chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician via a Pfizer representative. A 19 year-old male patient of unspecified ethnicity received a single dose of TRUMENBA via an unspecified route of administration, on 12Jul2016 at 11:00. Relevant medical history and concomitant medications were not reported. The patient experienced body ache and nausea on 13Jul2016, approximately at 3:00 pm. The patient was afebrile, and he did not have pain, redness, tenderness or swelling at the injection site. The patient was recovering from the events. The physician believed that the events were related to the vaccine.
Had chills, muscle pain, headache on the same day of vaccination and went away with Ibuprofen. On day 5 developed a burning rash in the middle of the night.  Currently taking Benadryl, but still have the rash.
Immediately had a 15x20mm induration @ inject site lt arm-ice applied immed; per MD to give DPH; rt hip induration immed started to receed; BP 110/40, P82, no wheezing;
Patient experienced dizziness, fainting,  sweatiness, and blurry vision 10 minutes after receiving the vaccine. Pharmacist asked patient to sit down and remove facial covering. Pharmacist took blood pressure, first reading was 104/56.  Pharmacist offered patient water to drink and continued to monitor patient's symptoms for 40 minutes. Pharmacist took another blood pressure reading and the results were 129/73. Patient stated he no longer feel dizzy or feel fainting. Patient's father took patient home. Pharmacist called patient 2 hours after he left pharmacy. Patient stated he has severe headache. Pharmacist advised patient to take one Tylenol and eat some snack.
Pt received a PPV23 on 01/26/2011 and relates the next day upper arm was swollen and hot.  C/o nausea that afternoon of 01/27.  Told her to try Benadryl and Tylenol as well as ice, and within the hour patient went to the ER for c/o light headedness along with the other symptoms.  CBC w/diff was done and was normal.  Was given Tylenol and Benadryl and the next AM felt much better.
Vomiting, fever, chills starting at 2am (apprx 9 hours after vaccination) Vomiting continued for 5 days. Prescribed Zofran at urgent care for nausea.
Woke up the morning of July 4 with an itchy top lip. The next morning it was pink and still itchy. By July 6-8 my top and bottom lips were so swollen, itchy and sore I couldn?t function regularly. It took a full week to recover after icing, applying an Origel product, Motrin and lip balm. The entire process happened again a week later and I have now not had an issue since July 24.
Patient diagnosed with Flu Type B on 12/18/12. Given TAMIFLU. Patient received FLUZONE on 10/06/2012.
New onset urticaria and angioedema; New onset urticaria and angioedema; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 12 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: ANGIOEDEMA (medically significant), URTICARIA (non-serious) all with onset 05Jul2022, outcome "not recovered" and all described as "New onset urticaria and angioedema". The events "new onset urticaria and angioedema" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of angioedema, urticaria.  Clinical course: On 15Jul2022 patient took dose 2 covid-19 Pfizer vaccine through intramuscular, left arm location, lot number was not available or not provided to reporter at the time of report completion. Antihistamines, Montelukast, prednisone, Xolair are the treatment received for the adverse events. Prior to COVID Patient took vaccination. No Covid test was performed post vaccination. No known allergies. Other medications in two weeks: No. Facility type vaccine: Pharmacy or Drug Store.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event urticaria and angioedema Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had numbness loss of feeling to leg leg. Was admitted to Hospital for 5days.  Had intermittnet seizure type episodes. Has had labs and  imaging tests that have been neg Under the care of the A Neuro Group. MRI scheduled for 1/20/21.  As of 1/20/21 feeling better but still weak.
Sore shoulder; Patient believe he received the wrong amount for the first dose; Patient believe he received the wrong amount for the first dose/He stated on his immunization the 1st he received is 0.5ml 50 mcg; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient believe he received the wrong amount for the first dose), ACCIDENTAL UNDERDOSE (Patient believe he received the wrong amount for the first dose/He stated on his immunization the 1st he received is 0.5ml 50 mcg) and ARTHRALGIA (Sore shoulder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History was provided by reporter.  Concomitant products included APIXABAN (ELIQUIS) from 15-Feb-2021 to an unknown date for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 50 mcg. On 15-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Patient believe he received the wrong amount for the first dose) and ACCIDENTAL UNDERDOSE (Patient believe he received the wrong amount for the first dose/He stated on his immunization the 1st he received is 0.5ml 50 mcg). On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). On 15-Mar-2021, INCORRECT DOSE ADMINISTERED (Patient believe he received the wrong amount for the first dose) and ACCIDENTAL UNDERDOSE (Patient believe he received the wrong amount for the first dose/He stated on his immunization the 1st he received is 0.5ml 50 mcg) had resolved. At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-369453, MOD-2021-369454 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Significant Follow up - event added On 02-Nov-2021: followup appended contains patient dose details, event updates, patient demographic updates, concomitant drug updates, reporter updates
Experienced shortness of breath and nausea approximately 5 minutes after receiving injection. Shortness of breath subsided within a few minutes, nausea within about 15 minutes.
