chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 42 year old female RN who was vaccinated with a 1st, 2nd, 3rd and booster dose of Hep-B vaccine recombnant in approximately 1987, 1990 and 1991 and sometime after the 3rd dose. A couple of weeks after the 1st dose, the pt developed a butterfly rash, stomach "problems" and joint pain. Following the 2nd dose, she developed heart problems and underwent a heart catherterization that revealed an irregular heart beat and heart murmur. Following the 3rd dose, the pt developed pneumonia. Subsequently, the pt's lab values indicated she did not seroconvert. Following the booster dose, she developed pneumonia. In 1996, "after having pneumonia 7 times, the pt broke her ankle and was dx'd with lupus." The pt reported that "seven other nurses at her hospital have been dx'd with either lupus, arthritis, chronic fatigue syndrome or fibromyalgia after receiving Hep-B vaccine recombinant. In addition, several others have experienced symptoms but not yet been dx'd". Additional information has been requested.
Throat swelling, rash on face and hives on back, chest tightening, metal taste in mouth, tingling lips (went numb for about 1 1/2 hours), eye swelling and feeling disconnected. - Benadryl at 6:15pm, went to Emergency Room at 7pm.  Was given Benadryl by IV, solumedrol, and Pepcid.
Rec'd DTaP/Hib combo in rt. delt IM on 06/17. Mother ret'dwith child on 06/19. Rt delt area reddened/hard/swollen. No tenderness. No fever. Mother to take to Dr if area worsened or child develops fever or illness.
Platelets being a lot lower now; This case was reported by a consumer via call center representative and described the occurrence of platelet count low in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 month after receiving Shingrix, the patient experienced platelet count low. On an unknown date, the outcome of the platelet count low was not recovered/not resolved.   It was unknown if the reporter considered the platelet count low to be related to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix and stated a month later when her labs were drawn, the results came back abnormal and also mentioned her platelets being a lot lower now. Referred to health care professional. Phone number was provided. The reporter consented to follow-up.
Information has been received from a pharmacy technician concerning her white 27 month old son with no pertinent medical history or drug allergies who on 29-NOV-1995 was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (Lot number not provided). There was no illness at the time of vaccination. On approximately 15-DEC-1995 the patient developed chickenpox, less than 20 spots found. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Gardasil vaccine administered without difficulty or reaction. RN notified that patient is pregnant approximately 10 weeks. Patient would have been 3 3/7 weeks at administration.
pain at injection site; Muscle soreness on back and hips.; feeling too hot and too cold; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EL3247) via an unspecified route of administration in the right arm on 22Mar2021(at the age of 27 years) at 12:00 as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medication included birth control. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EL3247) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 27 years) at 14:15 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 23:00, patient experienced pain at injection site, muscle soreness on back and hips and alternating between feeling too hot and too cold. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment for the events were not reported. The clinical outcome of the event pain at injection site, muscle soreness on back and hips and alternating between feeling too hot and too cold were recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Shortly after leaving vaccine site, noticed soreness in arm as I was driving home.  Within hours, it was to a point of not having full range in left arm and unable to sleep on left side. Started feeling better 48 hours later, almost completely gone now (currently 58 hours after shot)
I received a series of COVID-19 vaccine (pfizer) on 3/17/2021 and 4/7/2021 and developed skin reactions (suspecting atopic dermatitis/eczema) behind my knees that cover almost 1/3 of my legs. I am a health care worker and have never had atopic dermatitis/eczema or any other skin reactions every after administration of a medication. No medical history of any type of dermatitis in childhood. I can't recall when this really started but I noticed funny feeling on the back of my knees (dry patch like feeling when touched) after the first dose and developed into very dark hyperpigmentation with blisters along with some scaly/ peeling parts within the affected areas. I want to make a note though, this was not officially diagnosed by a medical doctor/ dermatologist.
Within 1 minute, patient started experiencing Chest pains across the ribs, heart palpitations and I measured her BP and it spiked
Patient reported swelling in both of her eyes and extreme pain and swelling in her hands approximately 2 days after receiving the Shingrix vaccine. The swelling went down after a couple of days, but the pain in her hands is severe and has persisted for 2 months.
PT had myocardial infarction 6 days after 2nd Pfizer dose
Pt experienced swelling of injection site, redness. Pt complained of feeling hot and nauseated.
