chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report 20010192221 described joint achiness in a 32 year old male who received Lymerix. This report was received from the pt's wife and has not been confirmed by a physician or other health professional. In January and February 1999, the pt received his first and second doses of Lymerix without adverse event. In January 2000, the pt received his third dose of Lymerix. Subsequently, he reportedly experienced general stiffness and achiness in the joints. Reportedly the pt's joint complaints have not been evaluated by a physician and he has not received any treatment for the joint complaints. Reportedly as of August 8, 2001, the outcome of the events was unresolved. The adverse events of joint achiness and joint stiffness do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Client began breaking out in hives 545 minutes after vaccine administered on legs and buttocks with itching. She applied Desonide 05% on areas (Prescription cream given to her father for itching). It provided relief but the next morning she broke out in hives again in same areas as well as under arms. Cream reapplied without relief. Benadryl cream applied PO min later with no relief. Took 25mg Benadryl PO and slept rest of day. January 22nd she broke out again and took Zyrtec. Hives resolved. No hives on January 23 but January 24th she broke out in hives again. Resolved with Zyrtec. So far no other outbreaks.
Lt arm swelling and redness noted and warm to touch Lt arm circumference 9.25" and Rt arm circumference 8". Rx for Prednisolone 15mg/5ml-10ml p.o. q day. EpiPen 0.3 mg also ordered. Swelling not relieved with BENADRYL q 6 hours p.o. No fever. On 9/9/16 at 1526 Tdap and Flu given IM in Lt deltoid.
Female who reports receiving 1/2 dose of AFLURIA vaccine in her left upper arm mid-afternoon on 9 OCT. She took her first dose of Ibuprofen 800 mg within 1 hour of vaccine receipt, and then continued to take this dose approximately every 8 hours (3 times per day) over the next 5 days. She denies any unusual or prolonged local reaction at the vaccination site. Around 2000, on the evening of vaccine receipt, patient felt more tired than usual, had a mild throbbing headache, generalized aching, and a sore throat. She denies fever or chills. She went to bed and slept through the night. On post-vaccine day (PVD) 1 (10 OCT), patient awoke with a headache that remained dull and throbbing throughout the day, despite taking Ibuprofen. (No decrease in pain intensity of headache following doses of Ibuprofen.) She felt more tired than the previous day, and she experienced "waves of nausea", with a decrease in appetite. She forced herself to eat, but did not push fluids. That afternoon, she experienced post-nasal drainage and rhinorrhea, as well as a continued sore throat and watery eyes. She did not develop a cough, wheezing, chest tightness, or facial edema. She denies vomiting or diarrhea. On PVD 2 (11 OCT), patient felt drained. Her aching was worse, but did decrease after she took doses of ibuprofen. Her upper respiratory symptoms and headaches began to wax and wane. That evening, she had difficulty going to sleep and sleeping through the night. By 12 OCT (PVD) 3, her rhinitis and throat symptoms had resolved. Regarding myalgias, headaches and fatigue, they were improving very gradually. Her nausea and decreased appetite continued, as well as her difficulty sleeping. (Denies difficulty with sleep being related to headaches, myalgias or other symptoms). She felt cold - "freezing" with chills, but no fever. She rested as much as possible over the weekend of 13 and 14 OCT. Over the next week, "it was more of the same". All of her symptoms resolved after about 2 weeks, with nausea being the symptom lasting the longest. Patient reports feeling fine on the day of vaccine receipt, with no recent infections or viral symptoms. She reports tolerating other vaccines without reactions, but prior to this year's flu vaccine, patient reports having a reaction to multiple doses of flu vaccine in the past. Prior to this year's flu vaccine, the last flu vaccine she took was in SEP 2004, which was given in her buttocks. Her reaction included body aches, headaches, extreme fatigue, chills, nausea and decreased appetite. Symptoms were severe enough, that she was bedridden for 7-10 days, and symptoms did not completely resolve for 2-3 weeks. During that course of time, she lost 7 pounds. She denies any fevers, local site reactions, hives, angioedema, respiratory symptoms, vomiting, or diarrhea. Prior to SEP 2004, she had not taken flu vaccines since the mid-90s - "took a break because of reactions each year". She reports similar episodes on more than 2 occasions within 3-4 days of receiving flu vaccines. She has never taken the FLUMIST vaccine.
