chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick; Initial information was received on 07-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got sick for three days from the senior one so I get the regular flu shot"  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Pt reports face tingling and redness in face and arms approximately 1-2 hours after receipt of vaccine
Random Hives started to be more frequent since first Covid Moderna Vaccine in 10/18/2021. Then had another Covid Moderna Shot on 03/24/2022, 2 days later developed hives on bottom thighs. Also had another occurrence in April 2022. And last episode of having hives was on 05/15/2022 covering neck and shoulder area.
Oh her way home (about 30 min after getting the injection) she developed tingling of her lips and tongue that lasted 15 minutes and spontaneously resolved without reoccurrence.
24 hrs after shot noticed redness and swelling to R arm. Rash continued down the arm to the wrist up the arm to shoulder, torso, neck and R cheek, + itchy. No cellulitis no induration at shot location.
patient experienced COVID; patient experienced COVID; Joint pain; MARKETING PROGRAM NAME WAS NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4233077-00.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single and intramuscular, administration date 03Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. 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 2021, outcome "recovering" and all described as "patient experienced COVID"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered", described as "Joint pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive, notes: In 2021, the patient experienced COVID. The action taken for adalimumab was unknown. In 2021, the patient experienced COVID and JOINT PAIN. On an unknown date, Joint pain resolved. Pfizer BioNTech COVID-19 vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 03Feb2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 01Mar2021, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.   The reporter's causality for the event of COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of joint pain was not provided.  The reporter's causality for the events of COVID and joint pain with BNT162B2 was Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, covid19, arthralgia cannot be totally excluded.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 19-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare providedr for shingles. The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
For first week after injection, only symptom was mild pain in the arm. After 7 days, injection site became very swollen, hard, itchy, red, and hot. Swelling and hardness went down after 2 days. Rash and occasional itching persists. It is now 13 days after the injection
I got my second Pfizer COVID-19 vaccination on April 13; had no symptoms beyond a sore arm with the first. About a week after the second dose, I began experiencing a lot of pain/irritation/itchiness along the side of my right breast, under my right arm, and around to my right shoulder blade/upper back. (I thought it was just dry skin or some random irritation ? but the skin looked completely normal.)   The skin irritation/pain/itchiness lasted for four days, and on the fifth day (Sunday, April 25) I began developing a rash where the pain was. I was diagnosed with shingles by my doctor on April 26 (via a telehealth appointment, I emailed pictures) and had an in-person follow-up on Tuesday, April 27, with another doctor at the same practice (mine was out of office that day but wanted me to come in asap). Shingles was confirmed and I was given some fun prescriptions.   It is April 30 now; I am taking valacyclov (1 gram tablets) 3x per day; I give occasional stink-eye to the bottle of gabapentin I was given... not taking it; I'm sticking with Motrin for pain.  I have had some intermittent chills here and there, low-grade fever (mostly in the evening, but it's probably because I'm still working during the day from home and I'm just extra run-down). The rash is pretty gross and angry-looking at this point, honestly. It's started blistering and running its course, which kinda sucks since it's underneath my entire right breast, beneath my arm (not IN my arm pit, but a couple inches below) and my right shoulder blade and now a patch in my mid-upper-back. Needless to say, I'm living my best life in a soft t-shirt with no bra. (Working from home for the win!)
Rash and swelling, pain for 6 days. Given Depo-Medrol 80mg I.M. for treatment.
patient was administered just the liquid diluent component of pentacel without being reconstituted with the lyophilized component of the vaccine with no adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who was administered just the liquid diluent component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]without being reconstituted with the lyophilized component of the vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 17-Aug-2022, the patient received a 0.5ml 1X(once) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot U7256AA and expiry date: 27-Apr-2023) via intramuscular route in the left vastus lateralis for Immunization.  On 17-Aug-2022 the patient developed a non-serious event of patient was administered just the liquid diluent component of pentacel without being reconstituted with the lyophilized component of the vaccine with no adverse event (product preparation issue, Latency: same day). Patient was just administered the diluent liquid component of Pentacel without reconstituting it with the lyophilized powder component. Wanting to know what the next steps are. Reporter also asked where can she get the 0.4 % NACL saline diluent to mix with the ACTHIB component.  No further information provided.  Action taken : not applicable.  Outcome: Unknown  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.
