chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 19 year old female with no medical history or allergies who in September 2007, was vaccinated with 0.5 ml dose of GARDASIL (lot # 658560/1062U). There was no concomitant medication. In September 2007, the patient experienced sore arm. It resolved in a few days in September 2007. On 23-FEB-2010 the patient would received second dose of GARDASIL. There were no laboratory studies performed. The patient sought unspecified medical attention. Additional information has been requested.
DID NOT TAKE DOSES ON TIME; A spontaneous case report was received from a nurse on 17-Oct-2019 for four consumers.  Based on the information obtained from the nurse four individual case safety report PVX201910-000804 (PVX2019-2599; first consumer), PVX201910-000805 (PVX2019-2600; second consumer), PVX201910-000806 (PVX2019-2601; third consumer), and PVX201910-000807 (PVX2019-2602; fourth consumer) were created and cross-linked in the database.  This case (PVX2019-2599) described a consumer who "did not take doses on time" (PT: Product dose omission), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif, then did not take the remaining doses for several days.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take doses on time" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "did not take doses on time" was considered as not applicable. US-PaxVax Berna GmbH-PVX201910-000805: US-PaxVax Berna GmbH-PVX201910-000806: US-PaxVax Berna GmbH-PVX201910-000807:
Vaccine administered to high in shoulder; Some of the vaccine dripped down arm; A spontaneous report was received from a consumer concerning a 68-year-old female patient, who received Moderna's COVID-19 vaccine to high in shoulder and some of the vaccine dripped down arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of Covid-19 infection.   The patient stated that the vaccinator administered vaccine too high in the shoulder and some of the vaccine dripped down arm. No further information was provided. Treatment information was unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events "some of the vaccine dripped down arm" and "vaccine administered to high in shoulder" was unknown.; Reporter's Comments: This report refers to a case of underdose, product administered at inappropriate site, and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.
1OCT lt arm swollen & hot from top of shoulder to elbow;2OCT striation of red dots 1/2" above elbow;by Monday 6OCt had turned yellow;did not see MD;has had hypersensitive rxn to Td;
2 to 3 hours post vax the pt developed hives and was treated with Benadryl.
complained of "inflamed bowels" on May 14,2021 then shortly expired that day.
48 hours after immunization redness, swelling, warm to touch, c/o pain from RA shot area to elbow.
pt recvd vax 30AUG95 & 11SEP95 pt exp a generalized rash consisting of 7 lesions; No further details were provided;
Low grade headache; Very tired; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 26Feb2021 at 08:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR); taken for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021, the patient experienced low grade headache on monday/tuesday/wednesday the following week (as reported) and felt very tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade headache and very tired were unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
The patient felt fine right after getting the vaccine. He and his family went to go walk around the store and were about to leave when the mother reported that he "couldn't see" (approximately 15 minutes after the vaccination). The family sat him down and we got the patient a bottle of water to drink. He felt fine afterwards within a few minutes.
Around February 2022, the site of the injection was still swollen and sensitive to touch. The swelling also included pain. I have not been able to lift my arm without severe pain. Simple task such as lifting my arm, clapping my hands, etc., have become almost impossible at times. I am also not able to remove my tops when wearing something which requires me to lift things over my head, i.e. t-shirts.  Some days, I have constant feelings of electric shocks in my left arm all day. I also experience some pain on the left side of my body.  I reported this information when I went in for my annual check-up in March 2022 to the nurse practitioner on duty and she stated there was not anything she could do except to tell me to report this to you all.  Therefore, no treatment options have been offered through a medical professional.
FIRST DOSE 12-31-2020: SORE ARM FOR 3 DAYS  2ND DOSE 1-29-2021:  (NEXT DAY 1-30-2021): HEADACHE, CHILLS, FEVER 102, BODY ACHES, SORE ARM, NAUSEA, VOMITING, FATIGUE
skin cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN CANCER (medically significant), outcome "unknown". The husband of the reporter's sister-in-law developed skin cancer after receiving Pfizer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received the first dose on March 24, 2021, are they still eligible for the second dose; 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 (Received the first dose on March 24, 2021, are they still eligible for the second dose) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose on March 24, 2021, are they still eligible for the second dose). On 24-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Received the first dose on March 24, 2021, are they still eligible for the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided.
Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; This is a spontaneous report from a contactable consumer. This 30-year-old female consumer (patient). A 30-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0198, Expiration date: unknown), via unspecified route, administered in arm right on 16Jul2021 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history includes Penicillin allergy and covid-19. Concomitant medications include vitamin e, cyanocobalamin (VITAMIN B-12), folic acid, omeprazole (PROTONIX). No other vaccines received 4 weeks prior to vaccination. Prior to vaccination patient was diagnosed with covid and since the vaccination the patient has been tested for covid. On 16Jul2021 12 :45 AM, after the vaccination, the patient throat started to feel "funny" her mouth and throat had a tingling sensation and a metallic taste in her mouth. Within 5 minutes her throat began to feel tight. It progressively got tighter. she went straight to the ER. her blood pressure was 160/95 and heart rate was 150. her throat did not close all the way off thankfully but closed enough for her to not be able to swallow. Patient received steroid pack and steroid shot as treatment for the observed events. The patient underwent lab tests and procedures on 16Jul2021 which include Blood pressure 160/95, heart rate 150 and SARS-CoV-2 test which showed a negative result. The outcome of the events are recovering.  No follow-up attempts possible. No further information expected
Information has been received from nurse concerning a 5 year old patient who was vaccinated with a dose of ProQuad. It was reported that the patient went into anaphylactic shock, a few minutes after receiving vaccine and was eventually taken to hospital after receiving two doses of epinephrine (Epi Pen).  Upon internal review, anaphylactic shock was considered to be an other important medical event. Additional information will be provided if available. This is one of several reports received from the same source.
Energy decreased; Joint aches/Pain in my joints (elbow, knees, lower back and hips); Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Energy decreased), ARTHRALGIA (Joint aches/Pain in my joints (elbow, knees, lower back and hips)) and FATIGUE (Fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Rocephin), Sulfonamide allergy and Drug allergy (Allergic to Morphine). Concomitant products included THERAWORX RELIEF for Muscle cramp, LEVOTHYROXINE SODIUM (SYNTHROID), ACYCLOVIR [ACICLOVIR], UBIDECARENONE (COQ-10), VITAMIN D3, FISH OIL, L-LYSINE [LYSINE], OCUVITE EXTRA and ASCORBIC ACID, BETACAROTENE, COPPER, DUNALIELLA SALINA, SELENIUM, XANTOFYL, ZEAXANTHIN, ZINC CHELATE (HEALTHY EYES) for an unknown indication.   On 15-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Energy decreased), ARTHRALGIA (Joint aches/Pain in my joints (elbow, knees, lower back and hips)) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN ongoing since an unknown date for Joint pain, at a dose of 360 milligram once a day. At the time of the report, ASTHENIA (Energy decreased), ARTHRALGIA (Joint aches/Pain in my joints (elbow, knees, lower back and hips)) and FATIGUE (Fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASTHENIA (Energy decreased), ARTHRALGIA (Joint aches/Pain in my joints (elbow, knees, lower back and hips)) and FATIGUE (Fatigue) to be possibly related.    Patient reported that prior to her vaccination she was a very high energy person with no joint pain.   This case was linked to MOD-2021-369104 (Patient Link).
Received Tdap & MCV4 9/8/2009 @ approx 1500.  Per mother child "Went to bed @ approx 2130 with c/o sore arms.  Woke up @ approx 0200-0300 on 9/9/2009 feeling cold, got up for a blanket, fell to floor, jaw felt clutched shut, and was shaking.  Got back in bed & went back to sleep.  Upon awakening at approx 0500, symptoms no longer present and child returned to school today".  Mother phoned child's physician who told her to monitor today and report even to our facility.
1208- Flushed/warm, scratchy throat. lethargy, decreasing oxygen saturation, placed on 4L NC, EMS called  1211- Diphenhydramine 50mg, Solumedrol 125mg, Epi pen injector adult 1231- EMS arrived, patient transferred to ER on 4L NC, SP02 94%
client stated feeling light headed after receiving 1st Moderna Covid Vaccine. Client had been in waiting room 30 mins when she approached EMT to ask if she could take her blood pressure. First vitals at 1022:  blood pressure 151/86, pulse 81, oxygen 100%. PHN  joined, upon arrival client was sitting on chair. Alert and oriented. Per client felt light headed and chills around neck and hands within 15 mins of receiving vaccine. At this time 30 mins had passed and client stated symptoms had resolved. Client stated just wanted to follow up with EMTs before going home. Client asked to stay longer as blood pressure high. Per client no relevant medical history, allergy to penicillin. No history of high blood pressure. Client denied headache, blurry vision, chest pain, dizziness. Second vitals at 1027: blood pressure 130/80, pulse 90, oxygen 100%. Per client feeling better and wanted to leave since blood pressure back to normal. Client advised to speak with provider prior to second dose. ER precautions given. Husband with client, would drive home. Client left facility with steady gait at 1033.
