chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021 at 1:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:50 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Mar-2021 at 1:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 03-Mar-2021, total doses given for the day was 200 with temperature 51 degrees Fahrenheit, 34 degrees Fahrenheit and 35 degrees Fahrenheit at 9 AM, 10 AM and 1 PM respectively. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. 16 vials were sent to clinic. Batch number 030B21A underwent temperature excursion on 31-Mar-2021, total doses given for the day was 199, Excursion time was 08 AM, temperature was 32 degrees Fahrenheit, vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021. 16 vials were sent to clinic. Excursion time was 09 AM, temperature was 32 degrees Fahrenheit, vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. 16 vials were sent to clinic. On 03-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM: 36, 3 PM: 36 and 4 PM: 36. On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46 and 4 PM: 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.
4 Painful sores in mouth on cheek, tongue and throat. One in nose. They look like ulcers.  Today cheek and tongue ulcers are painless.  throat is tender, but soothed by chewing "Aspergum"  I cannot see the one in my nose, but all are is much improved.   It took me several days to realize that the sores might be related to the vaccine.  That is for you to consider. Hope this is helpful. I am frightened to take the booster , due 02/24/2021.  I will take it.
+ raised, reddened, hardened area, > 2/3 R arm above elbow, laterally
The pt say she broke out on her arms like her blood vessels had been broken in both arms and she now says her lymph nodes are swollen and bruised ase well as her abdomen.  The pt did go to her md and her blood work was fine and her Md who is Dr. said it's possible it could be from the vaccine.
12/24/2022   My nose was running, sore throat and no other symptoms. It progressively got worse over the week.   On 12/31/2022 I went into Urgent Care. I was tested for RSV, Flu and COVID. I tested positive for COVID.  I tested negative for RSV and Flu. I went home and fought it off. It lasted about a week.
3/28/2021   Pt. was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness, FLUSHED, WARM AND SWEETY, NAUSEA WITH DRY HEAVES   Assessment : Time of assessment 0841. Alert and oriented.   Actions taken: VS taken at 0851- bp-131/92, p- 90, o2- 100%, VS RECHECKED - BP-112/78, P- 66, O2- 100%, 0855 SYMPTOMS RESOLVED, 0901 BP- 99/68, P- 67, O2-100% DISCHARGED HOME WITH FAMILY MEMBER.          Medications administered: Famotidine (Pepcid) 10 mg by mouth. Time: 0851. Administered by RN.  BENADRYL 25 MG po X 1   Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/28/2021  8:36 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8730   NDC: 59267-1000-1          Electronically signed by RN at 3/28/2021 11:13 AM  Immunization on 3/28/2021   Detailed Report  Note shared with patient
Starting 3 days after the vaccine (1/3/21) she had a severe headache. The next day she also had nausea and a mild cough. She was tested for COVID which was negative. She felt better by 1/5/21, but had muscle aches and fatigue on 1/7/21 and 1/9/21.
Fatigue- same day 4hrs later. That lasted 3 days. 2 migraines day after  Raised welp on injection site arm. The next day.
I felt shaky initially. The next morning around 230 am I woke up with a headache, pain at the injection site. As the day progressed, I had the chills and itching, pretty bad. Headache got worse. I felt very tired.
SO I took the second dose on Tue around noon. Wed around noon I started feeling slight chills and slight body ache. Slept it off until 7 pm . Thu around noon - more body ache about similar chills. Rest for a couple hours, slept it off for a couple of hours. Fri again around noon - similar body ache but significant uncontrollable chills.  Body felt warm on and off through these periods noon to 7 pm. Treated with Tylenol (300) + advil (600). Some comfort, but that comfort seems to be lessening over the period. For example the uncontrollable chills today started concerning me. Tylenol took more than an hour to slightly lessen the chills. Had advil to see if that helps. As I write this chills seems to have subsided. But that feeling of warmth especially in the face has returned. Feel like placing a cold towel on the face. Weirdly enough its this noon to 7 pm time frame when the symptoms are at their worst and in any combination really any given day. Outside of that I function pretty well, almost normal! Its past 48 hours so thought I'd report.