Chronic diarrhea; SORE ARM AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Chronic diarrhea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Surgery (Botched surgery from 30 years ago.) in 1992. Concurrent medical conditions included Diarrhoea (Since 1992, the patient had ongoing diarrhea that had gotten worse in 2022.) since 1992, Rheumatoid arthritis and Depression.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) daily. In November 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE). On an unknown date, the patient experienced DIARRHOEA (Chronic diarrhea) (seriousness criterion medically significant). In November 2021, VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE) had resolved. At the time of the report, DIARRHOEA (Chronic diarrhea) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.  Company Comment: This spontaneous case concerns a 56-year-old female patient, with relevant medical history of constant Diarrhea and Co-suspect drug Humira, who experienced the unexpected serious (medically significant) event of Diarrhea aggravated, and the expected event of Vaccination site pain. The events occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The outcome of the events was reported as resolved for vaccination site pain and not resolved for Diarrhea. The patient's medical history of constant Diarrhea and Co-suspect drug Humira, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-584794, MOD-2022-584795 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 56-year-old female patient, with relevant medical history of constant Diarrhea and Co-suspect drug Humira, who experienced the unexpected serious (medically significant) event of Diarrhea aggravated, and the expected event of Vaccination site pain. The events occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The outcome of the events was reported as resolved for vaccination site pain and not resolved for Diarrhea. The patient's medical history of constant Diarrhea and Co-suspect drug Humira, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
HTN (hypertension), Malignant and Numbness and tingling of left upper extremity
Information has been received from a registered nurse concerning a 15 year old female who on 08-JUL-2010 was vaccinated with a dose of GARDASIL, VARIVAX and hepatitis A vaccine (inactive) at the same visit. On 08-JUL-2010 the patient became dizzy and sat down. The patient went home and continued to complain of dizziness and headache and went to the physician on 09-JUL-2010. At the time of the report, the patient had not recovered. Follow-up information has been received from the registered nurse who reported the patient's age should be "10 years old" (previously reported as 15 year old). Additional information has been requested.
Patient reported a red arm, swelling and itching the next day after she received her booster shot.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L035878, expiration date 11-AUG-2018; lot # M006710, expiration date 06-DEC-2018; lot L042259, expiration date 18-AUG-2018; lot # L042259, expiration date 18-AUG-2018; lot # L030871, expiration date 10-JUN-2018; dose and route not reported). The doses of vaccine were improperly stored at 60 degree Fahrenheit for 25 minutes. Data logger was not involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 10-SEP-2011, the patient was inoculated with ZOSTAVAX at a clinic for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAR-2016, the patient was treated at the same clinic for the onset of rash which was diagnosed as herpes zoster, or shingles, and related sequelae. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
I developed tingling in left arms and fever, malaise. It progressed to memory issues and trouble concentrating for a few days.  The headaches were moderate but relieved by Advil which I took frequently. By Monday, 11/08/2021 I had lower left molars tooth pain with chewing. By 11/08/2021 this pain in my tooth continued to my left ear, left side of jaw and upper left side of teeth, intermittent. I still ran a fever. I had burning on my forehead, scalp (left side) and left temple near my ear lobe. I had sharp intermittent ear pain. I went to the dentist to see if I had a tooth infection and my dentist thought it was neuralgia shingles.(on 11/15/2021)I had three red bumps in that area.  I went to urgent care next and got started on an  antiviral medication for shingles by 1:30 pm. I am writing this today, 11/16/2021 with 12 red  bumps on the left side of my face,(following my Trigeminal nerve branch)  swelling in cheek (L) and neck as well as L ear lobe.  I plan to see an eye specialist at 1:30 pm since it appears that I have developed shingles.  My memory is better since starting the antiviral medication. I have an appointment with my Physician tomorrow at 8:45 am, Wed., 11/17/21 for his input and for any further medical treatment I may need at this time.  In conclusion, I think that I had a severe neurological reaction
The next morning I was awoken by intense full body aches and pains. I had a fever with chills. I suffered from nausea but no vomiting.
Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:00pm (shot was at 215pm). Upon awakening 1/19 at 6:00am, arm continued to be sore and I had fever registering at 102.5. I took two Tylenol then and again at 3:00pm. Headache appeared around 9:00am and was gone by 7:00pm. Temp began to decrease at 10am, to 101.1 and was 99.3 at 2:30pm. Sunday morning woke up with  no soreness in arm or fever/headache.
significant erythema/edema at site of injection and above injection site. given steroids IM and keflex.
