chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster; rheumatoid arthritis flare up; Drug side effect; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4014738-00.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1151650) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1st, Route of Admin : Intramuscular), administration date: 01May2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "COVID-19", "COVID-19"; Bnt162b2 (Dose:2nd, Route of Admin : Intramuscular), administration date: 15Jun2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "COVID-19", "COVID-19". The following information was reported: IMMUNISATION (medically significant) with onset 20Dec2021, outcome "unknown", described as "booster"; RHEUMATOID ARTHRITIS (medically significant) with onset Dec2021, outcome "unknown", described as "rheumatoid arthritis flare up"; ADVERSE DRUG REACTION (medically significant) with onset Dec2021, outcome "unknown", described as "Drug side effect". The action taken for adalimumab was unknown. Clinical course: Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID-19 with Humira (Adalimumab) was no reasonable possibility. For the events Rheumatoid arthritis flare up & Drug side effect Causality for Humira as per reporter (Drug/Vaccine) was Reasonable possibility. The reporter's causality for the of events Rheumatoid arthritis flare up & Drug side effect with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was possible.  Follow-up activities closed as this is an Other company report and routine follow-ups are not conducted as responsibility of f/up lies with the other company.; Sender's Comments: Based on the information provided, a causal association between reported events immunisation, rheumatoid arthritis, adverse drug reaction and the suspect BNT162b2 cannot be 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.
patient had the first dose on 21apr21 and is showing up today to get the second dose 49 days later; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient had the first dose on 21apr21 and is showing up today to get the second dose 49 days later) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient had the first dose on 21apr21 and is showing up today to get the second dose 49 days later). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient had the first dose on 21apr21 and is showing up today to get the second dose 49 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.
itchy hives/rash covering body starting 9 days post-booster. treatments of over-the-counter allergy and antihistamine medication (Benadryl, Allegra, Claritin, Cortisone cream) and well as prescriptions (hydroxyzine and Prednisone) to alleviate hives and rash.
Resulted in approx 2"X3" bump at injection site on left arm. Very itchy, hot to the touch. Lasted 2.5-3 days.
patient called pharmacy to advise the injection site of her vaccine (2nd dose) was itching. She stated it was irritated from her scratching , was red and felt like it had a small bump at the injection site.   Patient was informed to watch for swelling, redness area growing, and to seek medical attention if it got worse.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium
I started having a sore throat, achiness, then having chills. I used a home COVID-19 test that came back immediately. I called my doctor to let them know I was positive, they called in a prescription of the PAXLOVID that I started taking immediately. It took three days for me to start feeling better, the only thing was the taste of the medication. I did quarantine for a full ten days.
Reaction to 2nd shot on 03/05/2021 was intense lower abdominal pain two days after receiving the shot. It was thought to be a urinary infection and I was given a 10 day course of antibiotics and it finally went away after about 2 weeks.
Felt faint after HPV shot. Took 3 hrs to feel better. Slight dizziness 5/19/20.
Silver dollar sized raised area on (L) arm posterior to deltoid. Described as low class reaction per APN. Treating with hydrocortisone cream and ATARAX for itch.
Patient called the pharmacy on 1/1/21, 10:55am to state she has redness (about 1" diameter) at the injection site and swelling to upper arm. There is also a rash and swelling below her arm pit on her right side. She did not notice this until 12/21/20.  She states that the redness and rash are less severe today than yesterday.  She reports no itching.  She states she has full range of motion with her shoulder and no pain. No fever.
Patient vaccinated on 11/1/2016-experienced weakness in right upper arm on 11/3/16-extended to right shoulder on 11/10/2016-referred to MD.
3/27/21: Patient presented and was admitted through ED for epigastric abdominal pain, nausea, and vomiting. Patient was discharged on POD#2 after recent surgery of laparoscopic periesophageal hernia repair on 3/23/21. Imaging performed at admission showed ongoing versus recurrent hiatal hernia.   Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.
