chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a healthcare professional  on 28 October 2015. This case involves 80-years-old female patient who was vaccinated with first dose of FLUZONE HD (batch number: UI453AA, expiry date: 30 April 2016, dose, route and site of administration were not reported) on an unknown date. Illness at time of vaccination reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergy (NKA) and cancer. Concomitant medications were not reported. On an unknown date, few seconds (immediately/within minutes) following the vaccination, the patient had developed flushing, hives and shortness of breath. The patient required ER/doctor visit. Relevant diagnostic tests/laboratory data was none. The patient was treated with Benedryl and Steroids IV. It was reported that the patient was still on IV Chemotherapy that day. On an unknown date, the patient was recovered within a half an hour (after vaccination). Upon medical review, the case was considered as serious due to important medical event: shortness of breath, flushing, hives. List of documents held by sender: none. Follow-up information received from a healthcare professional on 15 December 2015. The patient was vaccinated with a dose of FLUZONE HD, intramascularly on 1 October 2015 at 10.14 am. On 1 October 2015 at 10.15 am, one minute following the vaccination the patient had developed flushing, hives and shortness of breath. It was reported that the patient gets vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE annually. The patient required doctor visit in outpatient clinic. On 10 October 2015 the patient got recovered.; Sender's Comments: Follow up information received on 15 December 2015 changes the medical assessment as follows: Shortness of breath, hives and flushing are listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset seems compatible with a role of the vaccination. To be noted, patient had a medical history of MDS (Myelodysplastic Syndrome) which could be an alternative explanation for the presentation of dyspnea and other symptoms. Based on available information, the role of vaccine cannot be assessed as it is confounded by underlying conditions.
Symptoms started 9/28/21 with bloating/cramping. Dry but not sore throat, HA, head pressure, and fatigue. Has some minor chest pressure but no difficulty breathing. Denies fever, diarrhea, vomiting, nausea, cough. Patient concerned because she has asthma.
Pt. developed erythema and swelling of right arm and was admitted to the hospital and treated for cellulitis of right arm with clindamycin 5/5/08-records received for DOS 4/21-4/23/08-DC DX: Right arm, cellulitis. Seen in ED for C/O right arm pain, redness and edema. Injection site redness, swollen, induration, itchy and temp to 100.3 times 2 days.
Pt had an immediate bleed under the skin where the injection was given.  We had patient raise arm over head and apply ice for about 10 minutes, until bleeding stops. Checked with patient on 9/29/21 and she reports she is fine, has a bruise the size of a half dollar.
A rash that spread from my stomach to back, shoulders, neck, arms and legs; This is a spontaneous report from a contactable Other HCP (patient). A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL8982, Expiration Date: unknown) via an unspecified route of administration in left arm on 01Feb2021 (at the age 26 years) as 1st dose, single for COVID-19 immunization. Medical history included COVID prior vaccination and allergy to animal (cats). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. On 03Feb2021, the patient experienced a rash that spread from stomach to back, shoulders, neck, arms and legs. AE resulted in doctor or other healthcare professional office/clinic visit. Patient visited Dermatology, topical steroid and allergy med were given a treatment for the event. The patient was not tested for COVID-19 post vaccination. The outcome of the event was recovering.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 30-OCT-2012 13:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
As soon as 3 seconds after the shot my right hand was numb and tingling. The tingling sensation is still there and I have chronic pain in my elbow running down my arm into my ring and pinkie finger.
Unable to move arm 12 hours after getting shot.  Range of motion improved after 24 hours.  Slight lower back pain 18 hours after shot however the pain intensified over the next few hours.  24 hours after shot, unable to stand or walk.  48 hours after shot, can sit or walk for short periods of time.  96 hours after shot, can sit and walk with very little pain.  Stomach cramps 12 hours after shot, able to keep food down 24 hours after shot.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 8th April 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 8th April 2019, less than a day after receiving SHINGRIX, the patient experienced tiredness, pain in arm and rash. On an unknown date, the outcome of the tiredness, pain in arm and rash were not reported. It was unknown if the reporter considered the tiredness, pain in arm and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. On 8th April 2019, the patient received 1st dose of SHINGRIX in left arm and complained of arm pain, spots on the arm, and feeling tired. Call ended before asking if symptoms were resolved and consent to follow-up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Day 0 of testing positive for Covid; (2023) Negative; (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a female patient of unknown age with no medical history referred to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (injection, strength, lot#, dose/frequency, route and duration were unspecified). There was no concomitant therapy. On an unknown date the patient experienced pain and redness at the injection site after receiving the ZOSTAVAX vaccine. Patient did not seek medical attention. No treatment was given for the events. The outcome was reported as recovering. Additional information is not expected.
