chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered (8-July-2022) only the liquid portion of the shingrix vaccine inadvertently.; Only the liquid portion of the shingrix vaccine inadvertently.; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2022, the patient received the 2nd dose of Shingrix. On 8th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date :08-July-2022 Reporters comment: Physician reported a patient was administered only the liquid portion of the shingrix vaccine inadvertently. The patient received shingrix in left deltoid. The reporter consent for follow-up. Additional Supportive information: The patient received 2nd dose of only the liquid portion of the shingrix vaccine which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication.
Polycystic Ovarian Syndrome; has a chronic lower back pain; severe menstrual cramps.; This case was reported by a consumer via interactive digital media and described the occurrence of polycystic ovarian syndrome in a 19-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, 7 years after receiving HPV vaccine, the patient experienced polycystic ovarian syndrome, chronic back pain and menstrual cramp. On an unknown date, the outcome of the polycystic ovarian syndrome, chronic back pain and menstrual cramp were not recovered/not resolved.   It was unknown if the reporter considered the polycystic ovarian syndrome, chronic back pain and menstrual cramp to be related to HPV vaccine.  Additional information was provided as follows: The case was reported by the patient's mother. The age at vaccination was not reported, but could be 19 or 20 years. The patient received HPV vaccine and experienced polycystic ovarian syndrome, chronic lower back pain and severe menstrual cramps. The reporter mentioned that, HPV vaccine had been used to sterilize the girls and she wished, she could have known this 7 years ago when her daughter was vaccinated. The reporter was regretting so bad, getting her daughter vaccinated at the age of 12. The case is linked with the case number- US2020AMR247406, reported by the same reporter ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR247406:same reporter
Swelling of the right side of face / neck, extreme redness on right side of face and neck ,  hot to touch on red areas, very disoriented, dizziness, headache.  Examined by doctor and give 2 Benadryl.
Within an hour after receiving the shot at 12:17 P.M. on October 11, 2008, I began to feel as though something was wrong. I continued to get more physically uncomfortable for the next 36 hours. By Monday morning the 13th I felt as though I had a mild case of the flu, but went to work anyway. By Tuesday morning the 14th, I was too ill with flu-like symptoms to go to work and stayed home. Wednesday morning the 15th, I went to work again, but was still ill. I feel as though I had a low-grade flu the rest of that week. Between the weekend (October 18) thru today's date (October 24), I continue to have bad cold symptoms including sinus, congestion, and coughing problems, but the flu symptoms are gone.
Covid-19 Pneumonia; Covid-19 Positive; A spontaneous report was received from a consumer concerning an 80-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and diagnosed covid-19 positive and covid-19 pneumonia.  The patient's medical history not reported. Concomitant medications was not reported.  On 03 Mar 2021 prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 002A21A) for prophylaxis of COVID-19 infection   On 15 Mar 2021, patient diagnosed with COVID-19 positive and COVID-19 pneumonia (medically significant), he was hospitalized for both events.  Treatment information was not provided for the treatment for covid-19 pneumonia infection.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events were unknown.; Reporter's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of Covid-19 test positive and Covid-19 Pneumonia after vaccination, these events are assessed as unlikely related to mRNA-1273.