A week after I received my first dose of the Covid Moderna shot, I have a red splotch under where the injection site is. It feels a little itchy on the corners of the splotch mass. The itching is not unbearable, mostly mild.
Two days after I received this vaccine I started feeling very dizzy and weak. I was having a lot of joint pain nausea, vomiting, and diarrhea. I was not able to keep food in my body at all. I was also having hot flashes that were pretty severe. My temperature never got above 100°F. I was having very intense abdominal pain and cramping that were so severe I was not able to do my work as I do work from home and I was unable to care for my child. After this went on for nearly a week I went to see someone at urgent care. He informed me that he sees many patients like me after receiving the Covid vaccines. And the problem is that they can neither confirm or deny that it is caused by the vaccine.  However, he did make sure that I was presenting as someone with similar symptoms after a Covid vaccine like so many other patients he has been treating lately. A flu strep and Covid PCR were completed all were negative. He prescribed me Zofran and Lomotil. The next day I felt much better, but to date, I am still not recovered.
Patient had tingling and numbness on the right side of face and arm for 15 minutes.
The pt died suddenly at home. Cause of death given as acute myocardial infarction.
Case number PHEH2014US023367 is an initial spontaneous report received from a medical assistant on 19 Nov 2014, and with a follow up report received on 05 Jan 2015. This report refers to an 11 years old female patient. Her medical history and concomitant were not reported.  She was vaccinated with 0.5 ml intramuscular MENVEO (batch number: M14040) on 18 Nov 2014. It was reported that the administered vaccine was stored below recommended temperature for a week. No adverse events were reported following the medication error. Follow up report received on 05 Jan 2015. No adverse event reported.
The first three days were normal expected side effects, such as fatigue, headaches, and so forth. I felt better after two days. Then on the 6th day, I suddenly broke out in hives, starting with a reaction at the injection site on my right deltoid. The hives continued to progress and get worse over the next few days and started welting. My legs and arms were covered in hives. I became dyspneic which was relieved by using albuterol. Hives reduced from antihistamines. For three days the hives would appear systemically with skin sensations of burning and itching.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 01-MAY-2015, unspecified number of REOCMBIVAX HB(lot # K006682, expiration date 17-DEC-2015, dose and route were unknown) which were exposed to temperature outside of the recommended range on 01-MAY-2015 have been administered to these unspecified patients on unspecified dates. This is one of several reports received from the same source. Additional information has been requested.
This person called 911 from her home and was apparently in and out of consciousness approximately 45 minutes after receiving the vaccine. Unknown if this client waited in the 15 minute area at the drive thru clinic.
Woke up on the 2nd with a full body rash and on arms and part of the thighs and legs. Mild itching in places and in the scalp. Clinician checked back and said some spots were there also. No treatment except told to take prednisone (2.5mg) for the itching. Told to go home from work. On the 3rd rash was lighter not itchy, took prednisone but then later in the day took BENADRYL rested for the day. On the 4th got up rash was light, took prednisone just on case reported to Employee Health. Rash had gotten slightly darker so was going to be sent home. Fact sheet for MMR said with this rash platelets could be affected so I insisted on a blood test to check. Blood take but sent home to wait for results.
Severe pain in arm, burning at injection site, decreased ability to use left arm, numbness, tingling in hand, still after three weeks.  Trying anti inflammatory, not working or helping.
