chrisvoncsefalvay/vaers-outcomes huggingface dataset:
plaque psoriasis near head/covid vaccine made plaque psoriasis worse; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (plaque psoriasis near head/covid vaccine made plaque psoriasis worse) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced PSORIASIS (plaque psoriasis near head/covid vaccine made plaque psoriasis worse). At the time of the report, PSORIASIS (plaque psoriasis near head/covid vaccine made plaque psoriasis worse) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication was not reported. It was unknown if patient was enrolled in a Covid-19 vaccine trial.  Treatment drug details were not reported.
I had a problem just a hoarseness and I was sick like 2 weeks; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FK8729) for covid-19 immunisation. The patient's relevant medical history included: "Immune system problem" (unspecified if ongoing), notes: Verbatim:Immune system problem., I have immune system problem (history). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "I had a problem just a hoarseness and I was sick like 2 weeks"; ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional Information: It was reported that, this report was not related to study or program. So the 3rd Booster and had a problem with too but it was just a hoarseness, and I was sick like 2 weeks from it but this one was the first time that actually had an anaphylaxis and that was not something you usually get. Patient had immune system problem (history). Consumer was informed about  Pfizer Drug Safety. Consumer was informed about Pfizer  Department. As consumer was not willing to proceed the call. Hence further probing could not be done. Limited information available over the call and appropriate response could not be provided.  No follow-up attempts are possible. No further information is expected.
Fever >100.8, chills, generalized body aches, headache, and anhidroses
First dose 07Mar2021, second dose 12May2021; Arm soreness; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in Arm Right on 12May2021 (at the age of 65-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included allergies to penicillin, sulfa, skin tissue adhesive, grass, and pollen (environmental) from an unknown date and unknown if ongoing. Concomitant medications included Estradiol, Simvastatin, Ramipril and Famotidine (medications prior to the event being reported) taken for an unspecified indication, start and stop date were not reported. The patient previously received Ampicillin, and Ciprofloxacin and experienced allergies.Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot Number: EN6199, Route: Injection) administered in Left upper arm on 07Mar2021 (morning) for Covid-19 immunization and experienced tachycardia, bounding heart beats, shortness of breath, dizziness, numb lips, tachypnoea, dry cough and hoarse voice. Patient previously had history of allergies and used Fluticasone proprionate and Fexofenadine as a specific medication for it. Prior to the event patient did not receive any recent vaccines for any other conditions. Prior to the event, patient did not receive any recent vaccines for SRAS-CoV2 other than Pfizer-Biotech COVID-19 Vaccine and not receive any other vaccines around the time of Pfizer-Biotech COVID-19 Vaccine Vaccination. Patient received first dose 07Mar2021 and second dose on 12May2021 (inappropriate schedule of vaccine administered). On an unspecified date in 2021, patient experianced arm soreness and reported that she had no other adverse reaction. The patient underwent lab tests and procedures which included on 12May2021, allergy testing for PEG allergy: negative and Sars Cov 2 AB (166) spike semi QN: zero and greater than 20 on 01Jun2021. The outcome of events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Patient became sore and sleepy within 20 minutes of vaccinations (DTP, Hep B, IPV, HIB, PCV, & Rotavirus). For the next two weeks his legs were rigid and hard as rocks near the vaccination sites, he had diarrhea, cried almost constantly, stopped sleeping through the night, ran a low fever, his legs hurt him even with a soft touch he would scream.  This lasted for two weeks and slowly went away.
fever,  excruciating pain (over entire body), histamine response, headache, swollen lymph nodes
One hour post-vax the patient returned to the clinic complaining of her left arm itching. The injection site was reddened 30mm in diameter. The patient was treated with Benadryl.
After receiving the 2nd dose of the Covid-19 vaccine  on 1/11/2021 at 8:15 am . On 1/12/2021 at 5:36 am I started to experiencing headaches, slight fever and whole body aches, and  both of the back and front of my calf's muscle felt very heavy had a hard time getting out of bed and not able to walk well,  I took Ibuprofen every 6 hours. The Ibuprofen helped with the headaches and fever.   on 1/13/2021 I woke up feeling better,  no fever  just very tired and had 3 headaches during the day.
