chrisvoncsefalvay/vaers-outcomes huggingface dataset:
child received vaccination 3/18/08 (MMR Varivax, Hepatitis A). I saw her in the office on 3/27/08 with diffuse marked urticaria. Mom reported that the rash started on the day after he received his vaccines (within 48 hrs) and has continued so she brought him in.
Immediately after injection, there was pain in injection site and it became very sore. By 10PM the night of vaccination, I was shivering, freezing and couldn't sleep; kept waking up all night. Next morning (10/23) I was miserable: nauseous, I had a migraine/ headache and couldn't even get out of bed until after 11AM. I took Aleve since I had to get out of the house for my dog's vet appointment. I felt better after taking Aleve, but I had loss of appetite that day as well. On the evening of 10/24, I felt a lump in the left side of my neck, same side as injection site. It was swollen and sore lymph nodes that lasted a few days, along with sniffles. I spent more time sick post-vaccine than I did when I actually got Covid-19 in Feb 2021.
Hypertensive and had tongue and throat swelling. Epi was administered per protocol an d transported to ED.
cough, worsening shortness of breath as well as pleuritic type chest discomfort
I was given the shot at approximately 8:30 am. I left the clinic and was driving home. At approximately 8:45 am, I had to pull over because I felt very drowsy. As soon as I pulled over, I got very tingly and blacked out. I?m unsure how long I was unconscious. I woke up and I decided to try to make it home. I parked in the parking lot at my apartment building where I blacked out again, this time having severe shakes. I managed to take a Zofran as I felt like I was going to vomit. I called 911 because I kept falling in and out of unconsciousness. I managed to tell the dispatcher where I was at and what car I was in, but again, I fell unconscious. I woke up to paramedics banging on my car windows because my car door was locked. I unlocked it before starting to pass out again. My blood sugar and blood pressure was taken. My blood sugar was 96, and I cannot remember my blood pressure. I had a weak pulse so they had to use a stethoscope to take my pulse. I do not remember what my pulse was either. I cannot afford a hospital visit so I asked the paramedics to just take my to my bedroom, and help me lie down. I have been in bed since. During these black out events, I was tingling all over my body, I could hear - but it sounded like I was underwater, I had very dry mouth and I was very sick to my stomach. As of right now, it?s been 7 hours since receiving the vaccine and I have a strong headache, and feel generally unwell and lethargic. I am 26 weeks pregnant with an expected due date of December 26th, 2019. I have not noticed any issues with my baby. He is moving around normally.
Fever up to 102, cough, sneezing, fatigue.  Advised to give Motrin, watch symptoms.  Call if any changes.
pt received 2nd booster of moderna (exp 9/1/2022; lot 054a22a); she mentioned she had previously only received pfizer for full series and 1st booster. pt started experiencing  red, itchy, raised, swollen area around injection site and feeling fatigued; she has not seen improvement in condition since noticing the reaction
At first just flu like symptoms (exhaustion, joint pain, headache) but this morning I stopped breathing in my sleep, then couldn?t move. My heart started racing, chest pain, and difficulty moving my left side. I was able to get my heart rate to go down with motherwort and CBD (heart regulators) and electrolytes, and took a baby aspirin. still experiencing chest pain and some discomfort
patients were administered with an expired pentacel with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 3 months old female patient where patients were administered with an expired diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (prevnar) and rotavirus vaccine live reassort oral 5v (rotateq) for Immunisation.  On 10-Oct-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot- UJ785AA and expiration date- 09-Oct-2023) via intramuscular route in the left thigh (strength: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I woke the next morning with symptoms worsening; slight fever; headache; pain at the injection site; pain in the armpit area of my left arm; swollen lymph node; body aches; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 09:00 (Lot number: ew0217) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: pet dander" (unspecified if ongoing), notes: No none allergens other than to pet dander, dust, and pine; "Known allergies: dust" (unspecified if ongoing), notes: No none allergens other than to pet dander, dust, and pine; "Known allergies: pine" (unspecified if ongoing), notes: No none allergens other than to pet dander, dust, and pine. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: ew0186, Administration time: 09:00 AM, Vaccine location: Left arm), administration date: 11Aug2021, when the patient was 33 years old, for COVID-19 immunization, reaction(s): "having a hard time breathing", "Started out with the need to constantly clear my throat and then became full on wheezing and coughing". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Sep2021 22:00, outcome "recovering", described as "pain at the injection site"; AXILLARY PAIN (non-serious) with onset 01Sep2021 22:00, outcome "recovering", described as "pain in the armpit area of my left arm"; LYMPHADENOPATHY (non-serious) with onset 01Sep2021 22:00, outcome "recovering", described as "swollen lymph node"; PAIN (non-serious) with onset 01Sep2021 22:00, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 01Sep2021 22:00, outcome "recovering", described as "chills"; CONDITION AGGRAVATED (non-serious) with onset 02Sep2021, outcome "recovering", described as "I woke the next morning with symptoms worsening"; PYREXIA (non-serious) with onset 02Sep2021, outcome "recovering", described as "slight fever"; HEADACHE (non-serious) with onset 02Sep2021, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, lymphadenopathy, pain, chills, condition aggravated, pyrexia, headache.  Additional information: Facility type vaccine was Workplace clinic. Other vaccine in four weeks were none. Other medications in two weeks were none. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. There was no other medical history. The patient developed pain at the injection site. She also noticed pain in the armpit area of her left arm, which she is assuming is a swollen lymph node. She developed body aches, chills about 12 hours after her dose. She woke the next morning with symptoms worsening and had developed a slight fever, and a headache. Adverse events resulted in none of the above.  Follow-up attempts are completed. No further information is expected.
Experienced fatigue, fever, and headache for about 1.5 days after shot that cleared up on their own.  The only thing I took for them were garlic pills and ibuprofen.
Tight sensation in neck and chest post vaccination (approximately 1 hour later) that came and went 3 times.
fatigue; drops in his blood sugar; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A male patient of an unspecified age (age reported as under 55/under 56 years old) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some fatigue and drops in his blood sugar after his first vaccine. The patient asked about any information about seizures or Pancreatic (low Blood sugar) issues and fatigue after receiving the vaccine, and wanted to know the additive/ingredients in the Covid 19 vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021071679 same reporter/drug, similar event, different patients
Exhaustion/fatigue; This is a spontaneous report from a contactable patient. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 04Feb2021 at 10:30, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EL3247) on 14Jan2021 at 10:45 AM, in the right arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. The patient showed a negative nasal swab on 21Jan2021. On 04Feb2021, at 19:00, the patient experienced exhaustion/fatigue. The event was considered non-serious. The patient did not receive treatment for the event. Outcome of the event was recovering. The patient has not been tested for COVID-19 since vaccination.
Patient received the COVID vaccine (Pfizer dose 1, lot #EW0171, expiration date 8/2021) in his left deltoid at 1437. The client was observed to fall out of his chair in the observation area, fall to the ground, and hit his head. The client made no attempt to protect his head or break his fall. RN, PHN, RN, and RN responded at 1438. PHN called EMS at that time as well. The client was observed to jerk his arms twice. The client was unconscious for approximately 90 seconds, and was turned on his side at this time. When the client regained consciousness, he was alert and oriented, complained of no pain in his head or any dizziness or lightheadedness. No difficulty breathing. Pupils were equal and reactive to light. At 1439, the vital signs obtained were: blood pressure 130/90, heart rate 57, O2 98, respiratory rate 26. The client denied any history of seizures, epilepsy, or any other medical history. The client stated he has no allergies and that he takes no medications. Upon examination, there were no cuts observable on the client's head. The client denied any feelings of dizziness before his loss of consciousness but stated he did not eat any breakfast or lunch that day. At 1443, the repeat vitals were as follows: 128/94 blood pressure, heart rate 60, respiratory rate 22, temperature 98. A manual pulse was 88 and thready. At 1447, EMR responded to the scene and assumed care of the client. Client transported to hospital.
