chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
On 6/27/22 6m-4 yr Pfizer first dose given.  On 7/25/22  6m- 4 yr moderna given. Parent notified, VAERS completed. On 8/22/22 second dose of 6m- 4 yr moderna given. No harm to patient noted. Second dose of moderna was given before the eight week time frame.  Second dose of moderna not vaild and will need to be repeated. Child will need to receive third dose of moderna.
This case was reported by a physician via sales rep and described the occurrence of rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced rash in the armpits located in lymph node area. The reporter did not give consent to follow up.
Information has been received from a consumer concerning her 12 month old son who was vaccinated with a dose of MMR II (lot# not provided) 0.5ml, and shortly after getting the vaccine he had a "violent reaction" to it. He had a "very high fever" and a rash. At the time of the report the patient had completely recovered. No further information is available.
Mom called 13JUN91 pt had T 103 & did not sleep well nite of 12JUN91, would not move affected arm--arm sore; On 13JUN91 T 101-102 con't w/APAP, pale, vomited p/H20 @ 100pm, then slept several hrs; Sx's subsided p/sleeping;
p/ pt vax which had expired on 12/10/97 subsequently 7 days later pt except less than 10 vesicles.
Chronic joint pain and high inflammation markers like seen in autoimmune diseases. Esr, scl 70, ana positive
This spontaneous repot as received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported.  The pharmacist informed that on 07-NOV-2014, the patient was vaccinated with dose of M-M-R II (injection, lot# K004948, expiration date: 04-APR-2016 (route and dosage were not reported). That underwent an unsupported temperature excursion. No adverse effects were reported.  Additional information has been requested.
R deltoid. Circular red raised, warm, tender to touch, 3x4 circular area.
left work 4PM felt tired; decided to take nap; cont to sleep through noc; spouse took to ER 10OCT in AM; seen by MD pt reports feeling exhausted like had been up for 2 days; @ ER pt threw up;
Knot under left arm 04/06/2021   -04/08/2021 Bell's Palsy 04/09/2021 to present
Noticeable head swelling, seizures, vomiting, interventricular hemorrhage after 2nd Hep-B (Engerix) at less than 6 weeks of age. Dates were from 12/15/95 through hospital admission on 1/25/96. Pt received the 1st Hep-B at less than 24 hours of age on 11/4/95. A nurse told me he was trembling (probably a seizure). Recent information and research regarding bleeds in the brain and the link with vaccinations has proven the pt's catastrophic event is directly the result of an adverse reaction.
The Menveo liquid conjugate dose was not diluted into the powder.  Pt received the "Liquid Conjugate Component" only.
Patient reported on 11/18/2020 that the injection site felt hot later that day and that one week after the injection on 10/13/2020 she became weakened to the point of needing to use her walker to ambulate. The weakness was generalized all over. She felt episodes of confusion and extreme tiredness. She reports that this lasted a month and while it is improving it continues to persist.  She did not seek medical treatment since the injection and came to clinic on 11/18/2020 for an unrelated issue.
Body hurt; Coughing; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body hurt), COUGH (Coughing), CHILLS (Chills) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DOM 2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Body hurt), COUGH (Coughing), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN (Body hurt), COUGH (Coughing), CHILLS (Chills) and PYREXIA (Fever) 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.