My immune system went into overdrive and produced an overwhelming amount of histamines.  I had a rash for weeks, developed asthma, itched on my scalp and other parts of my body.  Developed severe anxiety. Developed ghost smells of things that were not present in my environment. I was prescribed some OTC and prescription strength medications including: METHYLPREDNISOLONE 4 MG DOSEPK, LEVALBUTEROL TAR HFA 45MCG INH HFA AEROSOL INHALER, WIXELA 100-50 INHUB BLISTER WITH DEVICE, MONTELUKAST SOD 10 MG TABLET, QVAR REDIHALER 80 MCG HFA AEROSOL BREATH ACTIVATED, SYMBICORT 160-4.5 MCG INHALER HFA AEROSOL INHALER, Pepcid AC and Benadryl. My severe symptoms lasted for more than 90 days and I still suffer from time to time with itching all over my body and some difficulty breathing.
Urticaria on face, legs, torso - improved w/ BENADRYL in 24hrs.
Upper right arm within about 4" from injection site bright red, swollen, hard and hot to touch on 3/19/09. 3/20/09 signs and symptoms persist with larger area involved to about 6" from site. 3/20/09 treated with oral Prednisone 16 mg BID x 2 days. (on 3/19/09 - mother applied hydrocortisone cream). S/s subside 3/31/2009.
After orientating Mom on the vaccination process, the child is vaccinated. After vaccinating the minor, patient refers to feeling dizzy and begins to presents which suffers temporary loss of consciousness. She was offered the necessary care and first aid to stabilize the patient. After several minutes in observation the patient is stable, alert and oriented, Mom is recommended to visit a doctor.
Experienced joint pain / described as severe / resolved within two months; This case was reported by a Nurse via call center representative and described the occurrence of arthralgia in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2015-2016 season) for prophylaxis.   The patient's past medical history included psoriatic arthritis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2015-2016 season. On an unknown date, several weeks after receiving Influenza vaccine Quadrivalent 2015-2016 season, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was recovered/resolved.   It was unknown if the reporter considered the arthralgia to be related to Influenza vaccine Quadrivalent 2015-2016 season.  Additional details were provided as follows: Age at vaccination was not reported. The health care professional, who was also the patient, reported that she received an adjuvanted flu vaccine made in 2015. The  patient experienced joint pain a couple weeks after receiving vaccine. Joint pain was described as severe. Joint pain resolved within two months, no resolution date provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020242244:Same reporter
Side effects experienced: None; Inappropriate schedule of vaccine administered; This spontaneous report was received from a lawyer and a consumer, reporting on a 61-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.   On 16-OCT-2009, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). On 13-NOV-2012, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). On 17-JUN-2016, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, frequency, lot number, expiration date, route of administration and site of administration were not reported for any of the vaccines) (inappropriate schedule of vaccine administered). No adverse effects were reported.   On 15-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) and experienced shingles, anxiety, depression, loss of balance, bell's Palsy and enlarged aorta/cardiac aneurysm (case # 1803USA001121).  This is one of two cases from the same patient.; Sender's Comments:  US-009507513-1803USA001121:
Had an issue with vertigo after the vaccine. Its really sickening. I haven't seen the doctor yet but in the process of seeing one. It limits what I can do on the daily. I've never had vertigo last this long.
Patient did not know she was pregnant when she took the vaccine (smallpox).  Her LMP was 2 Feb 04, she received the smallpox vaccine on 25 Feb 04, pregnancy was confirmed on 15 Mar 04.
Headache. Chillls, then headaches and arm pain at vaccine site.  Narrative:
Information has been received from a 81 year old female with hypertension who on 22-AUG-2007 was vaccinated with ZOSTAVAX for prevention of shingles. Concomitant therapy included blood pressure medication (unspecified). On 24-AUG-2007 the patient experienced bumps on her left thigh. The patient's bumps on her left thigh persisted. No Further information is expected.
Severe shortness of breath while peak flow was 470 and O2 was 98%. Sharp chest pain on the left side on october 4 which has continued but become an ache.
