chrisvoncsefalvay/vaers-outcomes huggingface dataset:
55 y/o healthy male was admistered a live internasal influenza vaccine lot number: FK2037 manufacturer MedImmune. Patient waited 15 minutes after vaccine was administered before departing clinic.
Patient developed immune thrombocytopenia purpura approximately 1 month after his second dose of vaccine. He presented with platelet count of 1. Started on steroids and IVIG with minimal improvement. Starting eltrombopag now. Clinically stable currently.
Pentacel was given as the diluent only not with the additive. The lot number of the diluent is #U6945AA. Medical director notified. Diluent portion contained DTaP and IPV and is countable per Dr.  Client will return for single antigen Hib.
more tired than after the first dose; sore arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and FATIGUE (more tired than after the first dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). In February 2021, the patient experienced FATIGUE (more tired than after the first dose). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and FATIGUE (more tired than after the first dose) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-033538, MOD-2021-033602, US-MODERNATX, INC.-MOD-2021-033538 (Linked Report). This case was linked to MOD-2021-033783.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up email added; Sender's Comments:  MOD-2021-033538:crosslink MOD-2021-033602:crosslink US-MODERNATX, INC.-MOD-2021-033538:crosslink
This spontaneous report as received from a 48 year old female patient regarding herself. No concurrent condition was reported. The patient's medical history included mono 3 years ago. There was no allergy/drug reaction. In April 2013, the patient was vaccinated with ZOSTAVAX injection (dosing details, lot#, expiry were not reported). The patient was on several unspecified concomitant medications. Approximately in 2013 (reported as 4 weeks later), the patient broke out with rash on her back and from her knees down that lasted 5 months. Approximately in 2013 (reported as after 5 months), the rash went away but itching below the knees never went away. Itching then started on her head and scalp. Approximately in June 2016 (reported as a week ago), blood and urine test done were done but the result was not reported. The outcome of 'rash her back and from her knees down' was reported as recovered/resolved. The outcome of 'Itching then started on her head and scalp' was unknown. The outcome of 'itching below the knees' was not recovered not/resolved. Additional information has been requested.
On day 8, my right arm where the injection was administered developed a rash and the area became swollen. At times I felt a burning sensation in the area. It has lasted 3 days so far and the arm still swollen and itchy.
1/09/21 rash on neck and upper chest and below breast and upper stomach, resolved by next day in AM.  Arm soreness at injection site, symptom has resolved
Pt received vaccine, was observed for the standard 15 minutes and left, driven by her mother.  In the car, pt started to complain to mother about ?fire in her throat? and difficulty breathing, itchy/rash on right arm, coughing nonproductive.First set of vitals 1550/110 99 98%, no difficulty breathing noted, but pt seemed anxious.   After 10 minutes, vitals improved to 138/98 90 97%, respirations 16-18.  Pt seemed calmer, mother felt comfortable taking her home after about 20 minutes, cleared by EMS.  REVISED:  Allergies to mycins, latex, once experienced Steven -Johnson?s in response to an antibiotic
Patient associate stated later that evening she felt her heart was racing, she felt dizzy and had chills. This patient stated the evening she received the shot she developed a headache. Patient took advil and felt better
Fever up to 101.9F, fatigue, myalgia, abdominal pain, dysuria, headache. Pt declined treatment, opted to go to ER for evaluation
About 30 min after - felty very drowsy About six hours later -   Chills fatigue fever body aches  About four hour later - heart palpitations and facial numbness About ten hours later - abdominal pain
This spontaneous report as received from a 64 years old female patient with penicillin allergy and sulfa allergy. In October 2012, "about 1 year ago in October", the patient was vaccinated with PNEUMOVAX23 1 standard dose injection. Administration route and lot# were unspecified. Concomitant therapies included FORTEO, NASONEX, multivitamins and calcium supplement, and influenza virus vaccine(manufacturer unknown), administered 2 weeks before PNEUMOVAX23. In October 2012, within 1 hour of receiving the vaccine, the patient experienced swelling, rash, and tenderness at the injection site. Events were recovered shortly after the vaccine was administered. No treatment was given. No lab test was done. The patient talked to a doctor to seek medical attention. Additional information has been requested.
