chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 11:02, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000237:  US-009507513-1704USA000485:  US-009507513-1704USA000486:  US-009507513-1704USA000487:  US-009507513-1704USA000489:  US-009507513-1704USA000490:  US-009507513-1704USA000491:  US-009507513-1704USA000492:  US-009507513-1704USA000493:  US-009507513-1704USA000494:  US-009507513-1704USA000495:  US-009507513-1704USA000496:  US-009507513-1704USA000497:  US-009507513-1704USA000498:  US-009507513-1704USA000499:  US-009507513-1704USA000500:  US-009507513-1704USA000501:  US-009507513-1704USA000502:  US-009507513-1704USA000503:  US-009507513-1704USA000504:  US-009507513-1704USA000505:
Fever, NauseaVomiting, chills, body aches (unspecified)  Narrative:
stomach irritation; arm soreness; mild shortness of breath Normal vital signs; reassurance; monitoring total 60 minutes after vaccine; improved and released
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Headache-Mild, Additional Details: patient came to pharmacy 2/3/23, indicating a hard bruise,redness,itching at the site,tenderness at site,chills and headache. redness was around the site of injection on left arm. patient said redness was getting better but she was concerned
swelling of rt arm, blistering of skin, impetigo on legs;seen in ER;
Left thigh positive central clearing around injection site but erythema spreading around knees with blistery lateral thigh. Positive warmth, positive swelling.
Couple hours with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Couple hours with fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FATIGUE (Couple hours with fatigue). At the time of the report, FATIGUE (Couple hours with fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-041006 (Patient Link).
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient had a vasovagal reaction about 5 minutes post-vaccination. Patient fainted briefly for about 10-15 seconds. Clinic nurse and paramedics came and examined patient. Patient recovered within a few minutes.
Temperature 102.8 fahrenheit with warm, red, raised area at injection site.  Seen by primary care doctor on 10/05 and started on Amoxicillin.  Improved, but still low grade temp (100.6) on 10/6 in the evening.  Arm still red at injection site.
caller had covid shot yesterday and he got nosebleed; two doses previously and since they don't have a booster dose, the pharmacist recommended he get Pfizer. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (DOSE 2), for COVID-19 immunization; Janssen covid-19 vaccine (DOSE 1), for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 27Nov2022, outcome "unknown", described as "caller had covid shot yesterday and he got nosebleed"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Nov2022, outcome "unknown", described as "two doses previously and since they don't have a booster dose, the pharmacist recommended he get Pfizer.". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
PATIENT SAID SHE HAS BLUTY FEELING IN HER EYES SINCE GETTING THE SHOT
On 11/11/2011 at 7:45 PM, Pt came to the pharmacy, complained that 2 days after the shot, she had noticed redness, tenderness, and pain. I noticed the redness, and it was pianful to touch. On 11/14/11, I called her, she came to the pharmacy again, I have noticed that is getting much better, but it is still some redness. She was ok.
SOB; tachypneic; Flank pain; fever; general malaise; body aches; fatigue; R lower leg DVT Diagnosed; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular on 08Jan2021 13:45 (Lot Number: EH9899) as dose 2, single for covid-19 immunisation. Medical history included ophthalmic herpes simplex, irritable bowel syndrome. The patient's concomitant medications were not reported. Known allergies included Skelaxin. The patient was not pregnant. No other vaccine in four weeks. No Other medications in two weeks. The patient previously received first dose of BNT162B2 (lot number EH9899) intramuscular on 18Dec2020 01:45 PM for covid-19 immunisation. The patient had flank pain 29Jan2021 21:00 PM, and then fever started 29Jan2021 and lasted for 8 days, general malaise started on 28Jan2021 21:00 PM, body aches, fatigue. After the fever broke had tachycardia with dyspnea for 2 weeks. She had on observation hospital stay 31Jan2021 to 01Feb2021 and additional ER visits due to illness. Last ER visit was 14Feb2021 SOB and tachypneic. Two COVID tests were negative. R lower leg DVT Diagnosed 26May2021 that started 29Mar2021. Events resulted in Emergency room/department or urgent care. Recovered with lasting effects. No treatment. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovered with sequelae.; Sender's Comments: Based on the current available information a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
I had general soreness at the injection site for a day or two. In 2013, I was diagnosed has having heart palpitations. On 11/12/2022, I noticed the heart palpitations had changed in frequency and symptoms with each one. I would get a little lightheaded and dizzy after an episode. I regularly see my cardiologist. Per my doctor's directions, I increased my medication as needed to help me with my symptoms.
Patient came to our pharmacy on 2/1/2022 and requested the 1st dose of Pfizer vaccine. She indicated on the consent form she has not received the COVID-19 vaccine before, when in fact she did. We found out later this is actually the 4th dose of her COVID-19 vaccine.