Not really been able to keep anything down side; effects; not feel good; not feel like eating and did not eat or drink; does not get better; Body aches; Bad Headache; No fever probably some hot and cold feeling; Nausea; Vomiting/Throwing up; Not really been able to keep anything down side; effects; not feel good; not feel like eating and did not eat or drink; does not get better; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Lot number: EW0164, Expiration Date: Aug2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Her first one she did fine with". The following information was reported: NAUSEA (non-serious) with onset 01May2021, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 01May2021, outcome "unknown", described as "Vomiting/Throwing up"; FEELING ABNORMAL (non-serious) with onset 01May2021, outcome "unknown", DECREASED APPETITE (non-serious), outcome "unknown" and all described as "Not really been able to keep anything down side; effects; not feel good; not feel like eating and did not eat or drink; does not get better"; PAIN (non-serious), outcome "unknown", described as "Body aches"; HEADACHE (non-serious), outcome "unknown", described as "Bad Headache"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "No fever probably some hot and cold feeling". Therapeutic measures were taken as a result of nausea, vomiting.  Additional information: The patient received the Pfizer Covid-19 Vaccine on Friday and she was having some side effects. She had started having a lot of nausea and vomiting last night. She had not really been able to keep anything down. She did not feel good that day, but it was kind of what they expected. This was her second one, her first one she did fine with, had the body aches and did not feel like eating and really did not eat or drink very much and then about 1:30 last night she called the reporter because she was throwing up and she had continued to throw up. She had some Zofran (treatment) on hand had taken that and just like helped for a while but now was throwing up again and since then she had not really eaten anything, so the reporter was concerned about vomiting. The reporter knew nausea could be a side effect. This kind of vomiting, was that something they could see. Along with that she had got a really bad headache, the body aches were better, there was no fever probably some hot and cold feeling which they would expect.  No follow-up attempts are possible. No further information is expected.
06/03/2005 - 5pm left upper arm swelling, red, sore temperature 103 degrees by 7PM.  Treated with extra strength Tylenol and cream, temp did not improve.  06/04/2005 Fever continued redness and swelling now size of softball blisters at injection sites and around sites clear fluid.  06/05/2005 swelling increased, blisters more prominent skin area red and white striped appearance.  Took Benadryl today.  06/06/2005 Benadryl taken again swelling decreased, slight fever headache.
Initial unsolicited report received from a consumer on 11-FEB-2018. This case involves a female patient (age not reported) who was vaccinated with IMOGAM (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 08-Feb-2018. Patient's medical history was reported as none. Concomitant medications included IMOVAX on 05-Feb-2018 and 08-Feb-2018. On an unknown date following the vaccination patient experienced "twitching in her butt" and she has cold symptoms like a scratchy sore throat that makes it hard to swallow. It was also reported that after hours patient received adverse event on 11-Feb-2018. Other laboratory data and corrective treatment was not reported. The outcome of the event was reported as unknown. Follow-up information received from a physician on 12-Mar-2018. It was reported that IMOGAM was administered with second dose of IMOVAX and received the full IMOGAM dose divided to both thighs. It was also a case of actual medication error due to inappropriate schedule of vaccine administered and wrong technique in product usage process. List of documents held by sender: none.
Developed a fever between 102-104F; Sore arms; Injection site that was hot to the touch; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. This nurse reported similar events for three patients. This is the second of three reports.  An adolescent patient (reported between 16-18 year-old) of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant vaccine included meningococcal vaccine (MCV-4) for immunization. On an unspecified date, the patient developed a fever between 102-104F along with sore arms and an injection site that was hot to the touch. The outcome of the events was unknown.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019306418 same reporter, suspect drug and event; different patient;US-PFIZER INC-2019306395 same reporter, suspect drug and event; different patient
I got my Pfizer COVID 19 Booster shot on Sunday 11/19/21. The next day (Mon 11/20) I had numbness on the left side of my face along with mild drooping. Then on Tuesday 11/21, I had significant drooping along with asynchronous blinking, with my left eye blinking much slower and not closing all the way. The Pfizer Booster shot seems to have triggered Bell's Palsy, which according to the CDC "might be associated with a small increase in risk of Bell's palsy." I did not get Bell's Palsy after the first two shots.
Vaccine was administered at 6:01 pm . - At 6:14 pm , she began to experience dizziness, nausea, and tiredness.  - Vitals were monitored.  -  Denies lip/tongue/throat swelling.  - Denies difficulty breathing or SOB.  - Patient was monitored for a total of 75 minutes. - No wheezing. No lip swelling, No tongue swelling. No difficulty speaking in  full and complete sentences.
c/o throbbing h/a w/nausea-incoherent (parent unable to understand vocalization; given APAP; temp 102-heart rate inc; states inject site on leg sore;
Extreme muscle pain, edema to 3x regular size, rash, fever and general malaise.
