chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the mother of an approximately 12 year old male with allergies to unspecified foods, food coloring and milk and no other reported medical history who on 10/22/98, 11/23/98, and 5/3/99 was vaccinated with a first, second, and third dose of hepatitis B virus vaccine (lot # 624808/1532E, 625394/1554E and 628407/1590H), respectively. There was no concomitant medication. After administration of the vaccines in sixth grade, her son developed learning problems. The patient functioned normally during sixth grade, but barely finished seventh grade and was pulled from school by his parents in eighth grade. The mother stated that her son cannot function in public school and has not found success with placement in private schools. The patient's learning disability has been significantly detrimental to his development and his condition has not improved. No medical attention was sought but when the patient was younger, his family tried several unidentified medications for ADD which did not prove successful and were discontinued. The mother noted that she recently verified that the reported lot numbers contained mercury and expressed her concerns related to a correlation between thimerosal and autism. No product quality complaint was involved. The mother considered learning problems/learning disability to be disabling. Additional information has been requested.
mother of child stated she had pediatric dose for first dose and requested the same for second dose Nurse practitioner administered the pediatric dose Rejection noted by Clinical lead and system report generated.  Child age 12 yrs received adult 0.3cc dose at 12/4 visit, not pediatric dose- incorrect does of pediatric dose 0.2cc give today 12/24/2021; Stated dose accepted and no need for revaccination.
Approximately 30 minutes after receiving the vaccine, patient c/o shortness of breath. Patient stated that she could not "take another step" as she was walking towards her vehicle. Vital signs were checked, BP 170/90, HR 98, O2 Sat 98% on room air. Paramedics were called and patient was taken to ED for further evaluation.
As the nurse was administering the dose, the needle got separated from the syringe. most of the dose came out. We advised the patient's mother to redo it immediately but she was not comfortable with that.   We have contacted here the following day, after reviewing the CDC guidelines. We confirmed to the mother that she needs to bring her son back and get the full dose. She said she will bring him back for his second Covid-19 vaccine.
warm; scratchy throat; stuffy nose; thick mucus; tired; muscle pain; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm), OROPHARYNGEAL DISCOMFORT (scratchy throat), DYSPNOEA (stuffy nose), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (thick mucus) and FATIGUE (tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy. Concomitant products included NAPROXEN for Back pain and Back pain, ENALAPRIL for Blood pressure.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (warm), OROPHARYNGEAL DISCOMFORT (scratchy throat), DYSPNOEA (stuffy nose), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (thick mucus), FATIGUE (tired), MYALGIA (muscle pain), HEADACHE (headaches) and CHILLS (chills). At the time of the report, FEELING HOT (warm), OROPHARYNGEAL DISCOMFORT (scratchy throat), DYSPNOEA (stuffy nose), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (thick mucus), FATIGUE (tired), MYALGIA (muscle pain), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.            Patient has received Tylenol treatment for the symptoms.  Action taken with mRNA-1273 in response to the event was not applicable.
Loss of blood flow in left arm; Swelling at injection site; Inability to lift arm (injection site); Rash at injection site; Tingling in left hand; Muscle spasms in left side; Migraine; Vomiting; Diarrhea; Neck pain; Lethargy; Ringing in ears; Inability to complete normal daily tasks; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration, administered in the left arm on 24Jul2021 16:00 (at the age of 30-years-old) as dose 1, single for COVID-19 immunization. Medical history included anxiety, white wine allergy, depression, and post-traumatic stress disorder (PTSD). Concomitant medications included escitalopram oxalate (LEXAPRO) and alprazolam (XANAX). The patient previously took orphenadrine (K FLEX) and midazolam hydrochloride (VERSED) and experienced drug allergy with both. The patient previously received TDAP/DTAP vaccine and experienced vaccine allergy. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed COVID-19 infection. Since the vaccination, the patient has not been tested for COVID-19. On 24Jul2021 17:00 (1 hour after the vaccination), the patient experienced loss of blood flow in left arm, swelling at injection site, inability to lift arm (injection site), rash at injection site, tingling in left hand, muscle spasms in left side, migraine, vomiting, diarrhea, neck pain, lethargy, ringing in ears, and inability to complete normal daily tasks. Therapeutic measures were not taken as result of the events. The outcome of the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
About 1 week after I experienced itching , pain , and red rash around vaccination site.
While administering the vaccine, the vaccinator pushed the plunger before entering the arm muscle thus losing most of the dose and it not being administered. When it was determined that <1/2 of the dose was given, the plan was to revaccinate in the opposite arm. However, the patient refused to be re-dosed at the time of the event.