Information was received from a lawyer concerning a female patient who was vaccinated with a dose of PNEUMOVAX 23 (Lot #658074/0961U, expiration date 23-JAN-2009). It was reported that the patient had a site reaction on 01-OCT-2007 and visited the ER and was admitted for pneumonia, which the patient was told was caused by the vaccination. No outcome was provided. Additional information has been requested.
received Boostrix instead of Infanrix; 3 YO received Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7H593, expiry date 7th April 2024) for prophylaxis.   On 22nd July 2022, the patient received Boostrix. On 22nd July 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 08-Aug-2022 Reporter's comments: The healthcare professional (HCP) called and stated that a male patient received Boostrix instead of the intended Infanrix. Spoke per package insert and content. The phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The 3 years old patient received Boostrix instead of the intended Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Scarring under arm pit/groin area; Empty abscess under arm pit/abscess breast area/groin area; Soreness at first covid-19 shot; Leg muscle felt sore; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (Scarring under arm pit/groin area), SUBCUTANEOUS ABSCESS (Empty abscess under arm pit/abscess breast area/groin area), VACCINATION SITE PAIN (Soreness at first covid-19 shot) and MYALGIA (Leg muscle felt sore) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SCAR (Scarring under arm pit/groin area), SUBCUTANEOUS ABSCESS (Empty abscess under arm pit/abscess breast area/groin area), VACCINATION SITE PAIN (Soreness at first covid-19 shot) and MYALGIA (Leg muscle felt sore). At the time of the report, SCAR (Scarring under arm pit/groin area) and SUBCUTANEOUS ABSCESS (Empty abscess under arm pit/abscess breast area/groin area) had not resolved and VACCINATION SITE PAIN (Soreness at first covid-19 shot) and MYALGIA (Leg muscle felt sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of SORENESS AT FIRST COVID-19 SHOT, SCARRING UNDER ARM PIT/GROIN AREA, EMPTY ABSCESS UNDER ARM PIT/ABSCESS BREAST AREA/GROIN AREA and LEG MUSCLE FELT SORE with HUMIRA(ADALIMUMAB) was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt recvd vax & exp mild extremity weakness, pain, coldness; On approx 1OCT92 the 2nd dose of vax & w/in minutes of receiving vax pt exp extremity weakness, severe pain, feeling of coldness; EMG showed mild peripheral motor neuropathy;
administrated Menveo with another diluent; administrated Menveo with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number amva660a, expiry date 28th February 2023) for prophylaxis.   In July 2022, the patient received Menveo. In July 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's Comments: The director of operation reported that the multiple patient were administered with the powder of Menveo with another diluent between 6th July 2022 and 7th July 2022. No adverse event reported.  The reporter did not know how many patient were administrated with this lot number. No patient's identifiers provided. The reporter consented to follow up. Additional supportive information: The director of operation reported that the multiple patient were administered with the powder of Menveo with another diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with case US2022106107, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106107:Same report, diferent lot number
51 year-old F with multiple medical problems. Received PPSV23, Hib, MCV4P, and MenB vaccines on 28 Jan 2016. Received Hib and PPV23 in left upper arm, and received both meningococcal vaccines in right upper arm. Within 12 hours of vaccine receipt, patient noted reaction at vaccination site; initially, redness, warmth, swelling and tenderness about 2" in diameter in left upper arm, then rapidly increased over the next 24 hours. No streaking or lymphadenopathy. Patient also felt feverish on 29 Jan and her temperatures were initially around 101. She began self-treating with Tylenol and intermittent ice packs to left upper arm. By 30 Jan (post-vaccination day 2), patient's site reaction extended from left shoulder almost to elbow and affected area was about 2/3 circumferential around area of injections. Her temperatures peaked at 103.3 and she was shivering vigorously. She also noted her heart beat was rapid, but denies palpitations. Patient denies n/v, headaches, or dyspnea; she had minor body aches. During this time, she had a runny nose, which was responsive to treatment with antihistamines. She sought evaluation on morning of 30 January at Emergency Department. Initial vital signs: T 102.5, BP 132/77, HR 113, RR 18. She was treated with IV fluids and Tylenol. Her lab work was significant for leukocytosis. She was released after approximately 2 1/2 hours of ED check in. Diagnosis: presume fever/leukocytosis secondary to vaccine administration, vital signs and lab consistent with SIRS. Patient was discharged on Tylenol as needed, not to exceed 2 grams daily. Complete resolution of symptoms within 48 hours of ER evaluation.
right upper arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right upper arm pain) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PAIN IN EXTREMITY (right upper arm pain). On 23-May-2021, PAIN IN EXTREMITY (right upper arm pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD-2021-229303 (Patient Link).