Blood clot R upper leg.  4/24 left lower leg deep tissue pain x 1 week.  R lower leg pain 5/10 or 12 x 1 week.  Then redness started 5/31 saw Urgent care  6/1 started abx Bactrim DS 6/2 though was lymph node 6/4  increased swelling saw doctor. Clinic sent for US  + for blood clot started blood thinners on 6/5
After 2nd set of shots, some spastic movement noted, but most noticeable was after her 3rd set (June 2000), her speech, (babbling & saying da-da) had stopped and has not said anything since.
pain and soreness at the injection site lasting 3 days, he did not seek medical attention and it is no longer causing pain.
Exactly one week after vaccination, patient woke up to red rash on most of body but denied itching, pain, shortness of breath, swelling or swelling of throat. Patient decided to see MD and get MEDROL DOSEPAK to help if was allergic reaction.
I got my flu shot Wednesday and Thursday evening I couldn?t feel my legs. I was diagnosed with gullian barre syndrome due to the vaccine
had 4 shots and I have had COVID; had 4 shots and I have had COVID; have had 4 shots and I have had COVID, got it again; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 17Feb2021 as dose 2, single (Lot number: FL9267), in left arm, on 22Sep2021 as dose 3 (booster), single (Lot number: FD8448), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN taken for blood pressure measurement (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing). Vaccination history included: Shingrix (Prior Vaccinations (within 4 weeks): , Stated may have had the Shingrix Vaccine in February.  Manufacturer: Unknown , Lot Number: Unknown , Route, Anatomical Location: Unknown), administration date: Feb2022, for Immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "had 4 shots and I have had COVID"; DISEASE RECURRENCE (medically significant) with onset 2022, outcome "unknown", described as "have had 4 shots and I have had COVID, got it again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) had covid in Jun 2022 or Jul 2022. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical course: It was reported that, Patient have had 4 covid 19 injections with Pfizer with no problem and he was not 6 months out since the last one and he have an appointment in 3 hours for the other one. His wife was all of a sudden concerned and he told her he would call Pfizer and ask.  Is there anything different, really different with this Pfizer shot than the other 4 that he previously got. any side effects from any of it Are the side effects worse, Caller stated, he had no side effects from any of it. During conversation with the caller, he does also mention having had COVID. Further clarification provided and he did contract COVID after already having received his Pfizer COVID 19 Vaccination. Caller said "It didn't happen right away, it happened in June or July, not right away. Had the shot in April. There are break through cases." He have had 4 shots and he have had COVID, got it again, such a slight case, didn't know he had it, pretty much he was thinking 6 months down the line the proper precautions would be to take the new product at this time. He was calling about the Pfizer Covid 19 vaccine. He has had a total of four. He will get the Bivalent Booster today. However, he mentioned he had Covid in June or July. His last dose of the Covid-19 vaccine was in April; about six months ago.  No follow-up attempts are needed. No further information is expected.
Swelling in arm for several days . 7/9/ 2021 noticed pimples on hand and wrist.
Patient received  shot  on Saturday 10/12/2019  and by Monday Oct 14 2019 she developed  cellulitis in her upper  arm opposite of the injection site.
A report was received from a health care professional on 12/2/03 concerning a 7 year old female vaccinee who inadvertently received 0.25ml Fluvirin on 12/1/03. On 12/1/03, the vaccinee inadvertently received 0.25ml instead of 0.5ml of Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was vaccinated again with the correct dose of Fluvirin on 12/11/03. The vaccinee did not experience any adverse reaction at the time of the report. Follow up received 6/30/04 reporting no adverse events after the vaccinee was revaccinated on 12/11/04.
Severe fatigue and sore, scratchy throat.  Within hours myalgia, malaise, feeling of fever, burning eyes, sneezing, and cough.  Normal body temp of 98.2 became elevated to 99.2 three days later, accompanied by headache.  Treated with Tylenol and Cloraseptic until doctor visit five days later prescribed Flonase.
Shot was given 5/20/13 at 11:30AM at Dr. office evening of 5/20/13 left arm began to hurt and continued to hurt really bad unable to lift arm unable to sleep unable to move it at all pain was so bad went to ER. 5/21/13 at 2:00AM had ultrasounds and X-rays given pain meds severe pain entire arm shoulder and neck.
Pulmonary stenosis; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PULMONARY VALVE STENOSIS (medically significant), outcome "unknown", described as "Pulmonary stenosis". It was unknown if therapeutic measures were taken as a result of pulmonary valve stenosis. Clinical course: Patient who was a nurse reported that she developed pulmonary stenosis following the Pfizer vaccine. It was unknown if other vaccine in four weeks, Other medications in two weeks, had covid prior vaccination and if covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event PULMONARY VALVE STENOSIS  and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Myalgia Narrative: Employee states: she felt fine the rest of the day after the second dose but then around 1am the following morning she began to experience myalgia and overall achiness. That morning still felt myalgias especially achy around joints (hips, knees, neck). Took 400mg ibuprofen then around 6:15pm she began to experience severe burning pain the the leg muscles below the hips and took more ibuprofen. Additionally she experienced moderate pain in the arm/injection site which she did not experience with the first dose.
