chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), on 09Oct2021 at 09:30 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 05Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FM0698) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Meniere syndrome" (unspecified if ongoing); "Vestibular disequilibrium" (unspecified if ongoing), notes: vestibular disequilibrium; "Atrial Tachycardia" (unspecified if ongoing); "Cardiac dysrhythmia" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN oral, start date: 09Mar2011, stop date: 18May2022; VENLAFAXINE oral, start date: 11Feb2010; VITAMIN D NOS. Past drug history included: Prednisolone, reaction(s): "Known allergies: prednisolone", notes: Known allergies: prednisolone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: home antigen test positive results; (unspecified date) Unknown results, notes: Indication: treatment of covid-19; (30May2022) Positive, notes: 30May2022 symptoms returned and patient again tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks. Patient phoned in with home antigen test positive results and symptomatic of covid 19 infections was triaged to the paxlovid medication protocol. Patient received from 18May2022 to 28May2022 with Paxlovid. 65y/o cardiovascular dz. Patient was improved and 30May2022 symptoms returned and patient again tested positive with home antigen testing. She felt it necessary to report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination Failure (LOE) and COVID-19 cannot be ruled out.
The patient called in the morning and stated that when she woke up in the morning there was blood on her pillow that she felt was from a nose bleed that occurred overnight after getting her second dose of Moderna. She said that she was feeling fine this morning and there was no current bleeding but wanted to report it.
Haematochezia; This case was received via FDA VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HAEMATOCHEZIA (Haematochezia) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced HAEMATOCHEZIA (Haematochezia) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Haematochezia) 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.   Treatment information was not provided.  Concomitant product use was not provided by the reporter.  Patient reported to the nurse at his second COVID vaccine appointment that he had bloody stools for 2 days, and then the bloody stools stopped.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
After my 1st shot, I noticed abnormal stiffness and soreness in my left, I was advised to apply ice and heat to the shoulder.  I did not pay much attention as I thought it was normal.  Approximately 3 days later, I noticed weakness in my left arm and slight limited range of motion.  I did bring this to my physician's attention.  I was advised it was normally and should clear up in about a week.  A week sent by and there was no improvement.  I continued to follow in the instructions of ice and Tylenol.  I still did not see improvement  so at my 2nd vaccination.  I asked for guidance from the PT therapist regarding exercises that would help improvement range of motion.  I was instructed to do pendulums and overhead raises holding a stick or towel lying down.  Again there was no improvement.  At this point the weakness is more intense to the point that is I lean on my left arm, it hard to more it, I have difficulty using my left arm to wash my body and it constantly aches even when not in use.  I have tried taking tramadol and well as IBUPROFEN but none have yield relief.  I was also advised that I have frozen shoulder but there were no symptoms prior to the vaccination received on 03/29/2021
Patient was out of town when rash appeared. Discreet crusting observed in our office. Diagnosis: varicella.
