chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax;devel hard lump,was tender,hot & size of a grapefruit;rib pain 48 hrs p/ inject;
patient says arm/shoulder still hurting since 2nd dose. gradually gotten worse. radiating into neck as well
Red, hard area noted to vaccination site, measures 4 x 3 cm. Seen in office 5/21/14.
Patient reported malaise and dizziness, since receiving T-DAP. Patient responded well to benedryl (50mg IM)
Pt developed generalized urticaria 1 day after vaccination. pt has had intermittent urticaria and generalized pruritis intermittently since onset 1/3/22. OTC medication recommended to manage pruritis after clinic visit 1/17/22.
Generalized itching treated with steroids and antihistamines. Outcome to be determined.
10/25 pm, noted redness around injection site.  10/26am, noted increased swelling and redness around injection site.  10/27am, noted extended redness & swelling 6"x4 1/2".
Dizziness, Headache Fever, SOB, weakness, fatigue Narrative:
On March 13, 2021 I woke up with my arm red, swollen, and itchy around the injection site  The area was about the size of a golf ball.  By the afternoon it had spread across the upper area of my arm.  Very red, hot and swollen.  Over the next several days It has continued to spread across my entire upper arm.  As of today, it has even started to swell and be hot and red underneath my upper arm.
within minutes of receiving the TdaP vaccine, pt. developed urticaria at the site of the injection that spread around the deltoid and down to the mid arm. The welts were not itchy and patient did not have any dyspnea, wheezing or anaphylactic reaction and BP/VS remained stable.  Patient had a dose of Benadryl 25 my orally and observed for 1 hour in the office. The Urticaria (welts) started going away after 30 minutes and by 1 hours only a macular rash remained.
I had COVID, dry cough, runny nose, extreme fatigue. Joint pain, chills, brain fog and searing pain in forehead. Congestion, no appetite, nauseous, cramps, headaches, diarrhea. I was extremely exhausted. In December, I received antibody injection, autoimmune disorder.
states rt arm swollen ("double size of lt arm) & red from elbow to shoulder;pt saw MD 28OCT96 given med;cold compresses;
Redness, swelling, warm to touch over area about 5cm X 6cm and tissues are hard and tender.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error, on 4/05/2021 046a21a. Second vaccine provided 5/07/2021 - Moderna 023C21A after her 18th birthday. Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away on a Moderna-only day. Unreported as error, found in data mining. Age restriction/confirmation rules were put into effect after the date of the first vaccine to prevent underage vaccines.
Long term arm soreness - currently ongoing since 3/1/21 (over 3 months).  Feels sore to the touch, not to move.  Has tried ice and heat.
Patient received first dose of Moderna vaccine and was sitting in post vaccination area. In approximately 5 minutes he came to pharmacy counter and stated he didn't feel well and felt faint. We got him to the vaccination area and sat him down and put 2 cold compresses on his neck. Patient then passed out and his body made a jerking movement and then went stiff. Within minutes he regained consciousness. He then said he couldn't see and was very sweaty and breathing heavily.  Patient's pupils became extremely dilated. Within a few minutes patient passed out again. He came to within minutes again. The paramedics got here 3 minutes after that. They put a blood pressure cuff on him, heart monitor, and oxygen. His blood pressure was very low but I'm not sure the number. After about 15 minutes his blood pressure returned to normal. The patient refused to go the hospital and went home after.
Patient developed cellulitis of left arm (site of Tdap injection) 4 hours after injection and small local reaction (redness & swelling) of right arm (site of VARIVAX injection) treated with cold compress, BENADRYL, oral antibiotic.
No additional AE; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-MAR-2021, the patient was vaccinated with doses of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039319, expiration date: 04-DEC-2021, 0.5 milliliter (formulation, strength and route of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) lot # T025945, expiration date: 30-JUL-2022, 0.5 milliliter (formulation, strength and route of administration were not reported), both for prophylaxis.  On an unknown date, the doses of the vaccines were exposed to temperature excursion at -1.6 Celsius degrees (C) for 1 hour and 36 minutes. There was no previous temperature reported. The call was due to digital data logger. No additional adverse event was reported.