pt recv vax 18NOV97 & approx 1/2 hr p/vax 18NOV97 pt exp warmth, dizziness, nausea, h/a, fuzzy vision, body soreness, body aches, rt arm soreness, & redness @ inj site;pt was not treated for event;by 19NOV97 all sx x.body soreness resolved
they had a "bad reaction" to the PNEUMOVAX 23 / they "almost died" and were sick for 10 days/ they missed 10 days of work dut to this adverse experience; were sick for 10 days; left arm swellep up to 3 times its size; migraines/they continue to experience migraines/ the patient also went to an eye doctor for the migraines; scar on their left arm at the injection site; This spontaneous report has been received from a 59-year-old female patient, referring to herself. The patient's concurrent conditions included migraines and a drug reaction or allergy to penicillin, prochlorperazine (COMPAZINE) and sumatriptan (IMITREX). Historical conditions and concomitant medications were not provided.  On 20-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) subcutaneously in the left arm once yearly (dose, lot number and expiration date were not provided) for prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine; furthermore, on the same date, the patient was vaccinated with a flu shot (dose, frequency, route, lot number, expiration date and indication were not provided) and a COVID test.  On 20-SEP-2020, the patient experienced a bad reaction to the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the reporter stated that she almost died and were sick for 10 days following administration of the vaccines and COVID test (adverse drug reaction). The patient missed 10 days of work due to this adverse experience but were back to work at the time of the reporting. The patient stated that their left arm swelled up to 3 times in size (peripheral swelling) and scar on their left arm at the injection site (injection site scar); Moreover, the patient developed migraines for 10 days and went to an eye doctor which was treated with ibuprofen (MOTRIN) 600 mg. The patient stated that there was still a scar and felt sick (malaise), she continued to experienced migraines and the swelling had gone down a lot but was still swollen. Subsequently, on an unknown date in 2020, the patient was hospitalized due to the adverse events. The reporter stated that she filled a claim.  The outcome of adverse drug reaction, injection site scar, migraine, peripheral swelling and malaise was reported as not resolved.   The reporter considered adverse drug reaction to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The causal relationship between injection site scar, migraine, peripheral swelling, malaise and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Expected: headache, low grade fever, fatigue. Not expected: more than moderate fatigue lasting more than one week, some shortness of breath during and after moderate physical activity.  Blood oxygen levels tested at home during these times averaged 95 with lowest observed at 93
AFTER VACCINE, WHILE IN OBSERVATION AREA PATIENT HAD SUBSTERNAL CHEST PAIN FOR AT LEAST 5 MIN. REFUSED TRANSPORT TO HOSPITAL VIA EMS
Patient states that within 24 hours of receiving her vaccine her arm was red and swollen to almost the size of a baseball. She had body aches all over with nausea. Also says she developed a fever blister 2 days after the vaccine.
he woke up with a blister where the vaccine was administered; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received the first dose of BNT162B2 (PFIZER-COVID VACCINE) via intramuscular on left arm on 27May2021 (Lot Number: EW0161, Expiration date: Unknown) at the age of 16 year-old as single dose for COVID-19 immunization. Medical history was none. Investigation Assessment was none. Prior Vaccinations, the patient not received any other vaccinations within four weeks. AE following prior vaccination was none. There was no additional vaccines administered on same date of the Pfizer suspect drug. Family medical history relevant to AE was none. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) from May2021 and ongoing and ipratropium bromide (ATROVENT) for chronic nasal congestion from Dec2020 and ongoing. On 28May2021 morning, the patient work up with a blister where the vaccine was administration and the blister is about the size of a grain of rice and maybe a little bit smaller. The patient took the band aid and the cotton swab of on the night of 27May2021. The AE do not required emergency room and physician office. The patient reported that the hand writing for the lot was a bit obscure and was hard to read. The patient want to known if this is normal or if this has been reported, and should he get it looked at? Relevant tests was none. The patient wasn't bothered it and wasn't received treatment. The outcome of event not recovered.  Follow-up attempts are needed. Further information is expected.
after 1 week of the shot developed injection site redness,swollen and red with induration and mild tenderness ( 06/11/2020) with out vesicles or pustules. 06/12/2020 developed fever with Tmax 101.9F ,fever runs for 4 days .mom gave tylenol 06/14/2020 Developed erythematous macular  generalized rash  and five spots of typical umbilicated red rash with central vesicles with itching. right posterior back,right arm,right hand and right anterior chest , rash is itchy. decreased appetite  but not dehydrated
One week later following my vaccination, a rather large rash appeared below the injection site. The rash was very swollen, hot and hard to touch, itchy at times, and painful with pain traveling down to the tips of my fingers. I medicated with Tylenol for four days, Zrytec for one day, applied hydrocortisone cream, and iced it with an ice pack, all without any improvement. Five days later, the pain and swelling finally went away, but the rash does still remain to this day.
