chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in the refrigerator on 12-OCT-2022 and dose was administered on 17-NOV-2022; No adverse event; Dose was given beyond the 30 day refrigeration date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given beyond the 30 day refrigeration date (BUD)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-OCT-2022 and dose was administered on 17-NOV-2022) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given beyond the 30 day refrigeration date (BUD)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-OCT-2022 and dose was administered on 17-NOV-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given beyond the 30 day refrigeration date (BUD)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-OCT-2022 and dose was administered on 17-NOV-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was given beyond the 30 day refrigeration date (BUD)) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-OCT-2022 and dose was administered on 17-NOV-2022).    No concomitant medications were reported.  The vial size was reported as 2.5 mL.  The vial was initially stored in the refrigerator on 12-Oct-2022.  The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-682153, US-MODERNATX, INC.-MOD-2022-682156 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682153:MOD22-030328, same reporter US-MODERNATX, INC.-MOD-2022-682156:MOD22-030331, same reporter
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2014, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 2014, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
an expired dose of DAPTACEL was administered today with no reported adverse event; Initial information received on 14-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown age and gender and it was reported an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered today with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 14-Mar-2023, an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] suspension for injection (batch/lot number: C5829BA and expiry date: 01-Mar-2023; strength, route, dose: unknown) in unknown administration site for immunization was administered today with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Headache; shivers; coldness; body aches; mouth hurts; feel very weak; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported for self that the female patient of unknown age received bnt162b2 (BNT162B2, reported as PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. She had a COVID vaccine shot on Friday, on 18Dec2020, now she is experiencing a headache. She would like to know if headache is normal or if she should go to a doctor. Upon callback, consumer states she received the Covid19 vaccine on Friday 18Dec2020, and is experiencing "shivers, coldness, body aches, headache, mouth hurts, I feel very weak". Consumer wants to know if these things are normal, and if she needs the second dose. She wants to "make sure she's not dying". "Can I use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine?" Response: The interim ACIP guidelines note that, " Antipyretic or analgesic medications (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time.& quot; If you are a patient, you should discuss this with your healthcare provider. The outcome of the events was unknown.   Information about Batch/Lot number has been requested.
Patient reports a very sore/painful arm, which radiated up her neck and across to her back. After 3 days of rest, the pain has completely resolved.
The next morning around 10:30 am started with chills, a fever and body aches lasting all day. The highest fever was 101.7
Patient presented to the ER with progressive weakness, had tested positive for covid on home test. Patient initial o2 sat was 72% on room air and required non-rebreather in the ER. Patient admitted for Covid-19 infection pneumonia and acute respiratory failure with hypoxemia. Patient was started on IV steroids, empiric IV abx, vitamin supplements, Remdesivir and two doses of tocilizumab. Patient was also in acute renal failure. Patient also began to have bloody diarrhea, GI consulted and thought to be likely related to colitis from covid-19 infection. Patients acute kidney injury was resolved on discharge with creatinine of 0.9, hemoglobin was stable at 10.1. Oxygen was weaned down to 2L at discharge.  Patient was discharged to Rehab.
Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no drug reactions/allergies who no pertinent on 18-SEP-2008, was vaccinated IM with the third dose of GARDASIL 0.5 ml (lot#0573X). There was no concomitant medication. Shortly after her third dose, the patient developed pain at the injection site.  The patient's pain at the injection site persisted. No lab or diagnostic studied were performed. It was reported that the patient sought medical attention: office visit. Additional information has been requested.
Injection site became swollen, arm turned red in swollen area, it itched, it was painful throughout whole arm and elbow and across the upper chest area, and continued same adverse effects into Sunday, 12/14/2009 evening, and arm was close to disabled because of pain. Cold pack was applied initially, and only other course of treatment was sleep. The treating doctor was not available for reporting over the weekend.
Started running fevers of 101-103 the day after his shots. Enc. fluids and alt. Tyl./MOTRIN. Sunday early AM broke out in rash that spread. Took to Urgent Care. Treated with Prednisolone, Diphenhydramine and Hydrocortisone 1% lotion.
Chronic shoulder pain from time of vaccination (September 22, 2021) to present date (November 17, 2021) and continuing.  Diagnosed by orthopedic surgeon, as SIRVA.    Cortisone shot in shoulder gave temporary relief for several days.  Oral anti-inflammatory medication gave temporary relief until forced to discontinue after about a week due to darkening of stools related to bleeding caused by the medication.    The shoulder pain is chronic.
Pt received vaccines 8/8/2017. Parent noticed a red itchy spot on the (R) thigh the day after. Area warm to touch, red, measuring 2 inches x 2 inches. Pt seen in office 8/10/2017 by Dr. and recommended pt take BENADRYL, ibuprofen and apply hydrocortisone cream.