Rash that looks like measles all over his body but face; Red spots; Some places itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (Rash that looks like measles all over his body but face), RASH MACULAR (Red spots) and PRURITUS (Some places itchy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bladder cancer and Hypertension. Concomitant products included MITOMYCIN for Bladder cancer, ATENOLOL for an unknown indication.   On 07-Apr-2021, 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MORBILLIFORM (Rash that looks like measles all over his body but face), RASH MACULAR (Red spots) and PRURITUS (Some places itchy). At the time of the report, RASH MORBILLIFORM (Rash that looks like measles all over his body but face), RASH MACULAR (Red spots) and PRURITUS (Some places itchy) outcome was unknown. Not Provided          Treatment information was not provided.
A spontaneous report of inadvertent use of expired FluMist was received from a nurse concerning a 34-year-old adult. No relevant medical or drug history information was reported for this patient. The patient received the initial dose of FluMist on an unknown date. On 26Oct2007, a nurse reported the inadvertent use of expired FluMist vaccine in an adult. No adverse event was reported. The patient is being considered for re-immunization. The reporter did not provided a causality assessment for the adverse event reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
High fever 103.8. MOTRIN and TYLENOL. Fever returned to normal 12-15 hrs later (after vaccine).
Patient received the Moderna Covid 19 vaccine on 4/19/21. She presented to the pharmacy on the morning of 4/30/21 concerned because she had a rash appear on the injection arm.  The rash appeared to be a little raised, slightly red/inflamed, and localized to the injection site.  patient stated that the rash did not itch.  Patient was encouraged to try a benadryl to help combat her symptoms, as well as registering with V-Safe. In addition, we asked the patient to monitor the rash and let her doctor know if it appeared to be spreading.
Information has been received from a registered nurse via a company representative concerning a male patient (age not reported) who on 18-APR-2007, was vaccinated with a dose of Pneumovax 23 (Lot# 656222/0381U).   On 18-APR-2007 the patient developed cellulitis after receiving Pneumovax 23.  It was reported that the patient was treated with antibiotics and hydrocortisone.  At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Consistent shortness of breath on mild exertion and chest pain lasting 5 months. I had an aortic valve replacement in October of 2017 and under the care of a cardiologist. Because of these symptoms, and during the time of these symptoms, I had an echo cardiogram, a stress echo cardiogram and a CT scan, all which were normal.  The systems started several weeks after 1st or second vaccine. I never connected them with the vaccine, but looking back feel that is what triggered my symptoms.
Patient after shingrix vaccine, reported vesicle-like rash unilaterally on right side of body following dermatome followed by pain and burning sensation.
Employee states that 9 minutes after the vaccine her stomach started to hurt, but not to the extent of vomiting.  She states that she feels "off" Blood Pressure taken and patient moved to her side. She states she feels slightly woozy. The feelings of abdominal pain, tachycardia, and feel "off" came in intermittent waves.   was notified at 1545 and assessed the employee.  A decision was made at 1615 to transfer the employee to the ETC for monitoring.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 120 hours. The lowest recorded temperature was 34 F (1.111111111 celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
2 1/2 m/o male with poor feeding, fussiness & crying, seen 9/18 by Dr. at facility, sent home, emesis x2, yellow tinged, large bloody stool in diaper evening 9/18/09, went to ER. WBC 22,000, H/H=12/37, plt 710K, 18 bands, 82 PMNs, 8 lymphs, 8 monos. Admitted to PICU, surgical consult. Xray abd - less gas (L) abdomen. 10/22/09 Hospital records received for dates 9/18/09 to 9/29/09. DC DX: Intussusception, Arterial hypertension, rt. inguinal hernia. Presenting SX in ER: Pt received vaccines 9/2/09 and on 9/18/09 parent noted bloody stool, vomiting, irritability, decreased feeding. Assessment: fever, BP increased, bloody stool(+), hemangiomas, right nasolacrimal duct obstruction. Failed air contrast enema, will perform open laparotomy reduction. Surgical report: appendectomy, intestine partial resection, consistent with intussusception. ICD9 codes: 560.9, 578.1, 787.03, 401.1, 787.5, 782.4, 783.3, 799.3.
Dizziness; Weak muscles; Arm paining; Not feeling good; This is a spontaneous report from a contactable consumer. This 60-year-old consumer (female patient) reported for herself that.  A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jul2021 as (At the age of 60-years) DOSE 1, SINGLE for covid-19 immunisation. Medical history included high pressure from an unknown date and unknown if ongoing Verbatim: patient on high pressure and got high blood pressure pills. Concomitant medications were not reported. The patient experienced dizziness on 24Jul2021 and weak muscles, arm paining and not feeling good on Jul2021. It was reported that patient had question, she took the shot, and she had lot of side effects from the shot (COVID 19 Vaccine), so what should she do. Consumer was informed about the role of Pfizer Drug Safety. Consumer stated, "the side effects that they said you'll have I have; you know I took the shot yesterday and I am having dizziness and weak muscles you know I am just not feeling good and my arm paining too. Yeah, so this is the 'mid-day' so how many days it will take to stop bothering me" Consumer was informed about the role of Pfizer Medical Information department and offered the number. Consumer further stated, "I didn't think I will have side effects this bad; I just took the shot yesterday and it is still happening today." Later Consumer stated, "This is the First one. I don't know if I will take the second one." It was reported that Date of administration for first shot: Consumer stated, "23Jul2021 which is yesterday." Start date of event (Dizziness): Consumer stated, "Today, it nearly started at 12 midnight and it is still bothering today (24Jul2021)." and Treatment: Consumer stated, "No I haven't. No treatment was given. Reporter seriousness for events: Unspecified. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from a the patient's mother concerning her son (age unspecified) who in approximately 2009 ("about a year and a half") was vaccinated with MMR II, 0.5ml, two doses administered, subcutaneously. (Lot number not reported). The patient's mother said stated that her son broke out in a rash after being administered MMR II 0.5ml. It was reported that she was seeking one rubella vaccination because she did not want her son to received a third dose of the medication. She said her son received two doses. The patient sought unspecified medical attention. At the time of the report, patient's outcome was unknown. No further information is available.
