chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pale; Itching at the site; swelling to 3 cm x 3 cm (wheal); Initial information received on 27-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old male patient who experienced pale (pallor) , itching at the site (injection site pruritus) and swelling to 3 cm x 3 cm (wheal) (injection site swelling), while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Dec-2019, the patient received fifth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA and expiry date 09-Oct-2020 via subcutaneous route in the left thigh.  On an unknown date, the patient developed a non-serious (pallor) , itching at the site (injection site pruritus) and swelling to 3 cm x 3 cm (wheal) (injection site swelling) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  The injection was attempted in the left thigh and the child moved quite a bit but a little bit may have been given subcutaneously instead of IM.  Other relevant tests were not reported.  Final diagnosis was pale, swelling to 3 cm x 3 cm (wheal) and itching at the site.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The outcome was reported as recovered for itching at the site, as unknown for pale and swelling to 3 cm x 3 cm (wheal).
Child fainted at completion of vaccines. She stood up after vaccine administration and fainted within seconds of taking her first steps. There was no loss of consciousness and we were able to regain her focus immediately.
This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (only received first injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 041L20A) for COVID-19 immunization. No medical history reported. On Feb 7, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 7, 2021, patient experienced product dose omission issue (only received first injection). On Feb 7, 2021, product dose omission issue (only received first injection) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not reported. Reporter did not allow further contact.
Patient was a resident of Siskin Hospital for Physical Rehabilitation, recovering from CVA with ataxia, and tested positive for Covid-19 on 7/29/2021 and transferred to the Covid unit.  Patient received Decadron and Monoclonal antibodies, placed on 4.5 liters of O2 NC.  Patient expired on 08/13/2022.
Around 10 minutes after receiving the vaccination patient became light headed and fell to the ground from a seated position. Patient did not lose consciousness. Patient also reported numbness and a tingling sensation in his hands. Patient was back to normal around 30 minutes after the vaccination.
pt recv vax 16JUN97 & 19JUn noticed red, round, pimple-like marks on nose, cheek & forehead which became blisters;they were not treated;nurse suggested topical antihistamines;
Redness and swelling of (Rt) arm upper. (After administration of vaccine, patient pulled off bandage and started scratching at vaccination site).
Developed headache, fever and cough on 1/25 unable to come to work 1/26 and 1/17. Saw provider 1/28 was admitted to hospital with fever, pneumonia, dehydration, elevated d-dimer, headache and cough. Given IV fluids, antibiotics, steroids and nebulizers. Discharged home 1/30/2021.
lost their smell; muscle pain; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), HEADACHE (headaches) and ANOSMIA (lost their smell) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MYALGIA (muscle pain) and HEADACHE (headaches). On 09-Mar-2021, the patient experienced ANOSMIA (lost their smell). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MYALGIA (muscle pain), HEADACHE (headaches) and ANOSMIA (lost their smell) outcome was unknown. Not Provided      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.   No concomitant medications reported.
Developed shingles on L side approx 1 month after vaccine. Given an antiviral oral medication to take for about 5 days and the spots cleared up after about 2 weeks
Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 78 and receiving home based primary care prior to COVID vaccination for multiple conditions including CKD, T2DM, w/ complications, and CHF.
Patient has history of passing out after any vaccination. Vaccine was administered, patient was fine. Then patient passed out down from chair. Helped patient up, elevated patients feet and requested to remain at consultation room for 30 minutes to make sure no allergic reaction. Patient was ok and left.
fist dose October 15 2021 / second dose  January 20 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) (batch number a955s, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 15th October 2021).   On 20th January 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 20th January 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter that a patient received a second dose of Twinrix outside recommended schedule, which led to lengthening of vaccine schedule. No know side effect were reported. The reporter consented to follow up.
pt recv vax 26JUL96 & 29AUG96 pt exp tingling in hands & feet, SOB on exertion & dec muscle strength in all muscles groups;sx worsened pt to MD;19AUG96 adm to hosp x 5 days dx GBS;pt granddaughter recv OPV 24JUL96;
This spontaneous report was received from a registered nurse refers to 12 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 19-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Urticarial rash began day of immunization approx. 8 hours following immunizations fever began day following immunization. Treated with Benadryl.
The day after my 1st vaccine dose I felt moderate to severe fatigue and general myalgia. Shoulder at injection site was sore. Approximately 8 hours after my 2nd vaccine dose I started uncontrolled shaking with fever. Over course of night my shaking, fever, and chills continued. Fever remained above 101 through course of night, as high as 102.7. Early in morning around 18 hours after injection fever dropped below 100. Severe headache and fatigue day after.