Tiredness; Chills; Stayed in bed a day; This case was reported by a consumer and described the occurrence of tiredness in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced tiredness, chills and bedridden. On an unknown date, the outcome of the tiredness, chills and bedridden were unknown.   It was unknown if the reporter considered the tiredness, chills and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix few months ago and had tiredness for reaction and had some chills and stayed in bed a day. The patient asked should 1 get a second shot and how far apart can I get the 2nd shot without having to start again. The patient asked should 2nd dose be administered between 2-6 months following the 1st dose. The reporter not able to provide an answer to that questions.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. In approximately the fall of 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), for routine health maintenance and for the vaccine intended purpose: prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered from painful rashes across her back and abdomen. On 15-OCT-2018, the pt was diagnosed with herpes zoster and underwent medical treatment for these injuries. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. It was also claimed that as a tragic consequence of the company wrongful conduct, 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 company conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered. The reporter assessed that the event was related to the zoster vaccine live (ZOSTAVAX).  The reporter considered the event of herpes zoster to be disabling.
Chills with a fever for about 3 hrs the next day, headache, fatigue for the next 2 days following the vaccine.
The patient developed a rash around the injection site. 3 days later the patient noticed the rash had spread down his arm to his back, chest and to his right arm. The rash was solid on his right arm and neck and was scattered on all other areas. The patient experienced severe itching. The patient was seen by the doctor on 10/31/2001 and treated with a cortisone injection and medication for the itching.
patient s/p J&J COVID vaccine on 4/9 at pharmacy. admitted on 4/26 with acute onset paralysis to BUE and BLE. MRI c/w transverse myelitis
PATIENT WAS SITTING THROUGH THE WAITING PERIOD. ABOUT 10 MINUTES LATER PATIENT'S HUSBAND NOTIFIES ME (VACCINATING PHARMACIST AND REPORTER OF THIS FORM) THAT THE PATIENT WAS GETTING TIRED, ITCHY, AND RED SPLOTCHES WERE SHOWING UP.  I ASKED THE PATIENT HOW SHE WAS FEELING, AND SHE DESCRIBED THE SYMPTOMS ABOVE AS WELL AS HER THROAT "FEELING FUNNY." I ALERTED A FELLOW PHARMACIST WHO THEN MONITORED HER AND CHECKED HER BLOOD PRESSURE. PATIENT TOOK A DOSE OF HER ALBUTEROL HFA INHALER TO SEE IF IT WOULD HELP. AFTER SOME TIME, SHE THEN REQUESTED AN EPIPEN THAT SHE INJECTED HERSELF. A CODE BLUE WAS CALLED AND THE MEDICAL STAFF ASSESSED HER. HER CURRENT STATE DID NOT WARRANT HER TO BE ADMITTED. PATIENT REMAINED IN THE LOBBY FOR STAFF TO MONITOR HER. EVENTUALLY, PATIENT LEFT TO GO TO HER CARDIOLOGIST.  I CALLED THE PATIENT TO CHECK UP ON HER THE FOLLOWING DAY, AND PATIENT REPORTS THAT SHE IS DOING WELL.
I was having some issues with my throat being clogged and my sinus' were really irritated. I did take a COVID-19 Home Test and that was negative, but I called and had a virtual visit. They had me come in the next day and I was tested for strep throat. They got me on antibiotics, and I watched for a fever as well. I was able to go back to work after two days of being on the antibiotics.
Red and slightly itchy rash that spanned most of my upper arm around the injection site. It lasted several days.
an expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 27-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 18th January 2023, unknown after receiving Twinrix and Twinrix 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 Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: The nurse called to report an expired dose of Twinrix was administered to a patient. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used. The case had been linked with US2023011719 reported by same reporter.; Sender's Comments:  US-GSK-US2023011719:same reporter
Fast and irregular heartbeat that went on for 8 hours-up to 130 beats a minute when standing, 88-100 resting- 2 very strong beats then 2-3 very rapid soft beats- increased with exertion, even just standing up-took 1 cetirizine tab and rest-slept- woke up at 11:30 still having rapid & irregular heartrate- woke up at 4 AM and heart rate was normal and regular- 70 - has remained normal since then- no other symptoms.
edema at injection site; Erythema at injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE OEDEMA (edema at injection site) and VACCINATION SITE ERYTHEMA (Erythema at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE OEDEMA (edema at injection site) and VACCINATION SITE ERYTHEMA (Erythema at injection site). On 12-Jan-2021, VACCINATION SITE OEDEMA (edema at injection site) and VACCINATION SITE ERYTHEMA (Erythema at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Immediately for 36 hours  - left arm pain - head fog - thirsty - fatigued In addition: my 3 year old daughter developed roseola 4 days after I received the shot. I did not mention my vaccine, and her pediatrician informed us that roseola is a herpes virus and it is often a virus that sheds from parents and often lays dormant in parents. It is my belief that the vaccine caused me to shed this virus to her.
