chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of dysautonomia in a 23-year-old female subject who was vaccinated with Engerix-B for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Engerix-B. At an unspecified time after vaccination with Engerix-B, the subject experienced dysautonomia. At the time of reporting the outcome of the event was unspecified. Follow-up was received on 20 February 2007 by the reporting consumer. The consumer is the subject's father and a lawyer representing the subject. the lawyer presented this case as a legal complaint. According to the legal complaint, the subject experienced dysautonomia "as a direct and proximate result of hepatitis B vaccine". A physician or other health care professional has not verified this report. At the time of the administration of Engerix-B, August 1997, the subject was a teenager. On an unspecified date in August 1997, the subject received 1st dose of Engerix-B. Approximately one day after the 1st dose of Engerix-B, on an unspecified date in 1997, the subject experienced flu-like symptoms. "The day after that," the subject experienced dizziness and was unable to stand up without holding the walls. "The following day," the subject passed out. On an unspecified date, the subject received the 2nd dose of Engerix-B. On an unspecified date after August 1997 and before 16 May 1999, the subject received 3rd dose of Engerix-B. Approximately 2 hours after vaccination with the 3rd dose of Engerix-B, the subject "became violently ill". The lawyer reported that following the 3rd dose of Engerix-B, he "knew the vaccine was the catalyst of (the subject's) illness." Between August 1997 and 18 May 1999, the subject also experienced headache joint pain, seizures, nausea, hair loss, gastroesophageal reflux disease, and fatigue, was seen by "15 specialists." underwent tests with magnetic resonance imaging, computer aided scans, and spinal taps, and was seen in an emergency from and hospitalized. On an unspecified date after August 1997 and before 18 May 1999, the subject was diagnosed with dysautonomia and was unable to keep food down due to frequent retching and vomiting. The lawyer also reported that the subject "takes 10 doses of medication" to treat the events. An e-mail dated 31 January from the lawyer indicated that on unspecified dates between 18 May 1999 and 31 January 2007, thesubject experienced transient blindness and underwent "esophogeal surgery that was required to stretch her  esophagus". The outcome of the events was not reported.
None reported to me yet; I just called the parent (mother) to inform of incident (administered undiluted pediatric vaccine).
Patient noticed soreness in the arm the evening of the vaccination. The next day the soreness increased to where it was very tender to the touch. The area bacame red, swollen, and gave off heat. The affected area was not around the injection site. The affected area was below the injection site near the bicep. Patient does not remember any insect bites/stings and had limited exposure to the outdoors.
Two hours after I had memory loss and couldn?t remember what I did that day, my husband called the nurse hotline and they had me raise my arms and speak and smile but because of the memory loss they said to call the paramedics and my blood pressure was 230/105 and they thought I was having a stroke. My husband took me to the hospital ER and that evening I was checked in because my BP was 225/105 they thought I was have a stroke.  At the hospital, I had the first CT head w/o contrast, then a head neck CT scan and I was admitted into the hospital. The follow day they did an electrocardiogram, then an echocardiogram,  renal and duplex test, chest x-Ray MRI brain w/o contrast. There was no pain headache or body aches, then I was starting to remember what I had done the day before. A neurologist came into explain the results and all tests were negative, but I was diagnosed with Fibral Muscular Dysplasia, but because they didn?t have enough data, he couldn?t say that it was because of the Moderna vaccine. I was released 24 hours later. My BP went back to normal 120/70 3 days later.
had a sore arm (at injection site); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female 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 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received Sningrix and had a sore arm (at injection site). The patient received the first dose about 2.5 months prior to the second dose. She does not have the exact date of the first shot. She does not have the lot number or expiry date of either shot. She believed the shot were given in the left deltoid and was not sure but believed they were given intramuscularly. She did not see how long the needle was but said it felt like it went into the muscle. The patient received Sningrix and had a sore arm (at injection site). This case has been linked with case US2020031394, reported by same reporter for the same patient.
Nurse made an dilution error by mixing 0.6ml of NSS with pfizer 30mcg/0.3ml vial. Then she administered 0.3ml from the vial and administered the vaccine to the patient.
experiencing some muscle spasms; vomiting; chills; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. It was reported that with the second dose being given 60hours ago. She was now reporting that she's still experiencing some muscle spasms. She also mentioned in passing that she experienced vomiting and chills but those symptoms have resolved on an unknown date. She has already contacted her HCP who told her to follow-up if she was still experiencing the muscle spasms on 22Mar2021 (Monday as reported). She had some really bad reactions to the vaccine, right now she was still experiencing some muscle spasms. Vomiting, chills and everything were gone . Only been 60 hours since she took it. Patient already had plans to follow-up with her HCP. The outcome of events vomiting and chills was recovered on an unknown date and the event muscle spasms was not recovered.  Information about the lot/batch number has been requested.
