chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; incorrect product storage; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On 22-SEP-2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707496, expiration date 29-MAR-2022) at a dose of 2 milliliter, orally and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T037650, expiration date 21-JUL-2023) at a dose of 0.5 milliliter, both vaccines for prophylaxis. The vaccines had a temperature excursion of 46.9 F for 25 minutes. No previous temperature excursions were reported. no additional adverse events were reported.
The vial was initially stored in refrigerator on 06-Apr-2023 and was administered on 09-May-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Apr-2023 and was administered on 09-May-2023) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Apr-2023 and was administered on 09-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Apr-2023 and was administered on 09-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Apr-2023 and was administered on 09-May-2023).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided.
Woke up with severe nausea and vomiting - progressing to diarrhea.  The next day states had fever and chills. Upper respiratory symptoms within a couple of days of vaccine progressing to difficulty breathing.
Nausea beginning 6pm yesterday, a few hours later diarrhea and vomiting. Throughout night consistent diarrhea, chills, and body aches. Woke up with fever of 100.9 (normal temp 97.6). Finally able to keep water down this morning and eat plain rice. Still have fever, headache, and chills.
Call from Mom 11/28/2001 8 days after injections. Mom reports two lumps left leg described as "knots" or lumps at injection site. Mom called again 12/04/2001 one lump described as a boil without a head remains left leg also child congested with fever on/off since 11/20/2001.
he felt "very hot" ("felt like a heatlash"); itchy ("sandpapery") throat; This is a spontaneous report from a contactable consumer. A 25-year-old male patient received first dose of bnt162b2 (BNT162B2; lot number: EK5730), via an unspecified route of administration on 23Dec2020 at a single dose for covid-19 immunisation/ work. The patient has no medical history and concomitant medications. On 23Dec2020, the patient reported right after the first shot he had to wait 15 minutes for reaction-based purposes. Once he got to his car, the patient felt really really hot, and his throat started to itch described as was "sandpapery". It wasn't horrible. It was not like anaphylactic. The patient took 2 antihistamine tablets (Benadryl), and it went away. He has had no AE since. The outcome of the events was recovered on 23Dec2020.
injection site was sore for two days.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site was sore for two days.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 024M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced VACCINATION SITE PAIN (injection site was sore for two days.). In November 2021, VACCINATION SITE PAIN (injection site was sore for two days.) had resolved.            No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2022-455192, MOD-2022-455172 (Patient Link).
Headache, nausea, fever and continued headache. High fever (temp 105F). Onset of fever 12 hours later same day complained of sore throat.
I received the FluMist on Friday, October 15, 2004. On Saturday I noticed that I was becoming increasingly thirsty and my throat was very scratchy. By Saturday night I felt weak and very tired and my throat was very painful. All night Saturday and into Sunday my sx became worse with coughing and wheezing. All day Sunday and into Monday, I felt really awful with sweats and fatigue along with hoarseness, coughing and a sore throat.
A report has been received from a health professional concerning a male patient, estimated to be in his 40s. The patient had endoscopy at the hospital. The patient had been receiving FLUMIST (intranasal) 0.2 ml on 24-Oct-2014. The patient experienced severe sinusitis and runny nose which started on 24-Oct-2014. The patient took cold medicine for a week. The doctor diagnosed his case as severe sinusitis and put him on antibiotics for a week. Action taken with FLUMIST was unknown. The outcome of the events of sinusitis and runny nose were not recovered. The report was considered to be non-serious by the company physician. Corrected report 18-Nov-2014: Outcome updated. Patient initial, drug start date, intensity and dose added.
30 minutes after the vaccine I experienced painful stinging sensation in both hands and feet. I have had this symptoms everyday since the vaccine up to this current day.  Symptoms are affecting my ability to function as it is very painful.   Pregnant when I took the vaccine- EDD 05/2022.
Within one hour of injection pt experiences dizziness, lethargy, itching to site and around left post back. Reporting transient tingling around mouth and scratchy throat.
p/vax mom & grandma noted red patch like a rash & hard lumps to legs, one on each side, like bug bite;taken to MD; dx-poss sterile abscess; aspirated, refilled w/pus;hosp & leg(s) drained; no limit of leg movement 60 day follow-up received on 01/19/01 provided states the phone number for the pt has been disconnected. A follow up report received 6/6/2000 adds: (from pt's mother) She called the FDA to ask why a "Dr" from VAERS had called her. She said it was the "Dr" had asked her son's medical history. She has never received a consent form for release of info from hospital. I sent her one today. She was a McKesson case, never followed up from 11/4/1999. A follow up report received 6/12/2000 adds: Signed consent form received.  Another follow up report received 6/12/2000 adds: Medical records received. Case complete.
