chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one diluent was remaining in a box of ActHib and assumes the powder half of the dose had been given to a patient with sterile water instead, no adverse event; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA002810, 2020SA002811, 2020SA002812 and 2020SA002455 (same reporter).  This case involves an unknown demographic patient who was vaccinated with a dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] on an unknown date, (lot number UJ175AAA and expiration date 26-Nov-2020), other dosing details were not reported.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong solution used in drug reconstitution as Act-HIB was accidentally mixed with sterile water instead of the diluent that came with product and had been administered to the patient.  No adverse event was reported at the time of reporting.  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 Directive and Module VI of the 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.
felt badly; sore injection site right arm; vomiting; abdominal pain; weak; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain), ASTHENIA (weak), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt badly) and VACCINATION SITE PAIN (sore injection site right arm) in a 60-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.     No medical history was provided by reporter.  Concomitant products included MECLOZINE HYDROCHLORIDE (BONINE) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced ABDOMINAL PAIN (abdominal pain), ASTHENIA (weak), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (sore injection site right arm) and VOMITING (vomiting). On an unknown date, the patient experienced FEELING ABNORMAL (felt badly). At the time of the report, ABDOMINAL PAIN (abdominal pain), ASTHENIA (weak), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt badly), VACCINATION SITE PAIN (sore injection site right arm) and VOMITING (vomiting) outcome was unknown.            Treatment medications were not provided by reporter.   This case was linked to MOD-2021-296556 (Patient Link).
HYPOTENSION 3/19/2022 -- RECURRENCE OF SAME SYMPTOMS
24OCT96 1hr p/vax sharp pain was exp across chest which lasted 1/2hr @ that time;breathing was also diff;24 hr later site of inj was red 7 sore, completely resolved w/in 48hr;
Nausea. Bruise - bruising lasted several weeks. Swelling. Patient requested we send this info in to let company know.
diagnosed with 4th cranial nerve palsy; He was seeing double; his balance has been off; This serious case was reported by a consumer via interactive digital media and described the occurrence of ivth nerve palsy in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced ivth nerve palsy (Verbatim: diagnosed with 4th cranial nerve palsy) (serious criteria hospitalization and GSK medically significant), double vision (Verbatim: He was seeing double) (serious criteria hospitalization) and balance disorder (Verbatim: his balance has been off) (serious criteria hospitalization). The outcome of the ivth nerve palsy, double vision and balance disorder were not reported.   It was unknown if the reporter considered the ivth nerve palsy, double vision and balance disorder to be related to Shingles vaccine.     It was unknown if the company considered the ivth nerve palsy, double vision and balance disorder to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-JUN-2023 This case was reported by a patient's wife via interactive digital media. The reporter asked everyone to be cautious as her husband (patient) had vaccine and a few days later ended up in the hospital.  They thought he had a stroke and ruled that out. He was diagnosed with 4th cranial nerve palsy.  It had been a long road so far. He was seeing double, and his balance had been off.  They had always been pro vaccine but were questioning at that time. The follow-up could not be possible as no contact details were available.
Immunizer accidentally stuck herself with the needle and then proceeded to give the patient the vaccination with that needle. Both individuals are getting blood testing done.
Patient became lightheaded, dizzy and passed out.  Mother and nurse lowered her to the floor.  She recovered within 15 minutes.
25 -30 min after injection  my cheeks turned red and I felt  flushed/hot. Around 3pm I was very nauseated and feverish feeling but temp was 98.8
Flu injection on 10/3/11 Lt deltoid and PNEUMOVAX on Rt deltoid. 10/4/11 returned to clinic c/o rash around the injection. Redness & warmth anterior left deltoid new site of flu injection (8 x 4). Dx with cellulitis. Started Cefdinir 10/6/11 Area increasing pt came in for injection of ROCEPHIN 10/6/11.
Patient passed out while sitting in a chair during an observation period after the shot. His body started to slightly shake, and he urinated himself. The pt. woke up right after that. He claimed he felt very light headed and like he wanted to vomit.  The patient was given water and was observed for 15 more minutes. He claimed he felt better, just slightly light headed. A friend came to pick him up.
Shingles type sensitivity on left side (lower back and upper leg), continuing for several days, followed by shingles-type pain on third day. Identical to symptoms patient had when shingles was diagnosed several years earlier. Began anti-viral drug treatment upon advice of physician. Extent of shingles outbreak remains to be seen.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 08-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Even prior to vaccination, patient already appeared anxious. 5 mins. after 3rd dose of HPV given, patient fainted, noted to be pale. She was sitting and waiting for her other siblings to get their shots. BP taken 70/47. Denies itching, no hives noted.  Complained of throat and tongue swelling. Patient observed closely. She was hyperventilating and was told to breath slowly. O2 sat was 100% With history of DM type I, on Insulin, didn't take breakfast. Orange juice given. Called 911. Put on reclining position and VS monitored closely. After 5 minutes, pt, verbalized feeling better. BP 105/63. O2 sat 98 - 100%. Paramedics arrived and assessed pt. They advised to bring patient to ER for further evaluation but mother refused stating she would just bring her child herself to facility. Mother signed waiver.