"Moderna COVID-19 vaccine". Patient received 0.5ml instead of 0.25ml of COVID booster
vomitting 11pm, 1am, diffuse body hives noticed at 1am, gien 50mg benedryl at 130am, and again at 530am rash improved by 755am
This spontaneous case, initially received from other health professional (nurse) on 26-Sep-2018, concerns a 21-year-old, adult female patient. The patient's concomitant medication included ZITHROMAX. On 24-Sep-2018, the vaccines were out of the recommended range for 1 hour and minimum temperature reached was 33.8 Fahrenheit. It was the first temperature excursion (explicitly coded as incorrect product storage). On the same day, the patient was administered FLUCELVAX (QIVc) that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252670 and expiry date: 30-Jun-2019] (explicitly coded as drug administration error). The patient did not experience adverse event after administration of the vaccine. The reporter assessed the case as non-serious. This case (201804151) is linked to case 201804150 reported by same reporter.
no ad; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (no ad) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no ad). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (no ad) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no ad) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant product use was not provided by the reporter.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  The lot number for the monovalent vaccines with their corresponding BUD dates were 027C21A (BUD - 21-May-2021), 053C21A (BUD - 01-Jul-2021), 939902 (BUD - 02-Sep-2021), 011F21A (BUD - 04-Nov-2021), 012H21B (BUD - 23-Dec-2021), 056M21A (BUD - 12-May-2022), 082B22A (BUD - 08-Sep-2022).   The lot numbers for the bivalent vaccines with their corresponding BUD dates and the interval period of administration. 052D22A (BUD - 17-Nov-2022), dates of administration 18-Nov-2022 to 28-Nov-2022, 023H22A, (BUD - 15-Dec-2022), dates of administration 16-Dec-2022 to 20-Dec-2022.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up information received contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Intense back pain, lower back pain above buttocks, similar to contractions all day, joint aches everywhere, chills, temp 99.9, no appetite, head pounding, at 15 hours later, back pain continued and wrapped around quads and down to shins and calf?s, aches stopped but stayed strong at jaw. Neck pain stopped the following morning 7am, headache persude  lethargy, and weakness rest of day, more appetite but not back to normal, light headed rest of day.
Sweats, low grade fever, dry heaves, weak rubbery legs, slight sore throat.
This 66 year old  female received the Covid shot on  3/24/21    and went to the ED on  4/6/21    with the following diagnoses listed below. U07.1 - COVID-19
Information has been received from a doctor of pharmacy concerning a 72 year old female patient with no drug reactions or allergies who on 11-OCT-2011, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously (lot number not reported). On 01-NOV-2011, "3 weeks after receiving ZOSTAVAX (Merck)", the patient developed shingles. The patient initially developed lesions on her chest and back (unspecified if the lesions were on one side of the body or on both the right and left sides of the body). The patient was currently developing lesions in her mouth and nose. The patient described the lesions as being "painful". Unspecified medication was prescribed by patient's physician for the treatment of shingles. At the time of the report the patient's outcome was not recovered. No laboratory tests were performed. The patient sought medical attention, called pharmacist and visited physician. Follow-up information has been received from a doctor of pharmacy concerning a 75 year old female patient who on 11-OCT-2011, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously (lot number not reported). It was unknown if a rash occur at the site of injection or elsewhere within 42 days of the vaccination. The patient developed shingles covering back about 1 month after receiving vaccine, in approximately November 2011, that spread to face and in mouth. The patient did not contact reporting pharmacist until March. At the time of the report the patient's outcome was unknown. No photo was taken. The patient sought medical attention. Shingles was considered by pharmacist to be disabling. Additional information has been requested.
Pruritic rash at injection site starting 1 week after the injection, painful swollen lymph nodes in the ancillary nodes on the same arm
24hrs p/vax started coughing, another 5hrs later broke out in a high fever which lasted on & off for a wk;noc of 29th had mild szs & the shakes during fever;came down w/flu sxs w/in 24hrs & is still a little sick w/head cold;
Eye swelling and eye skin peeling under eye. To now completely raw and irritated.; Eye swelling and eye skin peeling under eye. To now completely raw and irritated.; Eye swelling and eye skin peeling under eye. To now completely raw and irritated.; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 18Mar2021 (at the age of 24-years-old) as unknown, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a reported as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. Medical history included undifferentiated connective tissue disease, Celiac and known allergies: wheat. Concomitant medications included methotrexate; prednisone; sertraline hydrochloride (ZOLOFT) and birth control. The patient previously took tramadol and experienced allergy. The reported events were eye swelling and eye skin peeling under eye. To now completely raw and irritated, all on 19Mar2021. The patient considered as serious due to disabling/incapacitating but did not result in death, non-life threatening, did not cause/prolong hospitalization and no congenital anomaly/birth defect. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Treatment for the events included steroid cream and benedryl. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Information described was reported to writer by RN.  She reports that client came to see her on October 11, 2005 at approx. 4:20pm. Client reported that she had received that influenza vaccine earlier in the day at approx. 10am.  Client reported that she experienced onset of symptoms at approx. 1pm consisting of tightness and heaviness in her chest, hoarness of voice with wheezing and coughing.  Client did reportedly stated she took 50 mg of Benedryl by mouth at 2pm with some relief of symptoms.  Client's medical hx is significant for Asthmatic Bronchitis and Cold Induced Asthma.  Client was assessed and a referral to the ED was made.
