chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 doses; Showing signs of having COVID-19; Showing signs of having COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Chronic Lymphocytic Leukemia" (unspecified if ongoing); "severely immunocompromised" (unspecified if ongoing); "very immunosuppressed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "3 doses"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "Showing signs of having COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (unspecified date) did not develop antibodies; sars-cov-2 test: (2021) unknown results. The patient showed signs of having COVID-19 after being exposed by her husband who was positive for COVID-19. The reporter stated that the patient received all 3 doses of bnt162b2 and developed no antibodies as determined by a SARS-CoV-2 semi-qauntitative antibody test. The patient and reporter were waiting on the COVID-19 test results to come back at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
by noon pt was sick had aches & chills; gland in neck & above clavicle became swollen; By 2JUL93 was still not feeling well; MD called but referred pt back to clinic;
Sudden onset of panic, anxiety, depression, suicide ideation. He is going on a year of panic disorder, extreme anxiety and depression as well as intermittent suicidal ideation. Symptoms still persist. Weekly therapy as well as care under a psychiatrist. Inability to attend school in person for the 2021, 2022 school year. Panic disorder and suicidal threats sent him home from school again today for safety concerns. He has had 2 emergency mental health assessments at behavioral health hospitals, weekly therapy visits, monthly psychiatrist visits. All which began with sudden on-set, shortly after the Pfizer vaccination.
Information has been received from a nurse practitioner concerning a female child who was vaccinated with GARDASIL. The patient had seizure after the vaccination. The patient sought medical attention. Upon internal review, seizure was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
inside of her mouth felt weird; hands starting to tingle and felt a bit numb; hands starting to tingle and felt a bit numb; lower lip started swelling up; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (left arm) on 01Jan2021 (10:45) at single dose for Covid-19 immunization. Medical history included Hashimoto's thyroiditis, uveitis, and known allergy to some antibiotics, artificial preservatives, artificial colors, many foods like egg, gluten. Concomitant medications included levothyroxine sodium (SYNTHROID), bimatoprost (LUMIGAN), timolol, and vitamin D3; all taken on unspecified dates for an unspecified indication. The patient previously took Benadryl and Aspirin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that an hour after the vaccine (01Jan2021 11:45), the patient's lower lip started swelling up. Then it got worse and the inside of her mouth felt weird on 18Jan2021 (11:45AM). The patient's hands starting to tingle and felt a bit numb on 18Jan2021 (11:45 AM) (as reported-pending clarification). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with Prednisone 40mg. The outcome of event lip swelling was unknown; while the outcome of other events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination.   Information on the lot/batch number has been requested.
Pt received the pneumonia shot on 10/5 and reported swelling and itching on 10/7. 4-5 inches below injection site. He was using hydrocortisone and CLARITIN.
Information has been received from a physician concerning a 6 year old female with a history of otitis media in February 2004 (treated with amoxicillin) who on 07-FEB-2004 and 16-FEB-2007 was vaccinated subcutaneously with her first and second doses of VARIVAX (Oka/Merck) (lot #647266/1098N and 655995/130F) in her arm, respectively. Concomitant therapy included 4th dose of PNEUMO on 07-FEB-2004, 5th dose of Tdap and 4th dose of POLIO on 16-FEB-2007. On 11-AUG-2008 the patient developed a varicella like rash. The patient developed a rash over the whole body including the scalp. On 15-AUG-2008 the patient was seen in the office and the rash was at least 25 lesions and was vesicular and had some early stage macular. No laboratory or diagnostics tests were performed. On 19-AUG-2008 the patient recovered. Additional information has been requested.
I had muscle aches, very tired and fatigue, a terrible sore throat and a heavy cough. I felt extremely weak, bad congestion, and loss of appetite. When I felt my headache progressing worse, I took an at-home COVID-19 on 06/21/2022 and it came back positive. So I went to the emergency room when my symptoms got worse, and they tested me again as I began experiencing a terrible fever. Their test as well came back positive. During my overnight stay, EUA-Bebtelovimab monoclonal antibody treatment. As of today (06/24/2022), I'm starting to feel better but not completely 100% yet.
1 week after Hep B vaccine I developed a hive like rash on my lower extremities and trunk for which I returned to occupational health.  This rash went away.  I was well until February 2003 when I developed burning pain in my legs and trunk and was subsequently diagnosed with transverse myelitis and multiple sclerosis.  I wasn't aware of the possible link between this illness and the hepatitis B vaccine until doing some research yesterday. Fatigue, numbness of hands, neck pain, dizzy spells, sexual dysfunction
Information has been received from a consumer concerning her child who on an unspecified date was vaccinated with a dose of MMR II. it was reported the the child "had a reaction" and had a fever following vaccination with MMR II. This is one of several cases from the same source. No further information is available.
fever up to 105 about 18 hrs following vax; diarrhea starting 8 hrs p/vax;
Admitted 9/29/15 from Emergency Room/Atrial fib. Transesophageal echo and cardioversion done 9/30/15 vaccine given shortly after the above procedures. Attempt to give me vaccine on 9/29/15; declined gave me vaccine when I was medicated from above procedures - respiratory symptoms (severe). Ensued on 10/1/15 for Z Pak x 2 weeks then VIBRAMYCIN - sinus infection/persistent cough - symptoms for approx. 5 weeks/bedridden on cough medicines/very, very ill. Several Dr. appointments. 11/20/15 unable to resume normal activity - still compromised/weak. Also on ADVAIR - PHENERGAN with codeine. I believe this vaccine should not be given to me. I was readied for discharge. The above was reported to infection control.