Discharge Date:04/26/23 from hospital. Transferred to hospital on 4/26/23 and is still inpatient at this time.  Admit Date:  4/3/2023  Attending Physician: Dr.  Consulting Physicians: Pulmonology, infectious disease, neurology, palliative medicine, endocrinology, general surgery Primary Care Physician: MD   Hospital Course:   The patient is a 69-year-old female with past medical history of asthma, T2DM, HLD, HTN, hypothyroidism, rheumatoid arthritis, cirrhosis. She initially presented to the ED 4/03/2023 with fever/chills, shortness of breath/cough and occasional hemoptysis.  These symptoms were present since she was diagnosed with COVID-19 on  3/13/23. She was treated outpatient with Paxlovid.  She was initially admitted to internal medicine on 4/3/2023 due to septic shock from bacterial pneumonia on top of COVID-19 infection.  Pulmonology was also consulted on 4/4/2023 for bronchoscopy.   Patient began a 7 day course of cefepime and despite further therapy had continued decompensation with ARDS. She was admitted to ICU 4/07 for intubation and then bronchoscopy.  Patient was eventually intubated and had a central venous catheter and arterial line placed 4/8 with initiation of vasopressor support.  She did eventually wean off all vasopressor medications.  A 7-day course of cefepime was completed and she was subsequently started on remdesivir for 10 days.  The patient's encephalopathy was worked up with CT head, MRI, EEG which did not demonstrate any etiology of the patient's encephalopathy.  Her encephalopathy eventually improved.  However, her respiratory status did not improve and she continues to have persistent vent requirements.  We conducted a repeat CT chest 4/19 which demonstrated worsened groundglass.  Due to the patient's persistent ventilatory requirements and no improvement on imaging, general surgery was consulted for trach/PEG, which was completed 4/21.   For the patient's type 2 diabetes with insulin pump at home, her insulin pump was not given due to acuity of illness.  Endocrinology was consulted and dosed the patient's Lantus appropriately along  with sliding scale.   The patient tolerated trach/PEG well and was able to tolerate trach mask.  She did require ventilator support overnight.  She became stable for discharge.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild
Redness and swelling of right upperarm after receiving flu vaccination, redness and edema is approximately 13 cm's by 8 cm's.
First 3 days my body was tired and fatigued. The second day my eyes started to turn red, like I had pink eye. They?ve been red & swollen since and it has been been 9 days now. I?ve used eye drops, taken allergy medicine & they are not better as of today.
A 37 year old man was given FLUZONE HIGH-DOSE instead of FLUZONE QUADARIVALENT.
suspected vaccination failure; had shingles twice after receiving the vaccine; This case was reported and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's mother. The age at vaccination was not reported. The patient had shingles twice after receiving the vaccine. This case was considered as suspected vaccination failure, as information about Shingles vaccine dose number, laboratory test confirmation for shingles infection and time to event onset was unknown. The follow-up would not possible as no contact details were available.
I wanted to let you know I had a very unusual and adverse reaction to the flu shot.  I received it Friday Sept. 25 about 2:45pm in an outdoor drive thru.  I was not feeling badly that evening but could not go to sleep (that is unusual for me on a Friday). I fFell asleep about midnight and at 3am work up with a massive case of chills.  Shivering so hard the next day I knew I strained muscles.   I woke up Sat. at about 7am feeling terrible.  I took my temperature and it was 101 and stayed that way all day. I had a terrible headache, nausea joint ache and body ache.  The rest of the day I kept napping 2-3 times and ate bread and crackers.  I took Tylenol and by late evening my temp was a little less than 100.  I felt the symptoms at that time did not warrant a visit to a doctor, however had they not gotten better in 24 hours I would make that decision to go to a Dr.    I slept well Sat. night and Sunday am my temp was 99 and is still 99 at 10:30am on Sunday 27th.    I have been taking the flu shots (yes I know each year the compositions changes) for 25-30 annually. I have had very minor reactions sore arm, elevated temp but this was debilitating.  Back to normal temp 98.4 by Sunday evening.
Pt developed redness, swelling, and heat in area (L arm) of vaccine. Mother took pt to ER 8/1/07 in evening was told to take Tylenol and apply ice. Pt. told in our office to continue applying ice and use Tylenol. After 72 hours, pt. can alternate ice and heat.
Within about 4 hours of receiving the vaccination, her arm swelled up with a defined outline, became painful and a little warm. Difficult to raise arm due to muscle pain.