Information has been received from a medical assistant referring to a 18 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB (10/1.0 Mcg/ml, 1.0 ml; frequency and route unspecified) (overdose and inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-SEP-2017, the patient was vaccinated with an expired dose of M-M-R II lot # L009544, expiration date 19-MAR-2017 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint has been filled.
1/19-1/22/22  17 yr/o 4 mth/o female patient s/p heart transplant at 11days of life for HLHS. Additionally has a complex medical history of chronic kidney disease, CLD, PTLD s/p partial lung resection, community acquired pneumonia, asthma, poor airway clearance, and insulin dependent diabetes who present to hospital ED with a 4-day history of chest pain, headache, fatigue, cough and wheezing.  Patient saw PCP on day of admission (1/19/21), where she tested positive for COVID-19.  Given patient's complex medical history and her diagnosis of COVID-19, she was admitted to the PCU for further monitoring and administration of Remdesivir.   Neuro: No acute issues during admission  Resp:  Patient remained SORA throughout her admiss Neuro: No acute issues during admission    She reports sore throat, cough, chest pain, difficulty breathing, nasal congestion for the past three days. She reports she has loss of taste and smell. She has not had any known sick contacts.   Resp:  Patient remained SORA throughout her admission.  Her CPT and Hypersal treatments were increased to QID to aid in mucous clearance however she was discharged home on her home regimen of Albuterol, Pulmozyme, Flonase, Dulera, Singulair and Spiriva.    CV: She had no changes to her CV management while inpatient.  She continued her home Amlodipine, Cellcept and sirolimus.  Her Troponin and BNP remained WNL throughout her admission.  A Sirolimus level was sent the morning of discharge however it is a send out lab therefore the results were not available prior to discharge.  The PAHFT team will be following up these results.    GI: Patient has Insulin dependent type 1 diabetes mellitus.  The Endocrine medical team followed her while she was inpatient and made some adjustments to her medications.  She will be discharged home on Lantus 33 Units daily with a carb correction of 1 unit: 4 carbs, 1 unit for every 25mg/dl >120mg/dl. Ketone corrections- 3- small, 4- mod, 5- large. (check ketones with BG >/= 250).  Her blood glucoses will be monitored via her Dexcom.  She was encouraged to take medications as directed and to continue her carb consistent diet.  She will continue her home Lansoprazole, Vit D, MVI and Calcitrol.      Heme: Per COVID guidelines PT, PTT/INR were drawn and WNL    ID:  Patient received 3 doses of remdesivir per COVID guidelines.  She tolerated this well without any complications.  A CMP was drawn on day of discharge to assess liver functions after receiving the remdesivir and there were no concerns.  She will continue her home Pen VK upon discharge.
Parents report on 12/24/05 infant came home from grandparents with a bumpy rash on chest and abdomen. Infant also had cough, congestion and fever to 103F. Took infant to private provider and Rondec drops given for problems. Physician told parents rash could be a allergic reaction from food or immunizations.
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA013686: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA013683.
COVID-19 Vaccine administered in left IM deltoid around 6:30pm for the 2nd dose in the series. Approximately 30 minutes after patient stated she's not feeling well and feel really sick to her stomach and nauseous and feeling hot. Tried to cool her off with fanning and cool wet towel but started to feel more severely nauseous and 911 EMS was called. they checked her vitals and ended up walking her out to her car.
Patient received a Moderna booster shot inadvertently on December 8, 2021. The dose was 0.25mL, Lot nuber: 033H21A, Expiration date: 03/25/2022,  and given in the left deltoid muscle. The patients first vaccine in her primary series was administered on 11/24/2021. The patient was being wheeled down the hallway when the resident assistant stated that she was signed up for her vaccine. Someone found paperwork for what she thought was for the patient and handed it to the pharmacy team. PharmD administered the vaccine. informed that patient was not signed up for the Covid Booster. When looking at the form staff member realized she had pulled patient's form instead. Factors that led to the error include the patient being cognitively impaired, patient having a similar name and date of birth with the patient, the nursing staff not being informed on the procedure for the clinic day and who was receiving a vaccine, not checking date of birth and name of patient, and pharmacy staff not being familiar with the patient population. The patient's primary care provider, was in house and saw the patient immediately following the injection. The patient's pharmacy was also contacted. The patient's family was notified and present at the facility. The patient is being placed on vital sign monitoring every 2 hours for the next 72 hours as a precaution.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient was dizzy post vaccination, gave her orange juice and had her lie down. Felt better after about 20 minutes
Patient received PedVaxHIB in right vastus lateralis on 11/5/2015. The next morning, the mother noticed his leg was swollen, red, and warm to the touch. Informed mother to put cool compress on site and to give child appropriate dose of infant's Tylenol. Informed mother to take child to MD or ED if site becomes worse or if child develops any other symptoms. Mother verbalized understanding.