This case was reported via a statement of injuries received via a lawyer and described the occurrence of flu-like symptoms in an adult male subject who was vaccinated with LYMERIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced flu-like symptoms, headaches, vision loss, possible memory loss and decreased activities of daily life, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.
Patient came into clinic on 4/16, left arm was mildly swollen with extreme erythema, hot to touch, swollen past elbow and into armpit. Very painful and itching.
Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-DEC-2010, at age 63, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
swollen arms; lymph node, arms and wrists hurt; arms and wrists hurt; wrists hurt; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN620G), via an unspecified route of administration, administered in left arm on 24Feb2021 (age at vaccination was 63-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient received concomitant medications in two weeks. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The facility where the COVID-19 vaccine was administered was in hospital. On 24Feb2021 at 16:00, the patient experienced swollen arms; and lymph node, arms and wrists hurt. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Felt warm first day but that went away. after 7 days my nose sudenlly  started dripping blood, not much but whole night few drops when I would bend( was at work). after that I have feeling my right side of sinuses are clogged abd have weird ( like there is water runing) in my ears. I have no pain or fever. Then in day 10, in morning when I got up, I was extremly dizzy and felt vertigo, now this simptom still is going on, dont kniw what to do about it...???
PATIENT NOTIFIED PHARMACY OF SORE ARM EVEN AFTER A MONTH OF VACCINATION. PATIENT STATED PAIN IN GETTING BETTER BUT NOT COMPLETELY GONE. NO REDNESS OR RASH IN THE INJECTION SITE.
expired ADACEL was given with no reported adverse event; Initial information received on 17-Aug-2021 regarding an unsolicited valid  non-serious case received from a other health professional via Media information (under the reference 00728465).  This case involved a 30 years old female patient who was vaccinated with an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication were given to the patient.   On 17-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, total, 1X(once), 0.5ml, lot U6214AA and expiration date: 14-mar-2021) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported, "HCP (Healthcare Professional) stated expired ADACEL was given and wanted to know what needed to be done. Attempted transfer to MIS-No answer. Placed in proxy for a call back. HCP request to be called on the mobile number on file. She would be leaving out the office in the next 25 minutes."  At time of reporting, no adverse event was reported and the outcome was unknown for reported 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.
Erythema Multiforme Rash, facial swelling, throat swelling, hand swelling, chest pain followed by daily urticaria.
Information has been received from a 51 year old female consumer, allergic to penicillin, who on 27-Jul-2006 was vaccinated with a dose of PNEUMOVAX 23. "Around" September 2006 the patient developed an itchy rash that started on her neck, and since she scratched the rash, it later became a blister. The rash then went from her neck, down across her chest, back up her shoulder and down her back over, her legs, arms, stomach, buttocks, and scalp. The consumer reported she had seen two dermatologists, another primary care physician, an allergist and recently an acupuncturist, but had not seen the physician who administered her the PNEUMOVAX 23. The consumer reported that she did not have a rash on her face, palms or bottom of her feet, but had been given seven doses of prednisone and "UNIBOT wrap" which gave her some relief and had been doing this for six weeks. The consumer reporter that she had a biopsy of her rash to see if it was fungus and it was not. The patient had an allergy test done which showed she was allergic to dust mites and found out that her IgE was extremely high. The consumer also reported that in December 2008, she had a self inflicted skin infection and then starting on 19-MAR-2009, she saw an acupuncturist which had "helped" the inflammation and since then she had not had any new outbreaks. The consumer reported that the physician did not known why she developed the rash but the acupuncturist and she believed it was from PNEUMOVAX 23. On 15-SEP-2009 the patient was getting a heavy metal test. The consumer reported that in 2008 she was informed she did not have lupus and had been misdiagnosed (previously diagnosed with lupus on 27-JUL-2006). The patient also stated that "while taking BACTRIM her body became swollen" (date unknown). Additional information has been requested.
