chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 17 year old female patient with no pertinent medical history. On 10-OCT-2013, the patient was vaccinated with GARDASIL (lot #J009243, exp. date: 23-APR-2016) second dose, 0.5 ml, intramuscular. There was no concomitant medication. On 15-OCT-2013, about 5 days after onset of therapy, the patient experienced tonsillitis like symptoms with sore throat, redness and swelling of throat. The patient sought for medical attention (office visit). No lab diagnostics studies performed. Treatment was given for the events (unspecified antibiotic in case symptoms persisted). The outcome of the events was not reported. This is one of several cases received from the same source. Additional information has been requested.
had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; This is a spontaneous report from a contactable other health care professional via a medical information team reported similar events for 4 patients. This is the 2nd (2nd patient) of 4 reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. It was stated that it was affecting 4 patients currently. They were totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test on an unknown date in 2021. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product Comirnaty to the reported 'COVID 19' cannot be completely excluded,Linked Report(s) : US-PFIZER INC-2021304208 Different paitent, same drug, same event (split)
Beginning 1/5/22, exhibited tingling sensation in hands and feet (pins and needles) progressing to similar  feelings all over body. Accompanied by pain in random locations across body, including sites of tingling sensation. Maximum effect felt on morning of 1/6/22. Sensation continues morning of 1/7/22, but decreases in duration.
Information has been received from a physician and a practice manger via company representative referring to a patient of unknown age and gender. On 18-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
bruising behind the left knee; unable to move; "cannot stand up sleep and sit"; "cannot stand up sleep and sit"; "cannot stand up sleep and sit"; muscle pain; This spontaneous case was reported by a physician and describes the occurrence of CONTUSION (bruising behind the left knee), MOBILITY DECREASED (unable to move), DYSSTASIA ("cannot stand up sleep and sit"), SITTING DISABILITY ("cannot stand up sleep and sit") and INSOMNIA ("cannot stand up sleep and sit") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruising behind the left knee), MOBILITY DECREASED (unable to move), DYSSTASIA ("cannot stand up sleep and sit"), SITTING DISABILITY ("cannot stand up sleep and sit"), INSOMNIA ("cannot stand up sleep and sit") and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, CONTUSION (bruising behind the left knee), MOBILITY DECREASED (unable to move), DYSSTASIA ("cannot stand up sleep and sit"), SITTING DISABILITY ("cannot stand up sleep and sit"), INSOMNIA ("cannot stand up sleep and sit") and MYALGIA (muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.
Wheezing; Difficulty breathing; Weakness; Sore arm; Vomiting; Nausea; Chills; Body aches; Joint aches; Possible Fever; Diarrhea; A spontaneous report was received from a consumer, concerning a 73- year-old female patient, who received Moderna's COVID-19 vaccine and experienced sore arm, vomiting, diarrhea, nausea, chills, body aches, joint aches, felt like she was running a fever, wheezing and difficulty breathing.  Patient medical history was unknown. Concomitant product use was not provided by the reporter.    On 24 Jan 2021, the patient received their first dose of mRNA-1273 (025L2OA) intramuscularly for COVID-19 infection prophylaxis    On 24 Jan 2021, after the first dose of  Moderna's COVID-19 vaccine, the patient experienced sore arm. On 25 Jan 2021, next morning after receiving the vaccine the patient experienced vomiting, diarrhea, chills, body aches, weakness. On 27 Jan 2021, on the third day after receiving the vaccine the patient experienced Wheezing  No treatment medication was reported.  The second dose of mRNA-1273 was discontinued by the patient in response to the events.   The outcome of the events, sore arm, vomiting, diarrhea, nausea, chills, body aches, joint aches, felt like she was running a fever, wheezing and difficulty breathing were considered recovered on an unknown date.
Within first 24 hours, initially drowsy, decreased appetite, fussy and left arm held flexed at elbow and at wrist and wouldn't crawl or roll over. Before shots he was advanced in motor development. by 04/14/2003 still won't bear weight on left arm and isn't crawling in a week and not normal yet.