Pt stated arm was red swollen next day. Very painful unable to work for 2 days. Left work. Drove home. Not aware that he was driving home, got home. Left car running for two HRS. Had chills. But did not take temp or go to Emergency. Unable to contact pt for more Info. Left 2 message no return calls. Arm (R) still soar.
Patient here for TB test reading. Noted that patient had red area on dorsal aspect of left arm. Area about 50x50 cm. Mother reports was larger and "itchy"yesterday. Area warm to touch, not raised. Mother reports area much improved today.
This case was reported by a healthcare professional and described the occurrence of rash in a 6-month-old subject of unspecified gender who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  On 26 March 2007 the subject received an unspecified dose of Pediarix.  On 26 March 2007, less than one day after vaccination with Pediarix, the subject experienced a rash (specified of rash not described).  The subject was seen in an urgent care center and treated with Benadryl.  At the time of reporting the outcome of the event was unspecified.  The healthcare professional considered the event was probably related to vaccination with Pediarix.
Around 1440 on 3/27 patient arrived to the local ER with difficulty breathing, hoarseness and asymmetrical closing of her throat. Throughout her stay she was intubated and monitored in the ICU. As of today 3/30 patient is alert, resting comfortable in med surg. Complains of a sore throat and should be discharge tomorrow.
No other AE reported; we inadvertently gave a 14-year-old patient an adult dose of VAQTA that was expired; we inadvertently gave a 14-year-old patient an adult dose of VAQTA that was expired; This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-MAR-2021, the patient was inadvertently vaccinated with an expired, adult dose of hepatitis A vaccine, inactivated (VAQTA) 1 ml, lot # S037821, expiration date 07-JAN-2021 (route of administration and anatomical location were not provided) for prophylaxis (accidental overdose, expired vaccine used). There was no product to retrieve as it was disposed of at the office. No adverse event was reported.
Pain, swelling and itching at injection site. Treated with topical steroids, Tylenol and ice compress. Tylenol has done the most to reduce symptoms. Still ongoing.
Patient had her 1st menses 10/08 - had a cycle 11/08 and 12/08.  HPV given 1-16-08 - no menses since.
Patient arrived for second dose of  COVID-19 vaccination (Pfizer). During review of pre-vaccination CDC checklist, patient admitted to having a reaction to the first dose. She understood the risk of a possible reaction to the second dose. Patient said "I am in the last three months of nursing school and will be kicked out of the program if I don't get the second shot. I have fought with them about it since August and they don't care. I have to get this." Patient was adamant about proceeding with second dose even after the risks were explained.    12:05 pm: Patient moved to medical area where emergency medication and monitoring equipment were available. A employee health nurse was also present for the entire encounter.   12:14pm: Patient was breathing rapidly, pulse and blood pressure were elevated. Upon auscultation, lungs were clear. No wheezing noted. The lead RN was notified of patient symptoms and the employee health nurse was still monitoring the patient.  12:18pm: Inspiratory wheezing could be heard from 5 feet away. Significant expiratory stridor were also noted. Patient was clearly in distress. Per protocol, 0.3mg of Epinephrine was given at this time and 911 was called. RN stayed with the patient and continued to monitor. Shaking and elevated pulse noted. Patient complained of heaviness in her chest.  Lungs were clear and with good air exchange. Upon EMS arrival report was given and patient was transported.
injection site started to itch 6 days after dose 1; 8 days after dose 1 a large rash appeared on arm; rash was warm to the touch. 11 days post vaccine rash is still present.
Developed red, tender warm area underside of upper arm. Size of red area 4-5 " x 1-2" saw MD on Friday 11/13/2000 at 14:30 advised that she had allergic  reaction and to take po Benadryl. Resolved in 3 days. Actual site of injection was very tender first 24 hours post vax. but no redness.