chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Replace a pacemaker; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC PACEMAKER REPLACEMENT (Replace a pacemaker) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 05-Oct-2021, the patient experienced CARDIAC PACEMAKER REPLACEMENT (Replace a pacemaker). On 05-Oct-2021, CARDIAC PACEMAKER REPLACEMENT (Replace a pacemaker) had resolved.            No concomitant medications or treatment details were reported.  Patient had a surgery on 05-Oct-2021 to replace a pacemaker that was put in 5 years ago. He reported this has nothing to do with the vaccine.   Reporter did not allow further contact
Initially, I was a bit tired and my arm was sore, but no more than any flu vaccine I've received.  On March 15, I began to feel very run down, but thought it was due to the change of time.    On March 16 around 4pm my arm began to feel as though the muscle was strained and I still felt tired.  Upon waking up on March 17, the area around the injection site was very red and hot.  I was still quite tired, even though I had gotten over 8 hours sleep.    I sent a picture of my arm to my primary care physician, and he asked me to come in on March 18.
Information has been received from a health professional concerning an adult male patient who in 2006 ("recently") was vaccinated IM with a 0.5 mL dose of Pneumovax 23 (possibly Lot# 655501/1035F). Subsequently, (2006) the patient developed an injection site reaction to include local pain, redness, general malaise and fever up to 102 F. At the time of the report, the reporter indicated that the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back hurt.; Dry mouth; coughing; random thoughts; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 15May2021 12:00 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15May2021 12:15, the patient only slept 1 hour, his arm, head and back hurt. Dry mouth, coughing, random thoughts. He felt like he was dying over here. Events were considered serious, disability. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
H/O Behavioral disturbance to the influenza vaccine coryza, cough; P/E No s/s of allergic reaction intervened while pt in Peds clinic.
Pt received KINRIX and PROQUAD on 9/28/2016. Parent noted on next day Left thigh, warm, swelling and redness. Pt C/O itching. Site evaluated by pediatrician.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/11/2021. PATIENT FULLY VACCINATED 02/27/2021.
Pt recv vax on 8/13/98; in 8/98 pt exp buzzing in ears; in 9/98 pt failed hearing test; dx=permanent nerve damage in right ear-1 decibel of damage in left ear
Severe tooth pain; This is a spontaneous report from the Pfizer-sponsored programs. A contactable consumer reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter was calling for a patient that was in severe tooth pain since there was no doctor available to ask. Reporter said that the patient had the first dose on 05Jan2020. Reporter was asking if there is interference of drugs like, ibuprofen, antibiotic, and anti-inflammatory. Reporter was asking if there is a website to check regarding these interactions. Reporter also said that it was an emergency since the patient would take a strong antibiotic for root canal. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
resident covered in hives, on left arm, trunk, groin. APRN orders for Prednisone 70 mg one time, oral Benadryl po 25 mg Q 6 hours Diphendydramine HCL Sol 1 time IM
Information has been received from a health professional concerning a 38 year old white female with no past medical history or allergies who on 8/27/01 was vaccinated with the 1st dose of MMRII, IM left arm (lot 632765/1308K). There was no known illness at the time of vaccination. On 8/29/01, (previously reported as starting on 9/8/01), the pt experienced hard, red and sore lump 1/2" diameter, at the injection site. It was noted that the pain radiated from the injection site down to elbow and was painful anytime the arm was flexed. The pt was evaluated by a physician on 9/12/01. The pt recovered on 9/30/01. Additional information is not expected.
I had immediate pain in the arm followed by the bruise and discomfort numbness in the arm and the chest. I have this weird chest heaviness feeling till 6weeks after my vaccine. On the 16 day I started having a large lymph nodes under my arm and on my chest on the left side of my body. This got smaller after seven weeks after my vaccination. I still have this tight muscle feeling on my chest and slight pain in my arm at the spot of injection . Seven weeks after high start having muscle cramps muscle trenching muscle pain and my legs which includes my thighs muscles my calf muscles my Feet muscles. All muscle on my body is sore my back muscles my hand muscles if I try to do any hard work my muscles feel like they are going to Crump. I feel weak I don?t feel myself. I was exercising regularly before my vaccine. Now I cannot do any exercises I cannot stand for a long time I cannot walk for a long time. I don?t really know what where I should go and who can help me?
