chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild arm pain; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild arm pain on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pfizer 1/18/21, 2/8/21, 1/13/22. Positive on 1/20/22
Had minor itching/ pins and needles feeling sporadically at different locations of my body starting about 1 hour after vaccine injection.  Pins and needles feeling grew less and less each day. All symptoms gone by day 6 after vaccine injection.  As a side note, my last flu shot was about 8 years ago and I had the same symptoms after the shot.
Muscle spasms involving small muscles in various different parts of body eg face, arms, legs which have persisted since 1-2 weeks post vaccination.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, doses of improperly stored GARDASIL (dose, lot# and route were not reported) were administered to these patients. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Two week after receiving DTaP, IPV, Comvax, MMR, CPX child was seen in ER because of listlessness. She (mother said) PMD said child was dehydrated and ordered Pedialyte (nothing else). Mom said ER report said "Viral Immunization Sequallae". Symptoms lasted 3-4 days?
No symptoms day of, no pain to injection site. Next morning, approximately 18hours after injection, mild pain to injection site. By 10am following day a headache came on lasting greater than 12 hours. Severe exhaustion. 3pm following day, low grade temperature
Patient stated that the second day after receiving she received the normal symptoms and then she started twitching. patient stated the twitching  is constant and has not stopped and it happens all over her body.
This initial spontaneous case, was received on 19-Oct-2017, from other non-health professional, concerning a 36-year-old, adult, male patient. The patient's medical history included confusion. The patient's concomitant medication included ADDERALL. The patient did not receive any relevant concomitant vaccines. On 17-Oct-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT59806, expiry date: 05-Jun-2018). On the same day, the patient had headache. The patient was taken to emergency room, but was not admitted. Treatment measures for the event were reported. The patient received from the event on the same day (17-Oct-2017). The reporter assessed the event was non-serious.
Marked redness 1.5x2.5 inches redness and induration of left upper arm at the site of DTaP and IPV injection.
vaccine administered 04/14/05-9:00 AM. 3:30 PM- numbness, tingling in tips of fingers radiating to mid forearm of arm vaccine was administered (left). 6:00 PM- playing soccer, noticed heavy feeling in arm and breathing difficulty. Seen in ER. 04/15/05- numbness and tingling still present in left hand and fingers to the wrist. In ER pt with rapid heart rate. Care advice: Referred pt to be seen in MD office in AM When called mom back she stated that child told her that her chest feels like something heavy is on it. Mom is concerned and took to ER nearby. ER: General: Somewhat anxious-appearing lady but in no distress. Vital signs: BP 102/60, P 82/ regular, R 18 unlabored, O2 sat 100% on room air, T 97.7. HEENT: mouth moist with clear throat. Neck: Supple non-tender, Lungs: Clear to ascultation and percussion, Heart: regular rate and rhythm, no murmurs or gallops. Chest: some slight tenderness over back and chest wall. Extremeties: some slight decreased sensation of left hand and slight decreased grip. Some slight tenderness over left shoulder and arm area. Abdomen: soft, flat, nontender. Neurologic: normal. Probable reaction to rabies vaccine. Advised to drink plenty of fluids, and Eat well. Get some rest tonight and touch base with MD in office tomorrow, this is who is administering vaccine and they can decide if they need to proceed on with this. If not improving by tomorrow morning need to see her MD, If it gets much worse tonight, instructed to go to the ER.
Presented to the ED due to midsternal dull ache in his chest. Two days prior, he had received his second Covid-19 vaccine dose. EKG was done which showed sinus tachycardia without ST elevation. Troponin was found to be elevated. Was given motrin, which improved chest pain. Consulted cardiology who recommended admission to hospital. Believed to be myocarditis secondary to covid vaccine. Upon admission, began trending troponin and obtained echo. Echo was read as normal. Troponin began doubling with each check, prompting a consult to cardiology. Cardiology recommended moving to once daily troponin checks, repeat EKG, and beginning aspirin. Repeat EKG was significant for ST elevation. GI was consulted for stress ulcer prophylaxis due to aspirin and recommended beginning protonix, and discontinuing prevacid.  Another repeat EKG was ordered which was significant for ST elevation similar to last EKG. When troponin began downtrending, patient was assessed for discharge and discharged yesterday 8/26/2021.