She went vesovagel and is fine now.  She fainted and convulsed almost immediately
606 doses were given after expiration date; Vaccine was stored in refrigerator on 21-Sep-2021 but expiration date given by Moderna was 09-Oct-2021 and administered on 19-Oct-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 21-Sep-2021 but expiration date given by Moderna was 09-Oct-2021 and administered on 19-Oct-2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 21-Sep-2021 but expiration date given by Moderna was 09-Oct-2021 and administered on 19-Oct-2021). On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 21-Sep-2021 but expiration date given by Moderna was 09-Oct-2021 and administered on 19-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided. The reporter was infection control manager. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator 21-Sep-2021. The patient did not experience any adverse event.
Patient was nauseous, pale, clammy hands.  Apply cold compresses to the patient's neck.  The patient felt better after 5 minutes.
Patient is a 16 year old female brought by mother with a blotchy, raised and red rash on her left arm around her varicella vaccine, given 8/9/2007 in this office. The rash occurred today. Parents observations of the patient at home are normal activity, normal appetite and normal fluid intake. There is no fever, vomiting, or diarrhea. No breathing difficulty, no fainting. 1 cm raised, round induration and 3 cm x 1 cm erythematous wheal located on right arm extending from varicella injection
Pt. stated that after the Flu vaccine was given her whole arm became bruised. She is not experiencing any pain currently from the vaccine however she is going to make a doctors appointment and have a proper diagnosis.
First day around bedtime 11:00pm sever body ache especially upper middle back, hands and feet. Heart rate high 90's. Felt better next day.  2 days later body ache again day and night, middle upper back, feet and hand, under arms. Shortness of breath especially at bedtime, heart rate has been dropping from 80's to low 60's. blood pressure a little high 130's/80's. Feel lump in throat, like choking sensation on and off. Severe weakness-tiredness. I wake up light headed and shortness of breath in the morning. Big bruise on left leg  2 inch long  by 1.2 wide. My oxygen usually is between 98-100, last night dropped to 94-95.  Doctor told me to report reaction. Feel a bit better today. Took today 2 Advils.
Information has been received from a healthcare worker (certified medical assistant) referring to a currently 23 years old female patient. The patient had no medical history, concomitant therapy or drug reactions. On an unspecified date, the patient was vaccinated with a dose of M-M-R II (unspecified lot, unspecified expiry date, dose and route were not provided). As a child, recently, the patient got titers drawn at the office resulting in no immunity to Rubella. Outcome of the event was unknown. No other adverse effect was reported. Additional information is not expected because of no consent to contact the physician.
Same day as first dose, I traveled out of state and started to feel a puffiness on the right side of my head followed by a slight tinnitus.
This spontaneous report was received from a medical assistant refers to a 13 year old patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 16-NOV-2018, the patient was vaccinated with GARDASIL 9 lot # 1586749, expiry date: 13-FEB-2021 (dose, frequency and route of administration unknown) for an unknown indication, which was improperly stored (product storage error). The product GARDASIL 9 was reportedly stored at temperature/ time frame of 23.7 Fahrenheit (below 32 degrees Fahrenheit) for 17 hours 41 minutes (3 cycles) and 51.9 Fahrenheit (47 degrees Fahrenheit to 77 degrees Fahrenheit) for 7 hours 30 minutes with multiple excursions. Data logger was reported as yes. No adverse event reported.
His friend has four friends that were in their early 50s that had mild strokes after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient in their 50's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "His friend has four friends that were in their early 50s that had mild strokes after the vaccine".  Clinical course: Case was assessed as non-serious by the reporter. The day after he could only bike 8 miles in two hours. He used to be able to bike up to 30 miles no problem, but now he struggles with short distances. His heart can't take it. If he does do a long bike ride, he has to sleep until 6pm the next day, he is just absolutely exhausted. He has been to the ER at least five times. He is scheduled to see a cardiologist but can't get an appointment until Aug. Now he has a nagging numbness that goes up and down from his elbow to his shoulder and then it'll go away. On the one year anniversary of the shot 04Jun2022 he had sharp pains to the heart. He thought he had severe asthma and that's why he wanted to get the vaccine. His friend had to be helicoptered to (withheld) for a massive heart attack after taking the vaccine. A friend of his, a 39 year old athlete, is having problems after the vaccine and the doctor says its all in her friend. His friend has four friends that were in their early 50s that had mild strokes after the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Much worsening of minor tinnitus; extreme headache and skull pain; post-concussive type symptoms such as hypersensitivity to ambient sound and physical movement and easily overwhelmed brain; fatigue. These issues at times debilitating. Still dealing with these issues.
lymph nodes are terrible sore; very uncomfortable and difficult to swallow; A spontaneous report was received from a consumer concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lymph nodes are terrible sore, very uncomfortable and difficult to swallow.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their last of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the events lymph nodes are terrible sore. very uncomfortable and difficult to swallow.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, lymph nodes are terrible sore, very uncomfortable and difficult to swallow was unknown.
