chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information hs been received from a lawyer regarding a case in litigation concerning a 40 year old female with a history of migraine, cold, pregnancy and delivery of three children (hospitalized), unilateral right carpal tunnel syndrome, joint pain (Jan 1998) and a family history of systemic lupus erythematous mother, who was vaccinated with a first and second dose of hepatitis B virus vaccine rHBsAg yeast manufacturer unknown, on 9/8/1989 and 10/12/1989. The patient did not experienced any adverse reactions after her first vaccination. on 10/13/1989 the patients joints felt stiff and by the evening her hands were frozen in a half open position. From that point on the patients pain worsened. She could not sleep through the night because of stiff joints and typically awoke every two hours. It was noted that the patients stiff joints affected her ability to work because her hands would freeze up and she could not use them. The patient complained of being so tired and in so much pain. On 3/6/1990, almost 5 months after her second vaccination, she visited her physician. During this visit she complained of swollen and painful joints. On 3/20/1990 the patient was seen for a follow up visit during which the physician noted a 6 week history of arthralgias. On 4/26/1990 the patient visited a rheumatologist with complaints of multiple joint discomfort that had existed for 14 months. The physician concluded that the patient had polyarthritis which was inflammatory in nature and her present picture looked most consistent with rheumatoid arthritis. It was noted that the patient refused a third dose of hepatitis B virus vaccine rHBsAg yeast (manufacturer unknown) due to increased arthritic activity. The patient felt that the hepatitis B virus vaccine rHBsAg yeast caused her rheumatoid arthritis. Information received on 4/25/2006 included the following adverse experienced, Stroke 10/07/1994 hospitalized, chest pain 1/25/1995 hospitalized, and carpal tunnel syndrome 6/20/1997. No further information is available.
Narrative: COVID infection following COVID vaccine series 05/25 Janssen, dose #1 08/17 pt cc: cough, fatigue exposure: unknown 08/20 COVID swab, result: detected 08/20 SARS-COV-2 Variant Sequencing result: pending 08/21 FIBRINOGEN result: 515 08/21 DDIMER result: 2.16 08/21 FERRITIN result: 147.8 08/21 ESR result: 40 08/22 FIBRINGOGEN result: 431 08/22 ESR result: 34 08/22 DDIMER result: 1.37 08/23 FIBRINOGEN result: 503 08/23 DDINER result: 1.54 08/23 ESR 40 08/24 FIBINOGEN result: 541 08/24 DDIMER result: 1.36 08/25 FIBRINOGEN result: 638 08/25 DDIMER result: 0.99 08/25 ESR result: 79 08/26 FIBRINOGEN result: 528 08/26 DDIMER result: 1.04 08/26 ESR 60 08/27 DDIMER 1.32 08/28 DDIMER result: 0.89 09/22 CXR impression: Clear lungs.
got infected; cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFECTION (non-serious), outcome "unknown", described as "got infected"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptoms".  Additional information: he got the first and second dose of the Pfizer vaccine and he is scheduled for a booster dose today. withheld mentioned that after getting both shots of the vaccine he got infected and experienced cold symptoms. the caller was not able to provide the colour of the cap.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tingling and numbness of face, hands, feet; Tingling and numbness of face, hands, feet; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced tingling and numbness of face, hands, feet. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcomes of the event tingling and numbness of face, hands and feet were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have runny nose, it's severe and I'm still having it. The cough is medium and I'm still having that. The headache is pretty bad only because I'm currently struggling with migraines that I'm under care for and COVID-19 triggered the migraines. Sore raw throat and it's mild to medium and currently have it. My ears and whole face is plugged tight and I still have that it's medium. Fatigue is medium and current. Chills and shivering at night, when I checked I didn't have a fever but at my worse I was too tired to check my temp. Symptoms started 07/11/2022.
Information has been received from a consumer concerning his approx 11 yr old daughter who was vaccinated with a dose of varicella virus vaccine live. In Sept 2005, the pt experienced chicken pox and went to visit a physician. The pt was not recovered. No product quality complaint was involved. No additional information was provided. Additional information is not available.
- Red and Purple blotches from knees to feet - Swelling from knees down - Dry Mouth - Severe drowsiness  Tried using vitamin K cream per dermatologist recommendation, Has helped to reduce color of blotches, but they still remain visible
pt recv vax 10MAY94 & 15MAY94 devel a rash all over body & generalized lymphadenopathy; No further details were provided;
Yesterday (3/31/21) after the shot (4:00pm) my arm at the injection site was sore.  This has continued into today.  No swelling or redness but my arm hurts to touch or move. Beginning this morning (4/1/21) around 7:30 am I started having a headache.  I took an ibuprofen which slightly lessened the pain but it has not gone away all day.  It worsens with activity. Starting around 8:30-9:00 am I started to feel nauseous and lightheaded.  I didn't take any medication for these symptoms.  They've stuck with me all day. Starting around 11:30am I started to feel cold chills and body/muscle aches.  This has continued throughout the day. Starting around 2:45 pm I've felt feverish, with severe cold chills.