Running a temperature for about 4 days of 100.9; got the sweats/clammy and sweaty; headache; cloudiness; she had shakes that went on for days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 09:30 (Batch/Lot number: unknown) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Obese" (unspecified if ongoing); "Knee replacement" (unspecified if ongoing). Concomitant medication(s) included: FLU, start date: 22Sep2021, stop date: 22Sep2021. Past drug history included: Flu, start date: 22Sep2021, stop date: 22Sep2021, reaction(s): "bump on the arm", notes: AE(s) following prior vaccinations: Caller states besides a bump on the arm. Vaccination history included: Bnt162b2 (1st dose, Anatomical location: left upper arm, Time of administration: 9 am), administration date: 07Mar2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "Pyr"; Bnt162b2 (2nd dose, this is 10 times worse that what she had with the 2nd dose, Lot number:EP7533, Anatomical location: left upper arm, Time of administration: 1:30, Expiry Date: 31Jul2021), administration date: 28Mar2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "worse that what she had with the 2nd dose"; She had typhoid shot (back in the ancient days she had typhoid shot and if there was an epidemic). The following information was reported: TREMOR (non-serious) with onset Oct2021, outcome "unknown", described as "she had shakes that went on for days"; PYREXIA (non-serious) with onset 13Oct2021 07:00, outcome "unknown", described as "Running a temperature for about 4 days of 100.9"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "got the sweats/clammy and sweaty"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "headache"; BRADYPHRENIA (non-serious) with onset Oct2021, outcome "unknown", described as "cloudiness". The event "running a temperature for about 4 days of 100.9" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient could not lift up arm.  It has been 3 weeks still in a lot of pain and cannot sleep due to pain.  Has been to internist, orthopedic and physical therapy.
The evening of vaccination 9/26/23 the patient experienced arm pain.  9/27/23 she visited urgent care and reported pain, and weakness in the left deltoid with tingling that ran down her left arm.  She reported difficulty driving and putting on clothes, tenderness in left arm and decreased range of motion.
I mistakenly gave this young lady a ENGERIX instead of the TDAP vaccine for which she had come. No ill effects were reported in a call 2/25/10.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # J014855, expiration date 16-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 48, 32 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
PT HAVING SORE ARM AND SOME NERVE PAIN IN THE UPPER ARM AROUND THE SITE OF THE VACCINATION--DR PUT HER ON PREDNISONE TO SEE IF IT HELPS  BEEN ABOUT ONE MONTH SINCE THE VACCINATION--HAD NO TROUBLE WITH THE FIRST VACCINATION
I have an enlarged and painful lymph node in my left breast that never "went away" after the vaccine, as promised.  I had to get it biopsied.  I am in constant pain EVERY DAY in my left breast.
extreme fatigue; chills; nausea; soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), NAUSEA (nausea), VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (extreme fatigue) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 24-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (soreness at the injection site). On 25-Jan-2021, the patient experienced FATIGUE (extreme fatigue). On 26-Jan-2021, CHILLS (chills), NAUSEA (nausea), VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (extreme fatigue) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, vaccination site induration, vaccination site pain, nausea, and fatigue are consistent with the product safety profile
The pt received the vaccine on 4/10/00. On 4/22/00 the pt experienced and elevated fever lasting until 4/25/00. On 4/24/00 the pt experienced a rash, saw by an MD and diagnosed with measles.
Feeling Yucky; looks like he is running a fever now. Running a temperature of 101; coughing some; just feeling horrible/Feeling rough; Still feels very uncomfortable and has no energy; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in right arm, on 27Mar2021 13:00 (at the age of 73-year-old), at dose 1, single for covid-19 immunization. Medical history included ongoing diabetes, covid-19 from Dec2020. Concomitant medication included glibenclamide (GLYBURIDE) taken for diabetes and blood pressure medicine (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. No additional vaccines administered on same date of vaccination. On 28Mar2021, the patient began feeling yucky, looks like he is running a fever, running a temperature of 101 F.; running off and on for two days, coughing some, just feeling horrible/feeling rough and he was feeling very uncomfortable and had no energy. The patient had not visited Emergency room or Physician office. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 28Mar2021, Covid: positive around the Christmas Holiday (Dec2020), for about three weeks. The outcome of the events was unknown.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355799 same reporter/drug & different patient/ event
Pt presented 10-8 with bruise that wraps around arm down to elbow. Stated it was previously red, sore to touch and more bruised. Stated it was not sore when given. Symptoms started day after. She said she was travelling for a few days after and it had gotten a lot better. Denied injuring or hurting arm. Says she is a breast cancer survivor and is very careful about how she moves her arms around.