I have food poisoning cramps and aches, but no throwing up or diarrhea. Intense abdominal pains.
1.  Arm sore 2. Body aches  3. Injection site 2 inch hive and itching  4. Congestion  5.fatigue
I started my period after receiving the vaccine and it has last for two weeks now and is not stopping. My period is never irregular; My cramps are bad as well; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8732) via an unspecified route of administration on 07Apr2021 at 10:45 (at the age of 34 years old) in left arm as dose 1, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks or any other medication within 2 weeks. The patient had her period cycle a week before the vaccine and it was normal. Then on 08Apr2021 at 10:00, she started with period after receiving the vaccine and it had last for two weeks and was not stopping. Her period was never irregular. Her cramps were bad as well which was not for her menstrual cycle. Patient did not receive any treatment for the events. The outcome of both the events was not resolved.  No follow-up attempts are possible. No further information is expected.
She had an allergic reaction; swelling underneath her arm in the lymph node; Injection site swelling; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old female patient received the second dose Pfizer BioNtech COVID 19 vaccine (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number EN6201), Injected in left arm unsure if given in muscle, on 09Feb2021 15:17 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. First dose of Pfizer COVID 19 vaccine given on 19Jan2021, Lot EL3247, injected on left arm and unable to confirm if intramuscular. Patient reported that after COVID 19 vaccine second shot she had an allergic reaction and got it done late afternoon on Tuesday. The lymph node under he left arm pit is completely swollen and has been since yesterday early Wednesday (10Feb2021) morning around 04:30. The injection site also swelled up immediately (09Feb2021 15:17). She had all the other stuff too, but she is only concerned about these two. The outcome of the event swelling underneath her arm in the lymph node was not recovered, event Injection site swelling was recovering. and the outcome of the event hypersensitivity was recovered.  No further details provided.
around 3 AM patient got dizzy and passed out. When I talked to patient at 6:30 AM, he stated to me that he was dizzy and fell during the night, his voice was very slurred and I could hardly understand him, he was also very disoriented. Took him to hospital ER around 7 AM
Information has been received from a registered nurse concerning a 18 week old infant who was vaccinated 21-NOV-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought, There was no product quality complaint involved. Additional information is not expected.
can't walk; nerve pain on her foot that seems to be getting worst; patient can't wear shoes; arm hurt/foot ankle pain slowly; feeling slightly dizzy; nervous; foot ankle pain slowly going to her leg; tiredness; headaches; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (can't walk), NEURALGIA (nerve pain on her foot that seems to be getting worst), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient can't wear shoes), PAIN IN EXTREMITY (arm hurt/foot ankle pain slowly) and DIZZINESS (feeling slightly dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-Dec-2021 at 9:22 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced GAIT DISTURBANCE (can't walk), NEURALGIA (nerve pain on her foot that seems to be getting worst), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient can't wear shoes), PAIN IN EXTREMITY (arm hurt/foot ankle pain slowly), DIZZINESS (feeling slightly dizzy), NERVOUSNESS (nervous), ARTHRALGIA (foot ankle pain slowly going to her leg), FATIGUE (tiredness) and HEADACHE (headaches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (can't walk), NEURALGIA (nerve pain on her foot that seems to be getting worst), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient can't wear shoes), PAIN IN EXTREMITY (arm hurt/foot ankle pain slowly), DIZZINESS (feeling slightly dizzy), NERVOUSNESS (nervous), ARTHRALGIA (foot ankle pain slowly going to her leg), FATIGUE (tiredness) and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  The patient stated that the nerve pain on her foot seemed to be getting worst. She was nervous and concerned about her symptoms. The patient mentioned that she was on her mid 40s and was a fairly healthy person and a vegetarian.