Pt was concerned due to close contact with a covid + patient in the 14 days prior.   66 yr old male contacted and consented for telehealth visit for Covid-19 f/u.  Pt started being symptomatic on 1/26/21 and tested (+) on 1/27/21. Pt states he  has no appetite and is having fever/chills off/on and body aches. Pt states his  temp was 100 deg F when checked.
This case was reported by a medical assistant and described an adult female pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The medical assistant reported two adult females pt's, however, no pt identifiers were provided. On unspecified dates, the pt received three doses of Engerix B (lot ENG 5379A4, lot ENG 5390A4, and lot ENG5507A4). On an unspecified date, a hep B surface antibody titer indicated that the pt was non reactive. The reporter stated that teh pt sought medical attention, however no further information was provided. Report received via manf.
tender swelling slighty red increased in size @ 4 days post immunizations swelling @ site of hib/heb b vaccine
high pitch scream type cry for 2 hrs inc temp; rt leg, inject site, was red & hard for 1 month w/limited motion;
Diarrhea, bloating, GI pressure typically of irritable bowel syndrome (IBS).
This is a spontaneous report by a contactable nurse via a Pfizer sales representative. A 16-month-old female received the fourth dose of PREVNAR 13, lot number 915186, intramuscularly in the left leg for the immunization and a dose of INFLUENZA vaccine, lot number UT3641CA, intramuscularly in left leg on 24Feb2011. Concomitant vaccines included the fourth dose of PEDVAX-HIB, lot number 1485Y, in the right vastus lateralis intramuscularly on 24Feb2011. Past vaccine history included three doses of PREVNAR 13, three doses of PEDVAX-HIB and a dose of FLUZONE. Relevant medical history included asthma. The patient had no drug history, drug allergies or family history. On 24Feb2011, the patient developed a circle formation on her left leg which was hard, red and swollen. There was redness which was quarter sized and was getting larger at the time of the office visit on 26Feb2011. The site was tender. The patient was diagnosed with cellulitis. No cultures or serotyping was done. Therapeutic measures taken as a result of the event included treatment with cephalexin 250mg/5ml, 4mg twice daily for 10 days and acetaminophen and ibuprofen as needed. The patient was considered recovered on 01Mar2011. The reporter considered that the events were related to the PREVNAR 13 and influenza virus vaccine. There were no relevant etiological factors to facilitate the assessment. Follow-up attempts completed. No further information expected. Follow-up (14Apr2011): New information reported included follow-up attempts. Follow-up (19Jul2011): New information reported from a contactable HCP includes: dose details, past vaccine history, medical history, clinical details, treatment, outcome and causality assessment. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR 13.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: NAUSEOUS BUT NO VOMITING
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 216 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Hives, very large on buttocks.  Took two benadryl tablets.  Next morning most were gone.  Also pain and redness at injection site (in the arm (left) where the pneumonia shot was given) lasting several days.  Swollen lymph node in left armpit.  I had two vaccines that day, the last (third) of the hepatitis B and Pneumococcal 23 valent.  Since I had no reactions to the previous 2 hepatitis shots and no pain in the arm in which it was given, I assume the reaction was to the Pneumomia shot.
Day #3 post vaccine 12/2/03: headache/sore throat. Day #4 post vaccine 12/3/03: body aches/fever. Day #5 post vaccine 12/4/03: Nasal discharge/chest congestion.
This spontaneous report as received from a nurse refers to a 65 years old female patient with hypothyroidism, hypertension, deep vein thrombosis (DVT), arthritis and reactions/allergies to CRESTOR, ZITHROMAX and CEFZIL. On 26-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, lot number and expiration date were not reported). In approximately January 2015, within 24 to 48 hours after vaccination, the patient experienced burning, itching, redness, purulent drainage and both eyes and bumps on the lower eyelid. The patient was given gentamicin eye drops for the treatment of the events. The patient was seen by physician on 04-FEB-2015. The patient had no improvement and was back to see physician on 10-FEB-2015. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Hot flashes04/26/2021, cold sweat04/26/2021, joint pain04/26/2021, migraine 04/30/2021
Patient began itching after about 10 minutes of having her COVID vaccine. She was being observed and c/o itching. She was observed about another 15-20 minutes. more.  She had some redness around injection site and head itching. The itching  subsided and she was d/c to go home with instructions for warning signs. She denied any difficulty swallowing, SOB, or other sx at that time. She was given previously the Fact Sheet and V-Safe sheet. She denied any new sx and stated she felt fine. She was given warning signs by self and stated she understood. She stated she had benadryl at home if sx returned she would seek medical attention. Patient returned to work at the hospital.
Patient received vaccine above (L) deltoid site (misadministration), near the left shoulder joint.