chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt exp localized rxn of redness & itching @ the site of inj given 7 days ago;area involved is the size of an orange;
patient received Trumemba vaccine instead of Menactra, No AE; Initial information received on 10-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to 2020SA209115 (same reporter).  This case involves a 16-years-old male patient who received MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA] (not produced by Sanofi Pasteur) (batch number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination on 03-Aug-2020 instead of second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, past medical treatment, vaccinations, family history and concomitant medication were not provided.  It was an actual medication error case due to wrong vaccine administered.  The patient has not had any adverse reactions to this and is not currently behind in his Menactra doses.  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 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.  There will be no information available on the batch number for this case.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/3/2022 FALSE LABOR BEFORE 37 WEEKS, THIRD TRIMESTER  R57.0 CARDIOGENIC SHOCK 8/3/2022 FALSE LABOR BEFORE 37 WEEKS, THIRD TRIMESTER  R57.9 SHOCK, UNSPECIFIED 8/3/2022 FALSE LABOR BEFORE 37 WEEKS, THIRD TRIMESTER  J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/3/2022 CEREBELLAR TONSIL HERNIA INTO FORAMEN MAGNUM  R57.0 CARDIOGENIC SHOCK 8/3/2022 CEREBELLAR TONSIL HERNIA INTO FORAMEN MAGNUM  R57.9 SHOCK, UNSPECIFIED 8/3/2022 CEREBELLAR TONSIL HERNIA INTO FORAMEN MAGNUM
First 24 hours fever of 101, did decrease with Tylenol.   Second 24 hours nausea, vomiting and Dizziness.
Patient had c/o HA, stiff joints, low grade fever of 99 on 8/28/07. He was seen in the field and given 2L of fluids. A heart murmur was picked up by the PA who saw the patient in the field. He was evaluated by the Medical Clinic that same day and the murmur was again heard. He returned to the MC on 8/29/07 for follow up, since the murmur was still present he was referred on to MC. Past Medical History significant for recent MRSA infection of the R axilla that was treated with I&D and antibiotics. There had been a question regarding increased swelling to the area so antibiotics had been restarted on 8/27/07. On assessment in ER SM reported dyspnea for the past 2 to 3 months. He denied CP but reported having a funny sensation in his chest. Axilla looked well healed. Heart regular rate and rhythm with a 3/6 sytsolic ejection murmur head at the apex. EKG was obtained, see lab data notes. Diagnosed with New systolic ejection murmur, HA, recent MRSA infection and transferred to MC for admission. I do not have a discharge date for this patient.  10/01/2007 MR received for hospital DOS 8/29-31/2007 for D/C DX of Hypertrophic, obstructive cardiomyopathy.  Suspected infective endocarditis.  R axilla abscess with (+) MRSA. Pt presented to clinic with fever, headache, lightheadedness, and arthralgias. Several week hx of fatigue, some dyspnea, and a funny feeling in his chest. Upon eval a new systolic murmur was noted and pt refered to hospital for eval.   D/C with activity limitations pending further testing. 10/05/2007 Additional F/U records received from reporter for Dx: Hypertrophic obstructive cardiomyopathy.  Endocarditis r/o and pt recommended for defibrillator.
Pt recv vax on 11/17/98; on 11/18/98 pt exp erythema, petechial rash, swelling, warmth, pain of LA; rash on neck & buttocks; tx=Benadryl
Sneezed. Nose got stuffy.  Throat felt irritated, but didn't close up.   Was irritated all day.  Same as when I have allergic reaction to certain foods.
Expired Vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) 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 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) 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 concomitant medications were reported. No treatment medications were reported.