Dizziness; Body pain; Nausea; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN (Body pain), HEADACHE (Headache), FATIGUE (Tired) and NAUSEA (Nausea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Depression. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LISINOPRIL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tired). On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness), PAIN (Body pain) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), PAIN (Body pain), HEADACHE (Headache), FATIGUE (Tired) and NAUSEA (Nausea) had not 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.
This spontaneous report was received from a pharmacy technician and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. From 23-JUL-2018 to 31-JUL-2018, the patients were vaccinated with incorrectly stored ROTATEQ, orally, lot # N030150 with expiration date on 29-AUG-2019 (dose was not reported) for prophylaxis. The vaccines were stored for 2 hours in temperature of 47 Fahrenheit degrees to 77 Fahrenheit degrees. No adverse event was reported. Digital data logger was involved.
Left arm was sore. I could not lift my arm from my shoulder to my elbow more than 10 degrees for 12 hours. I could only move my arm from elbow to fingers. Started about 1 hour after the vaccine and continues appropriately 20 hours. By 8am the next day, movement had improved. By 5pm, full function was restored. In 48 hours, soreness was resolved.
After receiving his vaccine today, immediately he turned red, he stated he felt like his stomach dropped(like being on a roller coaster), and had a brief moment for about 30-45 seconds of chest tightness, all symptoms that he has when he eats seafood (has seafood allergy).
This spontaneous report was received from a registered nurse concerning 3 patients of unknown age and gender. It was reported that on an unknown date, patients may have vaccinated with a dose of GARDASIL (lot number and expiry date reported as 0459AE and 13-DEC-2014 respectively, dose and route unspecified) which was exposed to 31 degrees Fahrenheit (F) for 27 days (648 hours), which was found to be an unsupported excursion by in-house stability data. The reporter was unable to provide the dates that these patients received this unsupported GARDASIL. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
itching; pain at injection site left arm; rash; heat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (pain at injection site left arm) and VACCINATION SITE RASH (rash) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (heat) and VACCINATION SITE RASH (rash). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (pain at injection site left arm). At the time of the report, VACCINATION SITE WARMTH (heat), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (pain at injection site left arm) and VACCINATION SITE RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment medication included patient applied cream twice.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Between 10-JAN-2015 and 26-JAN-2015, these patients were vaccinated with M-M-R II (dose, dose#, lot# and route were not reported), which was expired on 09-JAN-2015. No adverse effects were reported. Additional information is not expected because no reporter contact detail was provided.
Redness with slight swelling on the anterior left thigh, 10x5 cm. No induration. Denies any fever or administration of medications. Mother instructed by provider to apply cold compresses.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results; (07Jul2022) Negative, notes: Tested negative 1 day after stopping treatment; (08Jul2022) Positive, notes: Tested negative for 36 hours then positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: The patient had no known allergies. The patient did not receive other medication in 2 weeks. The patient received Paxlovid for treatment of COVID-19 on 24Jun2022 and stopped on 06Jul2022. On 07Jul2022, the patient tested negative 1 day after stopping treatment. Tested negative for 36 hours then positive on 08Jul2022. Going on day 5 of being positive. Experiencing more nasal congestion. Symptoms are more than first round. The medicine was terrible and strong so not sure how bad the original Covid symptoms were. The patient took medicine on day 1 of testing. The patient felt she could have had more and felt there was still Covid in her body on last day of medicine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reports Facial numbness/tingling  Refused to go to ER, states symptom is getting better Seen and cleared by EMS
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The reporter stated that the patient was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) intramuscularly on 10-SEP-2012 that had expired on 30-AUG-2012. No other co-suspects and concomitant medications were reported. No adverse effects reported. It was unknown if the patient had sought medical attention. This is one of two reports from the same reporter. Additional information has been requested.
Herpes Zoster Varivax given 12-5-06 (Patient had mild varicella Jan 1998- age 2). Complain of back pain 12/8, rash 12/9/06. Seen in office 12-14-06 with 2 patches of drying vesicular lesions left lower back.