irritation all over the body; redness on the arm; rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (irritation all over the body), ERYTHEMA (redness on the arm) and RASH (rash on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SKIN IRRITATION (irritation all over the body), ERYTHEMA (redness on the arm) and RASH (rash on the arm). At the time of the report, SKIN IRRITATION (irritation all over the body), ERYTHEMA (redness on the arm) and RASH (rash on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
1. Hand involuntarily Shaking (a few times, for about 1 minute each) on day two 2. Toe pain that made walking difficult starting on day two and lasting about 48 hours 3. Fever, Fatigue, Headache, Muscle Aches, Nerve Pain
Case number PHEH2014US024322 is an initial spontaneous report from a nurse received on 02 Dec 2014 with a follow up information received from the nurse on 19 Jan 2015. This report refers to a 59 years old female patient. Historical conditions were not reported. No concomitant medication was reported. Her vaccination history included administration of previous FLUVIRIN (batch number: not reported) which was previously tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in the right deltoid on 05 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The reporter confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received from the nurse on 19 Jan 2015: Updated vaccination history, site of vaccination and reporter's comment.
24 hours after injection, stomach pain, diarrhea, dizziness, head pressure  and mild chest pain / discomfort.  Still occurring at 11am same day.
Work up with fever over 104°, hallucinations and talking out of my head, right eye swollen shut, headaches, body aches, chest pain, cough
Fainted at 3:30am 4-6-21, fever 100 degrees, body and neck ache, migraine
spitting out blood and blood clots; sluggish; Dizziness; chills; low grade fever; Bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (spitting out blood and blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event since an unknown date.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HAEMATEMESIS (spitting out blood and blood clots) (seriousness criterion medically significant), SLUGGISHNESS (sluggish), DIZZINESS (Dizziness), CHILLS (chills), PYREXIA (low grade fever) and HEADACHE (Bad headache). On 26-Mar-2021, HAEMATEMESIS (spitting out blood and blood clots) outcome was unknown. At the time of the report, SLUGGISHNESS (sluggish), DIZZINESS (Dizziness), CHILLS (chills), PYREXIA (low grade fever) and HEADACHE (Bad headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Pyrexia: low (Low) Low.         This case was linked to -MOD-2021-068465 ( Linked Report).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded..-MOD-2021-068465:Dose 1
Asthma attack, severe cough            2 Steroid injections by family Dr.         Monday 2/1/21  2:30pm       No outcome at this time - still having asthma attack
Friday, April 2, 2021: Evening beginning around 6 PM?sore arm; chills so bad I couldn?t hold a glass of water and teeth were chattering. Fever of 102.8. F; coughing & congestion. Saturday, April 3,2021: All day: arm extremely sore; headache; nausea, fever 101.2 F; fatigue all day. Sunday, April 4, 2021: All day: fatigued; dizzy; shortness of breath; headache worse, so took Tylenol at around 3:pm; after 1st meal since Friday, had diarrhea once. Headache went away. Monday, April 5, 2021: woke up feeling normal except for mildly sore arm. A little light-headed. Felt weak in afternoon and took a nap. Have been unable to take temperature as battery died in digital thermometer.
Pt recv vax on unspecified day; post vax pt exp spontaneous deafness  Annual Follow-up received on 9/19/00 provided no additional data.
20 month old female was given fluzone hd with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 20-month-old female patient who was given influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 04-Nov-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.5 ml once (lot UT8817BA, expiry date: 30-Jun-2023) via intramuscular route in the left thigh for immunization.  On 04-Nov-2022, 20-month-old female was given fluzone hd with no reported adverse event (product administered to patient of inappropriate age, same day latency).  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 guidelines. 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.
PATIENT SAYS HER WHOLE BODY HURTS FEELS LIKE SHE HAS THE FLU AND FEELS LIKE HER FIBROMYALGIA IS FLARED UP.
3x3 redness & induration w/pain & heat over site of inj;began 8-12 hr p/inj;
Patient complains of pain in arm after close to a month from injection. Patient states that she has been having pain at the injection site for 25 days now. Patient has not seen her PCP yet for the arm pain. Patient confirmed that the pain is at the injection site. Patient states that during the injection, the plunger/needle malfuctioned. Incident confirmed with immunizing pharmacist.
The evening of the IMZ the patient had pain, redness and swelling that was uncomfortable and keep her awake. The next day she called and asked about reaction, she described as red, swollen and painful from injection's site to above elbow. No problems with arm movement. She decided to go to ER for evaluation. The ER discharge summary diagnosed localized allergic reaction with skin rash to IM drug. The discharge summary recommended antihistamine and cool compresses. Loratadine was selected to minimize sedation.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-JUL-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-JUL-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The date of vaccine administration was from 4-Jun-2022 until 26-Jul-2022. The vial did not undergo any temperature excursions. Patient received half dose. No treatment medications were reported.