Information has been received from a physician concerning a 24 year old white female with no pertinent medical history who on 13-MAR-2007, at 08:30, was vaccinated, into the right deltoid, with a first dose of GARDASIL (lot #657006/0188U). Concomitant therapy included ZYRTEC-D, AMBIEN CR and ALEVE. On 13-MAR-2007, at approximately 19:00, the patient had a seizure while driving. The patient went to the emergency room and underwent unspecified blood tests and a computed axial tomography (results not reported). On 14-MAR-2007, the patient was too tired to go to work. The patient was advise to follow-up with a neurologist. It was recommended that the remainder of Gardasil series was held until neurologic work up was complete. Upon internal review, the patient's seizure was considered to be an other important medical event. Additional information has been requested.
Rash on arm near injection site about a week after getting the shot.  And frankly left shoulder has been sore / felt off since injection
I had a flare up in my right foot, plantar fasciiitis.  I had to wear a cast on my right foot up to knee for 3 1/2 weeks.
Arm turned red; Arm got hot / hot to touch; Arm has itching; Arm swelled up; hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm turned red), FEELING HOT (Arm got hot / hot to touch), PRURITUS (Arm has itching), PERIPHERAL SWELLING (Arm swelled up) and HYPERSENSITIVITY (hypersensitivity reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Mercury sensitivity (mercury/ thimerosal -red rash if on skin, burning and red in eyes) since 1968, Allergy to topical drugs (Chlorhexidine-Burning red skin on area of application then spread to armpits and groin) since November 2019, Allergy to antibiotic (Cefaclor- Hives on arms when taken as pill) since 1990, Latex allergy (Skin irritation), Osteoporosis in 1998 and Hypersensitivity reaction. Concomitant products included ATORVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for Stroke, UBIQUINOL (COQNOL) and DENOSUMAB (PROLIA) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (Arm turned red), FEELING HOT (Arm got hot / hot to touch), PRURITUS (Arm has itching), PERIPHERAL SWELLING (Arm swelled up) and HYPERSENSITIVITY (hypersensitivity reaction). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Mar-2021, ERYTHEMA (Arm turned red), FEELING HOT (Arm got hot / hot to touch), PRURITUS (Arm has itching), PERIPHERAL SWELLING (Arm swelled up) and HYPERSENSITIVITY (hypersensitivity reaction) 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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant follow up received on 21-JUN-2021. Included medical history, concomitant medications, treatment medication Tylenol and ethnicity. Dose 2 information was added. Event hypersensitivity reaction, events stop date and outcome was updated
High fever, accelerated heart rate, muscle aches over whole body, swelling under arm, vomiting, headache, some diarrhea. Felt better after 3 1/2 days.
local swelling around inject site rt deltoid w/swelling 7cmx7cmx1cm thick; tender rt axillary lymph node 1 cm local warmth; sl fatigue lasted 3 days;
I did not have any adverse side effects with the first vaccine. The second vaccine was very different, which I know is common (nausea, fatigue, headache, fever, chills, body aches), but after 48 hours my arm became very red and swollen. The injection site is bruised and the redness and swelling is going down my arm from my shoulder to my bicep. I took Benadryl last night and will take Benadryl and Ibuprofen tonight and if the swelling gets worse a doctor will call me in a prescription for a steroid.
Left sided weakness, severe headache, extreme exhaustion, severe bilateral leg pains - to the point that he has been unable to walk at times