About 8 hours later, I feel like someone gave me a big shot of epinephrine. Jittery and revved.; About 8 hours later, I feel like someone gave me a big shot of epinephrine. Jittery and revved.; This is a spontaneous report from a contactable consumer. This 36-year-old female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 AM (Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation.  Medical history included asthma, migraine, obese, allergies. Patient had allergies to Albuterol. Concomitant medication(s) included cannabidiol and ibuprofen.  Historical vaccine included the first dose of BNT162B2 on 13Mar2021 at 11:30 AM (age at vaccination: 36 Years), vaccine location: Left arm, lot number: EN6204 for covid-19 immunization. On 03Apr2021 at 08:00 PM (about 8 hours later), patient felt like someone gave her a big shot of epinephrine. Jittery and revved with outcome of unknown. No treatment received for the adverse event. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are needed. No further information is expected.
12 hours after vaccine began chills and aggressive shivering that lasted multiple hours. Lethargic, inability to sleep over an hour at a time.  First Temperature check at roughly 13 hours from vaccine 102. 1000mg Tylenol taken.  Temperature  drops to 100 an hour or so later but jumps back to 102 a few hours later. 4 hours after first Tylenol dose took another 1000mg. Same outcome as before but Temperature spiked to 103.4 at about 26 hours post vaccine. Still very lethargic, no appetite since onset of symptoms. Headache, head feels weird when bending over.  36 hours post vaccine Temp raises to 103.8, another 1000mg Tylenol taken.  Next five hours spent being cold yet sweating.  42 hours post vaccine Temp returns to normal.  Rest of day feeling weak and head feeling odd when making quick movements.
Ataxia, dizziness 2 days after booster. Went to emergency room 4 days later as symptoms persisted.  Had MRIs of brain and cervical spine which were all negative. Admitted for observation. Symptoms improved but still have imbalance problems.
After administering the vaccine the patient felt her tongue was heavy and itchy throat. Then vomited. She had received a Benadryl capsule. She continued to feel unwell and 911 was called. They took her vital signs and gave her Benadryl and an injectable dose of Decadron. We called the patient later on and she stated she was feeling better.
Heart racing. Given water, crackers, juice. Pt rested in medbay for 15 minutes. Stable and released.
PAIN, SWELLING , ITCH & REDNESS AT INJECTION SITE.  FEVER, CHILLS, BODY ACHES, MUSCLE PAIN BASICALLY FLU LIKE SYMPTOMS STILL LARGE SOFTBALL SIZED RED SPOT, ITCHING, TENDER TO TOUCH, LARGE LUMP AT INJECTION SITE 5 DAYS LATER
Patient had pleural effusion within 8 hours of having seasonal flu vaccine. 11/20/09 Medical records received for date 10/22/09. DX: pleural effusion.Presenting SX: c/o pain in posterior back, worse w/ deep breath and cough. was seen recently in past few days in ER w/ dx of pleurisy. Assessment: WNL
Flu shot given to pt at 4:00 pm (10/28/05 - 0.25 ml IM right leg after 20 min at 4:20 pm - redness and warmth only on right leg. Notified Dr 2 hrs - cold compress & Tylenol dosage given. If swelling on mouth & eyes cold compress or call for appt. Difficulty breathing - 911 MM  revivification - understanding murmur develop for 2 hours.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a physician concerned a 74 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with MRNA 1273 for prophylactic vaccination (dose number in series 1). The patient subsequently received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 026C21A; expiry: 24-OCT-2021) dose was not reported, 1 in total, administered on 25-OCT-2021 as a booster for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient was administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Ache injection site 4 days Extreme sleepiness 24 hours Nausea 48hr Chills 12hr
no additional AEs; Caller reported patient received 1st dose of GARDASIL 9 on 9/15/2022, 2nd dose on 11/16/2022 and a third dose on 1/17/2023; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 15-SEP-2022, the patient was vaccinated with the first dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot# and expiry date were not provided) for prophylaxis. On 16-NOV-2022, the patient was vaccinated with the second dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot# and expiry date were not provided) for prophylaxis. On 17-JAN-2023, the patient was vaccinated with the third dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml intramuscularly (IM) in the right deltoid, lot #W015188, expiry date reported as 31-JAN-2025, but upon internal validation established as 06-JAN-2025 (conflicting information), for prophylaxis (inappropriate schedule of product administration). No additional adverse events (AEs) reported (no adverse event).