Developed petechiae to bilateral lower extremities 3 days following vaccination. Otherwise asymptomatic at the time of evaluation.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. It was reported that on an unknown date an unknown number of patients were vaccinated with GARDASIL or VAQTA (information captured in MARRS#1305USA013384) (dose, route, lot number and expiration date not reported). Medical assistant reported that the vaccine was stored lower than -1C (Celsius degrees) from July 2012 until the present. No adverse effect was reported. Additional information has been requested.
Pt reported that "within 5 seconds" of receiving her 1st Pfizer (30155BA) vaccine she developed "itching to my throat" but denied any swelling to her mouth or throat. Pt ambulated with very steady gait to monitoring area and continued to speak full and clear sentences. Within 3 minutes of monitoring, pt began having persistent clearing of her throat and coughing", pt also indicated that she was having a burning sensation to her bilateral ears. Call out to ER MD and verbal orders obtained for Cetirizine 10mg po now. Pt was medicated and tolerated very well. Approximately 10 minutes post medication, pt reported "feeling much better" with her itching and burning decreasing. Lung sounds remained clear to auscultation bilaterally. Pt was -stridor or wheezing. No rash or swelling noted on physical exam. She remained calm and very cooperative. Within 30 minutes of monitoring pt, her symptoms continued to get better, minimizing to a 2-3/10 from initially a 6/10 itching to her throat. She was speaking full and very clear sentences with no other complaints upon discharge.
pt recv vax & devel swelling @ inj site & nausea 3wks p/vax;
~3 MONTHS POST 2ND DOSE: HAIR THINING/LOSS, GENERALIZED ITCHING. ?FOLLICULITIS ?TELOGEN EFFLUVIUM ?DERMATITIS  DIPHENHYDRAMINE HCL 25MG PRN  KETOCONAZOLE SHAMPOO 2%  3 WKS DESONIDE OINTMENT 0.05% 10 DAYS
I woke up with pressure on my chest and pain on my left arm around the elbow. After a couple of minutes, I began to have a lot of cold sweat, and both the pressure in my chest and pain in my arm began to increase. Then I began feeling a tingling sensation on my neck/chin. After that, I felt lightheaded and decided to go to the hospital. At my arrival to the ER, I was given aspirin and heparin. I got a couple of EKGs and a chest X-Ray, as well as some blood work. I was then transferred to the medical center, where I had some more blood tests and EKGs done. I was also treated with Indocin, Lipitor and Aspirin. At around 9PM, I began feeling the pressure on my chest again, although with decreased intensity. I was given morphine and the pain went away. This event repeated at around 10AM next morning with the same outcome. After that I got an Echocardiogram, and began to be treated with Metoprolol. No other pain events happened for the rest of my stay at the hospital. On the next morning, April 26th, I was taken to an angiogram to rule out Coronary Dissection. After the test, I was discharged with a prescription for Metoprolol.
Forearms started itching and developed a fine rash, rash worsened at night, became slightly vesicular.
No adverse side effects from vaccine administration error. This is an error only report for expired vaccine given. Moderna was contacted in efforts to conclude if the vaccines administered on January 19th were efficacious or not. Moderna Case CEA-1680 was reviewed.  "The vaccine administered on January 19, 2022 from lot number 077C21B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. " No known sequela from the event.
Fever/chills/sweats Extremely soar and painful muscles Exhaustion Headache Red patch on injection site appeared 36 hrs after shot (I got this with the first shot which was in my other arm)  Tender lymph nodes in right armpit
Information has been received from a registered nurse concerning a 39 month old female with no medical history, no known allergies who on 10-OCT-2006 was vaccinated with the first dose of VARIVAX (Merck). The registered nurse reported that on 21-OCT-2008 the patient had a 2-3 day history of stuffy nose, no cough, no fever. The patient developed 10 red papules, some vesicles, no pustules. The patient recovered. The registered nurse reported the the patient experienced chicken pox on 21-OCT-2008. No lab/diagnostic tests were performed. There was no illness at the time of vaccination. No further information is available.