Flu vaccine was given for 4 month old baby. Pediatrician spoke with mother after the visit. No side effects reported. All concerned and questions were answered by the doctor.
haven't got their second dose; lymph nodes swollen every where in their body; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes swollen every where in their body) and PRODUCT DOSE OMISSION ISSUE (haven't got their second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol, Anxiety and Depression.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LYMPHADENOPATHY (lymph nodes swollen every where in their body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (haven't got their second dose). At the time of the report, LYMPHADENOPATHY (lymph nodes swollen every where in their body) and PRODUCT DOSE OMISSION ISSUE (haven't got their second dose) 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.   Concomitant medication history not provided. Treatment information was unknown.
Baby received vaccines in AM. Dad called reporting baby had nursing session several hours after visit & baby promptly vomited & had intermittent pallor. No fever. Had several more episodes of vomiting & some diarrhea.
Nausea  Dry heaving  Coughing Runny nose Headache with severe dizziness  Stiff neck Decrease Appetite  Fatigue  Took Ibuprofen and slept for 4 hours in the afternoon when woke up better but weak, ate, hydrated and rested. Tuesday recovered.
Itchy rash on front of legs, mostly around my knees, shins and inside my thighs.
Acute diverticulitis; Abscess; stiff; fatigue; ache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4459772-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 03Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162623) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIVERTICULITIS (hospitalization, medically significant), outcome "unknown", described as "Acute diverticulitis"; ABSCESS (hospitalization), outcome "unknown"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiff"; FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "ache". The patient was hospitalized for diverticulitis (start date: Jun2022); the patient was hospitalized for abscess (start date: Jun2022). The action taken for adalimumab was temporarily withdrawn.  Clinical course: On Unknown Dates, The Patient Experienced Acute Diverticulitis, Abscess, Stiff and covid vaccine issue/fatigue and achy. Pfizer BioNTech Covid-19 vaccine (Tozinameran) was also considered suspect. In Jun2022, the patient was hospitalized due to an abscess and acute diverticulitis. She was stiff due to being off of Humira. She also had covid vaccine issues of fatigue and achy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "fatigue" and "ache" related to BNT162b2 while reporter's causality for the event(s) of acute diverticulitis, abscess, stiffness was not provided. Reporter causality for events Acute diverticulitis, Abscess, Stiffness (Musculoskeletal stiffness), Ache and Fatigue with Adalimumab (Humira) was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events acute diverticulitis, abscess, stiffness  and the administration of the vaccine is unlikely. Based on the nature of the events  "fatigue" and "ache", a causal relation between the reported events and the administration of the vaccine BNT162b2 cannot be excluded
Swelling at injection site; Redness at injection site; Itching at injection site; Injection site Hot to Touch; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2019, less than an hour after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient receiving first dose Shingrix in late February 2019. Following vaccination, the patient experienced swelling, redness, itching, pain and hot to touch at the injection site.  It was reported that after the first dose symptoms lasted a day or so.  The reporter had consented to follow up. The case has been linked with the case US2019AMR128477, reported by same reporter for same patient.
Pt has red, raised, warm area 6.7 cc x 3.8 cc. SEPTRA DS one tab bid x 7 days. Pt will follow up in 3-4 days.
Right upper arm with localized redness/warmth/swelling- Onset day after immunizations. No fever/chills. No difficulty breathing, no difficulty swallowing- local treatment with cool compress. Zyrtec po, Keflex po
CONTACTED PARENTS AND INFORMED THEM OF THE ISSUE, THEY WERE GIVEN THE OPTION TO REVACCINATE THEIR CHILDREN, THEY WERE ALSO CONSULTED TO CONTACT THEIR PEDIATRICAN.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old male patient who received Shingrix for prophylaxis. In May 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: In 2018, the patient experienced a sore arm after the vaccination. This case has linked to case US2018171852, reported by the same reporter for same patient.
No additional AE/PQC; A patient who came to their office today received VAQTA that was expired on 08/23/2020; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported. On 14-SEP-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml injection, lot # S021449 has been verified to be a valid lot number, expiration date 23-AUG-2020 (route of administration and injection site, frequency reported as once) for prophylaxis.
For 5 plus months - Severe headaches on the left side; facial numbness on the left side; pain going down the left side starting with my head, down my neck, cramps in left calf; brain fog; extreme exhaustion
Pain, inflammation in the area. Patient also notes that he has warmth in the area and his left axilla is painful.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-MAY-2016, the patient was vaccinated with an expired dose of VAQTA (lot # J000366, expiration date 22-AUG-2015; dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
Mild headache, slight headache; Little bit of joint pain; Slight muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache, slight headache), ARTHRALGIA (Little bit of joint pain) and MYALGIA (Slight muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced HEADACHE (Mild headache, slight headache), ARTHRALGIA (Little bit of joint pain) and MYALGIA (Slight muscle pain). At the time of the report, HEADACHE (Mild headache, slight headache), ARTHRALGIA (Little bit of joint pain) and MYALGIA (Slight muscle pain) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient got the booster and was asking if it is ok to take aspirin for some of the mild headache and little bit of joint pain that patient got since had the booster. Patient had reported nothing from the original shots but, the booster gave slight headache and slight muscle pain.
