chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Headache; fatigue; This is a spontaneous report from a contactable other hcp. A 26-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EL3246,Expiry date was not reported),via intramuscular route of administration, administered in Deltoid Left on 07Jan2021 12:40 as DOSE 1,SINGLE for COVID-19 immunisation (At the age vaccination-26yrs). Medical history included appendicitis from 14Feb2014 to 15Feb2014, asthma from Sep2009 and ongoing, irritable bowel syndrome, anxiety, contraception, hypersensitivity. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT) taken for asthma from 2018 and ongoing; hyoscyamine sulfate (LEVSIN) taken for inflammatory bowel disease from 2016 and ongoing; escitalopram oxalate (LEXAPRO) taken for anxiety from 2020 and ongoing; ethinylestradiol, norethisterone acetate (JUNE FE 1/20)taken for contraception from 2019 and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for hypersensitivity from 2008 and ongoing; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication from 2008 and ongoing. On 24Jan2021 01:00 the patient experienced fatigue, fever, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 17Aug2020, sars-cov-2 test: negative on 28Aug2020, sars-cov-2 test: negative on 20Dec2020. Therapeutic measures were taken as a result for fever Tylenol and for headache Excedrin Migraine. And the clinical outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown gender and unknown age. On an unknown date the unspecified patients were vaccinated with improperly stored RECOMBIVAX HB. No adverse effects were reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. This is one of the several reports from the same reporter. Additional information has been requested.
The patient was indicated for the fluarix quad vaccine and was accidentally given Fluzone HD quad vaccine.
pt recv vax JAN96 & 9MAY97 pt devel breakthrough chickenpox;
I started feeling ill early April and it just continued. I thought I was having a bought of the flu. In middle May I went to the Doctor and they gave me the Flu and COVID-19 tests. Symptoms were shortness of breath, runny nose, coughing, diarrhea; fatigue and these lasted 2-3 weeks. They were pretty bad because I missed 5 days of work. I continue to have lingering breathing problems.
5:00 am i started shaking and was extreme fatigued. I tried to sleep but couldn?t.  I then was super cold sand achy all over my body. The injection site was extremely tender and tight.  Around 1:00pm i got a fever of 100°. I was super achy and had an extremely bad headache. Body aches continued and fever went away with medicine but came back after meds wore off.  Fever continues today (36 hours after shot), terrible headache, body aches, sweating, and i have an enlarged lymph node on my collar bone.
Vaccine was administered Friday and Saturday I had body aches, chills, neck pain, and fever. Sunday I woke up with a severely swollen armpit and anterior chest
This spontaneous report refers to  a 67 year old male patient reporting on himself. Patient's concurrent conditions included hepatitis C. Medical history was reported as none. On 14-DEC-2013, the patient was vaccinated with ZOSTAVAX for prevention of shingles (dose, lot number and concentration not reported). Concomitant medication was reported as none. Approximately on 16-DEC-2013 (reported as within a couple of days), the patient started experienced a tingling on the right side of his face around his eye. The patient developed a red rash and approximately on 17-DEC-2013 (reported as "the patient the next day") went to a clinic and was diagnosed with shingles. Patient received treatment with medications (dose unspecified). No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Within 1-2 minutes of vaccination, pt felt flushing. He sat down in waiting room. He started to sweat and felt dizzy. Pt requested help. He was brought back to medical room. Pt laid down for 5 minutes and felt better. He ate a snack and drank some water. BP was 162/102 initially. BP was 144/96 after 13 minutes.  Pt states he has had similar reactions after giving blood.
Initial misuse report received from a healthcare professional on 30 July 2013. It was reported that a dose of PENTACEL was administered to a 5-year-old patient. No adverse event was reported. List of documents held by sender: none.
vertigo; headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced VERTIGO (vertigo). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, VERTIGO (vertigo) and HEADACHE (headache) outcome was unknown.            Concomitantly the patient was on unspecified medications for blood pressure.