difficulty sleeping last night secondary to pain; soreness in upper arms bilaterally; tongue sensitivity to hot temperature and mint in mouthwash; Initial information received on 29-Nov-2021 regarding an unsolicited valid non-serious courtesy case from a consumer. This case involves a female patient age unknown who experienced tongue sensitivity to hot temperature and mint in mouthwash (glossodynia), soreness in upper arms bilaterally (pain in extremity) and difficulty sleeping last night secondary to pain (insomnia), after receiving INFLUENZA VACCINE and COVID-19 VACCINE and while treated with LENVATINIB MESILATE [LENVIMA]. The patient's past medical treatment included PEMBROLIZUMAB [KEYTRUDA] infusion. The patient's past vaccinations, concomitant medications and family history were not provided. At the time of the event, the patient had ongoing medical history of Malignant neoplasm of endometrium (C54.1) Endometrial cancer which was diagnosed. On 22-Oct-2021, the patient started taking LENVIMA (LENVATINIB MESILATE) 20 mg once daily route unknown (with an unknown batch number and expiry date) for Endometrial cancer. On an unknown date in 2021, the patient experienced a non-serious tongue sensitivity to hot temperature and mint in mouthwash (glossodynia) few days following the administration of LENVATINIB MESILATE. On 04-Nov-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site and a booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccinations. On an unknown date the patient experienced non-serious events soreness in upper arms bilaterally (pain in extremity) and difficulty sleeping last night secondary to pain (insomnia) (unknown latency) following the administration of LENVATINIB MESILATE, INFLUENZA VACCINE and COVID-19 VACCINE. Action taken with LENVATINIB MESILATE (LENVIMA) was unknown. It is unknown if the patient experienced any additional symptoms/ events. There were no laboratory data/ results available. The patient had spoke with oncologist's office and was advised okay to take MOTRIN [IBUPROFEN] for pain in extremity. At time of reporting, the outcome of the events was reported as unknown. There will be no information on the lot number for this case.
12/28: Received Moderna Vax?developed some swelling and redness to right upper arm (injection site) Since Dec. 28 to current, still has the redness (bigger than quarter size), itchiness, and some swelling.  She?s been taking over the counter meds for now.
Started as pain and ringing in right ear, headache, some stiffness and soreness in neck. End results partial loss of hearing in right ear. Did recover some hearing after several months.
Fever started exactly one week after shot. Fever lasted 3 days, on third day rash started on face 3 PM, by 7 PM rash all over body (9/27/02). Rash lasted seven days (10/3/03). Still present for few more days but fading. Rash was red and deep purple.
Fingers are tight like they are paralyzed; Fingers are tight; Pain from shoulder to wrist; Cannot carry anything heavy in his hands; Spot where vaccine was placed is purple colored; Intense pain in bones; Itching and little zits; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported for himself that he started to receive BNT162B2 (Bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) via unknown route of administration on 28Jun2021 at DOSE 1, SINGLE on left arm for COVID-19 immunization. Medical history and concomitant medications were not reported.  Patient got the first dose in a pharmacy a month ago, he went for the second dose and told them about the problems he had and they told they couldn't give him the second dose and to talk to Pfizer to make the report. It was reported that patient started having problem on 28th when he had the vaccine. Two days after that, started having this problem. Been having this problem for one month now. It's the first time this happened to him. This is the first time he had a vaccine like this. Clarified side effects as: First day after the vaccine, 1-2 day after that, the spot where the vaccine was placed, it was purple colored. Three days after that, started having pain from the shoulder to wrist. Experiencing an intense pain in the bones. Cannot carry anything heavy in his hands. Cannot even carry his phone in his left hand. Wakes up and his fingers are tight like they are paralyzed. Caller clarified he is only experiencing this on the left side where he received the vaccine. Outcome: lasted one week more or less. It was the whole area. Stated pain from shoulder to wrist and in his bones is the same. Has not improved at all. Will see the doctor tomorrow because he is not ok. It is not worse. Fingers are tight like they are paralyzed: Today was worse. He feels terrible today. Itching and little zits: Itches a lot from the wrist to elbow. There are little zits there and looks like he has been bitten by insects. Lots of itching. Is only on the left side. Received vaccine in left arm. It is nowhere else. Started 2-3 days after the vaccine. Still has it now. While he is reporting to this agent, he is experiencing the pain and itching. Patient reported that everyone in his family got the vaccine. He didn't want to have it. People said it was important. Didn't want to be the difficult child in the family. Stated the after results were worse. History and Investigations: Is not a friend of medicines. He doesn't like taking medications. He stated that tomorrow will see doctor about cholesterol tests. Will take advantage of tests, cholesterol tests, and will have blood work done as well. He is worried about it a lot. The outcome of events for paralysis, musculoskeletal stiffness, pain in extremity, muscular weakness, bone pain, and pruritus was not recovered. Outcome for event vaccination site discoloration was recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 4V (FLUAD QUAD) for Vaccination.    No Medical History information was reported.   On 29-Oct-2021 at 1:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and INFLUENZA VACCINE INACT SAG 4V (FLUAD QUAD) (Intramuscular) 1 dosage form. On 30-Oct-2021 at 8:00 AM, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No treatment and concomitant medications were provided.    This case was linked to MOD-2021-370445 (Patient Link).