Patient developed COVID symptoms 01MAY2021 (coughing, chest pain, fever, difficulty breathing) and was placed in observation by medics and physician. During initial evaluation vitals: temperature 102.7 °F, SpO2 95%, RR: 14, BP 132/90 and HR 115. The morning of 02MAY2021, patient had worsening difficulty breathing, lower oxygen saturations (88-92%) and sent to local hospital where he was admitted and found to have rapid antigen COVID test and confirmed with COVID PCR test. Patient was fully vaccinated as he received the vaccination 29MAR2021. Patient received antibiotics, 10L oxygen with non-rebreather mask, fluids and steroids.
Patient said that she woke on the floor in her bedroom (wasn't sure how) and was unable to move or call out for help. When her husband found her he had to lift her up onto the bed and he noticed that she was soaking wet from sweating. She believes that it was from getting both vaccines at the same time.
after the second got it has gotten extremely worse. It is worse than my pain, and it has radiated to her hand and fingers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (after the second got it has gotten extremely worse. It is worse than my pain, and it has radiated to her hand and fingers) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No medical history was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (after the second got it has gotten extremely worse. It is worse than my pain, and it has radiated to her hand and fingers). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (after the second got it has gotten extremely worse. It is worse than my pain, and it has radiated to her hand and fingers) had not resolved.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided.    This case was linked to MOD21-066386 (E2B Linked Report). This case was linked to MOD-2021-064167 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up received  on 24-may 2021 no significant information received.; Sender's Comments:  MOD21-066386:Husband's case
Extreme body and mind agitation, thought psychosos (first night after shot) Chest pains in left side (first night after shot) Pain spot inside of left elbow for 9 days Shortness of breath for first 2 days with intermittent recurrences for next 7 days Achy, dizzy, headache, fever, & fatigue starting evening after shot, lasting 2 days with intermittent recurrences for next 11+ days
Some normal widely reported side effects like fatigue, lightheadedness. A short time after injection felt mild soreness in the penis. As early as the morning after injection experienced difficulty with erection and ejaculated, and continued mild soreness. Report submitted day after injection, still experiencing symptoms.
Moderna COVID-19 Vaccine EUA 100.4 degree fever, chills, sweats, severe joint pain in thumbs, swelling in left testicle, headache, gained 12 pounds of water weight over two days. Swollen legs with painful rash from knees down. Continuing joint pain in hips, knees, ankles
This case was reported by a pharmacist and described the occurrence of nausea in three subjects of unspecified ages and genders who were vaccinated with ENGERIX B, (GlaxoSmithKline).  On the morning of 10 July 2008,  the subjects received unspecified doses of ENGERIX B (unknown).  After an unspecified amount of time following vaccination with ENGERIX B, on the morning of 10 July 2008,  the subjects experienced nausea.  All three subjects received doses of ENGERIX B from lot #AHBVB584AA; expiration date 06 November 2010.  At the time of reporting, the events were unresolved.  No further information was available at the time of this report.
It's still itching now; I felt extremely tired; Sore at the injection site; I had a real bad headache (lasted 3 days); Dizziness when I stand up; I feel like I'm going to faint when I stand up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizziness when I stand up), DIZZINESS (I feel like I'm going to faint when I stand up), PRURITUS (It's still itching now), FATIGUE (I felt extremely tired) and VACCINATION SITE PAIN (Sore at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced DIZZINESS POSTURAL (Dizziness when I stand up), DIZZINESS (I feel like I'm going to faint when I stand up), FATIGUE (I felt extremely tired), VACCINATION SITE PAIN (Sore at the injection site) and HEADACHE (I had a real bad headache (lasted 3 days)). On 12-Aug-2021, the patient experienced PRURITUS (It's still itching now). On 11-Aug-2021, HEADACHE (I had a real bad headache (lasted 3 days)) had resolved. At the time of the report, DIZZINESS POSTURAL (Dizziness when I stand up), DIZZINESS (I feel like I'm going to faint when I stand up), PRURITUS (It's still itching now), FATIGUE (I felt extremely tired) and VACCINATION SITE PAIN (Sore at the injection site) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Patient emailed her Doctor on 12-AUG-2021 regarding dizziness   This case was linked to MOD-2021-284552 (Patient Link).
Caller tested positive on 08Mar2021 after receiving the 1st dose last 23Feb2021; Caller tested positive on 08Mar2021 after receiving the 1st dose last 23Feb2021; This is a spontaneous report from a Pfizer-sponsored program. Support and medical information team. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 23Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, caller tested positive on 08Mar2021 after receiving the 1st dose last 23Feb2021.Would like to know how long she would wait to have the second dose scheduled on 16Mar2021. The patient underwent lab test and procedure which included COVID-19 test: Positive on 08Mar2021. The outcome of the events was unknown.
muscle pain in the shot arm, I am still having pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain in the shot arm, I am still having pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced MYALGIA (muscle pain in the shot arm, I am still having pain). At the time of the report, MYALGIA (muscle pain in the shot arm, I am still having pain) had not resolved.            No other concomitant medical  provided by the reporter. No treatment information provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.