I starting having headache since Dec 24th. In the past 2 to 3 months the headaches have become more serve. I went to the ER. They did a CT scan, normal results. They also did blood work, normal results. They diagnosed me with migraine headaches. The headaches are still ongoing.
neuropathy in his heel; Difficulty walking; fire up the calf of his leg into his knee that lasts like 2 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EN6205) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (ongoing); "High blood pressure" (ongoing); "broke his back", start date: 2020 (unspecified if ongoing), notes: last year and had physical therapy in the spring. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased (ongoing); LOSARTAN [LOSARTAN POTASSIUM] taken for hypertension (ongoing); AMLODIPINE taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Single, Lot: EM9809, Expiration date and NDC number was unknown), administration date: 23Feb2021, when the patient was 69 years old, for COVID-19 Vaccination. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 17Mar2021, outcome "recovering", described as "neuropathy in his heel"; GAIT DISTURBANCE (non-serious) with onset 17Mar2021, outcome "unknown", described as "Difficulty walking"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "fire up the calf of his leg into his knee that lasts like 2 hours". The patient underwent the following laboratory tests and procedures: blood cholesterol: high; blood pressure measurement: high.  Clinical course: On 17Mar2021, patient experienced neuropathy in his heel the morning after he got the shot and could not walk/difficulty walking the next morning, he got the shot because of the pain and for 3 weeks he could not walk. It was a struggle and had to walk on the ball of his foot. Patient said that he can almost get through a grocery store now without having pain. Patient can still feel it though and it was nagging and stated that if he over does it, like once a month in the middle of the night the heel was throbbing and feels like pins and needles and fire up the calf of his leg into his knee that lasts like 2 hours. It was when he really pushed it. Patient was getting around a little better, his physical therapist apologized for papooing him in regard to complaints about the neuropathy. Patient asked, since he has neuropathy, he wanted to know if the neuropathy patient experienced, is a contraindication from getting the booster dose of the vaccine or if the booster dose will make the neuropathy worse. Patient doctor told him to try a Moderna booster. Patient stated that he was not happy with what he told him and that he was not comfortable with that and that the morning after his doctor told him that, he said that  stopped using Moderna because they were having problems with it. Patient was following up with his doctor in about a month.
This spontaneous report as received from a physician via a field representative refers to a patient (age and gender not specified). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unknown date the patient was administered an unspecified dose in the GARDASIL series. It could not be confirmed if the product that was administered was GARDASIL or GARDASIL 9. The patient went out to the car to go home at an unspecified time after the GARDASIL injection and experienced syncope. The patient scraped his or her face and chipped a tooth while experiencing syncope. The patient was taken to the emergency room for unspecified treatment. The outcome of syncope, scraped face and chipped tooth was unknown. Additional information has been requested.
Severe body pain , headache, fatigue, fever, loss of appetite, dizziness, off balance, weak .  I could not perform and of my usual duties on Friday afternoon and needed to rest in bed. My symptoms worsened on Saturday and by then I was having difficulty breathing. I did not want to make a big deal out of my extreme discomfort as the information that  pharmacy had given me said such reactions might occur.  I used my inhalers  and I also have my own nebulizer in case  my oxygen saturation dipped to low. It was reading 92 so I figured I could weather through the storm.   By Monday I was back to "normal"  I just thought you should know that this SHINGRIX  vaccine  is awful . I will no be getting the second shot.
10/30/2010 at 9:30AM - local reaction c/o knot, redness, & warm to touch. Treated with OTC BENADRYL 12.5mg & SINGULAIR 4mg chewable.
Breast cancer; Really bad reaction; My arm hurt; All my joints hurt; Nauseous; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Breast cancer) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from March 2020 to April 2020. Concurrent medical conditions included Blood pressure abnormal, Cholesterolosis NOS and Diabetes. Concomitant products included METOPROLOL for Blood pressure management, ROSUVASTATIN and GEMFIBROZIL for Cholesterolosis NOS, METFORMIN for Diabetes mellitus, DULOXETINE HYDROCHLORIDE (CYMBALTA) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION COMPLICATION (Really bad reaction), PAIN IN EXTREMITY (My arm hurt), ARTHRALGIA (All my joints hurt), NAUSEA (Nauseous) and HEADACHE (Bad headache). In May 2021, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Surgery for Breast cancer. At the time of the report, BREAST CANCER (Breast cancer), VACCINATION COMPLICATION (Really bad reaction), ARTHRALGIA (All my joints hurt), NAUSEA (Nauseous) and HEADACHE (Bad headache) outcome was unknown and PAIN IN EXTREMITY (My arm hurt) had resolved.        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.   Patient stated that the symptoms were similar to COVID-19 which she had in Mar to Apr-2020 and found out that she still had antibodies from it. She also stated that she was as not aware of breast cancer at that time.  Company Comment: This case concerns a 62-year-old, female patient with relevant medical history of diabetes, who experienced the unexpected event of breast cancer. The event occurred approximately 2 months after the first dose of COVID-19 vaccine mRNA was administered. The rechallenge was not applicable since the patient has not received the second dose yet. The benefit-risk relationship of COVID-19 vaccine mRNA is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, female patient with relevant medical history of diabetes, who experienced the unexpected event of breast cancer. The event occurred approximately 2 months after the first dose of COVID-19 vaccine mRNA was administered. The rechallenge was not applicable since the patient has not received the second dose yet. The benefit-risk relationship of COVID-19 vaccine mRNA is not affected by this report.