Around 3:00pm on 3/7/21 I began to feel a little tired. But 3:45pm I was experiencing muscle pain through my body at only continued to get worse. At 4:30pm I took 400mg of ibuprofen since sitting, walking, and lying down were all painful. Relief came around 5:30pm and I was able to nap for an hour. At 6:30pm I awoke and attempted to eat, as I was beginning to feel nauseous. At 8:30pm I laid down again, my symptoms returning and worsening. I was now experiencing chills with my muscle pain and a headache. Pain was located throughout my body and my skin was sensitive to the touch. At 10:30pm I began shaking violently and struggled to feel warm, despite my skill feeling hot. My temperature was not taken. Another 400mg of ibuprofen was taken and one 350mg chewable of Tums anti-acid was eaten. It was not until 12:30am that I was able to sleep again.  The morning of 3/8/21 I was still fatigued and sore. Moving was difficult and painful and nausea was still present, and my headache returned. I was unable to eat despite trying. At 10:00am I took two tablets of Excedrin Migrain and napped for almost two hours. Currently, my muscle aches are minimal and my headache has improved. This may however be due to the medication.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Mild flu like symptoms) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The patient's past medical history included Stroke on 12-May-2012, Heart attack on 30-Mar-2020 and CPAP (sleep apnea) since an unknown date.Concurrent medical conditions included Crohn's disease since 1990, Sleep apnea (necessities nighty use of a CPAP machine), Blood pressure high (currently under control), Immunocompromised, Vitamin B1 deficiency, Chest pain, AFib, Prostatic disorder and Blood cholesterol abnormal. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, METOPROLOL for Atrial fibrillation, THIAMINE for Beri beri, ATORVASTATINE [ATORVASTATIN] for Blood cholesterol abnormal, ISOSORBIDE for Chest pain, TERAZOSIN for Prostatic disorder.On 27-Apr-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 PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Mild flu like symptoms). At the time of the report, PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Mild flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided   This case was linked to MOD-2022-468837, MOD-2022-468891 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow up received and reporter information, patient demographics, medical history, concomitant medications and new events were added. The event of VACCINATION COMPLICATION  was amended to sore arm and mild flu like symptoms.
Information has been received from a 20 year old female with no medical history and drug allergies who in February 2008 was vaccinated with her first does of GARDASIL. Concomitant therapy included birth control pill (unspecified which one). The patient was fine at first after vaccination but later she started feeling dizzy and light headed for the rest of the day. She was fine the next day and was now recovered. However, she did not receive the other two doses of GARDASIL. The patient did not seek medical attention. Additional information has been requested.
Pt vaccinated Pnuemococcal/FLU rt arm now swollen, wrist to shoulder. No known allergies.
MENACTRA administered by ID route inadvertently in (R) forearm approximately 9 AM. MENACTRA IM (L) deltoid; TB skin test ID left forearm - called Sanofi - advised to observe in 48 hours - awakened at 2 AM on 8/20/15 with fever 101, itchy (R) forearm at admin. site.
Approx 48 hours PCV7 #1 given pt presents with 4 hives of R arm and 2 hive of R leg.
POTENTIAL BLOOD CLOT SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included child delivered. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced potential blood clot side effects. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, and EKG (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential blood clot side effects was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Patient received vaccine (TDAP) 2/18/16. She started with redness at injection site (LD) and 2/21 was dx with cellulitis on 2/22 in ER. Pt on KEFLEX 500 mg 2 BID x 10 days.
Pt reprots she had Hives on her neck, stomach and leg area 5 hours after receiving the flu inactivae injection on 10/17/08. Pt felt itchy all over her body. Report no other sx and no new changes in her daily routine besides the flu shot. Pt states her hives have gone a way this am and after here reading her VIS sheet, she was insturted to call in to the clinic. Pt has had flu shots in previous years with no side effects.
Rash on arm side and leg; pustular rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date 2nd October 2021) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced rash and pustular rash. On an unknown date, the outcome of the rash and pustular rash were unknown.   It was unknown if the reporter considered the rash and pustular rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received Shingrix and developed on the same side of the vaccine, on her arm, side and leg, rash and some part of the rash was pustular.
This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP6955; Expiration date was not reported), via unspecified route of administration on an unspecified date in Mar 2021 (reported as 10:00 AM) (at the age of 29-years-old) as first dose, single dose for COVID-19 immunization. Medical history included COVID-19 (COVID prior vaccination) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not tested for COVID post vaccination. The patient has no known allergies. On an unspecified date in Mar 2021 (reported as 04:00 PM), the patient experienced heavy fatigue, weakness and pain at injection site. No treatment was taken for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Fatigued; Arm sore; Irritable; This is a spontaneous report from a non-contactable Other Health Professional (the patient).  A non-pregnant 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249), via an unspecified route of administration, in the left arm on 09Feb2021 at 11:30 AM (at the age of 57 years) as a single dose for COVID-19 immunization. Medical history included covid-19, prior to vaccination. The patient did not have any known allergies to medications, food, or other products. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Feb2021, the patient experienced fatigued, arm sore, irritable. Therapeutic measures were taken as a result of fatigued, arm sore, irritable, which included 2 Tylenol. The clinical outcome of the events fatigued, arm sore, irritable was  recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with unspecified number of improperly stored VAQTA (dose, route of administration, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395985 (Patient Link).
pt recv vax 24JAn96 & c/o leg pain that noc & next day;26JAN96 AM Mother noted inc edema in upper thigh & taut,erythema,blanching;diameter of leg involved inc 3.0cm up thigh,& above knee of other leg;
30-year-old after second Pfizer vaccine, developed rash on hand and painful joints. The rash was  erythematous target appearing and painful to touch.