Information has been received from a registered nurse concerning a 24 year old female patient with codeine allergy and no pertinent medical history who in 2008, was vaccinated IM with the first dose of GARDASIL (Lot#:not reported). On 12-AUG-2010, the patient was vaccinated IM with the third dose of GARDASIL (Lot number 666163/0664Z). Concomitant therapy included hormonal contraceptives (unspecified). The registered nurse stated that shortly afterward the patient had received the 3rd dose, as she was leaving the office, the patient fainted and fell. She hit a chair. She got a cut on her forehead, a bump over her eye, and a scrape on the arm. The patient was sent to the emergency room where tests were performed (results not provided). On 12-AUG-2010, the patient had recovered. Follow up information has been received from a registered nurse via medical records concerning a 24 year old female event planner with codeine allergy and a history of rhinoplasty who in 2008 was vaccinated with the first dose of GARDASIL. On 12-AUG-2010 at 10:00 am, the patient received the third dose of GARDASIL (Lot number 666163/0664Z) intramuscularly in the left arm. Concomitant therapy included TRI-SPRINTEC. Approximately 5 minutes after vaccination with GARDASIL the patient fainted while waiting to check out, she had loss of consciousness. She hit her shoulder and head on the chair arm. She was bleeding, developed a very swollen eye, had an abrasion on the shoulder. It was reported that she almost appeared like if she was seizuring. Her BP was 80/50 and her pulse was 50's. The patient was dazed, dizzy and pale. She was transported to the ER at 10:14 am, with tenderness, pain in the head (grade 5-7 per a word scale), left eye bruising, nausea and syncope. In the medical examination the patient's vitals were a heart rate of 64, respiratory rate 16 and a blood pressure of 97/61. The patient's EKG showed sinus rhythm and her head CT showed left periorbital hematoma, no old fractures of the poster wall was left maxillary sinus; clinically correlate to patient's history. No other fractures noted. There was no acute intracranial hemorrhage. The patient was treated with ibuprofen for her headache and nausea. She was discharged on 12-AUG-2010 at 13:20 pm completely recovered. Syncopal episode, fall, she hit a chair and cut on her forehead, shoulder abrasion, loss of consciousness, left pero-orbital hematoma, appeared as she was seizuring, dizzy, daze, pale, and headache (verbal grade 6-7) were considered to be an other important medical event by the reporter. No further information is available.
Severe generalized pain, convulsions, spastic involuntary movement, halluciantions x4 days
2 weeks post 2nd dose:  -Palpitations -Flutters  -Chest pain -Slight pain down left arm (rare, 4-5 times random) -Fatigue  -Shortness of breath (extreme dyspnea) -Lightheaded -Dizziness -Irregular heart rhythm  -Can?t lay on left side  -Unusual confusion  -Memory loss
MMR given on 3/26/15. Rash started 4/6/15, widespread by 4/7/15. No treatment needed.
hospitalized for 3 weeks and was having neurological problem; having problems to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose-1, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: NERVOUS SYSTEM DISORDER (hospitalization), outcome "unknown", described as "hospitalized for 3 weeks and was having neurological problem"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "having problems to walk". The patient was hospitalized for nervous system disorder (hospitalization duration: 21 day(s)).  Clinical course: 1 week after receiving the second dose, the patient was hospitalized for 3 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2/7/2021 at 0630, resident found in recliner without pulse or respirations. Resident had not been found to have any adverse reactions to the vaccine between the time of the vaccine on 2/4 until found deceased on 2/7.
flu vaccine done 9/22/2020 with local reaction on the left arms with soreness and warmth, tender and difficult to raise arm due to pain. No fever.  Used ibuprofen and ice pack for comfort. Got better by 9/28/2020.  Then on 9/28/2020 had a 16 yo well visit and received Menveo #2 and Bexsero #1 also on the left arm by request as the patient is right handed. The evening of 9/28/2020 the area turned pink and developed hives and tenderness. Improvement with application of ointment, ice packs and ibuprofen. Yet, still tender and hard by the time of presentation for vaccine reaction on 9/30/2020 by video visit telehealth.
Information regarding PREVNAR 13 was received from a physician regarding a "baby" who experienced vomiting - 3 episodes. The patient received the first dose "recently" on an unknown date in 2010. The patient experienced vomiting - 3 episodes following vaccination on an unknown date in 2010. Outcome was recovered. No additional information was available at the time of this report.
patient had received Kinrix vaccine on 28Nov2022 at a different facility when he was 4 months of age; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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: 04-JAN-2023 Reporter's Comments: The physician reported that she saw a 6 month old male patient in clinic today (on the day of reporting) as a new patient, and when she looked on his shot records, she noted that the patient had received Kinrix vaccine at a different facility when he was 4 months of age. The patient had no adverse effects noted and was doing well. The reporter did not had lot number and expiration date information. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Kinrix below the recommended age limit, which led to inappropriate age at vaccine administration. Note: The reporting system details captured as reported due to limited information.
Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received Shingrix. On 25th October 2019, 9 days after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient started having almost all of the side effects. The patient asked whether it was possible that the side effects would take 9 days to start. The patient assumed, that she had some sort of virus, but when she looked up the side effects she wondered if the vaccine could affect her that long after she received it.
Headache & Myalgia Narrative: 1st dose: day 2 and 3- pain and swelling at injection site 2nd dose: day 1 and 2: Muscle aches, muscle soreness at the injection site, fever, headache
Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of MMR (lot # not reported). Subsequently, the patient experienced recurrent urticaria. Unspecified medical attention was sought. The reporter indicated that this adverse event is a legal claim. No further information is available.
While sitting on couch pt began having labored and difficulty breathing.  Body became rigid and shaking, eyes rolled back into head, pt became blue around mouth, lips and nose. Pt was transported via ambulance using O2 and Neb.
coughing; head has been plugged up; nose and sinuses really; cannot lay down; slept three nights sitten up; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), HEAD DISCOMFORT (head has been plugged up), SINUS DISORDER (nose and sinuses really), HYPOKINESIA (cannot lay down) and SOMNOLENCE (slept three nights sitten up) in a 0-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04813218) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ATORVASTATIN and OXYCODONE for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing), HEAD DISCOMFORT (head has been plugged up), SINUS DISORDER (nose and sinuses really), HYPOKINESIA (cannot lay down) and SOMNOLENCE (slept three nights sitten up). At the time of the report, COUGH (coughing), HEAD DISCOMFORT (head has been plugged up), SINUS DISORDER (nose and sinuses really), HYPOKINESIA (cannot lay down) and SOMNOLENCE (slept three nights sitten up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medication included Prostate medication and Androgens.  Treatment medication use was not provided by the reporter.  Caller got tested for COVID.   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Follow-up contains no new information.
Autism; his back arched in agony; Severe constipation; fever; diarrhea; Rashes; he receive four vaccines: MMR, Hepatitis B, IPV and DtaP; His diarrhea looked like tar; losing his words; cognitive function plunged; Dark circles; gastrointestinal issues; screamed cotinuously for 12 hours; he became quiet; his back arched in agony; This spontaneous report was received from an other reporter who posted on social media and refers to a 13-month-old male patient. His concurrent condition included body temperature of 101 degrees and the doctor recommended acetaminophen (TYLENOL). No information regarding the patient's medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2005 (reported as in the fall of 2005), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (exact dose, site of injection and route of administration, lot # and expiration date were not reported) for prophylaxis reconstituted with sterile diluent (exact dose, lot # and expiration date were not reported). On the same date, the patient received hepatitis b vaccine (manufacturer unknown)(exact dose, site of injection and route of administration, lot # and expiration date were not reported) for prophylaxis, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP) and unspecified poliovirus vaccine inactivated (IPV) (doses, sites and routes of administration, indications, lots # and expiration dates were not reported). On the same day, the patient's body temperature spiked at 104 degrees and he screamed continuously for 12 hours, his back arched in agony and his diarrhea looked like tar. On an unknown date in 2005, the patient started losing his words (reported as almost immediately), became quiet and his cognitive function plunged. It was reported that dark circles appeared below his eyes, rashes and agonizing gastrointestinal issues plaqued him. Severe constipation made his stools like pebbles. The patient had two more visits with his pediatrician, who told there was nothing to worry about, because boys are usually delayed developmentally. On an unknown date (reported as on 22 December), the patient was diagnosed with autism. The outcome of the events and the relatedness between the events and the suspect therapies were not reported.  Upon internal review, the events of autism and tarry stool were considered to be medically significant.
HYPOtension Narrative: improved without medication-legs elevated- BP returned to normal-probable vasovagal reaction
Patient was given the monovalent mRNA COVID-19 vaccine as a booster. This was done after the FDA?s authorization of bivalent boosters on 08/31/22. Our clinic was not aware that the monovalent formulation could no longer be given as a booster at that time. The patient suffered NO adverse reaction.
