chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who on an unknown date was vaccinated with PNEUMOVAX 23 (Lot # 660685/0619X) in the arm (dose, route not reported). Subsequently the patient developed cellulitis. It is unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Hives on neck and arms; This is a spontaneous case initially received from Med Communications (case ID: SEQ19-03486) by pharmacist on 30-Sep-2019 and follow up received on 01-Oct-2019 (being processed together), concerning a 28-year-old, male patient.     The patient's current medical condition included penicillin allergy.   On 25-Sep-2019, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: right deltoid, route of administration: intramuscularly, batch number: P100116850, expiration date: 30-Jun-2020) for influenza prophylaxis.  On the same day, after the vaccination, the patient developed hives on neck and arms.  On 26-Sep-2019 in the evening, the patient came back to pharmacy with hives on neck and arms.   On 28-Sep-2019, the patient was seen at urgent care and came to pharmacy with prescription for hives.   At the time of report, the outcome for the event was not reported.  The reporter assessed the case as non-serious. The reporter did not provide causality assessment.  Event's causality was assessed as related to the suspect product per company.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
she had a bump the side of a gulf ball on her arm at the injection site; tumor; sick in bed for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (she had a bump the side of a gulf ball on her arm at the injection site), NEOPLASM (tumor) and ILLNESS (sick in bed for 24 hours) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M210A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis since 31-Oct-2018, Allergy to antibiotic (Cipro), Penicillin allergy (Penicillin), Drug allergy (macrobide), Iodine allergy (iodine) and Shellfish allergy (shellfish). Concomitant products included OCRELIZUMAB (OCREVUS) from 15-Mar-2019 to an unknown date for Multiple sclerosis.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (she had a bump the side of a gulf ball on her arm at the injection site), NEOPLASM (tumor) and ILLNESS (sick in bed for 24 hours). At the time of the report, VACCINATION SITE MASS (she had a bump the side of a gulf ball on her arm at the injection site) had not resolved and NEOPLASM (tumor) and ILLNESS (sick in bed for 24 hours) outcome was unknown.            Diagnostic results: On an unknown date, Antibody test-negative.  No treatment information was provided by the reporter   This case was linked to MOD-2021-031333.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Significant follow up appended: Event addition illness, height, weight, lab data On 17-Aug-2021: Follow up received contain non significant information
large knot in arm and large red circle for 5 days after; 7 months later pain in muscle where shot was given daily, very sore to touch and to move arm.
Patient had a syncopal episode followed by a brief seizure-like episode (5-10 seconds long). Was back to baseline after.
Left upper arm cellulitis as evidence by redness, warmth, tenderness at injection site. Treated with KEFLEX 500 mg 4x/day x 7 days and also IV ROCEPHIN 2 gm x 1 dose.
Patient developed 2 small bruises, one at each injection site about a pea sized.  Also had fever for 2 days, max 101.9.  Came in today with 2 red marks on arm and claimed they itched 1 was the size of an orange and 1 about quarter sized.
ARM PAIN, SWELLING AND WARMTH AT THE TOUCH LOW GRADE TEMP 99.0
Prolonged crying, some vomitting, unconsolable for ~24 hours following vaccination with Pediarix, Hib and Prevnar.  Hospitalized overnight for observation.  Discharge summary on 05/05/04 states: GERD.  Medical record on 05/05/04 states: Irritability 2° to immunizations.
Pt recv vax Nov96 & 02Mar98 lab eval lack of seroconversion for rubella. No further information
Information has been received from a pharmacist concerning a female patient of unknown age. The patient reported to the pharmacist that she forgot that she was vaccinated with ZOSTAVAX two years ago (date not specified) and had a second dose given to her at an unspecified physician's office within the last two months (date not specified, report date was DEC2014). The patient also reported that at some point in between the first and second dose of ZOSTAVAX she developed a case of the shingles. The patient did not seek treatment with the pharmacist for the shingles or for any concerns post the second dose of ZOSTAVAX. The patient asked the pharmacist if she should be concerned about receiving 2 doses of ZOSTAVAX. The pharmacist stated that there was no current adverse effect. Additional information has been requested,
Information has been received from an 84 year old female patient with hypertension, diverticulitis, acid reflux, celiac disease, "ceomalformations", allergies to generic medications: amoxicillin, acetaminophen and DARVOCET, LASIX, VALIUM and sulfonamide allergy (generic medication) and a history of shingles who on 28-OCT-2009 was vaccinated with a single dose of ZOSTAVAX (Merck) (Lot # not reported). Concomitant therapy included prednisone (manufacturer unknown), VALTREX, MICARDIS, amlodipine, SYNTHROID, COUMADIN, PLAVIX and simvastatin (manufacturer unknown). The patient reported that after receiving the vaccine on 21-JUN-2010 she developed shingles. At the time of the report the patient had not recovered. Follow-up information has been received from a physician who reported that the patient did not have adverse reaction. The patient was upset because of developing shingles outbreak 6 months post vaccination. Additional information is not expected.