Menstrual cycle started 5 days early which is highly unusual for me personally, it's never happened before. Day 3 of my period I was bleeding extensively - soaking through a super plus tampon and overnight maxipad every 45 minutes. I am used to having very heavy periods but this was extreme. At one point I was bleeding so much I had to sit on the toilet for 15minutes before the blood and clotting stopped, almost as if I was urinating. I was extremely light headed and woozy for the rest of the evening. By the next morning it had slowed down to a slightly heavier version of normal.
Following vaccination with Prevnar, the pt experienced a fever of 103 and a febrile convulsion. The pt also experienced diarrhea and vomiting.
Patient was given 1/2 dose (.25ml).  Patient should have received 0.5ml dose
Information has been received from a certified medical assistant (C.M.A.) concerning an 18 year old female patient with no medical history and allergy to amoxicillin and AUGMENTIN who on 07-FEB-2011 was intramuscularly vaccinated with the first dose of 0.5 ml GARDASIL (lot # 667866/1437Z, exp: 25-FEB-2013). There was no concomitant medication. The reporter stated that on 07-FEB-2011 the patient developed hives all over her body and itchy after administration of her first dose of GARDASIL. BENADRYL was given for the event. At the time of reporting, the outcome of the patient was recovering. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Narrative:  Patient with h/o COVID-19 positive test on 8/2 at outside facility admitted to hospital on 8/8/21 with COVID-19 pneumonia, acute hypoxic respiratory failure, cough, and congestion. Patient completed treatment inpatient and was discharged from facility. Patient completed COVID-19 Pfizer vaccines on 3/3/21.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 90-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  This case concerns a 90-year-old, male patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on unknown date after unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 90-year-old, male patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on unknown date after unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Cheeks were red and bumpy, eyes are itching and skin on faceitches. hot to touch. Pt given Zyrtec 10 mg.
Red, warm patch of skin with soreness formed about 3 inches under injection site of the left arm. Formed 2 days after vaccination and is tender to touch. No need for treatment for now, not excessive pain.
pediatric dose given to adult patient; pediatric dose given to adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 75-year-old female patient who received HAV (Havrix pediatric) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 patient received pediatric dose of the Havrix vaccine, which led to underdose and adult use of a child product. The reporter wanted to know if they had to revaccinate the patient or just give her another pediatric dose of Havrix. No further events were reported at the time of reporting. The health care professional did not specify which was the exact name of the vaccine other than saying pediatric dose of Havrix. The reporter consent to follow-up by email.
Her arm turned red in about a four inch circle. It was also hot and very uncomfortable. I gave her Tylenol and Benadryl. Influenza Vaccine: Sanofi Fluzone 2013-2014 5ml Multidose Lot# UH907AB Left deltoid.
Red, warm rash on arm immediately below injection site, which increased in size to 7" long x 5-6" wide over 3-4 days, then began to subside over 5 days.  He used ice and cold packs to the area x 7 days.  Rash was not itchy or lacey.  It became less red and more diffuse as it continued to spread/enlarge several days prior to disappearance.
Patient has had hives off and on since the day after the vaccination.  Hives cover her entire body.  Claritan or Benadryl will control them.  It has been 3 weeks since vaccination and she is still getting them
Shingles. Diagnosed on 5/8. Symptoms include fatigue, severe headache, tooth pain, jaw pain, scalp sensitivity, sores around mouth/chin/cheek/sideburn area.
Itching Follow weals and redness, Took Zyrtec, Hydrocortisone Cream, prednisone.
Started 09/10/2010 with 100.5 temp, Sore throat, tired, upset stomach Progressed Saturday 09/11/2010 with very upset stomach, sore throat and full body itchy rash (appeared at 7pm).  Sunday 09/12/2010 stomach pains and rash continue, rash somewhat better with Benadryl but not fully resolved.
IMOVAX (rabies vaccine) was given via gluteal administration. Per package insert gluteal administration is not recommended due to risk of vaccine failure due to reduced antibody formation.
This case was reported by a healthcare professional and described the occurrence of transaminases increased in a 20-year-old male subject who was vaccinated with Engerix B, GlaxoSmithKline for prophylaxis. On an unspecified date the subject received unspecified dose of Engerix B (unknown). In 2007, at an unspecified time after vaccination with Engerix B, the subject experienced transaminases increased. At the time of reporting the event was unresolved. The healthcare professional considered the event was unrelated to vaccination with Engerix B.