Pain in left shoulder that has not disappeared . Hurts whenever I get dressed, reach overhead, exercise or sleep.
Bone pain; General body pain; Fever; Chills; Headache; Vaccination adverse reaction; Mobility decreased; General body pain; Groin pain; Swelling arm; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction), MOBILITY DECREASED (Mobility decreased), the first episode of PAIN (General body pain), GROIN PAIN (Groin pain) and PERIPHERAL SWELLING (Swelling arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Bone disorder, Liver disorder, Drug allergy (Tramadol cause undescribed reactions with other medications), Psoriatic arthritis, Penicillin allergy (manifested by itching and swelling) and Drug allergy (Antiacids). Concomitant products included CALCIUM and VITAMIN D NOS for Bone disorder, URSODIOL for Liver disorder.   In 2008, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction), MOBILITY DECREASED (Mobility decreased), the first episode of PAIN (General body pain), GROIN PAIN (Groin pain), PERIPHERAL SWELLING (Swelling arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced BONE PAIN (Bone pain) and the second episode of PAIN (General body pain). The patient was treated with PARACETAMOL (PANADOL) at an unspecified dose and frequency. On 05-Sep-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. On 06-Sep-2021, MOBILITY DECREASED (Mobility decreased), PERIPHERAL SWELLING (Swelling arm) and HEADACHE (Headache) had resolved. At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and GROIN PAIN (Groin pain) had not resolved and BONE PAIN (Bone pain) and the last episode of PAIN (General body pain) outcome was unknown.            The reporter did not provide any causality assessment for the event of vaccination adverse reaction with Humira.  The reporter did not provide any causality assessment for the event of bone pain and general body pain (second episode) with Humira and assessed rest other events as not related to Humira.  The reporter did not provide any causality assessment for the event of bone pain and general body pain (second episode) with Moderna vaccine and assessed rest other events as possibly related to Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
5YO receive Boostrix; Patient received Boostrix instead of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 27th August 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the 5 years old child patient received Boostrix vaccine instead of Kinrix. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received Boostrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that, they were intending to administered Kinrix and inadvertently administered Boostrix instead of Kinrix, which led to wrong vaccine administered.
pain at the injection site; This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site on an unspecified date. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot obtained.
Immediately after my second injection my left arm below the injection site become painful, hard and extremely swollen. After two days the swollen area became itchy and I have a 4x4 red rash. This did not happen after the first vaccination. I would like to know how long I should expect to have this swelling and rash for and if I should be concerned.
Patient received ProQuad and Hep B on May 1, 2006 and became increasingly listless and developed a fever that lasted over one week and spiked as high as 105. On May 11, 2006 he was prescribed an antibiotic that did not help.  He developed chronic diarrhea and has had 2-4 runny, foul bowel movements per day since onset after his vaccination.  He began fitfully scratching and crawling in his sleep.  He began having "staring spells." Patient suffered with acute encephalopathy/significantly decreased level of consciousness as manifested by his decreased response to the environment, his absence of eye contact and his significantly inconsistent and often completely absent responses to even familiar stimuli;  today patient still suffers from everything described above, except the fever, which broke after ten days.  He now has chronic encephalopathy, as he has not regained his normal state of consciousness since his vaccination.  1/20/2009 Consultant records received dated 5/22/08 for eval of developmental delays, especially in communication. Impression: Language delay in a child who presents with immature socialization skills and cognitive skills close to age level. Speech therapy recommended. 1/22/2009 Neurodiagnostic records received dated 6/30/08 and 7/14/08 with impression: Clearly meets diagnostic criteria for autism. 1/23/08 Additional records received including neurology consults 6/26/08 and 8/14/08 for eval of staring spells to r/o absence seizures. Pt will respond to tactile stim during spell.  EEG (-) for epileptiform activity but some slowing of posterior basic rhythm. Staring spells attributed to dx of Autism.