Pt recvd 1st immun on 2MAY91 & had 2nd HIB/DTP/OPV on 6NOV91 pt was taken to ER & hospitalized; dx H. influenza meningitis; tx include Ceftriaxone IV & Dexamethasone; @ time of report pt is in peds ICU;
Patient received Bexsero on 08/14/2019 and Trumenba on 11/09/2020; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old patient who received Men B NVS (Bexsero) (batch number ABX797AA, expiry date 30th September 2020) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 14th August 2019, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th November 2020, the patient received TRUMENBA. In November 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: After receiving Bexsero, the patient received Trumenba on 9th November 2020, which led to interchange of vaccine products. The reporter consented to follow up.
First Dose: Right Arm Sore, just felt like an allergy shot going in; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 53-year-old female patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot/Batch number: ER8732, Expiration date: 31Jul2021) via an unspecified route in the right arm on an unknown date in 2021, as a dose 1, single for COVID-19 immunization. Medical history included Cushings syndrome from: 2007 (Ongoing) and lost her right adrenal gland, right adrenalectomy from: Dec 2007, Osteoarthritis (ongoing) and hypersensitive to chemicals (her body rejects chemicals) and she has to eat organic food, Cushings sucks. The patient concomitant medications were not reported. Patient states part of her Cushing's Syndrome she has a short memory. She doesn't take any other medication. Patient states one doctor had her take Avalox and it almost killed her (NDC, Lot, Expiration Unknown), it was years ago. There was a class action lawsuit, but it was for heart damage, so they didn't let her on the bandwagon even though she had tachycardia. States Avalox was a bad thing. Patient states she lost her doctor of 25 years, and the new guy she saw didn't care what vaccine she got or know what one she should get. States she still shopping around for a new doctor and the doctor she just interviewed knows nothing about Cushing's and he was slightly rude to her, so she still shopping for a practitioner, and she doesn't think she will find one. She would love for physicians to be aware of this reaction in Cushing's patients, but she can't find anyone in her area who was versed on Cushing's Syndrome. Patient received occasional Tylenol. CBD and THC, but they are not working. She rarely takes Tylenol in case of Liver Failure and doesn't take anything she doesn't have to. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, patient experienced right Arm was Sore for 2 days, just felt like an allergy shot going in. Adverse events did not result in emergency room or Physician office visit. She was scared to have to take a vaccine that had not been around very long, but she knew she had to since she was at high risk. States she definitely knew she was getting the vaccine. She didn't know if the vaccine would kill her, but she knew COVID would. Caller states for patients with Adrenal Disease and Cortisol Issues and hypersensitivity to chemicals, this could be an effect to watch out for. The clinical outcome of the event was recovered at the time of this report.  Additional information has been requested.
Information has been received from a physician concerning an 8 year old male who was vaccinated with the first and the second (lot # 657941/0851U) dose of VARIVAX (Merck), 0.5ml on 06-DEC-2001 and 10-AUG-2007 respectively. On 22-APR-2009 the patient experienced a case of chicken pox even though he had received 2 doses of VARIVAX (Merck). The patient's case of chicken pox persisted. The patient sought unspecified medical attention. Additional information has been requested.
No Adverse event; Patient received doses out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received doses out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original) and NO ADVERSE EVENT (No Adverse event) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received doses out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received doses out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received doses out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original).    No concomitant information was reported.  It was reported that there were no temperature excursions involved, and the vaccine was not expired.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666042, US-MODERNATX, INC.-MOD-2022-666046, US-MODERNATX, INC.-MOD-2022-666043, US-MODERNATX, INC.-MOD-2022-666045, US-MODERNATX, INC.-MOD-2022-666016 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666046:Same reporter US-MODERNATX, INC.-MOD-2022-666043:Same reporter US-MODERNATX, INC.-MOD-2022-666042:Same reporter US-MODERNATX, INC.-MOD-2022-666045:Same reporter US-MODERNATX, INC.-MOD-2022-666016:Same reporter
Swollen arm; it had a big red spot; it was itchy; A spontaneous report was received from an other healthcare concerning a 71 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen arm/peripheral swelling, it had a big red spot/rash macular, it was itchy/pruritus.   The patient's medical history included chronic lymphocytic leukemia. Products known to have been used by the patient, within two weeks prior to the event, included fluoxetine hydrochloride and centromine.    The patient received their first of two planned doses of mRNA-1273 (Batch number: 013C20A) on 19 Jan 2021 in the left arm for prophylaxis of COVID-19 infection.   Ten days after receiving the vaccine patient experienced swollen arm, it had a big red spot, it was itchy. Treatment for the event included Paracetamol and Ibuprofen.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The events swollen arm, it had a big red spot and it was itchy was resolved on unknown date.
14.5 x 8.5 cm area of induration, erythema, warmth & mild tenderness around site of injection of DTAP.
Within 5 minutes of injection, patient complained of throat tightness, swelling in throat, itch.  No swelling is seen in tongue/mouth.  Patient appeared well, lungs clear.  O2 sat was 100% throughout, and HR was in the range of 70-84.  Administered Benadryl 25 mg without much change, then took 2nd dose Benadryl.  Here BP became elevated, up to 170/101, before some gradual decline.