Presented to office 3/23/2006 with history of lesion eruptions on 3/20/2006 scatter on face and trunk 3-5 per part. Avoid immuno com and pregnant women (presently in a shelter). Recheck 3/27/06 and rash resolving.
Client presented with right upper thigh swelling, redness, warm to touch and hard (approx. area of 3" X 3". No fever and no problems walking.
Denies side effects or symptoms / no additional AE; 1st dose with MMR II and Varivax and 2nd dose with Proquad; PROQUAD second dose prior to age of 4-6 years of age.; This spontaneous report was received from a nurse and refers to a 15-month-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-OCT-2022 (at 12 months old), the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (M-M-R II) injection, lot #U006489, expiration date reported and confirmed upon internal validation as 26-FEB-2023 (exact dose, frequency, route and site of administration were not reported), and on the same day, she was vaccinated individually with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot #U039722, expiration date reported and confirmed upon internal validation as 15-DEC-2023 (exact dose, route and site of administration were not reported), both for prophylaxis. On 23-JAN-2023 (at 15 months old), the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin) (PROQUAD) injection, lot #W028564, expiration date reported and confirmed upon internal validation as 06-MAR-2024 (exact dose, frequency, route and site of administration were not reported) as second dose, also for prophylaxis (interchange of vaccine products, product administered to patient of inappropriate age). Side effects or symptoms were denied (no adverse event).
21May2021: I was supposed to get the 2nd dose.; My arm was sore /  sore arm at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (21May2021: I was supposed to get the 2nd dose.) and VACCINATION SITE PAIN (My arm was sore /  sore arm at the injection site.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Elective surgery (Patient Had elective surgery on 19-May-2021.) on 19-May-2021.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore /  sore arm at the injection site.). On 19-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (21May2021: I was supposed to get the 2nd dose.). On 19-Aug-2021, PRODUCT DOSE OMISSION ISSUE (21May2021: I was supposed to get the 2nd dose.) had resolved. At the time of the report, VACCINATION SITE PAIN (My arm was sore /  sore arm at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided. Consent given for Safety follow up/contact with caller & HCP.
This is a spontaneous report from a contactable health care professional,  received via a Pfizer sales representative.   A 16-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot# R45078, Expiration Date Sep2017), first dose, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dizziness, nausea, ovarian cyst and tachycardia, all on an unspecified date. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.
L shoulder pain; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0171, Expiry Date: not reported) via an intramuscular route of administration in deltoid left on 06Apr2021 (at the age of 56-years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously did not receive any vaccinations. The patient experienced left shoulder pain on an unspecified date in Apr2021. The event seriousness criteria was persistent/ significant / disability / incapacity. Ae required to visit physician office. Therapeutic measures were taken as a result of left shoulder pain with PT naproxen. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Injection site swelling; Injection site redness/redness around 3 inches; Headache; fatigue; Muscle ache; hyperglycemia; upset stomach; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 25th April 2019, the patient received the 1st dose of Shingrix. On 25th April 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On 28th April 2019, the patient experienced hyperglycemia. On an unknown date, the patient experienced headache, fatigue, muscle pain and upset stomach. On 29th April 2019, the outcome of the injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the headache, fatigue, muscle pain, hyperglycemia and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, headache, fatigue, muscle pain, hyperglycemia and upset stomach to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The patient received 1st dose of Shingrix on left deltoid. The lot number for Shingrix was not reported. It was reported that the adverse events after receiving 1st dose were at level 3 and the adverse events after receiving 2nd dose of Shingrix was around a level 5 to 6. The patient experienced swelling at the injection site of the left arm, redness around 3 inches in diameter, that resolved in 4 days headache, upset stomach, fatigue, muscle ache (thigh region of both the legs) that lasted for 36 hours and hyperglycemia lasted for about 2.5 days. The reporter consented to follow up. The outcome reported for adverse events injection site redness and swelling' in the structured field of source document was recovered/resolved with sequel' while in database it was reported as recovered/resolved'. For tolerance of 2nd dose of Shingrix, refer case US2019129931.
