chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In June 2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-AUG-2011, the patient was treated by a nurse practitioner at a health system for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and PERCOCET for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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. Additional information has been requested.
Pt developed pale skin, sweating, nausea, ringing in ears, feeling like passing out. Over the course of about 30 minutes total
Information has been received from the father of an 11 year old female who was vaccinated with a dose of measles virus vaccine live (Moraten), subcutaneous administration, 4 days before she turned 1-year-old (lot number not available). On a unspecified date, the patient received another dose of measles virus vaccine live (Moraten), receiving a total number of 2 doses. The father reported that after the second dose of vaccine, his daughter was "still showing up as not protected". Unspecified medical attention was sought. At the time of this report the patient's outcome was unknown. No further information is available.
Moderna was bad and the  Moderna gave him bad aches for two days; whole body aches; tired; not feeling good; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Moderna was bad and the  Moderna gave him bad aches for two days), MYALGIA (whole body aches), FATIGUE (tired) and MALAISE (not feeling good) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for COVID-19 vaccination.    No Medical History information was reported.   On 18-May-2022, the patient received fourth dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced FATIGUE (tired) and MALAISE (not feeling good). On 19-May-2022, the patient experienced MYALGIA (whole body aches). On an unknown date, the patient experienced PAIN (Moderna was bad and the  Moderna gave him bad aches for two days). At the time of the report, PAIN (Moderna was bad and the  Moderna gave him bad aches for two days) had resolved, MYALGIA (whole body aches) and FATIGUE (tired) had not resolved and MALAISE (not feeling good) outcome was unknown.            No concomitant medications were reported. It was reported that he had his 2nd booster dose and he had body aches and was tired.  He took Pfizer vaccine when it was first coming out and he never felt anything with the first two vaccines.  The only side effect he was having was whole body aches and he was tired. Patient started feeling his body aching on 19-May-2022, it was more intense. Patient did not want it to go into the second day. It was reported that patient's first booster was Moderna vaccine. All along he was saying, the Moderna was bad and the Moderna gave him bad aches for two days but was getting the same with the Pfizer vaccine. It was also reported that it may be because he took the vaccines months ago and they were in his system, because the first two he had nothing. No treatment medications were reported by the reporter.
facial swelling; This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had facial swelling after receipt of the Shingrix vaccine in April 2019.
15 x 18 cm area of redness in location of Tdap administration, painful & itchy.
Stored beyond use date.  Moderna ran analysis and reported The vaccine administered on October 13, 2021, October 14, 2021 and October 19, 2021 from lot number 020F21A likely maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration; however, some vaccine may have activity below the level studied in our clinical trials.  Patient will be offered another vaccine if desired.
COMPLAINT OF SCRATCHY THROAT AND DIFFICULTY SWALLOWING ON LEFT SIDE. PA ASSESSED PATIENT AND HYDROXYZINE 25 MG PO ADMINISTERED AT 1720, PATIENT HAD ALREADY WAITED 30 MINUTES AFTER RECEIVING VACCINATION.
Pt had to go to the hospital with dehydration and vomiting and received IV fluids. Pt's sister got varicella from pt and had a febrile seizure and toxic synovitis left hip- hospitalized 05/24-05/27/2003. Pt's father got disease and missed 3 days of work. The follow up received on 9/9/03 states no hospitalization, ER visit only. Non-serious.
Client started having soreness in the arm of vaccination approximately one week after vaccination administered. Pain progressed to include swelling in her shoulder, pain in the muscle where vaccine was administered and shooting pain in the arm and shoulder. Client was seen by Dr. on February 1, 2010 and was given some medication to help her sleep. Client is now using heating pad and Aleve twice daily for pain relief. Client also complains of phlegm, runny nose, headache, sinus pain, congestion and "blood from throat." Client was given Z-pak to treat those symptoms.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old patient (gender unknown) who received vaccines ACT-HIB and PENTACEL. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient received injection of suspect HIB (PRP/T) VACCINE lot number, expiry date not reported via unknown route in unknown administration site. It was an actual medication error due to extra dose administered. It was reported that the 2 months old in the office, received a PENTACEL and ACT-HIB on the same day. 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.
Headache, Fever, Diarrhea, NauseaVomiting,  Sweating  Narrative:
The Pfizer vaccine vial was not diluted properly. There was 0.8ml added to the vial instead of 1.8ml.
Patient received shot in Left arm and after a few minutes became to feel dizzy and warm.  Patient felt nauseous.  Pharmacist applied Ice pack to patient's head.  Dizziness and warmness subsided after 5 minutes.