Narrative:  COVID infection following COVID vaccine series 02/01, Pfizer, dose #1 02/22, Pfizer, dose #2 04/05 COVID swab, result: not detected 09/23 pt cc: chills, fatigue, sore throat exposure: unknown 09/23 SARS-COV-2 Variant Sequencing result: pending 09/23 COVID swab, result: detected
Breakthrough case after vaccination. Tested positive for COVID on 01/11/2022. C/O cough, chest congestion, headache, and fatigue, onset 1/7/2022
4yo; got orange vaccine first shot (7/1/22) and maroon second shot (7/22/22)  called family with this guidance: Children ages 6 months?4 years who receive different mRNA products for the first 2 doses of an mRNA COVID-19 vaccine series should follow a 3-dose schedule. A third dose of either mRNA vaccine should be administered 8 weeks after the second dose to complete the 3-dose primary series. Family states they will call scheduling for third dose.
My adverse event started on 11/26/2022 at night around 8:00AM. I started coughing, yellow drainage in my nose. On Saturday morning I had fever and cough. I went to the urgent care on Sunday morning. I passed out in the bathroom. They diagnosed me with Syncope Hypoglycemia. I tested negative for flu and COVID-19. I was positive for RSV. In the urgent care they gave me IV with fluids to hydrate me. They also prescribed me with benzoate 10 mg 3 times per day.
Pt was admitted to the hospital for palpitations(A. fib) and was awaiting possible cardioversion. She was COVID tested and was positive. She has had a cough, runny nose, and sore throat for 4-5 days.
Patient had pain in left arm initially, as well as feeling flu-like symptoms. She also states that since she had the injection, she is experiencing numbness and loss of strength in both arms, hands. She has trouble opening jars with right hand (even though she had injection in left arm). She has trouble standing and walking initially when she needs to. These symptoms have started since the injection and ongoing for approximately one month.
60 Second febrile seizure, went to ER by EMS, no treatment done besides Tylenol.
Erythema, warmth (R) arm below injection site. Differential include cellulitis.
Patient was immunocomprised but received booster dose on 28-Feb-2022 instead of third dose; Unknown whether third dose was full dose or half dose for immunocompromised patient; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was immunocomprised but received booster dose on 28-Feb-2022 instead of third dose) and ACCIDENTAL UNDERDOSE (Unknown whether third dose was full dose or half dose for immunocompromised patient) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0075212A, 022B21A and 0A0C21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic inflammatory demyelinating polyradiculoneuropathy and Cutaneous lupus erythematosus.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was immunocomprised but received booster dose on 28-Feb-2022 instead of third dose) and ACCIDENTAL UNDERDOSE (Unknown whether third dose was full dose or half dose for immunocompromised patient). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was immunocomprised but received booster dose on 28-Feb-2022 instead of third dose) and ACCIDENTAL UNDERDOSE (Unknown whether third dose was full dose or half dose for immunocompromised patient) outcome was unknown.            No concomitant medications information was not reported.  Patient stated that she was very confused about her personal booster schedule. After she had the second dose of the initial vaccine, she was told that the booster is in 6 months. When she went back, the pharmacist told her she was way overdue. She doesn't know when she was supposed to get the second booster. It was stated that she doesn't know what dosage she received. She received all three doses from the same vaccination facility.   No treatment medications were provided.   This case was linked to MOD-2021-209253 (Patient Link).
pt says that she has a big purple spot on her right arm around the injection site.  Next day she said the warm red spot is growing so she had a nurse at her workplace draw a circle around the site.  Within 2 hours the spot had grown bigger than the circle.  The spot is now bigger than a 50 cent piece.  Pt has taken Tylenol. Pt has an appt to see a NP today @ 2:45.
Neck is a little bit stiff, like when you are having a massage; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck is a little bit stiff, like when you are having a massage) and HEADACHE (Bad headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck is a little bit stiff, like when you are having a massage) and HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck is a little bit stiff, like when you are having a massage) and HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.
Child complained to parent when came home from school.  Arm swollen, hot and bright red down to elbow. No fever.  Dr. treated as skin infection with 7 day course of antibiotics, but wasn't sure if it was a shot reaction, so also prescribed Benadryl and ibuprofen.
Tired, irritable, neck ache, exhaustion, chills, fever for two days.  It was like having H1N1 all over again! (I had H1N1 in Oct. 2009). It completely knocked me out!  I was super healthy before the immunization.