Has trouble hearing in right ear.  Hearing is impaired, started about 3 days after vaccine administration.  Still impaired.  Not improved yet.
left deltoid region has the redness and tendernes following  meningococcal and TdaP vaccines there was No fever and not too much of discomfort.
Sore arm; Flu symptoms (cough); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INFLUENZA (Flu symptoms (cough)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INFLUENZA (Flu symptoms (cough)). On 24-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, INFLUENZA (Flu symptoms (cough)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. No treatment details was provided.   This case was linked to MOD21-034179, US-MODERNATX, INC.-MOD-2021-018287 (Linked Report).; Sender's Comments:  MOD21-034179: US-MODERNATX, INC.-MOD-2021-018287:
SEVERE PAIN / SORENESS AT INJECTION SITE - STARTED OVER 24 HOURS AFTER VACCINATION PER PT. - SEVERE PAIN/DISCOMFORT OVERNIGHT. DISCOMFORT/PAIN CONTINUED 4/3/13 SO SHE CALLED PHARMACY. NO OTHER REACTIONS (FEVER, RASH, HEADACHE, ETC...)
pt was seen in Urgent care on 14AGU92; mom stated pt vomited during noc, had high fever, seats, & sore arms; t97.1;
At first, tenderness. By evening, I felt SEVERE pain and now I cannot lift my arm to dress myself. I can barely type, drive, or do anything with my right arm. The pain is all through my upper arm, shooting down to my fingers, armpit, and to my shoulderblade. I cannot sleep on that side, and even the sleeve of my shirt hurts when it lays on my arm.
Per pt hx. small (app 10mm) area of swelling and redness @ injection site noted upon working 2/7/02. Reports gradual increase in size of local reaction and itching on2/12/02 local reaction @ injection site 2 1/2" X 2" of redness with slight amount of swelling. Tender to touch and itching. Generally feels bad, feels like she is coming down with something.
feeling something weird, a lump on the left side of her neck between shoulder and neck; tender at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MASS (feeling something weird, a lump on the left side of her neck between shoulder and neck) and VACCINATION SITE PAIN (tender at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (tender at the injection site). On 30-Mar-2021, the patient experienced MASS (feeling something weird, a lump on the left side of her neck between shoulder and neck). At the time of the report, MASS (feeling something weird, a lump on the left side of her neck between shoulder and neck) and VACCINATION SITE PAIN (tender at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   On 13th April 2022, the patient received Engerix B. On 13th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-Apr-2022 Reporter's Comments: Nurse reported that a female patient received on13th April 2022, an expired dose of Engerix-B by error. The reporter consented to follow up via email please. The Healthcare professional did not allow to create an account in database. Additional Supportive Information: The patient received expired dose of Engerix B, which led to expired vaccine used.
2nd dose of Shingrix given earlier than the 2-6 month interval; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number F4LV5, expiry date 27-SEP-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 19-OCT-2023, the patient received the 2nd dose of Shingrix (left deltoid) .5 ml. On 19-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose of Shingrix given earlier than the 2-6 month interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2023 HCP called to report the maladministration of a 2nd dose of Shingrix given earlier than the 2 to 6 month interval. The patient received the 1st dose of Shingrix on 2nd October 2023. The 2nd dose was given 3 weeks after, on 19th October 2023 which led to shortening of vaccinations schedule. The HCP reported that the patient did not have any events following administration and had left the office before the maladministration was known. The reporter agrees to follow up from GlaxoSmithKline.
Developed abdominal pain and purpura on legs consistent with Henoch-Schonlein Purpura flare. (She had initial HSP presentation 3 years previously). Symptoms resolved over 5-6 days.
During appt. on 4-3-23 pt. had allergic reaction  to vaccines on Left arm after vaccinations.  Redness at vaccination site was noted.  Benadryl 12.5mg 15 ml 7.5ml administered.  Pt. observed over 15 minutes, redness improved 4-3-23- No respiratory distress or rash noted at injection sites Labs drawn on 4-3-2023 for seasonal allergies Pt. mom reports allergy to TDAP vaccine.  Suspected allergy reaction to TDAP/Boostrix. 4-6-23 Called and spoke with pt. mom, reports redness on  Left arm at injection site the next day on 4-4-23. Has since gone away. Also reports soreness in both arms at injection  site and bruise on Left arm where injection site reaction ocurred.  Denies symptoms of itching, shortness of breath, difficulty swallowing or fever  To follow up with provider in regards to labs  drawn on 4-3-23 when results are in
Guillain barre; Vertigo; Cannot walk at all; weakness in my lower extremities; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain barre) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 GUILLAIN-BARRE SYNDROME (Guillain barre) (seriousness criteria hospitalization prolonged and medically significant), VERTIGO (Vertigo), GAIT INABILITY (Cannot walk at all) and MUSCULAR WEAKNESS (weakness in my lower extremities). The patient was hospitalized for 45 days due to GUILLAIN-BARRE SYNDROME. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain barre), VERTIGO (Vertigo), GAIT INABILITY (Cannot walk at all) and MUSCULAR WEAKNESS (weakness in my lower extremities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided. Company comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.