A few days after receiving the vaccine, I woke up with a blind spot in my central vision of my right eye. Small portion of the visual field but present. Seen by emergency eye physician with dilated retinal exam - nothing noted; thought to be transient and a floater that would go away. 10 month later, seen by primary physician with blind spot still there & sent to retinal specialist for further evaluation. Small ischemic spot noted on retina, diagnosed with idiopathic macular neuroretinopathy as my coagulable work up all came back negative as well as an echo and carotid ultra sound.
received 0.6 mL of Shingrix instead of 0.5 mL; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .6 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were reported as follows: The patient received 0.6 mL of Shingrix instead of 0.5 mL, which led to overdose. No more information available since reporter was not at work. Due to communication issues, a lot of information was not requested or tried to be confirmed after reporter mentioned the limited data available due to them not being at work. The reporter consented to follow up. This case has been linked with case ID US2021151036, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151036:Same reporter
Pt developed redness and itchiness on chest post-vaccination. Pt reports hx of allergic reactions after having surgeries in the past. Denies chest pain, palpitations, SOB, or trouble breathing.  SpO2 99% on RA, un-labored breathing, lungs CTA bilaterally.  Pt discharged under stable condition with Claritin 10mg x 1, ER precautions given.
High fever..going up and down...caused a febrile seizure...emergency room reported no infection.
Redness at site, 7 cm x 8 cm, tender to palpation, itching at site x 2 days. Treatment - KEFLEX 500mg 1 PO TID x 7 day, Hydrocortisone cream, BENADRYL 25mg PRN.
Within 1-2 minutes of receiving the vaccine, patient stated feeling hot with stomach discomfort, itchiness, heavy sensation on the chest causing a difficulty in breathing, and seeing stars.
Severe tinnitus in my right ear, high pitched and constant.  I sought help from my primary care doctor who referred to ENT doctor.  I was told nothing could be done.  The hearing test was normal.   Tnnitus is going on almost 5 months to date.
patient was mistakenly given the covid vaccine instead of a flu shot. Upon reviewing the patients profile with their caregiver it was determined patient was due for their third covid shot anyway.
Next morning red and heat, ibuprofen, ice applied 36 hours later on 10/7/10 noticeable swelling to (R) arm, sensitive to touch. By 10/9/10 resolved.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 18-OCT-2012 06:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
LA- 1st Covid Vaccine.  IMMEDIATELY after Vaccine: Tingling & NUMBNESS to my fingertips.  By Nine PM the night of vaccination, arm pain 10/10 with severe swelling, no mobility and feeling of a dislocated shoulder and elbow.  Severe pain the next day accompanied by loud "Cracking" of my L Shoulder and L Elbow.  Ongoing Shoulder/Arm pain with decreased mobility and numbness to the fingertips along the ulnar nerve & "cracking".  Taking Motrin. Rotational shoulder pain.  Consult Dr. 4/22/21. Consult Dr. (orthopedics)-- Prednisone prescribed.  Pain improved a bit for 4 days- then pain and rotational problems continued.  On 07/12: Visit to Dr., Orthopedics at hospital-- 2nd Prednisone dose pack. Continued from 1st page:  2nd Prednisone dosepak prescription.  Was told my Dr. that I had probable improper administration (wrong location- too high) of Covid vaccine and severe, prolonged inflammatory response.  I have been referred to physical therapy to improve mobility. Physical Therapy will call me for consult.  Problem ongoing...  I am tired of filling out this form and keeping it on my desktop.
Fever  (100.6 F) began on 1/30/21 and is remains and a mild headache began today
Approx. 10 minutes after receiving vaccine, pt. reported an "itchy throat", following another 10 minutes, approx. of "funny feeling in her throat". Then MD was paged in allergy, she talked with pt. and RN on speaker phone to assess patient. Two sets of vitals were taken, and pt. was administered another Zyrtec 10 mg. was given p.o. Pt. entire time was able to drink water and swallow. Pt. accompanied with a family member who can drive her home. Pt. stayed approx. 45 min, until all symptoms resolved.  Other nurses in clinic made aware.  MD instructed pt. that she would be contacted by allergy for further follow up prior to her second appointment for dose 2, and that patient was ok to come in for dose two.  Pt. had epi pen with her at al times in her purse.
