLU-LIKE SYMPTOMS - MILD FEVER, BODY ACHES, GENERAL MALAISE FOR 24-36 HRS.
Information has been received from a medical assistant referring to a 5 months old female patient. No relevant medical history or concurrent conditions were reported. On 02-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt devel erythema multiform rash 5-7 days p/vax;
Information has been received from a pharmacist concerning an 81 year old male with hypertension, cancer, diabetes and a history of heart attack who on 08-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 657525/0554U) IM, 0.5ml. Concomitant therapy included fentanyl, COMBIVENT, PLAVIX, insulin, LASIX, PRILOSEC, FLOMAX, IMDUR, antineoplastic (unspecified), RANEXA, metoprolol, OS-CAL and vitamin D (unspecified). On 05-MAY-2009 the patient experienced heart attack and was hospitalized. While at the hospital he was found to have pneumonia. The pneumonia was not diagnosed immediately so the patient now has difficulty breathing. The patient's wife reported that the patient did many tests at the hospital but the pharmacist did not know which ones. The patient had just been released from the hospital by the report time. Additional information has been requested.
2/19/10 Mother reports rash that started on feet about noon today.  Has spread to legs and neck.  Taking to a walk-in clinic.  Giving Benadryl per walk-in clinic, no cause of rash known (viral/bacterial).  2/22/10 patient still has rash but it is getting better per mom.
PT COMPLAINED OF HIGH FEVER (103 DEG), PAIN IN ARM, NECK, UPPER BACK, ARM STIFFNESS and TIGHTNESS, SWELLING, ARM WAS WARM TO THE TOUCH. ALSO, SOME RED AREAS ON UPPER ARM BUT NOT AN ACTUAL RASH (ALMOST LOOKED LIKE CELLULITIS OF UPPER ARM).
This spontaneous report was received from a registered nurse refers to a 0 month old male patient. On 14-JUN-2014 at 14:18 PM (same date that the patient was born) the patient was vaccinated improperly stored does of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2016 (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temperature dropped to 0-1 degree (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 degrees (units were not reported). This is one of several reports received from the same reporter. Additional information is not expected due to all follow ups requested to complete the case were received.
PATIENT RECEIVED 0.3ML OF PEDIATRIC DOSE INSTEAD OF 0.3ML OF ADULT DOSE.
difficulty breathing, elevated BP. 911 was called and the patient was taken to ER for further evaluation
I gave patient KINRIX and they should have received PEDIARIX. They need to come back and get a Hep B dose.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revaxed on 11-8-22
Patient presented to pharmacist with 8" by 4" red rash at injection site. Rash was not raised or swollen but was warm to the touch, had some deep red/purple areas at edges, and patient complained of itching. Recommended BENADRYL, Lidocaine spray and pt to mark borders and check with MD if no improvement in 12 hrs.
rapid heart rate, chest pain, fainting, low grade fever (100.5). Went to ER 9-9-21 @ Medical Center.
Day 2 - fatigue, muscle and joint aches until day 6.  Narrative:
Lock jaw on her left side; Caused her to not breath so well; Terrified of sleeping that night; More left armpit lymph node swelling/ lymph node swelling in the left side of her neck; This spontaneous case was reported by a pharmacist and describes the occurrence of TRISMUS (Lock jaw on her left side), DYSPNOEA (Caused her to not breath so well), SLEEP DISORDER (Terrified of sleeping that night) and LYMPHADENOPATHY (More left armpit lymph node swelling/ lymph node swelling in the left side of her neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TRISMUS (Lock jaw on her left side), DYSPNOEA (Caused her to not breath so well), SLEEP DISORDER (Terrified of sleeping that night) and LYMPHADENOPATHY (More left armpit lymph node swelling/ lymph node swelling in the left side of her neck). At the time of the report, TRISMUS (Lock jaw on her left side), DYSPNOEA (Caused her to not breath so well), SLEEP DISORDER (Terrified of sleeping that night) and LYMPHADENOPATHY (More left armpit lymph node swelling/ lymph node swelling in the left side of her neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-395861 (Patient Link).
Patient developed tiny little hives around mouth and 2 others over back and upper arms. No respiratory symptoms. She was a bit fussy and tachycardic HR 160. pOX 99 ROOM AIR. No oral edema. Patient calmed down spontaneously and observed for 15 minutes. HR down to 130. Hives-->  by 95% faded. Immunization given with latex free gloves.
It was reported that a 50 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/11/01. The next day, the patient contacted the physician's office to report she was experiencing "severe stomach cramping". Further information requested.
Tested positive to Covid 19; Tested positive to Covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two different patients (himself and his wife). This is the first of two reports.  This male patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration, in Apr2021 (16 or 17) for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The second dose was planned for 07May2021. The patient asked if he could receive the second dose as he tested positive to COVID-19. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : 2021496701 same reporter/product, different patient / event.
no adverse reaction; vaccine was administered before expiration date was checked; expiration of lot # is 3/11/23
As soon as the needle entered my arm I felt a warm, burning, painful sensation that increased as the vaccine was injected. Within minutes it started to hurt at the site of the injection. The pain continued to increase as the hours passed. The pain was not typical post-vaccine pain of muscle soreness but rather a pain that felt/feels like it is under the muscle and slightly electric in nature yet sore as well. I have some weakness in my right arm and any movement of my arm significantly increases the pain. I have had great difficulty sleeping for the past four nights because of the pain in my arm. It is impossible to find a position when lying down that doesn't make my arm hurt. When I'm up for the day, my arm has continued to hurt consistently with an increase in pain when I move it. I do not have any other symptoms. Just the pain in my arm and some perceived weakness in my arm/shoulder. It is now July 22, 2014 and I am still having pain and have made an appointment with my doctor today.
This spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with Tmax 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent temperature excursion with Tmax 9.8 degree centigrade for 23 minutes (explicitly coded as incorrect product storage). On an unspecified date, the two temperature excursions were identified after an audit. On 07-Nov-2018 the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse events after administration. This case is linked to (201805262) due to same reporter.
body aches migraines frequently inflammation in chest and rib cage shortness of breathe after minimal tasks such as dishes going up and down stairs started may 13th 2021 day after vaccine symptoms are frequent present day still
Pt received MMR vaccine on 5-10-19.  May 24th developed Right knee pain and swelling for 24 hours, limited mobility, On 5-26-19 Right hand, fingers and wrist pain, swelling, tingling, limited range of motion, Left hand index fingers pain in joint, pain when bending and tingling, On 5-28-19 pt saw family Dr. RX given for Medrol dose pack.  On the 29th all symptoms resolved except tingling in right hand index finger.
My reaction to the first needle it was terrible; I never felt so bad in all my life like I did last Friday; that's why I am refusing the second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) as dose 1, single 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) with onset 07May2021, outcome "unknown", described as "My reaction to the first needle it was terrible; I never felt so bad in all my life like I did last Friday; that's why I am refusing the second shot".  Additional information: The patient had an appointment on 25May2021 for second shot and she had the severe effect/ bad reaction from the first shot last Friday so she was not taking the second shot. She just want to tell them that they can give her space to somebody else on 25May2021. Her reaction to the first needle was terrible and she will not, she was an older lady, she will be 95 in June She never felt so bad in all her life. She was informed about the Pfizer Medical Information and provided with the number as # requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM as per EST.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headaches with blurred vision and headaches for several days. No over the counter meds have helped
Itching, large red rash, hard bump in left outside upper arm.  Appeared the morning of the ninth day after the vaccine (Monday, Jan. 25).  Slowly improved. By today (Jan. 29), still slight redness and hard bump, but much improved.
Muscle pains started one day after shots -> progressed to arm weakness-> referred to neurology.
Low-grade fever started on 1/6/03. Trunk and face had 50-100 crusting. Is doing well.
Injection site became very red and itchy (4 inches in diameter); Injection site became very red and itchy (4 inches in diameter); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site became very red and itchy (4 inches in diameter)) and VACCINATION SITE ERYTHEMA (Injection site became very red and itchy (4 inches in diameter)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site became very red and itchy (4 inches in diameter)) and VACCINATION SITE ERYTHEMA (Injection site became very red and itchy (4 inches in diameter)). At the time of the report, VACCINATION SITE PRURITUS (Injection site became very red and itchy (4 inches in diameter)) and VACCINATION SITE ERYTHEMA (Injection site became very red and itchy (4 inches in diameter)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Very painful left arm and extreme swelling from shoulder to elbow; skin pink and somewhat warm.  By 3:00 a.m. on 11/10/15 got out of bed and called 24-hour pharmacy to ask what to do.  Pain was then excruciating whenever I moved it.  Pharmacist said to take ibuprofen and get to the doctor.  Next day went to work with extremely swollen and painful arm.  Could not get to doctor until visit to Sisters of Mercy Urgent Care Clinic in Asheville, NC, before work on 11/11/15.  Was prescribed Prednisone 20 mg. (total 8 tablets to be taken over 5 days), Tylenol, and use of ice pack 4X/day for 20 min. was recommended.
Pt was diagnosed with lyme disease in 1995. In 1998 and 1999 was vaccinated with Lymerix at medical center in the lyme vaccine trial. Since that time has chronic and at times severe headaches-muscle and joint pain. Per follow up, box 8 on original VAES for should not have indicated prolongation of hospitalization. There was only IV therapy as outpatient. Also, this case is a clinical trial and is not worked up by VAERS.
I was very nauseated, shortness of breath, vertigo, tachycardia, body aches. I went to ER the following morning after my vaccine.
After I received the vaccine I felt fine. Later that night I had a slight headache and the injection site was sore. I took my medicine and went to bed. I woke in the middle of the night in serve pain at the injection site and still had a headache.  I went back to sleep. I woke at 8am  feeling nauseous and I started trying to walk to the bathroom and tried to throw up. I passed out my husband caught me. He sat me up and put water on face. He called the 911. EMS came out and checked my blood pressure was really low 80/60 range. The night before I checked my blood pressure before taking my blood pressure pill and it was 121/80.  Refused to go to the hospital and I stayed at home and just rested for a couple of hours. I went to work later that night. Every since then I have been feeling weak, dizzy, and moving slow. I feel like it I turn to fast I will fall. I have not been feeling myself.   Just got new insurance and has been trying to find a new doctor and she has been unsuccessful. She is going to urgent care tomorrow.
patient tested positive for the virus (COVID-19) after the first dose of the vaccine; patient tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored Program. This nurse reported the same event for twenty (20) patients (15 residents and 5 staff members). This is the sixteenth (16th) of the twenty (20) reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Started to feel a fever q6h after receiving the vaccine. Up all night with chills and fever of 101.1. Resovled with 400mg ibuprofen. Fever remained into the next day and peaked at 2:00pm on 1/26 (22 hours after vaccine). Resolved with 1000mg acetaminophen. Fever went down to 99.6. Took another 400mg of ibuprofen at 6:00pm and fever resolved with some remaining chills. Of note, pt was also extremely fatigued and had a headache for all of 1/26. Symptoms seem to resolve by 1/27 at 7:00am.
vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Dizziness, Headache, Myalgia & NauseaVomiting Narrative: missed one day work following 2nd dose