Severe reaction; This case was reported by a consumer and described the occurrence of adverse event in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. On Monday, the patient received her my first shingrix shot and experienced severe reaction. Because of this the patient assumeed that she should not get the second shot. The patient question was would the first shot provided any protection if she are unable to take the second shot.
Slight headache began about 6 hrs after shot.  Extreme tiredness and light headedness hit the morning of the next day.  Complete loss of energy...and I am a VERY energetic person.  Tiredness and light headedness has continued from 2/4 thru 2/13 with no let up. 11 hrs of sleeping at night after being on couch all day.  NO loss of appetite, taste, smell, fever, or aches.  Headache lasted only a few days.
Almost immediately after vaccine, pt felt very lightheaded, looked like she might faint.  Pt reclined as EMS arrived, vitals 132/82 64 95%.  Second set 7 min later 136/84 68 95%, patient able to sit back up comfortably..  History of 2 prior episodes over 5 years ago, once response of BP after food poisoning, the other she was driving and became stiff and immobile, taken to ER, recovered, no do.  Pt observed for total of 30 min, driven home by husband after clearance ny EMS
07mar90 pt vax hepta B. pt ex burning at inject site and up and down left arm.  approx 30 min later pt ex numbness in left leg, heaviness and cramping in left arm and hand and anterior chest musculoskeletal pain.   See worm...
Moderna COVID-19 Vaccine given at local health department on 2/1/21.  Patient developed nausea and loss of appetite post vaccine.  Became weak and sought care at ED on 2/5/21. Found to have leukopenia, anemia. Hydrated and discharged home.  Patient continued to feel unwell, developed vomiting and diarrhea (has chronic diarrhea since partial colectomy for remote colon CA, but symptoms were worse). Sought care at my health center on 2/9/21.  In-house CBC revealed pancytopenia and patient was clinically ill-appearing and severely dehydrated.  Patient was sent back to ED for further evaluation.  Patient admitted and consults made to Hematology and GI.  Stool culture and cdiff negative, Patient was hydrated and had electrolytes replaced.  Acute renal failure present on admission resolved with IVF.  Sepsis was ruled out. Developed epistaxis requiring 1 unit of platelets to which she had a moderate allergic reaction requiring steroids and benadryl. Severe thrombocytopenia treated with Peg Filgrastim.  CBC improved and patient was discharged to follow up with heme/onc.  Her methotrexate and eliquis was held.
he turned really pale; e turned really blue; couldn't walk; This case was reported by a consumer via interactive digital media and described the occurrence of pallor in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, 15 min after receiving Bexsero, the patient experienced pallor, cyanosis and walking difficulty. On an unknown date, the outcome of the pallor, cyanosis and walking difficulty were unknown.   It was unknown if the reporter considered the pallor, cyanosis and walking difficulty to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient was received Bexsero and had severe reaction about 15 minutes after he turned really pale and blue and he could not walk.
c/o mild itching. 132/78, 78, 18, 99% O2 sat. Narrative: After vaccine c/o mild itching. Cetirizine given PO. Observed 30 min. @ 1340: 132-78, 78, 18m 99% O2 sat. Feeling better. D/C'd stable
Symptoms are getting worst; Tightness in the chest; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Symptoms are getting worst), CHEST DISCOMFORT (Tightness in the chest) and CHEST PAIN (Chest pain) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E214) for COVID-19 vaccination.     The patient's past medical history included Childhood asthma.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced CHEST DISCOMFORT (Tightness in the chest) and CHEST PAIN (Chest pain). On 09-Aug-2021, the patient experienced CONDITION AGGRAVATED (Symptoms are getting worst). At the time of the report, CONDITION AGGRAVATED (Symptoms are getting worst), CHEST DISCOMFORT (Tightness in the chest) and CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.
15 min post COVID-19, Janssen, vaccination ct c/o tingling/perception of swelling L side face, RN did not note any swelling or bilateral facial asymmetry. Ct also c/o tingling in L arm. Ct denied swelling of tongue or throat, v/s taken x2, ct observed in recliner 10 min more, ct had reported feeling better after 1st set of v/s. 08/06/21 and 08/09/2021-attempted to call client 2, no ans x2 msg left to call PHN back, did not receive call back from client.