patient started experiencing trouble breathing after 20 minutes after giving the dose. this is her second dose in the series, had no issues with the first shot. administered EpiPen to patient and called 911
On 05/23/16, 32 yo F presented to clinic for comprehensive physical exam. During this visit, pt received MMR vaccination 0.5 mL SC in right arm (NDC: 0006-4681-00, Lot #M001200; exp: 08/28/2016). On 07/31/16, pt sent an e-mail stating "When I came in May to get my vaccines, the nurse told me that I may experience discomfort near the injection site for up to two months. It has now been just a little over two months and my arm still hurts, in fact it seems to be getting worse rather than better. I think I may need to see another doctor to determine if there was any injury from the injection. Do you have any advice on what I should do?" On 08/01, RN replied and asked pt to call and schedule an appointment for evaluation. On 08/15, pt was evaluated by MD and charted "The quality of the pain is described as aching. The pain is at a severity of 7/10 (up to 10 while sleeping). Associated symptoms include an inability to bear weight (struggle to use hair brush), joint swelling and a limited range of motion. Pertinent negatives include no numbness, stiffness or tingling. She has tried acetaminophen for the symptoms. Patient is concerned that it is all related to her MMR vaccination almost 3 months ago for her college and it was on her right arm and since then she is having this shoulder pain which is getting more worse." MD unable to rule out rotator cuff syndrome. Pt prescribed tramadol 100 mg PO Q6H PRN and referred to Orthopedics.  On 08/15, pt seen by ortho PA. Per note ...talked about potential neuritis or Parsonage Turner secondary to vaccination. Hopefully this is not the case. We have also talked about more common problems in the shoulder such as rotator cuff impingement and bursitis. Given the timing of the events, it does seem that the vaccination may be directly related to the onset of shoulder pain." Therapies discussed and pt given injection of 6 ccs of Marcaine 0.25%, 4 mgs Dexamethasone, and 40 mgs Kenalog into the right subacromial space. Pt also advised to start an exercise program. On 09/06, pt's emailed "I am still experiencing the pain in my arm, despite seeing and having to pay for a shoulder specialist for consultation." PA replied with options of physical therapy or MRI. No subsequent encounters charted. Current plan unknown. Reportedly, pt refused MRI.
My arm tripled in size and was hard as a rock. I had a red rash covering 6 inches of my arm. It all lated 3-4 days. I was also very tired with a headache. It was my 7th booster and I had no problems before.
After I received my second dose of Covid vaccine o started developing pain in my left arm n chest.  After a million test I was diagnosed with cancer primary mediastinal large B cell lymphoma ever since I took my second dose of Covid vaccine
pulmonary fiborsis; heart hurt; hearing and eyes are no good and he is old; COPD; hearing and eyes are no good and he is old; arm sore; lungs felt funny and airy but could breathe real good; real bad frontal headache and the top of the head that were two real strong headaches that lasted quite a while; change in smell for several days; he is in terrible pain lying in the bed due to dirty things wrong with him; terminally ill; neck pain; This is a spontaneous report from a contactable consumer or other non-health care professional via PPDI. An 80-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: en5318) via unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included twelve chronic conditions that he has been treated for, for years. Patient mentioned on an unspecified date, he already died once, clarified, it was very sudden and he had a heart attack in his sleep. He had central sleep apnea and he stopped breathing. He has atherosclerosis, his arteries are clogged and he has chronic inflammation, stated it is a can of worms. He has polycystic kidney disease, stated his kidneys are headed that way. He has chronic insomnia, Cerebrovascular accident from 2008, had mini strokes and had heart surgery for blood clots to his brain in 2008. The patient concomitant medications were not reported.   On an unspecified date, the patient experienced pulmonary fiborsis, heart hurt, arm sore, lungs felt funny and airy but could breathe real good, real bad frontal headache and the top of the head that were two real strong headaches that lasted quite a while, change in smell for several days, he is in terrible pain lying in the bed due to dirty things wrong with him, terminally ill, hearing and eyes are no good and he is old, copd, hearing and eyes are no good and he is old and neck pain. AE for second dose transmitted. Patient also stated that after the second shot, his arm was sore at the site, swelling and pain more profound and sooner, knot in the arm, arthritic knees and joints became more painful, illusion of a spider walking on the wall, pain in the left arm bicep, lower left back got painful and went down in to the hip and left thigh muscles and had headaches. Patient mentioned his heart and lungs heart a few days after the second shot and had a strange feeling in his lungs. Patient stated he had night sweats and got drenched but this is a symptom of a heart problem which he has. Patient stated his heart beat was skipping around 68-78 and his oxygen was skipping around. Patient stated that he has PVC. Patient stated he had a headache on the top of his head. Outcome of the events was unknown.
Day 1, almost immediate metallic taste in my mouth.  Followed by sore arm where shot was given.  Day 2 Sore arm and very tired          Day 3 Very tired, a bit sore arm, I noticed a bit of achiness in my joints and muscles  Day 4 Very tired, some achiness again in joints and muscles, chills, but no fever nausea off and on, threw up at night, once.  Day 5 - Diarrhea started at 11 PM and lasted through the night and into the morning.