Patient reported that immunizer did not administer full dosage due to syringe malfunction - he reported seeing a "consistent stream of liquid" coming from the syringe as it was placed in the Sharps container
The morning after I received both vaccine shots, I posted hearing from my right ear. The first time I received the vaccine shot, the morning after, I could barely hear out of my right ear.  It almost sounded like there was a clog or earwax build-up. I didn't really think much of it and it gradually went away several days later. The worst day was the next day after the vaccine and it lasted, even though in a small amount, until 3 days after. The second dose caused the same problem. The morning after the second dose of the vaccine, I lost my hearing in the same way as before. I could barely hear out of my ear, however, I was also exhausted and ended up sleeping most of the day. When I woke up in the afternoon, I couldn't hear from my right ear, but I could hear better. (maybe 25% back to normal). The two days after the vaccine, my hearing came back way better than the previous time. It felt like 80% back to normal and later in the today, it felt like it up to 95% back to normal. The best way I can describe the feeling was as if the sound was still being received to my hear, but it sounded muffled and turned down. I was still able to hear the deeper sounds during conversations and deeper 'beats' in music, but the sharpness of everything was turned off.
Patient administered vaccine post excursion with no reported advsere event; temperature excursion over the weekend, with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA377654(CLUSTER) and 2022SA377972(CLUSTER).  This case involves an unknown age and  gender patient who  administered vaccine post excursion with no reported adverse event and temperature excursion over the weekend, with no reported adverse event ,after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7681KA and expiration date: 30-Jun-2023) at an unknown dose via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient administered vaccine post excursion with no reported adverse event (poor quality product administered) ( latency): same day) following the administration.   On 07-Sep-2022, the reporter stated temperature excursion over the weekend resulting from a refrigerator/temperature monitoring system malfunction. The refrigerator reached the lowest temperature of 31.3 degrees F for 1 and a half hours before returning to recommended storage conditions(product storage error).  Action taken:not applicable  It was not reported if the patient received a corrective treatment for the events.   Outcome: Unknown for both events   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.
This initial spontaneous report was received from a healthcare professional referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on multiple unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB injection (lot # L019298 with expiration date 22-JUN-2017; dose and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT COMPLAINING OF SORE ARM FROM SITE OF INJECTION RADIATING DOWN TO HER WRIST. INJECTION SITE WARM TO TOUCH. PAIN HAS CONTINUED SINCE INJECTION.
Immediately after receiving vaccine, patient skin color was warm, pale, and sweaty. Patient had tinnitus. Patient began to have dystonia and nausea. Patient vital signs were within normal limits.  Patient received 25mg Benadryl at 4:30pm per physician orders. Patient symptoms subsided at approx. 4:55pm.
Per RN note, patient reporting getting a zoster vaccine. Patient has a history of shingles and after getting the vaccine, reported a rash and blisters on left labia for 2 days. Reported some pain and itching.
I had 3 allergic reactions after my 2nd does of Moderna Covid vaccine.  1- July 30th,2021: woke up in the middle of the night with swollen lips, rushed to ER, got admitted to hospital for overnight observation. Everyone thought I had a food allergic reaction but nothing special was added to my diet.  2- September 25th: same thing, swollen lips, went to ER. since I had all allergic tests done prior, they only injected epinephrine and put me again on Steroids.  3- third time, it happened on 10/7/2021: swollen lips again. I never had a reaction to food in the past, so this might have been a COVID vaccine related allergy.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-395985 (Patient Link).
PT REPORTED DIZZINESS AND PALPITATIONS POST VACCINE. WATER AND ICE PACK GIVEN AND PATIENT BROUGHT BACK TO OBS VIA WC. PT REPORTS RESOLUTION OF S/S UPON ARRIVAL TO OBS. VSS. DENIES SOB OR DISTRESS, ESCORTED TO EXIT WITH SPOUSE WITH NO ISSUES AT 0820; REFUSED WC, GAIT STEADY. 0815 BP 166/99 HR 104 RR 16 SATS 100% RA
pt recv vax;mom states pt has not been "well" since vax; low grade T ON & OFF; cold sx on & off; c/o migraine HA 1-2 x/wk; mom stated pt no longer able to see auras the way he used to;