Pt had temp 104, sore throat, & aching, infected tonsils seen by MD treated for acute tonsillitis w/inject Keflex; Has boil like sores on gums; Gums are swollen & raw; dx viral condition - gingivitis;
This spontaneous report was received from a health care professional refers to unspecified patients of unknown demographics. On an unknown date (also reported as since 09-APR-2015) the patients were vaccinated with LIQUID PEDVAXHIB lot # K015462; expiry: 10-JUL-2017 (dose, route, frequency unspecified). Other suspect therapies included GARDASIL (dose, route, frequency unspecified). It was reported that the vaccines which were exposed to temperature outside of the recommended range, have been administered to unspecified patients on unspecified dates since 09-APR-2015. No adverse effects have been reported. It was also reported that administrative worker, called back to evaluate the same doses, which were previously exposed to temperatures outside of the recommended range, and have been administered to patients. No additional information was provided. Additional information has been requested.
4/21/21 Reaction within 8 hours: tiredness, headache, nausea, diarrhea (consistent) 4/22/21 tiredness, headache, nausea, diarrhea, loss of appetite (consistent) 4/23/21 tiredness, nausea, diarrhea, loss of appetite (consistent, maybe 3 hours of reprieve) 4/24/21 tiredness, nausea, diarrhea, loss of appetite (intermittent) 4/25/21 tiredness, nausea, loss of appetite (intermittent) 4/26/21 nausea, diarrhea, loss of appetite, vomiting
nausea, fatigue, headache  used otc acetaminophen 500mg 2tabs  q 12hours & headache gone morning 2 ... night 3 of nausea, took ondansetron 4mg i had from old RX  once  and otherwise,  tolerated the little nausea left until gone night 4..brain fog for 4 days- remained without remaining headache
Started coughing about 4pm and over the next few hours starting having body aches all over & eyes are red
Bad stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Bad stomach pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Bad stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Bad stomach pain) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown.
43 year old female came in for Pfizer Booster at 3:50 PM on 02/09/2022. Client received 1st dose Pfizer Lot#EN6200 on 03/03/2021 and 2nd dose Pfizer Lot# ER8730. About 2 weeks later she noticed red raised bumps around the injection site and also on her lower back after both Pfizer vaccines. They were itchy and about 1" in size. The red bumps resolved after about a month each time and she did not take any medication to help relieve the symptoms. She did not consult with her PCP because she never felt like it was a life threatening situation. A med consult was performed and she was given the Pfizer booster Lot # FK9895 at 3:50 PM on 02/09/2022. She was educated about what reactions to watch out for and when to seek care in case of an allergic reaction. She was also advised to follow up with her PCP if symptoms reoccur.
Information has been received from a physician concerning 5 patients who were over the age of 32 weeks up to 9 months of age when they were vaccinated with the third RotaTeq vaccine 2 mL oral. Additional information has been requested.
I developed cowpox like lesions, 2 on my right wrist, 1 on my left wrist, and one on my left temple.  I was placed on Bactrim and Bactroban to prevent possible secondary bacterial infection.
09/29/2021 2:00 AM: Onset of fatigue, muscle weakness, general aches and pains, chills, headache, general feeling of weakness, and fever.
Covid19 breakthrough.  1st vaccine on 02/06/2021.  78y/o  PMH  HLD, HTN, DM, Pituitary dz, Thyroid dz, Brain tumor presents to ED after wife called EMS for increasing lethargy, Covid symptoms and AMS. T-100.7, CXR no acute infiltrates and room air sat 100%.  Started on IV abx/steroids and Remdesivir.
Brain aneurysm; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received COVID-19 VACCINE-MANUFACTURER UNKNOWN (BNT162B2; Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation .  Medical history and concomitant medications were not reported.  The patient experienced a brain aneurysm on an unknown date after receiving "unknown Covid-19 Vaccine". The patient who received one of the Covid-19 Vaccines was recovering from a brain aneurysm and having to learn how to walk again. The lot number for BNT162b2 was not provided and will be requested during follow up.