A week after the vaccine, I noticed the site of the vaccine was red and itchy. I thought at first I?d gotten a mosquito bite. But the site was right where the injection site was and over the next day a larger circle and itchy area developed. It?s now going on day 3 and just as bad. I?ve also noticed some general skin itchiness along lower torso but not certain of the timing of that.
rash at injection site, redness, body aches, enlarge lymph nodes left arm pit. Large red  rash left side with dark scaring
patient experienced ankle, knee, and wrist stiffness/pain and dizziness beginning within 1 day following vaccination; symptoms continued into the 3rd day after vaccination (the day patient called and reported)
a rash on her chest/have a rash on her chest that itches; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EK9231; expiration date: unknown), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. Medical history included blood pressure (blood pressure abnormal), borderline diabetes, hypertension, arrhythmia and cholesterol high. Concomitant medication included amlodipine besilate for blood pressure, metoprolol succinate (METOPROLOL SUCCER) for arrhythmia, metformin hcl and rosuvastatin calcium for cholesterol high. The patient reported that she received the first dose of the Pfizer vaccine on 22Jan2021 and two days later she noticed a rash on her chest. She mentioned that she has been using an anti-itch cream. She mentioned that she was supposed to schedule her second dose for 12Feb2021 but is unable access the website to schedule her appointment through. She mentioned that she had a rash on her chest that itches, and she have got some itching cream, but she keeps waiting for it to finally go away but so far it is still there. When asked about the treatment, she mentioned that she had Triamcinolone 0.1% for other usages from her skin doctor (her dermatologist). The outcome of the event was not recovered.
Fever , chills, aches, nausea after 8 hours; resolved after 36 hours Tinnitus after 48 hours, still present
Psoriasis flare-up; Second COVID vaccination had body aches; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and PAIN (Second COVID vaccination had body aches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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 started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN (Second COVID vaccination had body aches). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved and PAIN (Second COVID vaccination had body aches) had resolved.            No concomitant medication provided. No treatment information mentioned.  Patient experienced psoriasis flare. Patient experienced body aches after second dose of vaccine.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
MUSCLE CRAMPING; JOINT PAIN; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On an unspecified date, the subject experienced muscle cramping, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on MAR-2021, and had not recovered from joint pain, and muscle cramping. This report was non-serious.
First, had what seems like "COVID arm" if googled, which arose around 8 days after vaccine administered and resolved after 2-3 days: red, hot, uncomfortable near injection site, small rash  More seriously, around April 14 (13 days after vaccine), had unbearably painful knee pain suddenly arise in both knees where I could hardly move or sleep. No history of joint or knee pains before.  (And in fact I run about 3 miles per day, with no issues.)  No swelling or physical appearance that was off in the knees.  Has not resolved, and it has been two days.  I have been to the doctor and received a full bloodwork.
rxn from vax very serious weak, dizzy, lightheaded, muscle swelling in legs;
Following the administration of a Hepatitis B and a Zoster vaccine (both administered 9/3/2013), both in the left deltoid, the patient developed pain and hyperesthesia in a dermatomal distribution in the (L) rib region that was felt to be similar to a post-herpetic neuralgia. There was, however, no vesicular rash or skin eruption preceding the pain. This was first reported by the patient 9/30/13 - it is an ongoing issue. The patient does not recall developing any kind of rash preceding the skin discomfort. Since the development of the pain, the patient has tried gabapentin with nortriptyline, tramadol, and capsaicin cream without relief. The symptoms have steadily become worse, and the patient is unable to do activities he normally enjoys. The patient had a neurology consult in November 2013 resulted in a diagnosis of neuropathic pain.
During routine immunization, nurse administered IPV that was two weeks expired. This occurred at an ambulatory healthcare center, pediatrician visit nurse private stock vaccine.
This spontaneous case was reported by a consumer and describes the occurrence of SKIN PAPILLOMA (small warts in both of her arms) and BURNING SENSATION (burning in both of arms) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN PAPILLOMA (small warts in both of her arms) and BURNING SENSATION (burning in both of arms). At the time of the report, SKIN PAPILLOMA (small warts in both of her arms) and BURNING SENSATION (burning in both of arms) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was provided by reporter. No treatment medication was provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Live Non-Significant follow-up - No New Information.