allergic; Based on information previously received, the case classification and event was amended.  Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case involves a patient (gender unspecified) who was allergic (hypersensitivity), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was allergic (hypersensitivity) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company (Pfizer) concerned a 51 year old male. Initial information was processed with the additional information received on 21-DEC-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: childhood reaction to penicillin (Allergy). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: Unknown) dose was not reported, 01 total administered at left arm on 13-MAR-2021 11:00 for covid-19 prophylaxis. Age at time of vaccination 50 years old. No concomitant medications were reported.  The patient additionally received a non-company suspect vaccine included: elasomeran (Moderna) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered at left arm on 23-NOV-2021 16:00 for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with elasomeran (Dose number in series 2). The patient was also vaccinated with a non-company suspect vaccine included: elasomeran (Moderna) (Dose number in series 3) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered at left arm on 04-AUG-2022 16:00 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3).  After symptoms on Day 0 (24-NOV-2022), the patient took a rapid test and a PCR test on Day 1 (25-NOV-2022). Both were positive. The patient was prescribed Paxlovid via telehealth on Day 1 (25-NOV-2022), took first dose on Day 1. Took all doses as described, took last one on Day 6 (30-NOV-2022) for COVID-19 Treatment. After 3 days of negative rapid tests, unmasked on Day 8 (02-DEC-2022). On Day 11 (05-DEC-2022 19:00), symptoms started to return. The patient had a positive rapid test on Day 12 (06-DEC-2022). Still positive today (Day 15 /09-DEC-2022). The patient had sinus, throat symptoms and some fatigue at the time of this report (Dose number in series 3). On an unspecified date, the patient experienced confirmed clinical vaccination failure (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000264122.; Sender's Comments: V0: 20221243817-. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
- a moderate fever (38 Degrees Celsius) within the 24 hrs after the second dose; lasted for 24 hrs; took an ibuprofen pill   - headache and drowsiness appeared 24 hrs after vaccination - whole body pain appeared within the 24 hrs, lasted for 48 hrs
Approximately 12 hours after vaccine I started running a low grade fever that lasted for 3 days. Left arm was very sore. I took Tylenol to help with fever and muscle aches. On July 9th I had second dose of SHINGRIX and again 12 hours later I started running a fever that lasted 24 hours. Once again left arm was very sore. Pharmacist suggested I contact  you with information.
This spontaneous report as received from a pharmacist refers to a male patient of currently 58 years old. The pharmacist reported that he was informed by the patient itself. No information about medical history, concurrent conditions was reported for the patient. On 13-MAR-2015 the patient was vaccinated with ZOSTAVAX lot # K020802, expiration date 31-JAN-2016, dose 0.65 ml, subcutaneously. No concomitant therapy was reported. Approximately on an unknown date in 2015 the patient experienced unspecified reaction after receiving ZOSTAVAX. The patient was not treated for the event reported. The patient had sought medical attention. The outcome of event reported was unknown. No product quality complaint was involved. This case is linked to the case 1507USA009493 via same reporter link. Additional information has been requested.
Fever (T max 102.4), chills, muscle ache - started 11 hours after vaccination, continued for 36 hours Pain at injection site (max 2/10) - started immediately after injection, continued for 48 hours
Day1-5 Redness, hard lump size of a half dollar, warm to the touch, very painful to the touch Day 6 large raised rash like redness 2? wide by 2? high, all around injection site.
RIGHT THIGH SWOLLEN, RED AND WARM TO TOUCH SINCE VACCINES WERE GIVEN ON 01-24-07.  TYLENOL AND WARM COMPRESSES GIVEN BY MOTHER.  PER DR. DIAGNOSIS IS RIGHT THIGH CELLULITIS 2ND TO REACTION TO DTAP VACCIN.  MOTHER TO CONTINUE WARM COMPRESSES AND GIVE MOTRIN.
Normal soreness at injection site. After about 2 wks severe pain in shoulders and biceps. Ice bag and TYLENOL were used. Pain still elevated, hasn't decreased.
(L) arm redness @ injection site tx with - Cephalexin 50 mg 1 PO Q 8 hrs x 10 days -Prednisone 10 mg 1 PO BID x 5days
Narrative:  Patient received two doses of COVID 19 vaccine at a non-hospital site Feb/Mar 2021. The patient tested positive  for COVID 19 on 23 Jan 2022. The patient presented to the ED on 23 Jan 22 with cough and extreme weakness and was admitted to the hospital. The patient developed delirium and confusion and diagnosed with acute encephalopathy likely due to COVID 19 infection. The patient also developed hypoxemia, covid pneumonia, and sepsis. The patient was treated with remdesivir and dexamethasone. The patient died on 7 February 2022 of COVID 19 pneumonia.
Patient given expired Pfizer. Bottle transferred from Ultra Frozen/freezer to medical grade fridge on 2/10/2022. Expired 03/13/2022. Vaccine given on day 32 after transferred to medical grade Fridge. Per call with Pfizer, dose does not need to be repeated as vial is considered stabile x 45 days after transfer.
received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant medications were reported.  It was reported that, the patient received Moderna monovalent booster instead of the bivalent vaccine. According to the nurse, this happened because the monovalent vaccine with purple border was labeled as booster dose.  No adverse event noted.  No treatment medications were reported.
inflammatory issue in lower lungs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONITIS (inflammatory issue in lower lungs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung inflammation (Inflammatory issue in my lower lungs). Concomitant products included PREDNISONE for Lung inflammation.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONITIS (inflammatory issue in lower lungs). At the time of the report, PNEUMONITIS (inflammatory issue in lower lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-May-2021 and was forwarded to Moderna on 04-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONITIS (inflammatory issue in lower lungs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung inflammation (Inflammatory issue in my lower lungs). Concomitant products included PREDNISONE for Lung inflammation.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONITIS (inflammatory issue in lower lungs). At the time of the report, PNEUMONITIS (inflammatory issue in lower lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided.