5 minutes after vaccination, became pale, diaphoretic and tachycardic (HR 150s).  She reported that she felt like her throat was closing.  No itching, rash, nausea, vomiting, wheezing, swelling.  Epipen was administered to left lateral thigh.  3 minutes later, she reported that her throat felt better, overall felt better and heart rate decreased to 100.  She was transported to our ED.  She felt anxious and like her heart was racing.   She was observed in the ED and slowly reported feeling better with complete resolution of symptoms within 2-3 hours.  She did not require any further intervention.  She was discharged from our ED with an Epipen and Epipen teaching.
No Adverse event; Patients received 0.5ml of the the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received 0.5ml of the the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received 0.5ml of the the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received 0.5ml of the the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patients received 0.5ml of the the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine).    No concomitant drug was reported.  No treatment drug was reported.
patient was inadvertently given the liquid component of the Pentacel vaccine, containing the DTaP-IPV portion of the vaccine, without its being mixed with the lyophilized Hib component first; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Office staff).  This case involves a 17 months old male patient received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included ROTATEQ vaccine on 10-Jun-2019.   On 10-Jun-2019, the patient received a 0.5ml fourth dose in series of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UI953AAA, expiry date 30-Jun-2020 via unknown route in unknown administration site.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that patient was inadvertently given the liquid component of the Pentacel vaccine, containing the DTaP-IPV portion of the vaccine, without its being mixed with the lyophilized Hib component first.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
pt states he had a seizure at work at approximately 6:00 p.m., 4 hour after vaccine.  He states he is certain that it was from the vaccine as his seizures are under control until he received the vaccine.  Pt. could not stay any longer to speak about the seizure as his ride was here.
This spontaneous report as received from a physician via company representative, refers to a 16 year old female patient with allergy to latex. No medical history was reported. On 12-FEB-2015, the patient was vaccinated with a first dose of GARDASIL (lot # K007264, expiration date not provided), intramuscularly, dose was not reported. No concomitant medication was reported. On 12-FEB-2015, after first injection of GARDASIL, the patient, experienced syncope (reported as 'cynope'), clinching arms, nausea, dystonia, hypertensive crises, became disoriented, had 15 minute lack of awareness, tachycardia, hyperventilating, panic attack, and low blood sugar of 25 (units not provided). The patient was given sugar and oxygen while in physician's office. The patient was then transported to hospital emergency via ambulance. The patient was hospitalized for two days (from 12-FEB-2015 until 14-FEB-2015). While in hospital, the patient had magnetic resonance imaging (MRI) and 24 hour electroencephalography (EEG), and was treated with BENADRYL. The outcome of all events was not reported. Relatedness between the events and GARDASIL was not provided. Upon internal review, hypertensive crisis was considered to be medically significant. Additional information has been requested.
I noticed a few hours ago that I have a very light swelling at my left arm that in my armpit area, I am assuming that would be the lymph node area, that it's on the same site of vaccine; Swelling at my left arm; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 2, SINGLE for an unspecified indication. The patient medical history was not reported. Patient took first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) on an unspecified date for covid-19 immunization. The patient's concomitant medications were not reported. On an unspecified date the patient experienced i noticed a few hours ago that i have a very light swelling at my left arm that in my armpit area, i am assuming that would be the lymph node area, that it's on the same site of vaccine, swelling at my left arm. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Got a slight skin rash several days after first shot.  Did not think much about it at the time but after second shot it got much worse.  I went to the clinic and they diagnosed me with eczema.  After a couple of months my body was covered and I got a referral to Dermatology and they diagnosed me with severe plaque psoriasis.  My labs were normal and there is no history in my family with this skin disease.  I am now having to take tremfya injections.
Swelling to left side of face same afternoon, sore throat  Patient reported this on 12/1/21. States swelling is down this morning and has no sore throat anymore.
Became sick Monday after shot. Threw up 3 to 4 times daily for 7 days. Stopped but very slow recovery. Have major brain fog and dizziness.
Breakthrough bleeding, when I have an IUD and haven?t had a period in over 3 years, sore arm, body aches, severe body aches, headache, sleeplessness, fever, aches
First series, first Moderna dose was administered 4 days prior to patient being 6 months of age. Patient's parent's were called 3 days post vaccination for status check and no adverse events had occurred. It was recommended that patient wait 30 days from 6 month old date to obtain 2nd dose.