chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in an 83-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The vial initially stored in the refrigerator was unknown. Number of doses/vials were 173. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received non significant information, reporter added.
Pt developed a fever, was fussy, had redness and swelling of the right upper leg.
Acute limb ischemia- with left internal iliac, common femoral, popliteal artery occlusive thrombosis- underwent emergent Fem-Fem bypass with fasciotomy. Patient subsequently developed respiratory failure with shock and encephalopathy- remains undertreatment.
vomiting, severe abdominal/stomach muscle cramps, difficulty breathing, chills.  1 episode of vomiting.  3 episodes of stomach cramps lasting about 5 minutes each.  Cramps occurred approximately 20 minutes after vomiting.
pt recv vax 18DEC97 & exp a rash over the face;also exp itching all over body but the rash was only on the face;tx DPH;
Patient reported SOB, chills, fatigue, muscle aches and red site reaction.  Patient needed to use her oxygen.
The patient is a 64-year-old medically complex male with a history of renal and pancreas transplant, significant dementia, heart failure, coronary artery disease, peripheral artery disease.  He was found to be positive for COVID-19 yesterday.  Has been exhibiting symptoms concerning for urinary tract infection since Sunday, UA obtained yesterday at his residence is suspicious for infection, treatment is pending culture results.  He complained of a sore throat yesterday and a rapid test at the facility was positive for COVID.  He has fallen recently and has multiple areas of skin tears that are quite uncomfortable for him, this includes his posterior right and left hand as well as his left posterior wrist.  He also has a chronic wound on his right heel and a 2 cm pressure ulcer on his left BKA stump.  He does have a cough.  He was febrile at 102 at the residence.  He is hypoxic and requiring nasal cannula oxygen.
Monday 6/10/19  7:30 PM  cramping, diarrhea, 9:30 PM vomiting Wednesday 6/12/19  3PM complained of mild back pain in the low back and pointed to lumbar region of the spine Thursday 6/13/19       3PM stated that back pain worsened over the course of the school day.  Very painful to sit or stand. Pain    unresponsive to Motrin Friday    6/14/19       6AM extreme localized back pain in the lumbar region. Severe muscle weakness in the legs upon standing.  Nausea and light headed upon standing.  We were seen at the Center around 9 AM and were sent directly to the ER at Hospital.
Injection site soreness, warmth, erythema, swelling, induration, nausea, arthralgias, myalgias, headache, urticaria, joint pain, pain up arm head and neck R black and blue.
Very tiny bit of a headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age started received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization, alprazolam (XANAX), via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dosage regimen for an unspecified indication. Medical history included headache from an unknown date and unknown if ongoing (known to have headaches since her husband passed away in May2020). The patient's concomitant medications were not reported. The patient received the vaccine 2 hours (as reported) and experienced very tiny bit of a headache on an unspecified date. The action taken in response to the event for alprazolam was unknown. The patient inquired if they can take ibuprofen. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Stuffy nose  tingling lips tingling face i took 50 mg of over the counter benedryl..symptoms resolved
Swelling of left bicep, streaks of red down bicep from injection site to elbow, skin hot & painful to the touch. 48 hours after injection, severe nausea, weakness and muscle pain. Nausea subsided after another 24 hours; weakness and muscle pain persist.
Information has been received from a RN concerning a 4 yr old female with no allergies or medical conditions who on 17Jun03 was vaccinated SC with a first dose of varicella virus vaccine live (lot 644974/0196N). There was no illness at the time of vaccination. On 03May05, the pt presented with a varicella rash. Unspecified medical attention was sought and she was treated with diphenhydramine hydrochloride (Benadryl) and calamine (+) camphor (+) pramoxine hydrochloride (Aveeno) baths. At the time of the report, the pt was recovering. A product quality complaint was not involved. Follow up information was received from the RN who reported that on 01May05, the pt had a rash located at the head and face, both arms, chest, breast, axilla, back and both lower extremities. The rash was described as itchy, red, raised, and spreading. There were no complications. The pt was seen in the office on 03May05 and treated with calamine (+) camphor (+) pramoxine hydrochloride (Aveeno) bath and diphenhydramine hydrochloride (Benadryl). No diagnostic lab tests were performed. The pt was determined to be recovered on 03May05. No further information is expected.