Knee pain/Joint aches in the spine area around the shoulder blade/reappearing side effect; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain/Joint aches in the spine area around the shoulder blade/reappearing side effect) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Knee pain/Joint aches in the spine area around the shoulder blade/reappearing side effect). At the time of the report, ARTHRALGIA (Knee pain/Joint aches in the spine area around the shoulder blade/reappearing side effect) had not resolved.            No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Updated vaccine route and location and updated event coding; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
injection site irritation; redness; itchiness; burning; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (injection site irritation), ERYTHEMA (redness), PRURITUS (itchiness), BURNING SENSATION (burning) and SWELLING (swelling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE IRRITATION (injection site irritation), ERYTHEMA (redness), PRURITUS (itchiness), BURNING SENSATION (burning) and SWELLING (swelling). The patient was treated with BACITRACIN at an unspecified dose and frequency. At the time of the report, INJECTION SITE IRRITATION (injection site irritation), ERYTHEMA (redness), PRURITUS (itchiness), BURNING SENSATION (burning) and SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included Bacitracin ointment.   This case was linked to MOD-2021-103479 (Patient Link).
pt recvd vax 28MAR94 & reported lt arm was sore for 2 1/2 days; couldn't lift above shoulder then it was fine; arm again was a little achy yesterday 4APR93; by evening it was swollen felt like a belt around it; woke up today swollen;
This spontaneous report was received from a medical assistant regarding a 12 month old patient of unknown gender.The patient's medical history, concomitant medications and drug reactions/allergies were not reported. On 09-NOV-2017, the patient was vaccinated with M-M-R II subcutaneous injection, lot # L041455 and expiration date 22-OCT-2017 for prophylaxis (dose number, frequency,route and therapy type were not provided). On 09-NOV-2017, the patient received an expired dose of M-M-R II (expired product administered). No adverse effects (no adverse event) reported. At the reporting time, the outcome of expired product administered is unknown.
TACHYCARDIA AND HYPERTENSION WITH ''TIGHTNESS OF THROAT", TREATED WITH IM BENADRYL, IMPROVED AND PATIENT RELEASED SAME DAY
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt was given vaccine. RPH sat with pt for  approx 5-8 mints following admin of vaccine to make sure pt feels well. He had mentioned he had passed out once before while blood was drawn. After Vaccine, RpH asked how pt was feeling and he stated he was feeling well. Him and his companion walked over with rph to designated area by the pharm to sit for at least 15 mints to ensure no rxn. After abt 10 mits pt feels lightheaded. Legs elevated bp 123/70. HR normal. pt refused ambu.ok after several mints
Pain and decreased ROM in right shoulder. Has been seen by family doctor twice and has been referred on to orthopedic doctor.
Persistent cyclical scabbing at site of major reaction. Experienced 3 episodes of fever/diaphoras + diarrhea/nausea. Within 24 hours of vaccinia 03/26/2003 (5x for 3 days); about 04/04/2003 (5x for 3 days); about 04/19/2003 (5x for 2 days). Also experienced headaches (severe) that wakened her in night along with diaphores x 4  in same time frame as above March-May. Self-treated headaches with Ibuprofen. Most symptoms resolved except persisting, worsening knee joint pain (bilat)
Localized reaction redness around injection site 6 1/2" x 6", use ice oral BENADRYL and Topical BENADRYL.
Migraine h/a, nausea, stiff neck, muscle cramps, and blurred vision also double vision.
9/19/06 9 yo brought in by mom. Noticed red raised area on right arm on 9/16/06. Area doubled in size each day until wrapping around arm. Temp 98.0. Pt c/o of itching and discomfort in reaction area. Area very red and raised. Area measures at 3"x4.5".
This spontaneous report as received from a nurse practitioner refers to approximately 18 year old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. The patient was vaccinated with first dose of GARDASIL (route, dose not reported) for vaccination on an unknown date in May 2012 and second dose of GARDASIL on an unknown date in January 2013. The reporter stated that male client was vaccinated at another facility with third dose of GARDASIL on 17-JUN-2014 (reported as today) and is late for his GARDASIL vaccination. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Changed menstruation. Started cycle a few days early after the vaccine.  Typically have mild to severe cramps and nausea requiring a day off work or a few hours with a heating pad. So far for 2 cycles I?ve had very minimal pain.  If my next cycle is easy I?ll be more convinced of the link.  Oh had Johnson and Johnson vaccine
Flush feeling all over body; Lightheaded; Weak; This spontaneous case was received 19-Jan-2021 from other non-health professional (consumer) via Pfizer (reference number: 2020502909) and concerned a female patient of an unreported age.   The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies.  On an unspecified date in 2018, the patient was vaccinated with Afluria (TIV) (influenza vaccine; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date in 2018, immediately after receiving Afluria (TIV), the patient was lightheaded, weak and had flush feeling all over her body. The patient went to the hospital, sat in the waiting room for about 30 minutes and symptoms went away totally. The patient did not require treatment.    On the same day, the patient recovered from the events.  The reporter did not provide causality assessment. The patient hadn't had a flu shot since per her doctor's advice. The patient wanted to get Pfizer-Biontech COVID-19 Vaccine, and she wanted to know what ingredients Afluria TIV and Pfizer-Biontech COVID-19 Vaccine might have in common.   The case was assessed as non-serious.  Company comment:The patient developed flushing, dizziness and asthenia on the same day after receiving Afluria (TIV). Chronology is suggestive. The patient's relevant medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed flushing, dizziness and asthenia on the same day after receiving Afluria (TIV). Chronology is suggestive. The patient's relevant medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Auto immune fair-up (Had been in remission 15 year, self managed, no medication). Visual disturbance that five days later progressed to double vison caused by eye muscle not working right. (Diagnosis - Abducens Nerve Palsy. Confirmed by both Primary Care and Optometrist). Low energy. Balance issues. Prescribed Prognozone.