pt came to 2nd heplisav-b but was given engerix-b instead.  no side effect but given adolescent shot when she is 25 yrs old
Fever; Body aches; Shakes; Fatigue; Joint pain; Headache; Weakness; Chills; Sore arm; Nausea; Stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had only known allergy with z-pak. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR), estradiol (ESTRACE), simvastatin (ZOCOR) and multivitamins, all for unknown indication received within 2 weeks of vaccination and was unknown if ongoing. The patient experienced fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea on 20Mar2021 at 06:00. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea was resolving at the time of reporting. Information about lot/ batch number cannot be obtained. No further information expected.
Narrative: Patient reported scratch throat and thirst within first 5 minutes of receiving vaccine dose. This progressed to feeling of difficult swallowing and throat closing. Patient denied dyspnea but was observed to be tachypneic. Patient was given diphenhydramine 50 mg orally once and observed for 1 hour and symptoms by which point symptoms had subsided. Patient did not require emergency medical care.
Coughing related to allergies; Just more saliva than usual resulting in drool/excess moisture when coughing. (Coughing related to allergies/choking on excess saliva); Just more saliva than usual resulting in drool/excess moisture when coughing. (Coughing related to allergies/choking on excess saliva); Just more saliva than usual resulting in drool/excess moisture when coughing. (Coughing related to allergies/choking on excess saliva); Excess saliva, does not effect day to day life. Just more saliva than usual resulting in drool/excess moisture when coughing. (Coughing related to allergies/choking on excess saliva); This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (no pregnant) received the first dose of bnt162b2 on 14Jul2021 at 13:00 (lot number: EW0198) via unknown route of administration in Left arm at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO); methylphenidate hydrochloride (RITALIN); prazosin; cetirizine; paracetamol (TYLENOL). Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination, and did not had covid tested post vaccination. Patient received the second dose of bnt162b2 on 04Aug2021 at 13:00 (lot number: FC3180) via unknown route of administration in Left arm for COVID-19 immunisation. On 21Jul2021, Patient experienced excess saliva, did not affect day to day life, just more saliva than usual resulting in drool/excess moisture when coughing. (Coughing related to allergies/choking on excess saliva) Patient did not receive any treatment. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Moderna Covid-19 Vaccine EUA Swollen lymph node in right arm pit: starting 12/27/20 at 11:00 pm
Both my legs from the top of my thighs to my ankles ache. Mainly when I sleep.; Both my legs from the top of my thighs to my ankles ache. Mainly when I sleep.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 11:00 (Lot number: ER8727) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 26Mar2021, outcome "not recovered" and all described as "Both my legs from the top of my thighs to my ankles ache. Mainly when I sleep.". Therapeutic measures were not taken as a result of pain in extremity, arthralgia.  Additional information: Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medication within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 since the vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
7PM day of vax arm hurt-APAP given 19FEB96;20FEB96 head hurt @ school;t101.6 p/school;c/o h/a,& sore throat,stomachache,aching arms & legs;21FEB96,neck hurt,throat sore-not red,neck glands swollen;recovered 22FEB96
Right deltoid erythema/burning/itching-measures 12x10cm not indurated. Also systemic symptoms-mild headache, myalgia, fatigue, chills symptoms started approx 12-18 hrs post-immunization.
11 Days after the booster shot on the 12/24/2021, I had itchy hives all over my body. This includes my face/legs/arms/body. I also had a very strong fever and extreme tiredness. I started taking anti histamines such as bennadryl. On the 27th it was still bad so I went to the doctors and they prescribed me Prednisone for a week. I have continued using Prednisone and bennadryl and currently it is helping my symptoms.
Woke up unable to breathe; visited campus health nurse who informed me that my blood preasure and pulse were unusually high. Took Benadryl. Later in the day developed swelling at the site of the injection, rash on my torso, and continued to experience tightness of chest and difficulty breathing. Symptoms continued aprox. three days.
5 X 4 CM CIRCULAR EMTREMATOUS CIRCULAR AREA AT INJECTION SITE.