I started having reactions to sunlight.  My skin breaks out in a rash now when subjected to sun.  I went to my dermatologist and was diagnosed with Chronic Solar Urticaria, something which I've never had.  The night of the shot I got very hot and uncomfortable and was unable to sleep.  I think it changed something in my immune system which has now caused this disease.
The patient called today complaining of pain, primarily in her legs, that had not improved since receiving the Janssen vaccine on 4/10. She thought it felt muscular but wasn't sure. The pain was affecting her ability to work today. I advised her to contact her primary care dr's office or go to urgent care. She called back after seeing her dr today - the dr recommended ibuprofen for pain and said she had a "strong reaction" to the vaccine. According to the patient, no further concerns were identified.
Redness, moderate swelling, warm and itchy at the site of injection 7 days after administration
persistent skin rash; vertigo; balance issues; issues with her vision; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions and concomitant medications. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt suffered persistent skin rash (rash), vertigo, balance issues (balance disorder) and issues with her vision (visual impairment). 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 vaccination, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the vaccination, the pt sustained severe and permanent personal injuries. Further, the pt suffered 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. As a direct and proximate result of the vaccination, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of rash, vertigo, balance disorder and visual impairment was not recovered. The reporter considered rash, vertigo, balance disorder and visual impairment to be related to zoster vaccine live (ZOSTAVAX). The reporter considered rash, vertigo, balance disorder and visual impairment to be disabling.
administered a vaccine that was expired with no reported adverse event; Initial information received on 25-Jul-2023 regarding an unsolicited valid  non-serious case received via Nurse.  This case involves an unknown age and unknown gender patient who was administered a vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength, expiry date, lot number: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, the patient was administered a vaccine that was expired with no reported adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  It was unknown if nay lab data/tests available.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  Outcome: Unknown for the 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 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.
9 month old receiving Kinrix; receiving Kinrix instead of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2020, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd December 2020, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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 was an Health care professionals. The patient had received a shot of Kinrix instead of Pediarix at 9 months of age, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter stated that they realized this mistake on Thursday before reporting date. The reporter consented to follow up.
Pt. developed a large area of redness, itching and swelling on RUE, following her second of (2) Varicella vaccines, given on 3/28/12.
Rash, iching on neck, chest, thighs, and behind ear for one week.
mom awoke @ 2AM to check on child;noticed lips & finger tips were purple, child was shivering & extremities appeared stiff;immed took pt to ER dx acute febrile illness;most likely secondary to recent vax;T101;
Shingles / Feel them starting to come back / Suspected vaccination failure; Shingles / Feel them starting to come back; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had several times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received the Shingles vaccine but occasionally he/she felt shingles starting to come back and immediately he/she take Valtrex and they go right away. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age. When he reconstituted an unspecified number of ZOSTAVAX vials, the total volume of reconstituted product withdrawn is approximately 0.6mL. Pharmacist stated that these doses have been administered to an unspecified number of unspecified patients on unspecified dates. PQC filed. This is one of the reports from the same source. Additional information has been requested.
Covid arm; A spontaneous report was received from a healthcare professional concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) covid arm and want to know if there were any report of this during the clinical trial and if the patient can continue to take the 2nd dose of the vaccine.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event covid arm was unknown.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with ROTATEQ, orally (dose and lot number). No co-suspect or concomitant therapies were reported. The medical assistant reported that multiple unspecified patients were administered ROTATEQ that was improperly stored (dates not specified). No adverse effects were reported. This case is linked to cases 1406USA008435, 1406USA008521, 1406USA008522, 1406USA008523 and 1406USA008525 (same reporter link). Additional information has been requested.
On 3/2/2000, 2 days, post vax, pt had redness, swelling, warmth to both legs from groin to ankle and not wanting to walk. No systemic fever. On 3/28/2000, 2 weeks, post vax, had recurrence of same symptoms with red rash, swelling to bilateral legs. Rash present on legs both times.
Patient received the COVID-19 vaccine on 5/26/21. The next day she developed a headache and became fatigued, achy, febrile, and hypoxic. She was admitted to Hospital on 5/31/21, where she remains inpatient.
No adverse event; Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.  Patient was administered with Moderna vaccine which were beyond the 30 day beyond use date.  Patient received vaccine from lot 042J21A with a BUD of 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up received: Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
sore arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose on unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sore arm on an unspecified date. Outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.