TOOK VIVOTIF TOO CLOSE TO TRAVEL; This spontaneous case report was received from a pharmacist (PVX2019-540) on 28-Feb-2019. The report describes a female consumer who "took Vivotif too close to travel". The consumer was receiving Vivotif (lot number: 3003248 and expiry date: Nov 2019) for an unknown indication.  It was reported that the consumer started Vivotif on 25-Feb-2019 and she will be leaving on 01-Mar-2019.  The action taken with Vivotif with respect to the event "took Vivotif too close to travel" was not applicable.  The clinical outcome of the event "took Vivotif too close to travel" was unknown.  Company's Comment: The causality of the event "took Vivotif too close to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif too close to travel" was considered as not applicable.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (lot# M037248, expiry date: 21-FEB-2019) (dosing details were not reported) for prophylaxis (incorrect product storage). Information regarding prior excursions was unknown. Temperature/Time Frame as follow: 32 Fahrenheit (F) to 35 F and 47 F to 77 F for 345 hours over a 90 day period. Call was not because of data logger. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA001550: US-009507513-1704USA014865: US-009507513-1705USA001549:
This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient third dose (booster) of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 68 years), as dose 3 (booster) single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first and dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 68 years), as dose 1 and dose 2, single dose for COVID-19 immunisation. The patient reported that can the Booster shot increase white blood cell count. He had a booster shot and had taken blood tests the following day on an unspecified date. His white count was 16000. He normally run between 11 and 12000. The patient stated that there was a potential increase in his white blood cell count after getting the booster dose of the Pfizer BioNtech Covid-19 Vaccine and that both of his doctors weren't sure if this was brought about by the vaccine. He was advised by the doctors to see a hematologist. The patient underwent lab test and procedure included white blood cell count was 16000. I normally run between 11 and 12000 on an unspecified date. Outcome of the events was unknown.
Patient reported allergic reaction after receiving 1st dose with associated facial rash, swelling and pruritis. No SOB or difficulty swallowing.  After discussing risks vs benefits, 2nd dose was not administered today.
I received the Pfizer vaccine on Friday afternoon, and the rash presented on the face (both cheeks and forehead), chest, and both arms on Saturday morning.  I also woke up with puffy cheeks, and the swelling is now gone.  The facial rash is itchy, and there is tiny pustules present?however, no shortness of breath, sore throat, fever, anaphylaxis, or other severe symptoms.
Per mom noticed Saturday morning (10/27) area red and swollen gradually gotten bigger now softball size. Warm to touch, and itchy. KEFLEX BID started for cellulitis. Sight marked for increasing severity.
Approximately 6 hrs after vaccination, patient experienced swelling and itchiness at the injection site.   The swelling was approximately 4 inches in diameter.  Patient took benadryl and used hydrocortizone cream and a cold pack.  The symptoms did not resolve, and did not worsen.
Sore tender arm for 4 days. Headache. I started to menstruate a week early, beginning yesterday, 10/24/2021. Today, 10/25/21 I woke with severe cramping and inflammation in the area  around my uterus. The cramping is causing me to miss work today which isn't normal for me.
This spontaneous report was received from an office manager (health professional) via a field representative regarding a 12 week old patient of unknown gender. No historical or concurrent conditions were reported. On 28-DEC-2015, the patient was vaccinated with first dose of oral ROTATEQ (lot # unspecified). On 18-JAN-2016, the patient was inadvertently vaccinated with another dose ROTATEQ. No concomitant medications were reported. No symptoms were reported. No product quality complaint (PQC) was reported. No further information was provided. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases: A0756483A - A0756503A, A0756505A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received from batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received from batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
On 9/25/99, had a fever and was up all night. On 9/30/99, onset of autism, eating problems, sleeping problems, chronic diarrhea, hyperactivity, hand flapping, constant lining up of objects and never developed language from 9/23/99 through 4/00.
start to bleed; leg started to itch, middle of my back, my lower back; scratched; This case was reported by a consumer via interactive digital media and described the occurrence of skin bleeding in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2022, the patient received the 1st dose of Shingles vaccine. In December 2022, 1 week after receiving Shingles vaccine, the patient experienced skin bleeding, itchy legs and scratch. On an unknown date, the outcome of the skin bleeding, itchy legs and scratch were unknown.   It was unknown if the reporter considered the skin bleeding, itchy legs and scratch to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media.  The patient received 1st shot in the first part of December. The reporter reported that about a week after vaccine patients leg, middle of back and lower back start to itch. The patient scratched so much and start to bleed. It did not hurt it was just the itching that drives. The follow-up could not be possible as no contact details were available.
Aching on right side - everywhere. 10/22/10 aching & rash on right side - increasing each day even into today 10/27/10. Has been to Dr. several times. Dx: Shingles. On Acyclovir & Prednisone.
9/21/09 Received TC from client-received AFLURIA yesterday-stiffness in neck today. Questions if flu shot related. Advised call MD-putting ice on site, sore and took TYLENOL.
" Per program and FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and DHA instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes."