Pt had local reaction to DTaP and Hib thighs bilat swollen, red and hot to touch.
C/O Sinus & Forehead pain, & difficulty breathing.  BP 140/103, Pulse 78, O2 sat  98% on RA.  Encouraged to remain at facility for further Observation & pt agreed.  Sitting in chair & drinking water with  son sitting nearby. Symptoms subsided after resting for 20 minutes. BP 128/85, pulse 78, & O2  sat 97% on RA. Awake, Alert, & Oriented.  No C/O pain, discomfort, or difficulty breathing, prior to discharge. Instructed pt & son to follow-up with ER, Urgent Care, or Primary Physician. Verbalized understanding.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 27Jun2022(no stop date provided). Clinical course: Patient did not receive any other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
on the night of 2/9/2021, patient was carrying a conversation in his sleep practically all through the night. The morning of 2/10/21 called 911 to ER.
Mixing/Administration error: Nurse drew up 1.8ml of saline diluent and then drew up 0.3ml of vaccine concentrate from second vial. Injected patient with 2.1 ml of fluid. Did not reconstitute properly.
Swelling of face & face red, chills, headache :  all started when I awoke. Lasted until the next morning.  (I took benadryl and tylenol  on that Tuesday 1/5/2021 to relieve the swelling & help with the discomfort.) My  left arm was red & hot for the whole week-It area was the size of my whole hand. Today, 1/09/2021, things have cleared up.
Two weeks after receiving vaccine, began experiencing chest pains. Doctor diagnosed as costochondritis. Was given an antihistamine to take at night to reduce inflammation. After about a week on  the medicine, the symptoms mostly went away, was told 4-6 to fully be down.
Patient experienced dizziness, headache and chest tightness. Dizziness has subsided but still has headache and chest tightness. Patient will follow up with PCP
PAIN AT THE INJECTION SITE; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) and CHILLS (CHILLS) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNKNOWN and UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) and CHILLS (CHILLS). At the time of the report, INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) and CHILLS (CHILLS) had not resolved. Not Provided          No concomitant medications reported by investigator TYLENOL AND ORANGE JUICE used as Treatment medication.
4/6/21 @ 6pm - Severe chills and body aches.  Lasted until 4/8/21 4/11/21 afternoon - hives started.  By 4/12/21 hives covered both thighs.  From 4/12/21 to current time hives have continued on both arms, legs, hands and feet.  Treatment includes benadyl and hydrocorisone cream.  Benadryl helped on 4/12, but currently taking up to 50mg at a time and is not helping today.
Sharp pain in both ears that come and go; fever; rash on stomach; hives on legs; severe body aches; chills.
Hives/ itching on arms legs and back. Took Benadryl, relieved itching, hives remain.
Seriousness criteria Other medically significant (OMIC). Initial report received from a consumer, who is a physician, on Dec 13/2005. A 62 year old male patient with no significant past medical history, received a dose of Fluzone SV 2005-2006 USP, lot number unknown, in the left deltoid on Nov 29 2005. The route of administration was not reported. Two to three hours post vaccination, the patient experienced myalgias in his neck and shoulder area, which were followed by pain from his neck to chest with deep inspiration. The symptoms resolved by the following day. The symptoms reoccurred on Dec 6 2005 and resolved by Dec 7 2005. On Dec 10 2005, the patient again developed the same symptoms, but had more severe crushing chest pain. The patient was seen in an ER that day and an electrocardiogram was suggestive of pericarditis. He had EKG changes that suggested acute ischemia and he was transported via helicopter to a heart center. The EKG changes reverted to normal within eight hours. An echocardiogram on Dec 11 2005 was suggestive of pericarditis. A cardiac catheterization on Dec 12 2005 was normal. On Dec 13 2005 he had studies showing open coronary arteries, but apparent pericarditis. No treatment information was provided. At the time of this report the patient was still experiencing mild chest pain and had not recovered from the events.