1 minute post HPV vaccine syncope episode noted. B/P before vaccine 104/64-At onset of episode B/P 80/40-pale diaphoretic-1 hour unresponsive 2 minutes post incident 90/60 alert and responsive-5 minutes post incident 106/60. Rest 30 min.
SUSPECTED CLINICAL VACCINATION FAILURE (VACCINE INEFFECTIVE); SUSPECTED COVID-19 INFECTION; MARKS/PIMPLED ON HAND AND THIGHS; EXPERIENCING HEART PALPITATIONS; FEELING WEIRD; HAIR FALLING OFF ARMS/ LOST HAIR ON LEGS AND ARMS; SKIN LOOKING WEIRD; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. Initial information was processed with the additional information received on 25-JAN-2022 and 29-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 11-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-SEP-2021, the patient experienced feeling weird and not the same, his hair falling off arms or lost hair on his legs and arms, his skin looking weird, all had happened since he had received vaccine. He had marks or pimpled on his hand and thighs, and he had trouble in breathing, experienced heart palpitations and he reported that vaccine was ineffective as he caught the COVID (coronavirus disease) and had suspected clinical vaccination failure. He stated that he were live in a homeless shelter and could not got a job. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling weird, hair falling off arms/ lost hair on legs and arms, skin looking weird, marks/pimpled on hand and thighs, experiencing heart palpitations, suspected clinical vaccination failure (vaccine ineffective) and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000214414.; Sender's Comments: V0:20220146969-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
"Moderna COVID-19 Vaccine EAU"  Severe nausea, bruising, swelling, large bump, tenderness and pain within first three days (still present as of 4/3), large red rash on arm, severe itching and pain, irregular heartbeat (began 3/31 and still present)
Date and time of adverse event: - SOB during exercise started Sunday, 3/27/2021; improved but not resolved - flu-like sx (aches/chills) started later in the day 3/24/2021; resolved within 24-48 hrs - headache started later in the day 3/24/2021; resolved within 1 week - first noticed some shortness of breath while exercising the following Sunday (March 27, 2021) when she was trying to run; this has improved somewhat since then but has not fully resolved; she really only notices it when trying to exercise or is walking at a brisk pace - had some flu-like sx (aches, chills) that started later the same day of the vaccine; went away within 24-48 hrs - had a headache that started the same time as the flu-like sx; resolved within about a week Name of physician or treating hospital (if applicable): n/a (hasn't spoken to PCP yet)
pt was fine p/shots-mom gave APAP preventively, put pt to bed 730PM; woke 8PM & started crying (did this frequently) but this time suddenly became quite-mom checked & found pt blue & unresponsive to stimulation-took pt to ER;
The patient was asymptomatic of any illnesses at time of event, she was here for her 2 y.o. WCC w/ a pediatrician. This nurse, accidently administered the whole vial, or 3-dose vial of undiluted Pfizer, COVID-19 6mon-<5y.o. formula via IM injection.
Pt referring general malaise, fever (101-102 degrees F) fine rash, and mild swelling of an testicle as pt refers. Pt visited his doctor in his town & ordered Ibuprofen 200 mg & something for rash and runned few other tests on pt refers to me 9/8/10 and referring feeling fine no more sintomatology that started 10-12 days after receiving MMR TD vaccines 8/17/10.
Localized allergic reaction to IPV with hives and erythema around injection site. Patient placed on BENADRYL.
Information was received from a nurse concerning a female patient. It was reported that on 12-OCT-2010, the patient was administered the first dose of GARDASIL, 0.5 ml, intramuscular. On 11-SEP-2012, the second dose of GARDASIL (lot# 673256/0629AE exp. December 2014) was administered. No adverse effects were reported. No further information is expected.