While at recovery after 3 minutes pt complained of dizziness, became pale diaphoretic. put pt on cot to lie down feet elevated with ice pack to back of neck.  no LOC no SOB no NV VS taken 116/78,  HR 68 reg strong, resp 12 reg non labored.  pt stated she is afraid of needles.  Also stated she didn't eat anything all day.   Monitored for 30 min. pallor, diaphoresis and dizziness subsided. Provided reassurance sat for 30 minutes.  stated I feel fine now. OKd to exit
Patient presented to facility ED with shortness of breath, fevers, cough and fatigue. patient had previously been seen in ED a week prior on 9/2/21. Patient was admitted after x-ray showed diffused patchy bilateral pulmonary infiltrate.
On the morning of  02 March 2021 I started to experience pain and inflammation on the right upper check, next, arm, back, and abdomen side of my body.   This pain occurred for 2 weeks and subsided for a week. After a week the pain appeared again in the same positions.   At the time due to the pandemic, I could not see receive an appointment with my primary care physician. On 21 April 2021, 5:40 P.M.  I visited Urgent Care with Doctor C  at Clinic.   The results of the X-Ray near my neck/spinal area/chest were normal. Following the visit, my primary physician Doctor O. referred me to a neurologist. On 04 May 2021, 3:45 P.M., I visited Doctor A at the Clinic.  Doctor A. assessed my condition and ordered an MRI. On 24 May 2021 at 3:50 P.M., I visited the Radiology Clinic. There they conducted the MRI for about an hour.   Three days later 27 May 2021, 4:30 P.M. I had a follow-up appointment with my neurologist, Doctor A. She confirmed I had a pinched nerve originating on the right side of my neck with a substantial amount of inflammation and degeneration throughout the upper part of my body.   On 26 August at 2P.M. I underwent a steroid/cortisone injection procedure with Doctor H. Imaging.  There he conducted a CT scan and administered a cortisone/steroid injection. Afterward within minutes my pain and inflammation were gone. This was temporary.  Afterward, 2 days up to a week later my pain and inflammation returned at 50% remaining. As of 09 September 2021, my pain and inflammation are at 25% remaining. Currently, I am in the process of completing and turning in a self-assessment to the radiology department to determine if I should undergo a 2nd steroid/cortisone injection in hopes to further reduce the inflammation/pain.   On 08 September 2021, at 2:20 P.M. I visited my primary physician Doctor O. to provide an update and overview of my prognosis and condition in the past 6 months In order to assess follow-up care. Recommendations were to possibly undergo a 2nd Cortisone/Steroid injection, continue physical therapy, take muscle relaxers, and ibuprofen in hopes of continuing to reduce the inflammation down to 100%.   On the following dates I conducted the following pain management/anti-inflammatory treatments in the interim of my test procedures, findings and treatment course of action.   Physical Therapy.  ? 28 April 2021  ? 05 May 2021.   Acupuncture w/ Doctor C.   ? 29 April 2021 ? 01 May 2021 ? 03 May 2021 ? 07 May 2021 ? 10 May 2021 ? 13 May 2021 ? 21 May 2021 ? 28 May 2021  Chiropractic Care w/ Doctor O. Chiropractic Clinic.  ? 18 June 2021  ? 21 June 2021 ? 24 June 2021 ? 29 June 2021 ? 07 July 2021 ? 16 July 2021 ? 30 July 2021  The lead time for the referral, lab/diagnostic test, and treatment was due to my pre-authorization approval of my insurance benefits.