Five minutes after receiving the vaccination, he developed sweating, lightheadedness, and blurry visio . He was taken to a private section of the arena and monitored. His heart rate was initially in the 40s and systolic BP  in the 70s, and subsequent monitoring should resolution of his bradycardia and hypotension.    25 minutes of monitoring, his symptoms have completely resolved. He has a history of similar symptoms with IM iniections.
15 minutes after pt received his first dose of the Moderna COVID19 vaccine he reported feeling light headed. Lost color in skin, diaphoretic. Near syncopal episode. Laid pt down. Pt began feeling much better. BP 130/84 HR 59 O2 Sat 98 Repeat BP 150/92 HR 63 O2 Sat 98 %  EMS called and evaluated pt. Sitting up BP 154/92. Pt signed refusal for transport to hospital with EMS.  Pt was given information for high risk clinic at HHC for 2nd dose.
Narrative:  05/11/2021 ADDENDUM STATUS: COMPLETED Patient brought in by his brother for COVID,dose #2. Patient seemed anxious and clammy. No immediate allergic reaction or anaphylactic reaction to immunization or any injected medication in the PMHx. This RN requested 30 minutes monitoring after #2 was administered. RN Signed: 05/11/2021 12:22 5/11/2021 ADDENDUM STATUS: COMPLETED S/O: Patient brought in by brother for patient's 2nd covid vaccination. Patient has hx of anxiety and mental disabilities. Brother reports behaviors of contacting EMS for anxiety relief. Patient received shot and was wheeled over to waiting area for 30 minutes. Upon arrival, patient got up and out of the Wheelchair and walked throughout the clinic heading for the door. Front door person alerted us that patient was on stairs and needed assistance. Patient found about 3 steps up in fetal like position, active writhing and rocking, diaphoretic indicating that he needed a doctor. Introduced myself to him and had him take some deep breaths to slow down his agitation. Patient started shaking similar to a seizure, but was coherent throughout, padded head with hand to prevent patient from hitting head on stairway wall. Patient assisted by 2 people to a sitting position and then standing position, assisted to geurney. Patient assisted somewhat getting on the geurney, continued to writh and posture back and forth. EMS called. Brother reports he is caregiver and has POA for HC. Patient lives at home with brother. BP at 12:14 on stairway was 159/96, no pulse recorded. BP checked again about 12:19 was 153/90 with HR 120 and O2 sats of 97%. EMS at bedside and transporting. A: Patient aggitated after his 2nd Covid vaccination. Suspect anxiety and behavior is the cause of current behavior. Patient was able to calm somewhat with deep breathing. P: Patient transported for further evaluation of medical status. RN Signed: 05/11/2021 12:52 Receipt Acknowledged By: 05/11/2021 14:03 MD.
Information has been received from a physician concerning a 58 year old female with hypersensitivity, osteoarthritis, intervertebral disc degeneration, anxiety and frequent bronchitis and a history of lap band surgery who on 28-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included BENICAR, MOBIC, XANAX, LORCET, SOMA and ALLEGRA. On 30-OCT-2009 the patient experienced erythema and swelling at the injection site. On 03-NOV-2009 they had also developed a fever. The physician prescribed doxycycline (manufacturer unspecified) for treatment. On 09-NOV-2009 the swelling and tenderness were reduced and as of 11-NOV-2009 the fever was gone. No lot number was provided. At the reporting time the patient was recovering. Follow up information has been received from the physician concerning a 58 year old female patient with no known allergies who on 28-OCT-2009 was vaccinated with the second dose of PNEUMOVAX 23 (lot #664864/1365Y) in her left deltoid. On 29-OCT-2009 (previously reported as 30-OCT-2009) the patient experienced pain and tenderness over the left deltoid area. Redness + 4 cm warm tender mass over the left deltoid. The patient was treated with doxycycline 100 mg BID x10 days #20. At the time of the report, the patient had recovered on unspecified dates. Erythema and tenderness at the injection site and 4 cm warm tender mass were considered to be other important medical events by the physician. No further information is available.