At 7:57am, Patient came in to clinic to received Covid 19 vaccination given by Medical Assistant. Patient was in sitting position and fainted after receiving vaccination. Fell and hit left side of face on stand. I Medical Assistant ran out to get provider on site. Blood pressure, pulse ox and assessment was done by medical doctor. Ice pack and orange juice were ordered by Dr.  and given to patient. Patient remained sitting for 15 minutes and left clinic. This patient had same reaction during the first dose.
my throat began to swell shut; my lips became numb and tingly; my lips became numb and tingly; This is a spontaneous report from a contactable consumer (patient).   A 52-year-old (non-pregnant) female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration in right arm on 29Jan2021 10:30 as single dose for COVID-19 immunisation. Patient's medical history included known allergies from sulpha medications and latex. Patient did not receive any other vaccine in four weeks. The concomitant medications of patient included levothyroxine sodium (UNITHROID), lisinopril, nebivolol hydrochloride (BYSTOLIC), furosemide. On 29Jan2021 10:30, the patient experienced my throat began to swell shut, my lips became numb and tingly. There was no covid prior vaccination and no covid tested post vaccination. Event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment. The outcome of event was recovered on an unknown date in 2021.
I saw the eruption after it was beginning to resolve. From the initial description, it was bullae on erythematous plaques, consistent with a bullous erythema multiforme, or bullous drug eruption. This eruption began 2 to 2.5 weeks after smallpox vaccination. Eruption decreased after 4 days of prednisone.
NECK PAIN; NAUSEA; HEADACHE; FUNCTIONAL MOVEMENT DISORDER; 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 pre-existing medical conditions included the patient was healthy. 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 28-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.   No concomitant medications were reported. On 25-JUN-2021, the subject experienced functional movement disorder. On an unspecified date, the subject experienced neck pain, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, neck pain, nausea and functional movement disorder was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
hosp personnel reported inc frequencies of inj site rxn & soreness of the caller, a pharmacist;
The patient stated that the day after he got his second shingles shot (Saturday 7/29/23) he began feeling very ill.  On Sunday he had fever and chills.  On Monday he said that he went into afib which did not resolve.  He went to the hospital on Thursday to have the afib treated.  He went home but the afib continued off and on.  The following Wednesday he was admitted to the hospital for breathing problems and was diagnosed with heart failure and pneumonia. He has a history of heart valve problems and he states that it now requires surgery.
pt recv vax 5JUN97 & immed p/vax pt exp vagal response;pt turned white;
SHINGLES ON HANDS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced shingles on my hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles on my hands was not reported. This report was non-serious.
Headache, Fever, NauseaVomiting, chills, upset stomach Narrative:  Fever 101.4, headache, stomach upset, nausea, chills; took tylenol; resolved 48 hours  Other Relevant History:
felt a little tightness on my chest and like a flush of heat; felt a little tightness on my chest and like a flush of heat; Felt muscle pain with cramps from my neck down to my toes; I might feel muscle pain and head ache, but instead I Felt muscle pain with cramps; hand and feet swelling; joints pain; chills; This is a spontaneous report from a contactable consumer reported herself via Pfizer sponsored program Pfizer RXPathways. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization. Patient took the first dose of vaccine on an unknown date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was told that she might feel muscle pain and headache, but instead she felt muscle pain with cramps from neck down to toes, hand and feet swelling, joints pain, and chills that lasted 12 hours. It has been three days after being vaccinated and patient had only felt a little tightness on my chest and like a flush of heat. The outcome of events "felt a little tightness on my chest and like a flush of heat" was unknown, the other events was recovered on an unknown date.  lot/batch number has been requested in follow-up.
3/24/21 - 6:15pm Nosebleed while out at restaurant eating dinner. (Right nose) 3/26/21 - 1:15am -Awaken from sound sleep with nosebleed. (Right nostril) 3/27/21 - 7:30am - While taking morning shower, got nosebleed in shower. (Right nostril) 3/30/21 - 3:00am - Awaken from sound sleep with nosebleed. I felt extremely tired at 8:00pm prior to bedtime at 9:30pm. (Right nostril) 3/31/21 - While washing face before bedtime, small amount of blood from Right nostril.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
tender lt axilla 12hrs p/vax T98.7, flu shot 15NOV95 prescribed 17NOV9 w/soft tissue, swelling & 1.5cm tender node anterior axilla
pt recv vax 1APR96 & 3wks later pt was exposed to varicella;lab eval revealed a titer of 0.10 & pt was not immune to varicella;
local reaction @ inject site 6 days p/inject; central indurated wheal like plague surrounded by erythemaotus pruritic area measuring 12 cm overall;