No additional AE; administered a separate dose of this Case's improperly stored GARDASIL 9 to Patient; This spontaneous report as received from a physician assistant and healthcare business professional refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-NOV-2021, the patient was vaccinated with a separate dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # T025370, expiry date 01-DEC-2022 (exact dose, route and anatomical location of administration were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (F) on 04-NOV-2021 (53.0 degrees F for 3 hours and 30 minutes), on 11-NOV-2021 (59.7 degrees F for 6 hours), and on 15-NOV-2021 (48.2 degrees F for 1 hour and 30 minutes). No additional adverse event details were provided (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA002418:
Patient recieved a dose of Moderna at our store. She said this was her first covid vaccine and that she missed the clinic dates where she worked.  When we reported it to the state registry, we saw that in December and January she received 2 doses of the pfizer vaccine.  We called her to confirm and she said she thought she only got the flu shot in December, and that she would ask her workplace and get back with us. She called us back and confirmed she did actually get both doses at work and did not realize that is what she got.
under arm lymph node swollen; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 14Apr2021 at 11:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, degenerative disc disease, spinal stenosis, irritable bowel syndrome (IBS), sulfonamide allergy and vegetable allergy (tomatoes and broccoli).  Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), pregabalin (LYRICA), escitalopram oxalate (LEXAPRO) and vitamin d nos (MANUFACTURER UNKNOWN) on unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 24Mar2021 at 12:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation and took levofloxacin (LEVAQUIN), duloxetine hydrochloride (CYMBALTA), clavulanate potassium; amoxicillin trihydrate (AMOXICLAV), sulfur (MANUFACTURER UNKNOWN); all on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 00:00 the patient experienced under arm lymph node swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events.  The clinical outcome of the event under arm lymph node swollen was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient developed red, inflamed, itchy rash at injection site 13 days after injection.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date unspecified patients received improperly stored VARIVAX (Merck) (route, dose, frequency and lot # not reported). No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Patient experienced L ear swelling about 2 hours after vaccination on 10/29/21. The swelling worsened and was tender and red and began to spread to neck, scalp, and face. This did not resolve and patient presented to ED on 11/2/21 after speaking to his primary care provider who told him to come to the ED.
Information has been received from a registered nurse concerning a five year old with no known allergies who on 08/01/2001 was vaccinated with varicella vaccine. Concomitant therapy included diphtheria toxoid/pertussis vaccine/teta. There was no other concomitant medication. After receiving the injections the child began to cry and developed a flat, red rash on both arms, the front and back of his neck, and behind his ears. No other symptoms were noted. The mother stated that the child develops a similar rash "whenever he cried hard." On the advice of the reporting nurse, the child was taken to a local ER, where he was examined and released with no recommended follow-up treatment. The rash resolved totally within one to two hours post vaccination. Additional info has been requested.
Provider order an Polio vaccine, MA administer DTAP instead. She stated she heard provider had said DTAP
Information has been received from a nurse practitioner concerning a 22 year old female with minocycline allergy, who on 06-OCT-2009 was vaccinated with her second 0.5ml dose of GARDASIL (lot # 663452/0671Y) IM. The same day on 06-OCT-2009 the patient experienced myalgia and nausea, which lasted for 2 days. It was unknown if the patient sought medical attention. The patient recovered on 08-OCT-2009. Follow up information has been received from a nurse practitioner concerning a 22 year old female with minocycline allergy, who on 06-OCT-2009 was vaccinated with her second dose of GARDASIL (lot # 663452/0671Y) IM in the right deltoid. On 08-OCT-2009 (previously reported as 06-OCT-2009) the patient experienced myalgia and nausea for one day. The patient did not seek medical attention. The patient recovered on 09-OCT-2009. No further information is available.
kinrix was administered to a 8 year old patient; administered on 6/2/2022, IPV:1 DOSE :6/18/2013, IPV:2 DOSE : 8/22/2013; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa-IPV (Kinrix) (batch number 24P2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included IPV (On 18th June 2013 1st dose received) and IPV (On 22 nd Aug 2013 2nd dose received).   On 2nd June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-SEP-2022 Reporters comment: The medical assistant reported 2 doses of IPV in 2013 and that the 8 year patient received Kinrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up Additional Supportive information: The 8 year patient received kinrix vaccine and already 2 doses of IPV in 2013, which led inappropriate age at vaccine administered and inappropriate schedule of vaccine administered. Date of birth and age provided by Health Care Professional did not match. Unable to reach Health Care Professional clarify.
Pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm of the injection) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0ZSB21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy. Concomitant products included ATORVASTATIN, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm of the injection). The patient was treated with MONTELUKAST ongoing since an unknown date for Pollen allergy, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Pain in the arm of the injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-083785 (E2B Linked Report). This case was linked to MOD-2021-095693 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Updated the outcome of the event vaccination site pain from unknown to recovered/resolved.; Sender's Comments:  MOD21-083785:
Vomiting at 8:50 pm the day after the shot. She had no fever, no fatigue, and no pain at the sight of injection yesterday (the day of the shot) or today. She's only vomited three times in her life so this is very unusual. She is currently homeschooling and not interacting with others without a mask. Her sister, 8 y/o female,  received the same shot and also experienced symptoms that started sooner (low fever, fatigue, and aches). This was a booster shot wherein she previously received the two shots of the Pfizer vaccine.
pt developed fever later the day after getting his covid vax so he took ibuprofen and went to bed.  Next day he went back to work.  Pt showed no symptoms until the month of June when he started complaining about pain in both arms.  He was using a heating pad on his shoulders to help with the pain.   He was taking Aleve for the pain but it was not helping so he no longer wanted to take it.  He had a vomiting episode on the afternoon of June 16th stating he thought he has eaten a bad lemon.  He wasn't feeling well the morning of June 18th, 2021 but continued working.  He only wanted something light to eat since he didn't feel well and was headed to bed.  When his wife went to go to bed she found him collapsed on the bedroom floor with face forward in the bed.  She turned him around and found him unresponsive.  She contacted 911 and he was taken to Medical Center ER.  They were not able to revive him.  County conducted an autopsy where they found a blood clot in left artery.
On 01/29/2021 I began to have severe chest pain, shortness of breath, fatigue, dizziness, right arm numbness, severely low BP. I was taken to the ED on 01/30/2021, 02/04/2021, and 02/18/2021. Each time I was cleared for COVID-19, heart attack and stroke. I was given bags of IV to help increase my BP because it was (on average between the 3 visits) 90/55. Other than that I was not "treated" for anything. I followed up with Cardiology and Endocrinology and continue to follow up to hopefully find an answer and a "cure" to start to feel better.
Pt started complaining of headache, dizziness (BP 60/40), pain at injection site and nausea but unable to "throw up", occasionally lethargic; all symptoms occurred in 7 minute time span; treated with epinephrine/SC and ammonia for sniffing purposes, notified EMS, transported to ER. According to MD, I feel that the pt experienced a vasovagal episode and not an allergic reaction.
High fever 103.8 for 7+ days, child was lethargic, weak, would not eat, only breastfed.  Delayed his progression.  Had huge red welt around injection site the next day.
3 days after receiving my second dose of the Covid vaccine I started to have right sided neck discomfort. No interventions were taken for the first week. I continued to have discomfort so went to see Dr for my right sided neck pain. He ordered an ultrasound of my neck and labs. Report on ultrasound revealed I had  3 thyroid nodules.  I am now waiting to have a fine needle aspiration biopsy to what these nodules are. In the past I have never had any thyroid problems or  was i aware that i had thyroid nodules. I?m writing this as an adverse event because I?m not sure if the vaccine cause the nodules to become inflamed causing me to have neck pain.
Pt recv vax on 8/24/98; on same day pt exp pain & unable to walk, joint pain in fingers, knees &feet w/ swelling;dx=post reactive arthritis tx=Prednisone
Narrative:  She reports to the emergency department today with shortness of breath. 3 or 4 days ago she took a home Covid test and it was positive. She has had congestion, cough, fever and body aches. She is also had wheezing and decreased O2 sat when EMS arrived. She reports loss of taste and smell. Admitted to general medicine floor.
11/6/13 Today red lump appeared on upper (L) thigh 1 1/2 cm - flu injec - site. Sl. tender. No decreased ROM (L) leg.
On Dec 24 mother noted fever of 100 at 8:00A - shortly after noticed raised red rash on both legs - no apparent itching. Rash became worse over next 2 days & spread to thighs, feet, forearms & face. No further fever after 1st day. No other family members symptomatic. Advised to consult PCP. 1/5/11 child recovered w/o physician exam or treatment - per mother.