This patient was admitted to Hospital on 12/24/2021 for complications caused by COVID-19 infection. This is considered a breakthrough case.
more of the exhaustion and nausea; more of the exhaustion and nausea; but it is now somewhat different as I have more energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 10:30 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "CAD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Costracontritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: cats" (unspecified if ongoing); "Known allergies: Crabmeat" (unspecified if ongoing); "Known Allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CLOPIDOGREL; AMLODIPINE; SIMVASTATIN; ALPRAZOLAM. Past drug history included: Prednisone, reaction(s): "Known Allergies: Prednisone"; Iron injections, reaction(s): "Know Allergies: Iron injection". Vaccination history included: Bnt162b2 (dose 1, single, administration time 15:30, vaccine location-Left arm, No treatment was received for AE), administration date: 09Feb2021, when the patient was 81 years old, for covid-19 immunization, reaction(s): "nausea", "exhaustion".  The following information was reported: NAUSEA (non-serious), FATIGUE (non-serious) all with onset Mar2021, outcome "recovering" and all described as "more of the exhaustion and nausea"; ENERGY INCREASED (non-serious) with onset 2021, outcome "recovering", described as "but it is now somewhat different as he have more energy".  Additional information: It was reported that, the patient was not diagnosed with covid prior vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Approximatley 12 hours after receiving the vaccination patient developed a hard, swollen red area the size of an apple on her left arm.  This area was not at the site of the injection but directly opposite it on the same arm.  Upon questioning, patient revealed that she had had a mastectomy many years ago on that side which she did not report to the vaccinator.
pt's daughter came in after pt had passed away about 2 months after vaccine. stated that the reason pt went into health decline was due to a fall the day she received her vaccine. she felt light headed and was "out of it"in the even. she had multiple neck fractures from a fall the evening after 2nd dose. pt's daughter asked for this to be reported.
Patient presented 2 days after immunization with swelling and hard mass (small) in her arm. Told to take Ibuprofen & BENADRYL and go to MD if getting worse.
Restricted breathing, difficulty taking deep breath,, expiratory wheezing, shortness of breath
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:53 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 61.18.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 34 and 37 respectively, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Information has been received from Pfizer Inc. (Manufacturer report #2015332567) via a registered nurse on behalf of herself. The patient was a 62 year old female with an abnormal clotting factor diagnosed (dx.) 2008 and a medical history of pulmonary embolism (dx. DEC 1997) and pulmonary embolism (dx. 2008). On an unspecified date in AUG2012 the patient was vaccinated with PNEUMOVAX 23, (dose not provided), subcutaneously, in the arm (patient could not recall which arm), at approx. 1400 hours. Approximately 12 hours after she was vaccinated with PNEUMOVAX 23, (approximately 0200 in the morning the following day), the patient experienced severe muscle and joint pain. She reported that she could barely move. She also ran a temperature of 102 degrees or higher for three days. The patient completely recovered from the severe muscle pain, joint pain and temperature of 102 degrees or higher approximately three days later. She called her doctor and notified him of her experiences. She did not receive any additional medical treatment. "She just suffered through it until her experiences resolved". She did not have any tests done after the events. The patient placed a call to Pfizer to ask how PREVNAR 13 compared to PNEUMOVAX 23 and questioned if she would have the same reaction. Additional information is not expected.
13JAN child had injury to head & seemed to have sz like activity. on 14JAN rec'd DTP vax later that day child seemed to have more sz-like activity. Seems okay except does not want to eat. Rec'd MMR & OPV on 25FEB91.
Large, hot red lump at injection site, extreme change in behavior (inconsolable crying, lethargy) fever pox over entire trunk and extremities.
Large red rash, very hot to touch, on injection site. Itchy.  I had the same reaction on injection 1, but it is bigger & longer lasting on injection 2. Still present on 3rd day after appearance
plaintiff alleges that as a result of OPV vax 8DEC79 pt devel URI on 24DEC & flaccid paralysis of lt leg on 26DEC79 w/dx of poliomyelitis
Pt presented to the hospital 1 week after testing positive for COVID. Patient has had nausea and decreased oral intake and muscle aches.  She denied any respiratory symptoms or any fever or cough or shortness of breath or chest pain or any abdominal pain.  She was diagnosed with mild dehydration due to COVID-19 infection. Patient was admitted under observation for mild hypokalemia and dehydration and also row complain of bleeding around the ostomy site.
This patient developed hives after 2 month shots. Got Prevnar, DTaP, IPV, and HIB. She also had a stuffy nose for 2 weeks.
Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and Older) preparation and administration instructions.  1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml. The dose given out of this vial was 0.3 ml. The children (age 5-11) received 0.3 ml x 41.9 mcg/ml - 12.6 mcg Pfizer Case #: int00506363
The patient received a second dose of VARIVAX instead of VAXELIS; The patient received a second dose of VARIVAX instead of VAXELIS; The patient received a second dose of VARIVAX instead of VAXELIS; No additional AE; This spontaneous report was received from other health care professional referring to a 2-year-old female patient.   The patient's pertinent medical history and concomitant medications were not reported. Was reported that as the patient was born during the Covid pandemic and was limited to go out, she was behind schedule on all vaccinations.   On 16-MAY-2023, the patient received the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (dose, vaccination scheme frequency, route, anatomical site of administration, lot number and expiration date were not reported), and was supposed to receive the first dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) on 17-OCT-2023, but instead, that day, the patient was inadvertently administered a second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection 0.5 mL as prophylaxis (vaccination scheme frequency, route, anatomical site of administration, lot number and expiration date were not reported) (Product administered to patient of inappropriate age/Inappropriate schedule of product administration/Wrong product administered). No additional adverse event was reported.