ALLERGIC REACTION  HEART RATE UP INTO 120's ... SHORT OF BREATH, SHAKEY AND JITTERY, LIGHT  HEADED ;
Rash, blisters, warmth, swelling of arm with subsequent cellulitis.
Acute cerebellar ataxia-severe. No yet recovered. An annual follow up report received 6/9/2003 adds: Ataxia continued.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 23-MAY-2013 the patient was vaccinated with the first dose if GARDASIL (dose 0.5, lot number and expiration date not reported) intramuscular for the prevention of the HPV virus. On 27-SEP-2013 the patient was vaccinated with the second dose of   GARDASIL (dose 0.5, lot number and expiration date not reported) intramuscular for the prevention of the HPV virus. On 17-DEC-2013 the patient was vaccinated with the third dose of GARDASIL (dose 0.5, lot number and expiration date not reported) intramuscular for the prevention of the HPV virus. The nurse reported that the patient received the third dose of GARDASIL "3 days earlier of the 12 week interval within the provisional dosing schedule. No adverse effects reported. It was reported that the patient did not seek for medical attention. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE SLEEP APNEA ACUTE HYPERCAPNIC RESPIRATORY FAILURE
Information has been received from a registered nurse concerning a child who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Patient informed the clinic that he began feeling "itchy like bugs crawling all over" on 2/16/21.  He proceeded to take Benadryl which was effective.  On 2/20/21 he woke up with swelling on the left side of his face.   On 2/21/21 he woke up with swelling on the right side of the mouth and reported "tingling like I just went to the dentist".  Symptoms were resolved by 2/22/21.
Information has been received from a nurse practitioner referring to a 10 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. Concomitant therapies included VARIVAX, hepatitis a virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 10-MAY-2016 at 12:18, the patient was vaccinated with M-M-R II lot # reported as L042818 dose 2, subcutaneously in the right arm. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
After I rec the 2nd dose of the vaccine the injection site started getting itchy, Around sat and sun itching increased and the area  became hot to touch swollen and a red ring formed around the injection site the size of a golf ball. I went to the ER this morning and they told me I had an allergic reaction but it was minor. Prescribed prednisone.  Still in pain and can feel the area is still very hot and its itchy
Pt received Regeneron mab on 12/17 and presented for vaccination on 12/29, it was mistakenly administered.
This spontaneous report was received from a registered nurse and refers to multiple unspecified, newborn patients of unknown age and ender. The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. The registered nurse reported, that it was a routine practice at the hospital unit where the newborns are delivered to remove RECOMBIVAX HB from refrigeration and to store it at room temperature of an unknown amount of time until administration. Administered doses of vaccine experienced a temperature excursion between 47 degrees Fahrenheit to 77 degrees Fahrenheit for unknown amount of time. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
Approximately 2 1/2 - 3 hours following vaccination of MCV4 patient stated he noted neck stiffness, dizziness, sore throat, nausea without vomiting, diaphoretic, generalized malaise.  Patient states he felt like he had fever but did not check temperature.  Patient reported he slept on an off the following day with symptoms continued.  Approximately 48 hours post vaccination patient stated most symptoms had subsided.  Stiff neck with night sweats remained 6 days post vaccination otherwise must better. No treatment reported by patient.
Patient had a very large (approx. 20 cm diameter) confluent, blanchable urticarial plaque at immunization site on left deltoid, that was moderately erythematous, tender, and warm to touch. Patient denies having any fever, chills, dyspnea, or other illness.
7MAR devel gen malaise;8MAR itchy throat, h/a, rash antecubital & popliteal region;9MAR itching rash in above areas w/pealing;11MAR tx by dermatologist;12MAR tx by allergist;16MAR devel pneumonia;
thinks he may have covid; thinks he may have covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome unknown. Reporter believed had at least started vaccination course as of Dec2020 but not sure of the current vaccination course status.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of paralysis in a 82-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX. On 14th August 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain. In August 2018, the patient experienced paralysis (serious criteria GSK medically significant) and injected limb mobility decreased. On an unknown date, the outcome of the paralysis and injected limb mobility decreased were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the paralysis, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient developed severe pain at injection site after receiving initial dose of SHINGRIX. It was reported that the pain began "about 2 hours after" receiving the injection however pain had subsided, but the patient was unable to move arm due to a feeling of paralysis in her shoulder at the time of reporting. No further information was reported regarding the event.
This was 4th shot or booster; On 2JUN93 about 5AM heard noise found pt in sz, cyanotic, stiff, not breathing, t103, aspirated, post sz sleep, adm to hosp w/lt lower pneumonia & szs; t dec in 12 hrs;
19AUG97 pt exp bilat parotid swelling;pt devel rash which was pruritic;devel lt facial palsy w/minimal gag reflex & miller fisher variant of what is believed to be a GBS;ataxia & not walking;pupils do not react to light or accommodation