On 12/27/2022, I did not have symptoms, but I tested for COVID-19 out of precaution. I was going to be around immunocompromised individuals. I did an at home COVID-19 test and it was positive. I did another test to confirm those results. The next day, I began to develop aches, lethargy, congestion, a mild cough, chest tightness, and a sore throat. I was prescribed PAXLOVID and began taking that on 12/28/2022. I was also instructed to use my nebulizer and I was using my inhaler more regularly. I experienced really bad COVID-19 brain fog, so some of it is a little hazy to me. I think it was 12/29/2022 that I had high blood sugar which is abnormal for. I typically run low, and it was quite high without food. I think it was 146 and normally, I'd be around 90-100. That only lasted a day or two. On either 12/30/2022 or 12/31/2022, I had high blood pressure. I was having at home readings of around 140 over 95. That lasted several days where it just kind of stayed high. My normal is around 117 over 75. Around 12/31/2022 or 01/01/2023, I began having difficulty keeping my oxygen levels above 90 while trying to sleep. I struggled with that for around two days. My at rest oxygen was around 94 to 96. My active oxygen was above 95 but I was having difficulty breathing while lying down and that lasted for around five days, maybe a little longer. It wasn't until last week that me at rest oxygen was staying above 95 and above 93 while laying down. On 01/03/2023, I had a lot of leg weakness and cramping. on 01/04/2023, I had muscle weakness and fatigue. On 01/05/2023, I had a lot of random numbness that would travel all over my body, along with fatigue. I tested negative on 01/03/2023 and again on 01/06/2023. I went to a local urgent care on 01/06/2023 because I was having trouble breathing. I had a lot more problems with my breathing after I was testing negative. I never lost my taste or smell, but I had a metallic aftertaste the entire time I was on PAXLOVID and a little bit after from around 12/28/2022 to 01/05/2023.
I had a bad cough; chest congestions; no fever; tired; exhausted. I tried to take MUCINEX for the chest congestions for few days till I  contacted my doctor. On 07/14/2022 I did a telehealth with my doctor. He prescribed me with PALOVID for 5 days. I started feeling better after taking the medication. On the 5th day I tested negative. I still have lingering cough.
15 min. after administration skin around injection turned red, spread to 3 x 4 cm. 90 min. later, did not spread further, pt. taking diphenhydramine.
Really bad body aches the next day.; Itching at site and then itching went to rest of body. No hives.; Itching at site and then itching went to rest of body. No hives.; This is a spontaneous report from a contactable nurse (reported for herself).  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot/batch number and expiry date not reported), intramuscular on 18Dec2020 16:45 at single dose (dose number 1) in the right arm for immunisation. Medical history was none. Patient was allergic to medication sulfa, food, or other products.  She had no other vaccine in four weeks, no covid prior vaccination. The patient's concomitant medications included unspecified multivitamins. The patient experienced itching at site and then itching went to rest of body (no hives) on 18Dec2020 16:45. She had really bad body aches the next day (19Dec2020). No treatment was given. No hospitalization reported. The outcome of events was recovered on unknown date in Dec2020.  Information on the Lot/Batch number has been requested.
Right acute lumbosacralplexopathy dx on EMG. Severe pain and weakness right thigh, leg began approximately 3 days post second vaccine. Progressive pain, weakness, atrophy.