Lethargic, congestion, not eating, vomiting, T 99.6
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient took antiviral paxlovid from 29Sep2022 to 04Oct2022 for covid-19 treatment. No other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately one hour after receiving the flu vaccine, client approached me reporting that he felt "queasy stomach and a mild headache. No other symptoms reported.  Advised to try to take antiacid and Tylenol which he states he has and then he wants to go home. I advised to call his personal physician for further advise, or care. Patient had hx of adverse reaction to flu vaccine?  close to 7 years ago and states that he had taken flu vaccines every year for the last 6 years with no problem. I called client after 3 hours and the following day (he went back to work) and said he was fine after he took several hours nap.  This is a second report filing to make sure the first one was  received.
I felt an unusual feeling in my chest like a bubbling feeling and I went to the doctor. I sometimes have gastric issues and this felt different than normal. I went to the doctor and they took blood work. I was told that my Pancreatic enzymes were very high and I was told to go the emergency room. After testing there was no problem with my Pancreas, and I did not feel really sick.  I got the second dose of the vaccine and I had fever and chills the next day. I didn't have any more of the chest feeling like the first time.
Case number PHEH2013US022396 is an initial spontaneous report from a health care professional received on 23 Oct 2013. This case refers to a patient of unknown age and gender. This patient was given only MenCYW-135 liquid component of MENVEO (batch number: unknown) intramuscularly on an undetermined date. MenA component was not administered to the patient. No adverse event was reported following this administration error.
Developed itch and rash. Went to doctor and was told he had hives. States he received a couple prescription meds and is better. Still has a few hives (rash) left. Has had flu shots in past years.
Patient reported the reaction to our pharmacy on 1/5/2017. We tried to contact patient's physician on the same day of 1/5/2017.  Patient stated the day after vaccine, she developed itchiness, feeling of "skin crawling", itchy and swollen, painful breasts. She took Benadryl for 1 day and symptoms got better, but she stopped taking the Benadryl. Two days after vaccine, she says she developed accumulation in her nose with blood, plus throat irritation with phlegm. On 1/7/2017, patient stated her hands were still swollen and back still itchy. The doctor's followed up with patient on 1/10/17 and the nurse informed patient to keep taking Benadryl. Patient stated around 4pm on 1/10/17 she noticed the feeling of pricking on her skin (bottom, sides, and stomach.  She stated her legs were fine.  Today on 1/11/7, patient reports itching on back and breasts and skin is still sensitive.  She stated she went to the gym today and her hands became red and itchy when she grabbed her weights. She also stated her blood pressure increasing but feels it is due to the Benadryl.  Informed patient to contact MD regarding her raise in blood pressure and her persisting symptoms.
angioedema; urticaria; tongue swelling; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 14:00 (Lot number: FJ8762) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2011 (unspecified if ongoing), notes: diagnosed in 2011 but have had no events since 2014); "Angioedema", start date: 2011 (unspecified if ongoing), notes: diagnosed in 2011 but have had no events since 2014); "Urticaria", start date: 2011 (unspecified if ongoing), notes: diagnosed in 2011 but have had no events since 2014). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]. Past drug history included: Demerol, reaction(s): "Known allergies:Demerol". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 13Feb2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5206, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 06Mar2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: SWOLLEN TONGUE (medically significant) with onset 25Dec2021, outcome "not recovered", described as "tongue swelling"; ANGIOEDEMA (medically significant) with onset 21Jan2022, outcome "not recovered", described as "angioedema"; URTICARIA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "urticaria". Clinical course was reported as follows. Since receiving the 3rd dose, she had experienced angioedema and urticaria. It started on 25Dec2021 with tongue swelling. She was seen in the ER. On 27Dec2021, she got a hive on my back leg, 31Dec2021 and 11Jan2022 more hives. On 21Jan2022, angioedema top and bottom lip, right side. On 25Jan2022 hive on her hand, and on 27Jan2022 a hive on my right shoulder. The adverse events resulted in emergency room/department or urgent care visit. The patient was given IV epinephrine.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events angioedema, urticaria, swollen tongue and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
After my second dose I had a very high fever of 104.5.  I felt as though my chest was very tight and I though I might have a heart attack.  I got my body to cool down with tylenol and cool compresses - I felt extremely tired through the next 24 hours but then got better.  I am hesitant to do the booster for this reason.
I received the vaccine on the 15th. Had mild chills and fatigue the following day. The morning of the 17th, I woke up and felt like the right side of my face was bruised, just under the apple of my cheek. Looking in the mirror, I saw my right side of mouth had a droop.  I notified the County Health Department where I had received the vaccine and then called my PCP.  My PCP did a telehealth visit with me and confirmed Bell's Palsy characteristics. I had no other issues so no further testing was deemed needed and my PCP prescribed a short course of steroids and vancyclovir.  I have an in person visit with PCP tomorrow.
Red swelling at injection site.  High pitched screaming for several hours at a time that lasted for more than two weeks and still happens occasionally.  Seems to be in terrible gastric distress during these times.
Pt Felt Anxious and reported feeling Itchy all over her body. No signs of urticaria, no S.O.B. only feeling of anxiety and an urge to scratch herself. EPFD Called out for evaluation and patient refused transport.