Within several weeks of receiving the vaccine I had internal bleeding in my left knee and left calf muscle. The vaccine caused my auto immune disease to drop. I had serve pain and swelling in my left knee.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 17-year-old female patient who received Bexsero for prophylaxis. Co-suspect products included Fluarix Quadrivalent 2018-2019 season for prophylaxis. The patient's past medical history included migraine. On 2nd October 2018, the patient received the 2nd dose of Bexsero .5 ml and Fluarix Quadrivalent 2018-2019 season .5 ml. On 2nd October 2018, unknown after receiving Bexsero and Fluarix Quadrivalent 2018-2019 season, the patient experienced drug administration error. On 3rd October 2018, the patient experienced pain in arm, light headedness, weird feeling and migraine. On 4th October 2018, the patient experienced nausea. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the light headedness, weird feeling, migraine and nausea were recovering/resolving and the outcome of the drug administration error was unknown. It was unknown if the reporter considered the pain in arm, light headedness, weird feeling, migraine and nausea to be related to Bexsero and Fluarix Quadrivalent 2018-2019 season. Additional details were provided as follows: This case was reported by the patient's mother (GSK employee). In evening, the patient received Bexsero and Fluarix at different sites on same arm, which led to drug administration error. One day after receiving Bexsero and Fluarix, the patient experienced sore arm, lightheadedness and weird feeling. Later, the patient experienced a migraine. On 4th October 2018 in morning, 2 days after, migraine continued and patient felt nauseous. Arm was still sore but otherwise feeling better by evening. The patient did not visit to physician, emergency visit, or did not require hospitalization. The reporter agreed to receive follow up from GSK.
CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) once a total dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fever, and chills. This report was non-serious.
Heavy, painful menstrual bleeding occurred the day after vaccination. Menstrual period was not expected to start for another 2 weeks.
Patient had a febrile seizure and was seen at the ER.   Patient was treated with Tylenol and Motrin
Three months after my second dose of the vaccine, I felt chest pressure on 04/24/2021. I was not having trouble breathing and my breaths did not seem as breath because it hurt. I went to Urgent care and later returned to the ER. I saw my Primary care doctor and she said she could not hear my breath sounds well. I got a breathing treatment and it helped a little. I was given Steroids and an inhaler. I used the inhaler twice per day but after ten weeks I am down to once per day. I have since been diagnosed with Asthma and I have never had any Asthma symptoms before. I still feel pressure on my chest which happens intermittently.
Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized; restless; angry; Couldn't sleep after Day 2 AM and PM doses; Racing heart; Racing thoughts; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized), RESTLESSNESS (restless), ANGER (angry), INSOMNIA (Couldn't sleep after Day 2 AM and PM doses) and PALPITATIONS (Racing heart) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035c21a, 010a21a and 010a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Chemotherapy (I've taken steroids in the past as part of my chemotherapy treatments.). Concurrent medical conditions included Drug allergy (kna) and Breast cancer. Concomitant products included TAMOXIFEN from 07-Jun-2021 to an unknown date, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) from 17-May-2022 to an unknown date and GABAPENTIN from 28-Mar-2022 to an unknown date for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022, the patient experienced ENERGY INCREASED (Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized), RESTLESSNESS (restless), ANGER (angry), INSOMNIA (Couldn't sleep after Day 2 AM and PM doses), PALPITATIONS (Racing heart) and TACHYPHRENIA (Racing thoughts). At the time of the report, ENERGY INCREASED (Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized), RESTLESSNESS (restless), ANGER (angry), INSOMNIA (Couldn't sleep after Day 2 AM and PM doses), PALPITATIONS (Racing heart) and TACHYPHRENIA (Racing thoughts) outcome was unknown.            Patient was on Steroids. The patient hadn't taken any other medications/products within 2 weeks of starting COVID-19 treatment. Stopped taking Paxlovid after 4 doses. Device Date : 22May2022. Treatment information was not reported.