vaso-occlusive event; thrombocytopenia; splenic sequestration and abdominal ultrasound showed a diffusely echogenic and atrophied spleen.; This is a literature report for a Pfizer sponsored program (005851) for the following literature source(s): "Thrombocytopenia in a teen with sickle cell disease following COVID-19 vaccination.",  As per source verbatim: Drug Safety : ADR Case Report. COVID-19-vaccine-pfizerbiontech/ibuprofen/oxycodone. Vaso-occlusive event, thrombocytopenia and lack of efficacy: case report. Serious. Narrative Summary: A 14-year-old boy developed vaso-occlusive event and thrombocytopenia following vaccination with COVID-19 vaccine pfizer biontech. Additionally, he exhibited lack of efficacy with ibuprofen and oxycodone while being treated for vaso-occlusive event [dosages and routes not stated]. The boy, who had homozygous sickle cell disease and was chronically prescribed with hydroxycarbamide [hydroxyurea] and voxelotor, received COVID-19 vaccine pfizer biontech [Pfizer COVID-19 vaccine] 23 days before presentation. He presented with the 3-day history of bilateral anterior hip and back pain (first vaso-occlusive event). He had received treatment with ibuprofen and oxycodone at home; however, the treatment was unsuccessful (lack of efficacy). He had a history of acute chest syndrome. At the time of presentation, he had nonpalpable spleen, elevated WBCs, and decreased platelet count i.e. thrombocytopenia [duration of treatment to reactions onsets not stated]. His SARS-Cov-2 PCR was negative. He was hospitalised and was found to have splenic sequestration and abdominal ultrasound showed a diffusely echogenic and atrophied spleen. The boy was treated with unspecified opiates and anti-inflammatory medications. He was discharged after 4 days of hospitalisation. Four days after discharge, during follow-up, his platelet count was found to be normalized.  Author's Comment: "The teen presented here is the first child with SCD reported to develop [vaso-occlusive event] and thrombocytopenia after the [COVID-19-vaccine-pfizer-biontech]." "He had unsuccessfully been treating symptoms at home with ibuprofen and oxycodone."; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
On 11/20/01 varicella lesions in varying crops >30, L 50 11 P-O ?  in office.
PATIENT HAS A SWOLLEN ARM  ON THE INJECTION ARM BUT NOT AT THE INJECTION SITE
No adverse reaction or symptoms. Patient received incorrect dose of moderna Covid vaccine. Instead of getting the 6-11 year old primary series of moderna vaccine, she received 6 month-5 year old supply of covid moderna vaccine. 2nd dose of primary series will need to be completed.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant follow up: Added age group and updated narrative.
Patient states initial reaction was feeling feverish, pain, and chills that went away shortly but after a few days a rash developed on arm where vaccine was given. Rash started at the site of injection and continued down to elbow.
Became lightheaded & fainted after leaving office. Returned to office by father: BP 92/50. Received Gatorade & crackers & recovered.
No Adverse Event; Due to the leaking the patient received a smaller than recommended dose; There was product leaking from where the needle attaches to the syringe.; There is a possibility the leaking was due to user error as there was no noticeable damage or issues; This spontaneous report was received from pharmacist and referring to a patient of an unknown age and gender.  The patient's pertinent medical history, current conditions, drugs reactions or allergies and concomitant medication was not provided.  On 16-JUL-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection,  for prophylaxis lot #U035117 validated upon internal review, expiration date: 18-AUG-2023 (strength, dose, frequency, anatomical location and route of administration were not provided).  That day after the administration was completed the health care professional (HCP) noticed there was product leaking from where the needle attaches to the syringe (syringe issue) (also reported as between the syringe hub/luer lock and the syringe needle). Caller stated due to the leaking the patient received a smaller than recommended dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (accidental underdose). Additionally, it was reported there was a possibility the leaking was due to user error as there was no noticeable damage or issues with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (device use error), but it could not be confirmed as the HCP did not check the tightness of the needle after administration. The reported confirmed the syringe needle was attached securely to the syringe tip before the leaking occurred (conflicting information, also reported as the HCP possible did not properly ensure the needle was tightly secured to the syringe). Caller stated this product was not available for retrieval nor are pictures able to be taken as the product had already been disposed of. No adverse events (AE) were reported.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Current conditions and other relevant medical history were not reported. The nurse reported that on an unspecified date in January 2010, the patient was vaccinated with the first dose of GARDASIL (Intramuscular injection, strength, dose, route, anatomical location, lot # and expiration date not reported). Then, 0n 22-AUG-2014, the patient was in the office to receive the second dose GARDASIL (Intramuscular injection, strength, dose, route, anatomical location, lot # and expiration date not reported). No adverse effects reported. No further information was provided. Additional information has been requested.