C/o severe headache approximately 10 minutes after receiving Moderna vaccine. BP 100/72 initial check, then 10 minutes later went to 140/100. Patient refused evaluation by EMT. Called husband to come get pick her up. Tried to notify patient but no answer.
Reports having sore arm after vaccination and some cold symptoms but really became symptomatic 10/10/16 with fever, body aches, sore throat, congestion, wheezing and cough. HX of asthma now exacerbated. Has received flu vaccine in past with no reaction.
Pfizer COVID-19 Vaccine EUA: patient hospitalized for COVID-19 pneumonia. Intubated due to acute hypoxemic respiratory failure, received antimicrobials, steroids, and oxygen. Improved, extubated, and discharged home with home health support and oxygen.
Patient experienced light headedness and fainting after receiving vaccine. Patient was give soda to drink and issue resolved. He had not eaten all day before vaccine and had swim practice for several hours
Fever of 103.3, measles-like rash on body. Gave ibuprofen followed by acetaminophen 3 hours later.
Patient received Pfizer vaccine, before sitting in waiting area.  Almost immediately complained of SOB and tongue feeling thick.  Epipen given.  BP 180/68 HR163 POX 93% on RA.  Stat Team called.  BP down to 158/42, HR 137, Pulse ox 99% on 2L, tongue feeling better and less SOB.  Move to ER with stat team.
large red area below and anterior to injection site - slightly itchy, measuring 8 x 6 inches - woke up with it on day 2 post vaccination - not getting any worse, slightly warm to touch
I have a muscle disease, Polymyalgia Rheumatica ; side effects : extreme muscle pain when standing ,  and walking  experienced with both doses of vaccine (2/3/21 and 2/24/21)  (usual prednisone 8mg does not help the pain) went to urologist Mon Feb 8 for burning, urinary tract, no infection; (nurse practitioner said was side effect of another patient. ) this burning I experienced with the first dose of vaccine  (2/3/21); burning lasted two weeks Muscle pain experienced with both doses of vaccine took AZC pills for urinary tract burning.
Patient experienced HA and dizziness approximately 40 minutes after vaccination. Patient was monitored to have diaphoresis with slightly elevated BP ranging from 138/72- 142/88 with HR98. Patient was monitored while standing and had no changes with dizziness but had an elevated HR of 114 with BP 131/84. After sitting again patient's BP 129/81 and HR went down to 88.
Slightly itchy and painful generalized rash around my entire torso and up my neck.  Some itchiness in my limbs but no visible rash. Pt took Benadryl 25mg PO without  any relief. 5 Feb: rash is spreading around chest area lower abdomen and around back side. No reports of dyspnea.
Soon after vaccine was administered my daughter started having symptoms. It has been 6 days since the vaccine and she has high fever (over 103), muscle and joint pain, fatigue, edema and headache. We returned to facility on June 22nd and doctor ordered blood tests. Waiting on results.
Patient given Moderna.  Should have been given Pfizer due to age, under 18.  Patient accompanied with mother, patient observed for 30minutes, no adverse reaction.
Brain fog... It continued for 3 days and I could not drive. However, it continues now to a lesser degree with light headedness and loss of balance
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported   No adverse reactions were reported by any patients.   No Treatment medication reported
pt recv vax 30AUG95 & 28MAY97 pt devel 20 gen pox;
Severe pain to injection site radiating down arm and up to the neck; HA; sore throat; disorientation; vertigo; general malaise; difficulty swallowing; voice disturbance; throat tightness; nasal congestion.  OTC Benadryl x 3 doses over 48 hours.  Symptoms resolved
Small rash appeared on genitals 5 days after injection. Presumed it was a new form of diaper rash but it did not respond to creams and didn't look like diaper rash. Fever starting 6 days after immunization. To date has lasted five days and on the 12th day the rash has appeared all over his trunk, legs, arms, and face. Baby is irritable, lethargic and scratching. Highest fever recorded was just under 102 F at 101.7. Could have been higher throughout the last two nights but gave baby infant's Motrin. Should these symptoms continue to worsen throughout the day will not wait until monday to visit doctor, will take child to Urgent Care.