BlurredVision loss of appetite, malaise/extreme fatigue. Narrative:  employee reports that when she woke up on 4/8/2021 @ 0400 her vision was "like a total white out". vision white out lasted 4 hours and gradually came back. Now still experiencing periodic blurred vision.  Other Relevant History:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, on 05Aug2022 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes; "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Manufacturer unknown), administration date: 09Dec2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 05Aug2022, outcome "not recovered" and all described as "Red area and itches". Therapeutic measures were taken as a result of erythema, pruritus. Additional Information: patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Blister noticed by client at site of injection on 1/7/10. Bandage had remained in place from time of injection. Currently, an area measuring approximately 5 x 9 mm appears dark red with a discolored area immediately above. New bandage applied. Area is not hot to touch, there is no rash. Client denies pain. There is no discharge.
Fever, chills, body aches, stomach pain, chest pain, bone pain, nausea, headache
patient complains of dizziness, shooting pain, headache, nausea and vomiting
She got her vaccine, she did well.  She had chronic hives that were presenting at first, but was very nervous and her arm hurt a little.  Later that evening she could not lift her arm at all, just midway, but no rash or anything else at that time, just the pain.  She felt real achy, her knees hurt, felt like she had a fever but did not.  Then on 6/2/21 she had a rash that started on her lower left arm 6" from her shoulder, just underneath the injection site, and it has continued to spread.  It is a wide band now and has normal skin tone in the middle, and the outskirts is gravitating, angry and rashy and looks like it wants to wrap around the entire arm, and it's itchy and burns.  She called her allergist and to take her Allegra and cool compresses.  The swelling has gone down, but the burning and itching are still there and not improving.  She originally had a lump near the biceps that has gone down some, but not as profound as it was at the beginning.  She is going to go to the ER as what she is taking now is not resolving it, and needs medical attention.   She has called her allergist to ask for some sort of steroid ointment but they refused to give it to her, and would not schedule her an appointment to be seen as it was a common side effect with Moderna and that it should go away.    She wishes that they would do more research and have a place in the hospital for people with autoimmune diseases to be closely monitored after getting the vaccine.
Had SOB and Nebulizer Tx given at home with poor results. Vomited x2 mother states child choked on emesis and turned blue and pulling to right ear x1 week.
Mild problems: soreness at injection site and nausea, some aching on the following day throughout body.
Upon awakening 2/27/2021 left arm was sore all the way to wrist.  I noticed my left armpit was swollen all the way across and down to the top of left breast.  The swelling is going down as of 3/3/2021 but not completely.
redness, warmth, swelling, pain at insertion site 11 days post vaccine; nothing treated with
Approximately 8 minutes after injection began noticing a feeling of shakiness with slight visual tremors of hand. This could be described as after taking a dose of albuterol or drinking a lot of caffeine. It was mild, but I did have a feeling of being hyper until about 24 hours after the injection. My BP & P one hour post vaccine was 127/83 p-70. I notified my primary care provider this am. they gave me the VSafe web info.
PATIENT PRESENTS WITH C/O NUMBNESS TO THE PINKY/RING FINGER OF RIGHT ARM FOLLOWING 1ST DOSE OF PFIZER VACCINE. PATIENT BEING ASSESSED BY EMT. 0 PAIN. 0 SOB. 0 RESP DISTRESS NOTED. 0 HIVES L/S CLEAR
fatigue, upset stomach, diahhrea, body aches in bed for 3 days.  Then on the 11th, attempted to eat steak and got Dysphagia for the first time to the point I almost went to ER as couldn't swallow for 5 hours!