DTaP vaccine administered 6/8/17 in (R) thigh, 6/10/17 parent noticed red area around injection site. Eval 6/12/17, examined (R) lateral thigh 12x12cm red slightly warm area w/o significant edema. No fever. Mom advised to ice area, try OTC allergy med and f/u if no improvement.
R arm and shoulder pain 2 hrs after injection, increasing in severity over next 4 days. L arm pain began 2 days later. Saw PMD-given PERCOCET for pain which resolved. No pain now.
3-3-21 unable to open jaw, sweating (sweating resolved). 3-4-21 swelling to chin area with redness. took tylenol reports it helped him. asked if he had any fever, wife reports "no". called PCP spoke with his nurse, pending further instruction from PCP and or nurse. Wife called back states her Husband has abscess tooth, so feels maybe related to that. Wife states he was given  Amoxicillin yesterday at MD office. She states he is feeling better today, eating slowly.
Information has been received from a nurse concerning a 10 year old patient with no pertinent medical history and no drug reactions/allergies who on 10-FEB-2004 was vaccinated with the first dose of VARIVAX (Merck) (lot# 647241/0894N, expiration date unspecified). Concomitant vaccine administered on the same day included M-M-R II (lot# 646431/0679N). On 16-AUG-2007, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot# 657944/1003U, expiration date unspecified). On 18-MAY-2010 the patient came into the office and was diagnosed with chickenpox. The nurse reported that the patient had multiple varicella like rashes from the upper left torso and had multiple varicella like rashes above the eyebrow. No laboratory tests were performed. The nurse reported that the patient was recovering. In follow-up, the nurse indicated that the female patient received the first dose of VARIVAX (Merck) (lot# 647241/0894N) into right arm in the office on 10-FEB-2004 and the second dose of VARIVAX (Merck) (lot# 657944/1003U) SC into the left thigh out of the office on 16-AUG-2007. On 18-MAY-2010 the patient was diagnosed with chickenpox after 6 days of rash. On 25-MAY-2010 the patient recovered from chickenpox after 5 complications. Additional information is not expected.
muscle pain and joint stiffness in neck, lower back, and especially hips and upper thighs; been experiencing this since day after second COVID injection; stiffness occurs as I stand up from sitting or laying down, regardless of how little I am sitting or laying down.  Tylenol helps for a little bit, but not for long.  Makes normal everyday activities difficult and painful. Hard to walk most of the time.
pt recvd vax & devel tenderness & swelling 8FEB93; poss sterile abscess;
Patient reports pain since 5/6/2021 in arm and lack of range of motion.  He has not reported to the doctor.  He reports no swelling, no rash ever.
My left pupil became larger than my right pupil. Noticed sometime in February after the vaccine.  The beginning of May my left pupil was permanently larger than my right pupil with increased blurry vision. I went to 2 Ophthalmologists and a neurologist and a Neurologist Opthalmologist in June and July when there was no resolve on its own.  Had an MRI and dx of Adies Pupil. recommended by Neurologist to defer any future COVID vaccine due to the nature of the neurological event that has caused decrease in vision and blurry vision and increase in light sensitivity.
Positive test for COVID/COVID 19 Treatment; Positive test for COVID/COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Positive test for COVID/COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diffuse rash on neck/face, back of arm, belt line & legs 2 days after receiving ZOSTAVAX. No rash around injection site. More painful than itchy.
The patient after getting the flu shot told the staff that she intended to receive the pneumonia booster shot. She was subsequently given the pneumonia vaccine. She reported a headache as her only side effect/ adverse event as of 10/2/19. The pharmacist on duty on 10/2/19 contacted patient's nurse to report the vaccines that were administered and that the patient had now claims to have not requested one of them. The nurse for the provider said that no action was needed at this time and that the provider will be notified.