Within 6 hours of Moderna booster I was having chills and fever. Next 24 hours loss of appetite, headaches, and dry heaving.  Muscles felt like cement.  Could barely lift myself from bed.  Day 3 still no appetite or food consumption. Again, dry heaving and headaches. Day 4 beginning to eat small amounts.  Extreme fatigue. No energy.  Day 5 energy slowly returning, but no stamina. Day 6 appetite slowly returning, still have difficulties with fatigue. Day 7 slowly continuing to get strength back.
pt called several hours after vaccine describing redness and some swelling around injection site.  About 4pm she came to pharmacy and showed me the site.  It was red and raised.  She also mentioned her arm hurt and was a bit tingly.  I called her before leaving work 09/14/21 and she reported the same. I called her 09/15/21 at around noon to check on her she reports the redness to be gone and the swelling down some but her arm does still hurt and periods of tingling.  I will touch base again this evening
Developed wheezing a few hrs post inject. Spontaneous Pneumothorax. Was seen in ER.Child still wheezing 2 wks later. 1st DTP
Patient is a 54 y.o. female Patient received Covid vaccine at immunization site.   During 15 minutes post-monitoring period:     COVID-19 Vaccine Adverse Reaction Reaction due to: First dose of vaccine Symptoms: Chest pain, Shortness of breath, Muscle aches/Joint paint, Dizziness/Lightheadedness How long after administration did the symptoms start?: Immediately (within 15 minutes) Previous reaction to prior vaccines: Patient reports similar previous reactions Interventions: PO fluids, Additional monitoring, Education provided regarding symptoms and home care, Other (comment) (Code team called) If reassessed, patient's condition: Improved Disposition: Transferred to Emergency Department    At 1350 Pt. Reported "my heart feels a little irregular". Pt. Was transferred to recliner chair. Vitals: BP 156/73 HR 120 O2 98% RA   At 1402 Pt's HR 94   Pt. Stated that her K+ was 2.6 "a couple weeks ago". She states she has had diarrhea for "a couple months". She says she has been taking PO K+ and Magnesium replacement but her next appointment isn't until October. Pharmacist assessed pt.  Pt. Drinking fluids.    1405 While this RN was talking with the patient at she started feeling short of breath, her bilateral hands started contracting, and she became anxious and started crying. Pt. Stated she was unable to move her hands. Pt's O2 desat to 80% on RA. Pt. Placed on 25L O2 simple mask. Code team called.   1409 Pt. HR 136 Pt. States she has history of "QT syndrome" and that she feels "jittery". Pt. States this reaction feels "similar to her iron transfusion reaction". Pt. On 25 LO2. Zoll pads placed on pt's chest and back to monitor pt. Zoll placed on manual mode and HR 136.    1411 Code team arrived.    1412 HR 117 O2 100% on 25L simple mask   1415 PIV placed by VAT in pt's left arm, NS started to gravity. HR 106 O2 100% on 25L O2 simple mask. BP 172/67   1419 Transport team arrived. Pt. States her hand cramping and breathing feel "better".    1423 Blood glucose 196. Lifeline trialed pt. On room air. Pt. O2 sat 99% on RA, pt. Taken off of simple mask oxygen. All questions answered for patient's husband.    1427 Pt. Transported to emergency department with Lifeline team on monitor.
Patient reported sudden SOB accompanied by sharp flank pain 4 minutes after dose administration. HR 68, spo2 100, BP 147/82. Patient assessed and escorted to ED for further assessment by w/chair. Patient assessed in ED and discharged to home without further incident.
Fever of 102 degrees/chills started around 6pm. Physician called 7pm-pt was told to take extra strength Tylenol every 4 hours.  Temp 100 degrees next morning. Fever gone by evening of the next morning.