Immediately began feeling a stiffness in my neck and a stinging heart flutter. That's the best way to describe it. Both were sporadic, meaning not non-stop, however they existed consistently off/on from time of shot until I went to bed at 10pm that night.   Today, October 6, 2021 at 0857am I began feeling the stinging heart flutters again. They don't feel 'severe' but are most definitely noticeable.  I've never experienced this sensation before with anything else. FYI
Ringworm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "hypoactive thyroid" (ongoing), notes: she has no thyroid function and was initially diagnosed with hyperactive thyroid at age 24; "Sjogren's disease" (ongoing), notes: Sjogren's disease has Sjogrens disease and symptoms started approximately 20 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Lot Number: EL9263), administration date: 26Feb2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, Lot Number: EN6198), administration date: 19Mar2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: BODY TINEA (non-serious) with onset 10Jun2022, outcome "not recovered", described as "Ringworm". Therapeutic measures were taken as a result of body tinea.  Additional information: The patient had ringworm and started taking an antifungal cream on 11Jun2022 and that was when noticed it and had the HCP through telehealth when asked about allergies gave the caller a topical treatment to use for that but only on legs and not on arms and the ringworm began on 10Jun2022; stated it was distressing that cannot find the antifungal cream and needs to find it before the end of the day. Caller stated the topical antifungal cream was Ketoconazole to apply topically daily to affected areas for two weeks and to keep it on as often as possible; stated the Ketoconazole had lot 637121, expiry date Jan2024 and also had NDC 00093-3219-92; stated the Ketoconazole was to be put on the two spots of ringworm and was still getting ringworm and took Ketoconazole still and this morning she had a 2nd location where it was starting and started using the antifungal cream for that.
pt & sibling broke out w/pox;pt had approx 5-7 pox on 1st day;10-15 total lesions;
Extreme sensitivity reaction level 4  burning blistered skin severe rash itching and now shedding  layers of skin extreme sunburn  feeling  48 hours and going on three weeks extreme pain after second dose
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding patients' pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was provided. On unknown dates, patients were concomitantly vaccinated with doses of PNEUMOVAX 23 injection (dose, route of administration, lot# and expiration dates were not provided, along with doses of influenza virus vaccine (unspecified) (dose, formulation, route of administration, lot# and expiration date were not specified). On an unknown dates, patients experienced injection site reaction. The nurse stated, that some of them were injection site cellulitis. The outcome of injection site reactions and injection site cellulitis was not reported. The relatedness between adverse events and the suspect vaccines was not reported. Additional information has been requested.
Patient c/o pain and swelling right mid to upper arm following pneumovax vaccination. Described pain as constant, throbbing, rated pain as 6/10.
pt recv vax & pt sought medical attention & lab test have revealed that pt seroconverted for rubella;
1/11 vaccination; followed with flu like symptoms; 'run over by a freight train'. I took Tylenol and it went away. 1/16 2am, I woke up in my sleep. R sided chest pain; hurt to breathe in. Wouldn't go away. 7:30 I went to ER. The pain didn't subside. EKG; negative  1/18 I went to work at urgent care. After 1 hour, it still hurt to breathe. I ended up putting self on list for urgent care.  1/19 PCM; she ordered a chest CT. Steroids, antibiotics.  16-19 was the duration of chest pain tapered off after the antibiotics, steroids. I stayed the Prednisone for 9 days.
Initial report received from a health care professional, who reported the information to a liability specialist. This information was then reported to sanofi pasteur via other manufacturer on 01 July 2011. A 16-year-old male patient received an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. batch number 8YO OVR660K, on an unknown date. The patient became dizzy, left arm tingling and face flushed. The patient was administered ammonia salts which revived him. The outcome was not reported. Follow-up information received from a health care professional on 05 August 2011. The patient received a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number C3899AA. On 20 June 2011, the patient developed the reaction of flushed, dizzy and tingling. The patient was treated with smelling salts and 911 was called. It was unknown if the patient was seen by a physician. The outcome was reported as unknown. No information was available. Follow-up information was received from the reporter on 01 September 2011. The patient outcome was noted as "recovered". No additional information was reported. Documents held by sender: None.
local reaction-redness, swelling; febrile 103 16APR93-19APR93;