Left deltoid - tense and warm erythematous 8 X 4 cm swelling around shot site of DTAP.
brain dead; strep pneumonia; headache; lethargic; positive for flu B; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 3-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 23Apr2021 as dose 4, single (Batch/Lot number: unknown) at the age of 12 months for immunisation. The patient's relevant medical history included: "Flu B" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Prevnar 13 (first dose), for Immunisation; Prevnar 13 (second dose), for Immunisation; Prevnar 13 (third dose), for Immunisation. The following information was reported: BRAIN DEATH (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 22Jul2023, outcome "not recovered", described as "brain dead"; HEADACHE (caused and prolonged hospitalization, disability, life threatening) with onset 22Jul2023, outcome "not recovered"; LETHARGY (caused and prolonged hospitalization, disability, life threatening) with onset 22Jul2023, outcome "not recovered", described as "lethargic"; INFLUENZA (caused and prolonged hospitalization, disability, life threatening) with onset 22Jul2023, outcome "not recovered", described as "positive for flu B"; PNEUMONIA STREPTOCOCCAL (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 22Jul2023, outcome "not recovered", described as "strep pneumonia". The patient was hospitalized (hospitalization duration: 10 days). The patient underwent the following laboratory tests and procedures: Influenza B virus test: (22Jul2023) positive. Therapeutic measures were taken as a result of brain death, pneumonia streptococcal, headache, lethargy, influenza. The physician did not believe the patient will live. The physician also stated that the Serotype that caused the pneumonia was not covered in Prevnar 13, but the physician didn't know the serotype of Streptococcus pneumonia that he was infected with.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: All events are considered unrelated to the use of PREVNAR 13;  pneumonia not covered by PCV 13 represents an intercurrent bacterial infection.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Information has been received from a physician concerning a 7 week female pt who on 05-JUL-2006, was vaccinated with an oral 2ml first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Concomitant vaccine administered at the same time included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. It was reported that the evening after receiving rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) the pt had a fever over 102 degrees. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on approximately 07-JUL-2006 the patient experienced a fever of 102 degrees and fussiness for 24 hours. It was reported that the patient recovered on 06-JUL-2006. Additional information has been requested.
Modern COVID-19 Vaccine EUA administered on 06/14/21 at 11:00 a.m.  Fever:  1) Temperature reading of 99.6 F observed on 06/15/21 at 6:00 p.m. 2) Temperature readings of 99.5F, 99.4F, and 99.0F observed on 06/15/21 at 11:00 p.m. (I understand that 99.5F is the threshold for and elevated temperature)
I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I cannot walk, move or sleep without pain; I cannot walk, move or sleep without pain; I cannot walk, move or sleep without pain; I started to feel lower back pain(on left side); I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got a booster shot/I have received 3 doses of the Pfizer Vaccine.; I got a booster shot/I have received 3 doses of the Pfizer Vaccine.; This is a spontaneous report from a contactable consumer (patient) reported for himself that. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 3 intramuscular, administered in Arm Left on 07Sep2021 10:00 (Batch/Lot Number: FD8448) as DOSE 3, SINGLE for covid-19 immunization (Age at vaccination: 48 years). The patient medical history included Rheumatoid arthritis from an unknown date and unknown if ongoing I am immunocompromised as I have Rheum Arthritis and Sulfonamide allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included celecoxib (CELEBREX, 200mg/Daily) taken for an unspecified indication, start and stop date were not reported; tofacitinib citrate (XELJANZ, 11mg/day) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination.  Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient reported 1 week after receiving the 3rd dose he started to feel lower back pain (on left side) on 14Sep2021, 10 days after the booster I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg. I cannot walk, move or sleep without pain on 17Sep2021.The event ae resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient received a treatment with Physical therapy and an anti-inflammatory prescription. The event outcome was not recovered.  Follow-up attempts are completed. No further information is expected.
Probable chicken pox started Sunday 9/22/02. Fever started Sunday. 300 pox present. Rx oatmeal bath.