swelling & discomfort @ site, lanced area, sterile cult, no sure if recovered;
Pt started to had redness and pain to arm then went to ER on 1/1/11 secondary to increased redness and warmth to arm. Patient diagnosed with cellulitis and given IM Rocephin and oral antibiotics and is improving
Myalgia & Arthralgia Narrative:  MYALIA, ARTRHALGIA AND LETHARGY REPORTED
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (lot # not reported) on 05-AUG-2010. On 13-JUL-2011 the patient was vaccinated with dose 2 GARDASIL (lot # not reported), which was late. No adverse reaction reported. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 22Nov2021 as dose 3, (booster) single (Batch/Lot number: unknown) at the age of 66 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High BP (moderate). Concomitant medication(s) medication in 2weeks included: AMLODIPINE, start date: 01Jan2017, OLMESARTAN, start date: 01Jan2017; GLUCOSAMINE 1500mg & CHONDORITIN 1200 mg, start date: 01Jan2017; FLAX SEED OIL 1000 mg, start date: 01Jan2017; KLOR-CON 10 meq, start date: 01Jan2017; CHLORTHALIDONE 25mg start date: 01Jan2018; PANTOPRAZOLE, start date: 01Feb2022; VITAMIN D3, start date: 01Jan2020; ZINC, start date: 01Jan2021; Alive Multi Vitamin 200 mg, start date=01Jan2017, COENZYME Q10 [UBIDECARENONE], start date: 01Jan2017; ASPIRIN 81, start date: 01Jan2017; BENZONATATE 100mg, start date: 08Apr2022, stop date: 27Apr2022; ADVIL [IBUPROFEN] 200mg, brand= Advil, taken for sinusitis, hypersensitivity, start date: 09Apr2022; TURMERIC CURCUMIN taken for sinusitis, hypersensitivity, start date: 01Jan2017. Past drug history included: Vioxx, reaction(s): "Drug allergy"; Caffeine, reaction(s): "Drug allergy". The following information was reported: COVID-19 (medically significant) with onset 14Apr2022, outcome "unknown", described as "Had several home and Rapid tests - still positive"; DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown result, notes: Took PCR test today. Awaiting results; Negative, notes: Tested negative on Rapid and PCR test; positive, notes: several home and Rapid tests - still positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Anti viral details, product= COVID-19 Treatment, brand=Pfizer Paxlovid, treatment start date=08Apr2022, treatment stop date=12Apr2022, indication=Treatment of COVID-19. Adverse event: Took Paxlovid as directed by (name) Clinic Nurse Practitioner (after also consulting with my primary care Doctor), For five days as directed. Felt better on 5th day. Tested negative on Rapid and PCR test. Then had relapse with similar symptoms for next two weeks. Had several home and Rapid tests - still positive as of this week. Took PCR test today. Awaiting results. Adverse event start date: 14Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt had fever to 105 w/a 1-2min tonic clonic gen sz
None known at this time, vaccine was given today, supervisor/doctor/parent notified of error.
4PM t100 mom noted trembling/shaking overall-T cont to inc to 103 despite APAP; when seen @ 1130 T down to 98.6 w/Advil
About 3 minutes after giving the child the immunization the area was red and swollen. Recommended cold compresses call in am following day if SX do not improve.
Started with painful spasms in the right jaw and swollen, then remains numb and swollen for many hours.  Now , in the third day after I?m still swollen and numb, but less. Also experienced pins and needles in the body,  in different parts.
Pt. had the shot on Sunday on Wednesday (6/29) she called and complained of tiredness, weak, dizziness she wants to know if it was the yellow fever vaccine that was causing it. She stated that she is anemic.
Marked edematous swelling of extremity developing over 48 hr. Non painful. Treatment Benadryl.
the next day the doctor notice redness on left arm at injection sites of vaccine and 2 days later patient developed a fever of 39.3 C
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be 1) 10-AUG-2012 and 2) 20-AUG-2013. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Lethardgy X1 week, diarrhea X4 for one night week 3 Narrative: