chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date in 2013, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. Later in 2013, the patient was treated at a clinic for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The outcome of vaccination failure, immune system disorder, and herpes zoster was unknown. The reporter considered vaccination failure, immune system disorder, and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Wheezing, nasal congestion for 3 weeks. No prior history. Treated with Flovent and Albuterol.
Patient had labs drawn and returned to room for Prevnar 20 and ear irrigation -as her irrigation was started, she began to feel bad, asked to lay down -she became unresponsive, had lateral nystagmus -her breathing pattern changed, gasping and slowed - EMS called -BG was taken: 130 -Pulse ox 91, HR 55 -she was unresponsive 1-2 minutes, then responsive to name -she was diaphoretic -she continued to be sedated but arousable to name -she started vomiting - HR down to 51 and pulse 88% -EMS arrived and patient to be taken to facility
shoulder warm; shoulder swollen; she was seeing swelling under her arm; Shoulder sore; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (shoulder warm), SWELLING (shoulder swollen), LYMPHADENOPATHY (she was seeing swelling under her arm) and ARTHRALGIA (Shoulder sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN WARM (shoulder warm), SWELLING (shoulder swollen), LYMPHADENOPATHY (she was seeing swelling under her arm) and ARTHRALGIA (Shoulder sore). At the time of the report, SKIN WARM (shoulder warm), SWELLING (shoulder swollen), LYMPHADENOPATHY (she was seeing swelling under her arm) and ARTHRALGIA (Shoulder sore) outcome was unknown.            Patient was taking steroids. No treatment information was provided.   This case was linked to MOD-2021-293902 (Patient Link).
Approximately 45 min. after vaccine administration, pt experienced tingling on tongue and scratchy feeling in throat. Took Benadryl 25mg po and went to ER. The ER /// the po Benadryl and prescribes Prednisone 60mg stat x qd times 5 days.
1 of 3 pts recvd vax from the same vial who exp inj site rxn;pt recvd vax 4MAY94 & w/in 24hrs exp inj site rxn of erythema, swelling, & hot to touch from elbow to shoulder; pt couldn't use arm because of pain;rx w/ice
I had a tingling/numbness feeling in my face similar to Novacaine.  It was only in the areas of my face where my beard and mustache were.  It dissipated in about 30 minutes.  Then I had chills at about 1.5 hours.
Client passed out in clinic after receiving vaccines - though stated he had only 'eaten a donut at 8am'.  Father of client called the following day to say that client also passed out at home at 1am - 'was feeling hot and fell over'.
Chest was burning/Chest pain; Body temperature was warm; Chills; Fatigue; Breathing issues got worse/More shrotness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest was burning/Chest pain), DYSPNOEA (Breathing issues got worse/More shrotness of breath), PYREXIA (Body temperature was warm), CHILLS (Chills) and FATIGUE (Fatigue) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shortness of breath. Concomitant products included BROMELAINS (BROMELAIN) and CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 22-Jan-2021, the patient experienced DYSPNOEA (Breathing issues got worse/More shrotness of breath), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced CHEST PAIN (Chest was burning/Chest pain) and PYREXIA (Body temperature was warm). At the time of the report, CHEST PAIN (Chest was burning/Chest pain) had not resolved and DYSPNOEA (Breathing issues got worse/More shrotness of breath), PYREXIA (Body temperature was warm), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include Fish oils.  Treatment information provided was Homeopathic Remedy.Patient had to increase the use of  Bromelain and Glucosamine/Chondroitin to help breath better. Exercise and walking also seemed to help. Cold air helps.
COVID arm.  The afternoon of 2/19, noticed an itchy sensation on my left arm where I received my COVID vaccine shot.  The area started to turn red and was warm to the touch.  Over the next 2-3 days, the redness continued to grow.  The area was slightly itchy but not unbearable.  The redness has continued to spread, but seems to be lessen in brightness as of 2/22.  Out of curiosity, I used a an IR thermometer, and it read 101 degree F on the red area but only 93-94 on the unaffected area lower on the same arm.  Started taking some ibuprofen on 2/21 to see if it would lessen the inflammation.  Arm is still red and warm to the touch as of today (2/22).  Itchiness seems to have decreased.  Contacted my doctor to notify them and also to be sure that there was nothing else to do at this time.
complex with potential life threatening condition which was monitored closely in the office with frequent re-evaluation for over an hour.; Life threatening illness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 15:45 (Lot number: FF2590) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: NEAR DEATH EXPERIENCE (life threatening) with onset 03Nov2021 16:15, outcome "recovered" (2021), described as "complex with potential life threatening condition which was monitored closely in the office with frequent re-evaluation for over an hour."; ILLNESS (life threatening) with onset 03Nov2021 16:15, outcome "recovered" (2021), described as "Life threatening illness". Immediate risk of death from the event. Since the vaccination, patient had not been tested for COVID-19. The events "complex with potential life threatening condition which was monitored closely in the office with frequent re-evaluation for over an hour." and "life threatening illness" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of near death experience, illness with Antihistamines and Steriods.
TB tine reaction, 15-20mm induration, red, irritated, warm to touch, and tender.
PRESSURE IN THE CIRCLE AREA BETWEEN ARMPIT AND ABOVE THE BREAST (LEFT SIDE ONLY); BURNING AT ARMPIT AND ABOVE THE BREAST; NUMBNESS AT ARMPIT AND ABOVE THE BREAST; PRESSURE IN UPPER AREA ABOVE ARMPIT AREA; GETTING HEAVY ABOVE BREAST; HEAVY ARM; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced pressure in the circle area between armpit and above the breast (left side only). On 03-APR-2021, the subject experienced burning at armpit and above the breast. On 03-APR-2021, the subject experienced numbness at armpit and above the breast. On 03-APR-2021, the subject experienced pressure in upper area above armpit area. On 03-APR-2021, the subject experienced getting heavy above breast. On 03-APR-2021, the subject experienced heavy arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pressure in the circle area between armpit and above the breast (left side only), burning at armpit and above the breast, numbness at armpit and above the breast, pressure in upper area above armpit area, getting heavy above breast, and heavy arm. This report was non-serious.
Headache, 20 hours, onset after 10 hours Injection Site Pain, 72 hours, onset after 10 hours Injection Site Itch, onset after 72 hours
HCP called to report that the patient received their first dose of GARDASIL ( quadrivalent) at the age 14 and they received a  dose of GARDASIL 9  today at the age of 28. No additional AE/PQC. No additional information provided.  Operator of device=; Inappropriate schedule of vaccine administered; No additional AE; This spontaneous report was received from a pharmacist and refers to a 28-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On an unknown date the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On an unknown date (reported as "today at the age of 28), the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter for prophylaxis (route and site of administration, lot number and expiration date were not provided) (interchange of vaccine products, inappropriate schedule of product administration and no adverse event).
There may have been a break in the cold chain storage of the vaccine upon arrival.  We explained what we knew of the events surrounding the shipment to Pfizer and received the following incident number
so sore everywhere and coulden't stay awake; coulden't stay awake; This is a spontaneous report from a non-contactable consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 12May2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient historical vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number/Expiration Date was not reported), via an unspecified route of administration on unspecified date for COVID-19 immunization. Patient reported that his second Pfizer COVID shot was on 12May2021. Patient reported he was so sore everywhere & couldn't stay awake after the shot. Patient said those symptoms from the shot lasted for about 24 hours. The outcome of the events was unknown.  No further follow up attempts are possible. no further information is expected.
pt recv vax & exp breakthrough chicken pox;2 patients w/the same exp were reported @ this site;
The pt experienced intussusception one day after the Prevnar vaccine was administered. Reduction was performed and was successful.  Follow up:  04/18: crying, stomach ache, unconsolable after eating, vomiting, no eating, pale.  Low grade fever, 100.2 F, few hours in hospital, stayed in hospital for 2 days.
Had a very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Had a very sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Viral meningitis in 1986. Concurrent medical conditions included Allergy to antibiotic (Levaquin), Allergy to antibiotic (Biaxin), Penicillin allergy, Lyme disease, Mycoplasma infection, Migraine, ADD and Costochondritis (costochondritis comes and goes, after each vaccine it actually improves and then comes back - very odd.) since 2020.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Had a very sore arm). At the time of the report, VACCINATION SITE PAIN (Had a very sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medication was reported. Treatment information were not provided.  Patient had been tested Negative for COVID-19 many times.   Patient reported that each time I had Moderna vaccine, this strange chest wall pain would completely go away for a few weeks and then return 4-6 weeks later.  Very odd but figured it was worth reporting.  Patient was currently being evaluated for CIRS (chronic inflammatory response syndrome).   This case was linked to MOD-2021-308000, MOD-2021-308016 (Patient Link).
Headache, nausea but no throwing up, tiredness, lack of energy, soreness at the sight of the injection.  Feeling generally bad all over, aching muscles, much like the symptoms of the covid 19 but only lasted a day and a half.  I had covid in December through the new year and it last 3 1/2 weeks.
I have a splotchy rash on my stomach and sides and back; This is a spontaneous report from a contactable consumer (patient). A 19-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 10:00 (at the age of 19-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication received in two weeks included finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took D-tap vaccine and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination and was not tested for covid post vaccination. The patient reported that, I have a splotchy rash on my stomach and sides and back on 28Feb2021 at 11:00. He said, it has been here for 5 days and started a day after I got the vaccine. The patient did not receive any treatment for the event. Event resulted in the Doctor or other healthcare professional office/clinic visit. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient, pregnant, by mistake was given states nasal form of H1N1 vaccine. No f/u checks have been scheduled at clinic. 11/25/2009 OB records, pregnant patient with no reported side effects.
she has a long problem and that she was in a hospital for 4 days. She also has sepsis in the lungs.; This is a spontaneous report from a contactable consumer. A 83-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 10Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on an unknown date in Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that She had the first dose of the vaccine on Jan2021 and the second dose on 10Feb2021. She said that she has a long problem and that she was in a hospital for 4 days. She also has sepsis in the lungs on an unspecified date in 2021. Caller said that she as happy about her vaccination but she is worried it has been so long since she had it. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Febrile seizure after temperature spike to 104F. Seizure did not respond to Ativan or Versed.  Rapid sequence intubation done & pt started on Cerebryx. Admitted to PICU. Rapidly weaned & extubated after sizure stopped. CT of head & EEG WNL.  Discharged on Diastat 2 days later. DC Summary for DOS 7/11/06-7/13/06: DC DX: Complex febrile seizure. HX of present illness and hospital course: On 7/11/06 had generalized tonic-clonic seizures associated with fever 12 hours prior to seizure received DTAP and hepatitis A. Seen in ED seizing and had temperature of 104.1. Given Versed and Ativan and intubated. He was loaded with Cerebyx. Extubated following morning. Continued with fevers, treated with Tylenol. Afebrile for greater than 12 hours and discharged home. PE: normal DC with Diastat as needed for seizures.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The nurse reported that a patient received an expired dose of GARDASIL (lot # 668261/1397AA, exp date 09-APR-2013) today (10-APR-2013) as the second dose. The patient received the first dose of GARDASIL on 05-FEB-2013. No adverse event reported. Additional information has been requested.
Within 5 minutes of getting the vaccine, I felt extremely light headed and completely passed out to the ground ripping my shirt and requiring medical assistance. While sitting there getting medical attention, I felt like I was going to pass out again. I was checked out in the cardiac unit of the ambulance and they determined my vitals were good. I've been monitoring symptoms ever since and have extreme back pain today.
Employee stated that he began experiencing swelling and pain in his throat approx. 30 minutes after Hep B vaccine administration on 01/24/2020, that he reported the following day 01/25/2020. Employee stated that post vaccine symptoms of pain and swelling in throat have prevented him from eating since prior to vaccine administration on 01/24/2020. Employee denied any SOB or dyspnea and none observed; employee denied any rash at injection site or; Called non-emergency nurse line and employee was instructed to report to Urgent Care for evaluation and treatment.
Initial misuse report received from a healthcare professional on 29 April 2013. ACTHIB and DAPTACEL were mixed together and given to a child as the 4th dose in the series. No adverse event was reported. List of documents held by sender: none.
This spontaneous report was received from a physician refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with ROTATEQ (dose, dosage schedule, lot number and expiration date was not provided). On an unknown date ROTATEQ was improperly stored and administered to unknown number of patients. The vaccine was exposed to 9 c for total of 60 hours. No adverse effects reported. This one of 5 reports received from the same reporter. Additional information has been requested.
Extreme joint pain.  I experienced this after my second vaccination as well.  It occurred between hours 12-18 after administration.
Nausea, dizziness, generalized myalgia, 24 hr after Adacel. Per follow-up: Mother complained of 'swelling' at injection site. Pt had FB (needle) removed from foot in ER - date/time not noted.
8/22: Felt sick (no fever). 8/23: Vomited. 8/24: Muscle pain across shoulders/neck/upper back.
No additional adverse effects reported.; one patient received an improperly stored dose of VARIVAX; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.   On 21-APR-2020, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S022755 with expiration date: 22-JUL-2021; route, strength, frequency, dose were unknown) for prophylaxis (incorrect product storage). The sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. No additional adverse effects reported.  Administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion under 6 degrees fahrenheit (F) to 14F (7.89F) for 90 minutes. The previous temperature excursion was under 15F to 46F (26F) for 36 hours. The digital data logger was involved to capture the temperature excursion.
Wrong vaccine given.  Dtap should have been given.  Tdap was given.  Mom called back 2 hrs after OV to report that pt had vomited.  Pt had been very upset and crying in car on the way home.  Vomited 2h after vaccine given.
became faint & sleepy, passed out pulse became weak & thready;adrenalin administered & 911 called transported to hosp;
Pt states she felt like she was going to pass out. Pt moved outside to cool environment. Pt states she felt better after about 10 minutes.
Patient had first COVID injection 1/22/21. States vaccine was given too high and hit a nerve and tendon in her arm. Patient has been experiencing pain since and receiving treatment from external neuro-physicial therapist for a partial frozen shoulder.