Swelling, and redness, slight itch.  Swelling subsided a lot after a week.
vertigo; nausea; right ear feels congested or clogged; Initial information received on 01-Dec-2022 regarding an unsolicited valid  non-serious case received from a Patient .  This case involves a 70 years old male patient who experienced vertigo, nausea, right ear feels congested or clogged after receiving vaccine Influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Nov-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.5 ml QY (Lot Number- UJ933AD)(strength, formulation, expiry date: not reported) via unknown route in unknown administration site for Influenza (Influenza immunization).  On 06-Nov-2022 the patient developed a non-serious events vertigo, right ear feels congested or clogged (ear congestion) (Latency- within 15 minutes), nausea(Latency-15-20 minutes), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported Patient states he has an appt with an ENT 10 days from now, also stating the symptoms were severe for the first two days, not as severe now but everything is still there.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events (vertigo, nausea, right ear feels congested or clogged).  At time of reporting, the outcome was recovering for Ear congestion and Not Recovered / Not Resolved for all other events.  Additional information received on 02-Dec-2022 from a patient: dose added for suspect, event outcome updated for ear congestion and latency updated for ear congestion and vertigo. Text amended accordingly.
Migraines, Dizziness, Anxiety, Heart palpitations, Thyroid issues, Nausea, Vertigo, Fainting, Hormone imbalances, headaches, vomiting, Depression, suicide thoughts. All this has been happening for months daily.
At approximately 9:20pm, I suffered a "sinus type" headache.  This caused tenderness to my face on each side of my nose as well as my upper gums.  I self administered ibuprofen at 10:30pm.  By early morning the pain had subsided.
Beyond use date for this vial was 2/7/23, vaccine given on 2/10/23. Patient was monitored for 15 minutes after administration per protocol and no adverse reaction noted.
About 2 minutes after vaccine injection patient became pale, hands became cold and purplish. Patient's head leaned to the left side,  started slurring and became unconcious while his eyes were open.  I tried to get the patient's attention but saying "hello, are you still with me?" loudly and he did not respond.  His eyes were still open at the time. At that point I yelled for help and other colleagues were calling "911" immediately. Based on store protocol and knolwedge of  CPR and CDC guidlines, I checked for pulse and respiration - did not have any.  I grabbed epinephrine injection 0.3 mg and injected him on left thigh. He immediately gasped for air, then started to faint again. His face color turned pale. At this point he is still sitting upright and EMT has arrived. His blood pressure was lower than normal based on EMT report.  I called the patient on 5/12/21 (one day post-event) and patient reported no adverse reaction from vaccine site, he also reported taking 1.5 hours nap. The injection site on epineprhine injection was somewhat painful.
Symptoms - regularly swollen feet; pain and tightness in calf muscles. Had overall body soreness for about 2 days after injection, but the calf pain/tightness has continued since to varying degrees of intensity.  Symptoms have not fully gone away over the last 6 weeks.
Noticed intense and continuous tinnitus approximately 6 weeks post the first Booster vaccination. Tinnitus has remained consistent day and night since the startup. Tinnitus is most noticed at night on waking from sleep when the room is quiet. Tinnitus is also noticed during the day during more quiet periods.
Moderna Covid-19 Vaccine EUA Fever (102), Body, aches, bruise/ tender at injection site. Large tender lymph node of axilla area with swelling. Flu-like symptoms
pt recv vax 2FEB99 & 4FEB99 pt devel a maculopapular pruritic rash;ER or MD visit required;tx w/pred;
Bruise-like circular lesions around the toenail; single purple spots on other toes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 08:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Back pain" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "Complex regional pain syndrome in other foot" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin"; Ellavil, reaction(s): "known allergies: Ellavil". Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 Immunization; Bnt162b2 (Dose 4, lot number: Unknown, Left arm), for COVID-19 Immunization. The following information was reported: SKIN LESION (non-serious) with onset 30Dec2022 at 12:00, outcome "not recovered", described as "Bruise-like circular lesions around the toenail"; RASH MACULAR (non-serious) with onset 30Dec2022 at 12:00, outcome "not recovered", described as "single purple spots on other toes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of skin lesion, rash macular.  Additional information: Also reported dose 4 Pfizer vaccine on 09Dec2022. The patient got Covid test at about 4 weeks after bivalent vaccine (dose 5). No covid prior vaccination and not covid tested post vaccination (as reported).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
At recovery table pt became dizzy, lightheaded, slightly nauseated, pale, diaphoretic. Brought to recovery cot to lie down with feet  elevated.  Ice pack to back of neck. VS taken 98/60, HR 66 reg strong, rest 16 reg non labored, SpO2 99% no LOC,  no  SOB, no N/V.  Left deltoid site benign - redness - swelling - bleeding. Changed to monitor 30 minutes. Pt stated he was anxious about getting the vaccine.  after 15 min pallor, dizziness, diaphoresis and  nausea subsided.  2nd set of VS taken 110/72, HR 68 reg strong, resps 16 reg nonlabored. Provided reassurance, provided water for hydration . Vasovagal response to vaccine. pt stated "I feel better"  Ok'd to exit after 30 min.
pain in his Right; hardness at the injection site; i had fever; i felt like something was moving in my back; feel a bit of hot; cold; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (i had fever), MOVEMENT DISORDER (i felt like something was moving in my back), FEELING HOT (feel a bit of hot), NASOPHARYNGITIS (cold) and PAIN IN EXTREMITY (pain in his Right) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (i had fever), MOVEMENT DISORDER (i felt like something was moving in my back), FEELING HOT (feel a bit of hot) and NASOPHARYNGITIS (cold). On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in his Right) and VACCINATION SITE INDURATION (hardness at the injection site). At the time of the report, PYREXIA (i had fever), MOVEMENT DISORDER (i felt like something was moving in my back), FEELING HOT (feel a bit of hot), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in his Right) and VACCINATION SITE INDURATION (hardness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided Treatment for the events were not provided
Patient came in with redness on injection arm that looked raised. Area was warm to the touch and spread from previous day. Patient also stated she maybe running a fever.
rash; This spontaneous report was received from a nurse refers to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-APR-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N020352, expiry date 10-APR-2020 for prophylaxis. On an unknown date, the patient experienced rash. The outcome of the event was unknown.  This is one of the report received from the same reporter.  Lot No. N020352 has been verified to be a valid lot number for [hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)], expiration date not reported, but upon internal validation established as 10-APR-2020.
LUMP INSIDE MUSCLE OF LEFT  SHOULDER WHICH IS TENDER TO THE TOUCH ON A SCALE OF 1 TO 10; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced lump inside muscle of left shoulder which is tender to the touch on a scale of 1 to 10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lump inside muscle of left shoulder which is tender to the touch on a scale of 1 to 10. This report was non-serious.
Patient states he had numbness of entire tongue approximately 2 hours after he left the clinic. Had a small sensation of tingling of tongue as well. Denies any sensation of throat swelling or shortness of breath. Did not try any treatments and symptoms resolved in about one half an hour.
This case was reported in a literature article and described the occurrence of acute myocardial infarction in a 53-year-old male subject who was vaccinated with DTPa (with small D and P, manufacturer unspecified). Concurrent medical conditions included multiple cardiac and neurological conditions. On an unspecified date, the subject received unspecified dose of DTPa (with small D and P) (administration site and route unknown, batch number not provided). 69 days after vaccination with DTPa (with small D and P), the subject experienced acute myocardial infarction and died. It was unknown whether an autopsy was performed. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed Tdap vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports distributed. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's Palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
Redness (more than usual) not at injection site but below deltoid area and surrounding arm. Pain (soreness) reported by patient more severe evening of/after vaccination.
Narrative:  A 41yo female with PMH of Low Back Pain, Knee Pain, Migraine, Chronic PTSD, Pain in Right Ankle Joint, Sjogren's Syndrome, and Rheumatoid Arthritis, On January 24, 2022 physician reported the patient had a historical ADR of Influenza Vaccine induced Neuropathy with history date of January 1, 2001 and classified as severe. No other detailed information regarding the vaccine was provided. Unable to find on immunization record.
Menstrual cycle induced (cycle had completed one week previous, full cycle triggered with much worse cramps than usual),  bodyache, fever, chills, headache, nausea
(L) upper arm with swelling, erythema, c/o pain with difficulty of ROM, warm to touch. Rx with BACTRIM, DS 1 tab BID x 7 days.
Patient reports sharp pain in left upper chest area and into the under arm area and reports she may pass out. Patient had a vasovagal syncope episode followed by vomiting. After 30 mins of resting, she reports she was no longer lightheaded or nauseous. Chest pain resolved. Patient does report headache at departure. 12:53 - BP 152/82, P-73, R-20, Pulse Ox-97%. 13:00 - BP 140/80, P-87, R-20, Pulse Ox-100%. 13:10 - 122/78.
had weirdness in his chest; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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, SINGLE), for COVID-19 immunization. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "not recovered", described as "had weirdness in his chest"; NAUSEA (non-serious), outcome "not recovered", described as "nauseous". Additional information: after second shot, had a weirdness in his chest. Didn't know, if like the phlegm, the weirdness in his chest had nothing to do with the shot. He had a truck driver come in who stated his sister also had weirdness in her chest after the second shot. This sister did not have phlegm after her first shot. Caller does not know how to describe the weirdness in his chest. Stating it was across the chest and very strange. Wanted to know if the weirdness in his chest has been reported before. Maybe it was just him and this truck driver's sister who are experiencing this. Stated the weirdness in chest goes from left to right. It was just strange.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101327679 same reporter/product/event, different patient
Double Vision/ Blurred Vision ... still continues. .. Opthamologist is monitoring. No treatment.