Patient states she had a lot of pain and swelling at the injection site that occurred immediately after the injection she received at the local vaccination clinic.  It did not improve over several months.  This occurred in January 2021 and she was still having symptoms when we saw her in our office on 10/21/2021.  She still gets swelling, has decreased range of motion of her shoulder and a lot of pain.
approx 2min p/all 4 immun pt stopped crying became limp & pale;seen by MD immed, HR 132, R40 easy 02 sat 97%;fell asleep approx 30min;lethargy VS stable sent to hosp for observation overnoc;
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Nausea-Severe, Additional Details: The evening after receiving the shot, the patient experienced severe chest pain followed by nausea. The nausea resolved first, followed by chest pain which was mostly better by the next morning.
pt recvd vax & passed out; no pulse & also hives; pt was unconscious; eyes & arms & legs were swollen; admitted to hosp for 2 days;
Moderna COVID-19 Vaccine  Vaccine administration was okay and without issue.  Patient reports having sensation of "vice around heart" that spontaneously resolved less than 5 minutes after injection.  No anaphylaxis or shortness of breath, but sensation of tightness in chest that subsequently resolved within the 10-15 minutes after injection.
this time she is having really bad cramps; this time she is having really bad cramps; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACINE), administration date 09May2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "She normally has mild cramps on her first day" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSMENORRHOEA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "this time she is having really bad cramps". The event "this time she is having really bad cramps" and "this time she is having really bad cramps" was evaluated at the physician office visit. Therapeutic measures were taken as a result of dysmenorrhoea, condition aggravated. Additional information: Paracetamol (TYLENOL) and ibuprofen were not helping. The doctor said the vaccine might give her more cramps than usual.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within a few minutes after flu vaccine developed neck, chest pain lasting a few minutes. Then tingling of face, hands and left arm (injection site). Later that day swelling of lips, eyes and skin rash.
Elevated blood pressure (160/89); This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure (160/89)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure (160/89)). On 23-Mar-2021, BLOOD PRESSURE INCREASED (Elevated blood pressure (160/89)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Blood pressure measurement: 160/89 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication.  The patient stated that he wasn't sure if the elevated blood pressure was due to the vaccine or due to the anxiety of his daughter getting diagnosed with COVID 19.  Treatment included use of his regular blood pressure medication.
Acute pain behind left eye.  Over the counter pain meds did nothing.  My first trip to the ER was at 9:30 pm on 8/22/2021.   CT Scan was good.  All vitals were normal.  I was negative for Covid.   I was prescribed Ibuprofen (600 mg).  The pain never diminshed.  On Tuesday, 8/24/2021, I went back to the ER at 9 AM.   All my vitals were normal.  I had a few small spots of a skin rash above my left eye.  The Dr. immediately said I have shingles.  She prescribed Acyclovir (800 mg); Gabapentin (300 mg); Hydrocodone 5-325 mg.  and made me an appointment with an eye doctor.  Dr. confirmed the shingles diagnosis on 8/26/2021 and prescribed Valacyclovir (1 Gm) and eye ointment.  Follow-up visit was 8/30/2021 - Dr. prescribed Prednisolone AC 1%.
No 2nd dose due to health insurance issues; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st Shingrix shot 3 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. Patient did not got 2nd dose due to health insurance issues. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Patient received his 4 month immunizations on 5/6/03. On 5/7/03 he reported to the office with a fever of 38.1 C and behavior consistant with hallucinations. He was admitted to the hospital on 5/7/03 and discharged on 5/8/03 after the fever and hallucinations resolved. At a recheck on 5/9/03 the fever and hallucinations were resolved but he was diagnosed with a URI. The physician suspects the DTaP immunization for the fever which lead to the hallucinations.
Information has been received from a school nurse concerning an approximately 16 year old female who on an unspecified date was vaccinated with a dose of Gardasil. Approximately 5 minutes after receiving the dose, the patient experienced a fainting spell and a seizure. Unspecified medical attention was sought. Subsequently, the patient recovered. Upon internal review, the patient's seizure was considered an other important medical event. Additional information has been requested.
Chest pain (towards left side); Nausea; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Oct2021 at 18:00 in the left arm (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other concomitant medications within two weeks prior to the vaccination. On 25Oct2021, at 10:00, the patient experienced chest pain (towards left side) and nausea. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain (towards left side) and nausea was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt reported severe neck pain radiating down left arm. She went to the ER and was diagnosed with transverse myelitis at C2. More information will be available from the facility that treated her, but I do not know who it was.
bursitis of the left elbow; A spontaneous report was received from a physician concerning a 83 year old male patient who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced bursitis of the left elbow. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included high blood pressure medications.  The patient received first of two planned dose of mRNA-1273 (039K20A) on 28-JAN-2021  for prophylaxis of Covid 19 infection.  Patient developed Bursitis of the left elbow few days ago.The treatment for the event include amoxicillin.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event were unknown.
swelling, redness around site of vaccine, patient was seen 3/3/22 and put on antibiotics,  redness spread patient than seen last night in ER per physician recommendations. Patient put on a different antibiotic.  Mom states  the redness has not spread and patient doing better today.