TOOK VIVOTIF WITH FOOD; This spontaneous case report (PVX2019-2777) was received from a pharmacist on 11-Nov-2019. It described a 21-year-old female consumer who "took Vivotif with food" (PT: Product administration error). She was receiving oral Vivotif for typhoid fever.  Case report: The consumer took her second or third dose of Vivotif with food last month.   Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.
Hospitalized 11/11/2021; COVID-19 positive 11/11/2021; fully vaccinated plus booster  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: ANP Admission Date: 11/11/2021 Discharge Date: Nov 15, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypocalcemia [E83.51] Hypokalemia [E87.6] Weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 84 y.o. male with past medical history for CHF, HTN, atrial fibrillation, T2DM, CKD. He presented to ER with 3 days of decreased intake, fatigue, malaise and weakness.  His COVID19 pcr is positive. Labs notable for hypokalemia, hypocalcemia, hyperchloremic non gap acidosis, elevated beta hydroxybutyrate and leukocytosis. CXR with similar appearance of cardiomegaly, minimal CHF and bibasilar atelectasis. Patient given monocolonal AB on 11/13.  Continued to do well and remain on room air.  Electrolytes normalized with IVFs and replacement.  Patient also treated for a urinary tract infection with 3 days of IV Rocephin.  Culture was not available.  Patient with good PO intake and able to ambulate well on day of discharge.  Patient feels ready to discharge home.  Advised holding Lasix and checking daily weights as concerned that po intake may not be truly back to baseline yet and do not want patient to returned to dehydrated state with electrolyte abnormalities seen on admission.  Recommend lab work within 1 week with PCP.  Metformin also held on discharge until patient feels his food intake returns to baseline
Customer care reported AE , no further details provided; Hives on both his hands and face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on both his hands and face) and ADVERSE EVENT (Customer care reported AE , no further details provided) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced URTICARIA (Hives on both his hands and face). On an unknown date, the patient experienced ADVERSE EVENT (Customer care reported AE , no further details provided). At the time of the report, URTICARIA (Hives on both his hands and face) was resolving and ADVERSE EVENT (Customer care reported AE , no further details provided) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: No specific follow-up information recorded.
On 10/8/01 at 18:15, pt went to ER with itching, facial flushing, throat tightness and stridor. At 18:20, she was given epinephrine 1:1000 0.2cc SC-IV and started Benadryl 25mg IV, Solu-Medrol 125mg IV and Zantac 50mg IVPB. At 18:35, Benadryl 25mg IV was repeated. At 20:20, she was discharged home. Her temperature was 97.3F (oral); HR 120; Respirations 22 and BP 168/96 on arrival.
after the vaccine he has felt uncomfortable; neck pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization; Bnt162b2 (Dose: 3 (booster)), for Covid-19 immunization. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "after the vaccine he has felt uncomfortable"; NECK PAIN (non-serious), outcome "recovered".  Additional information: It was reported that the patient had the primary series and two booster shots of the Pfizer BioNTech COVID-19 vaccine. He was planning on getting a third booster shot today but took Tylenol two days ago. Asked if its ok to take the booster shot even if he had the Tylenol. The patient had his last Pfizer COVID-19 booster shot on 13Jul2022 and getting surgery on early August. He also usually took 81mg Aspirin. Referred that after the vaccine he felt uncomfortable and with neck pain for about a day and a half "but nothing serious" Caller was asking if that inhibits him going today and getting his next shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I am 67  years old female with no health conditions and take no prescribed medication.  I had the first Moderna shot on Friday February 5th st 3:00 pm.  By 8:00 that night   joint. muscle and skin pain and headache started.  The next morning February 6th my  temperature dropped to 96 and I had extreme chills all day. That night my temperature was 103.2 ,  diarrhea and vomiting started with all the previous reactions except chills still there.  Sunday morning February 7th,  all effects from vaccine still there- joint, muscle, skin pain, headache, diarrhea and vomiting but no fever.  Sunday night, fever of 102.4 .  Monday morning February 7th,  headache and fever are gone but extremely weak and body aches still here.  My question to you is "With such a reaction to the first shot,  should I get the second one? "