After administration of Moderna COVID vaccine, patient had ringing in ears, felt dizzy and faint for a few minutes.
Axillary pain/tenderness; LN swelling; A spontaneous report was received from a physician who was also a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced axillary pain/tenderness/LN swelling.  The patient's medical history was not provided. Products known to have been used by the patient were not provided.  On unknown date, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On unknown date, approximately 14 days after vaccination,  the patient had difficulty getting the axillary pain to completely go away.   Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, eye irritation and a little diarrhea, were resolving. The outcome of the events, being a little bit tired and injection site sore and hard, was not provided. The outcome of event, axillary pain/tenderness/LN swelling was not reported.; Reporter's Comments: Very limited information regarding these events of axillary pain and lymphadenopathy has been provided at this time.  Further information has been requested
COVID; COVID; Very sick with vaccine and lasting symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID"; ILLNESS (non-serious), outcome "unknown", described as "Very sick with vaccine and lasting symptoms".  Clinical course: Patient stated that she felt very sick with COVID and the vaccine. She had lasting symptoms and did not know if she would ever vaccinate again. The reporter consider event as caused by suspect product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I do not have a period due to me taking birth control continuously but I have gotten my period. I have not missed any pills and have no explanation for why this happened other than the vaccine
She said that it looks like she is looking through water.  She has a retinal bleed.  She is going tomorrow 2/19/21 for a shot in the eye to stop the bleeding.  The outcome is pending.
Information has been received from a LPN concerning a male pt in his 30's with no past medical history and no allergies who on 23Feb2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, instead of a PPD intradermally. There was no concomitant medication. On 24Feb04 the pt was seen in the doctor's office with redness, swelling, and pain of left forearm inner aspect. The pt was treated with cephalexin for one week. There was no quality of product complaint involved. Additional information has been requested.
Small tender supraclavicular bump; has not noticed any other side effects. feels fine. We rec to use warm compress/NSAIDS and see her MD if this persists past 10 days.
Mild rash on left chest, same side as injection; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 12Sep2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included cardiovascular disease. It was unknown if the patient had any known allergies. 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. Concomitant medications were not reported. On 12Sep2021 the patient experienced mild rash on left chest, same side as injection. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the event mild rash. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild rash on left chest, same side as injection was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient developed urticaria on left arm post vaccination, evaluated by EMS and transported to the hospital.
This is a spontaneous report from a contactable reporter who reported for her daughter. A 6 months old, female patient received on 06Apr2010 the following vaccines for immunization: PREVNAR 13 (Lot # E44519; Expiration Date May2011) at single dose on the right thigh, polio vaccine, HIB vaccine on the left thigh and DPT vaccine on the left thigh. Relevant medical history was none. On 06Apr2010 the patient developed a red spot at the site of injection on the top of her right thigh. This spot further darkened over the time (3 to 5 days after of the vaccination) in Apr2010. Relevant laboratory data was none. Therapeutic measures taken in response to the event were unknown. The clinical outcome of the event was not recovered at the time of report. Follow-up (21Jun2013): This is a spontaneous report from a contactable physician. This physician reported that the patient is not one of his/her patients. Follow-up attempts completed. No further information expected.
Multiple episodes of vomiting and diarrhea starting approximately 7.5 hours after administration lasting throughout the night until around 0500 the next day; significant muscle cramping (Potassium depletion?), pain at the injection site still occurring; headache,
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old male patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (1st and 2nd dose received on an unknown date.). On 5th November 2021, the patient received the 3rd dose of Engerix B. On 5th November 2021, unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: The pharmacist reported that, the patient received the third dose of Engerix-B two months early which led to drug dose administration interval too short. The reporter consented to follow up.
7 minutes after receiving the Pfizer 1st booster vaccine, patient began to experience tingling, numbness and burning on her left arm. VS obtained at 10:45 am: HR 67, O2 97%. At 11:01 am, she stated the tingling and numbness was less but "still there." VS at 11:01 am: BP 130/70, HR 72, O2 97%. VS at 11:10 am: HR 66, O2 99%, BP 132/66. At 11:23 am, she stated she felt better. Educated her to seek emergency care if symptoms return or worsen. Cleared her at 11:23 am.
Patient says she cannot lift right arm. Also pain in arm. Visual exam shows no obvious rash or swelling.