27APR94 24 hrs following vax started w/elevated oral t101.5 & severe h/a @ base of occipital region both lasting 5 days today 9 days later t100 & h/a improved; also exp sore throat;
On Wednesday 2/16/22 a patient (11yrs 6months old) received the adult (12yrs and up)  Pfizer BioNtech COVID 19 dose. Dr discussed error with father. Patient was monitored in the office following dose and followed up on. No adverse side effects or symptoms experienced by the patient or reported by parent. Teammate counseled on error. Patient will follow up in 21 days to receive correct 2nd dose.
24 hours after vaccine developed headache (x4d) then dizziness (x 3 days with lingering fatigue x7 days and ongoing). RUQ abd discomfort began 6 days post vaccine. Telephone report-  advised to see own physician in his home town.
12 minutes into monitoring, patient felt lightheaded and dizzy. She is diabetic. She hasn't eaten anything. Vitals taken. She ate a snack and felt better at 1:40 pm. Continued to monitor until 1:53 pm. Symptoms improved.
Lip swelling.  Took Benadryl, symptoms resolved 15 minutes later.
Nauseous after the 2nd dose; Stomach ache after the 2nd dose; Gassy after the 2nd dose; Headache after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous after the 2nd dose), ABDOMINAL PAIN UPPER (Stomach ache after the 2nd dose), FLATULENCE (Gassy after the 2nd dose) and HEADACHE (Headache after the 2nd dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0488b21a) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No medical history was provided by the reporter.  Concomitant products included Thyroid medication for Thyroid disorder.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (Nauseous after the 2nd dose), ABDOMINAL PAIN UPPER (Stomach ache after the 2nd dose), FLATULENCE (Gassy after the 2nd dose) and HEADACHE (Headache after the 2nd dose). At the time of the report, NAUSEA (Nauseous after the 2nd dose), ABDOMINAL PAIN UPPER (Stomach ache after the 2nd dose), FLATULENCE (Gassy after the 2nd dose) and HEADACHE (Headache after the 2nd dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
28JAN96 had 2 sz;1 @ home witness by parents lasting 45seconds;was transported by EMT to ER where second sz was witnessed by ER MD lasting 30seconds;pt was afeb,99R EEG nl;
Dull headache (persistent, now Day 6 that won't go away and is troubling me); Fatigue (continuous, now Day 6, Can't keep my eyes open). Both headache and fatigue persist almost a week out.   Symptoms 24-48 hours following the vaccine included: Low-grade fever 100 degrees F Sharp menstrual cramps (I am in menopause) Dark bruising on top of right foot (below 3rd finger and pinkie) Nausea Shoulder soreness surrounding the site of injection Feeling in a daze Fatigue (see above) Dull headache (see above)
This medically confirmed spontaneous report (initial receipt 17-JUL-2014) concerns a 57-year-old male patient. The patient had drug allergy to codeine. On 23-OCT-2013, the patient received AFLURIA (batch number not provided) in the left deltoid. On 27-NOV-2013, the patient received subcutaneous ZOSTAVAX (batch number J008433, expiry date: 11-OCT-2014) at 0.65 ml.  On an unspecified date, after receiving ZOSTAVAX, the patient experienced pain at the injection site of left upper extremity. The pain at injection site had continued. The patient had soreness at the injection site especially when lifting her arm, where he received a flu shot one month earlier. Outcome was not reported.
pt had local reaction occur 24 hrs p/vax reddness & hard knot, warm to touch; area is 6x6 in diameter;
Chills, fever, fatigue, muscle soreness, headache, muscle pain, skin sensitivity
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. In 2015, the patient was inoculated at a clinic (by an unspecified health care professional) with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-APR-2016, the patient was treated (by an unspecified health care professional) at a hospital (It was not further specified if the patient was admitted to the hospital.) for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Chest pain, random little pains, with tightness, after first vaccine; Chest pain, random little pains, with tightness, after first vaccine; Heart palpitations, fast beating after first vaccine; Heart palpitations, fast beating after first vaccine; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179, Expiry date: not reported, at the age of 26 years), dose 1 via an unspecified route of administration, administered in Arm Left on 27Aug2021 18:00 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She never had heart palpitations before. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No adverse events following prior vaccinations. The patient experienced chest pain, random little pains, with tightness, heart palpitations and fast beating (all throughout the day) 2 days after first vaccine on 29Aug2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Transverse myelitis. Received Flu shot on 10/10/11 at local pharmacy. Seen in ED 10/17/11 got oral steroids. Saw Dr. 11 days later on 10/21/11. Referred to neurologist shortly after for tx w/ IV steroids.
Patient is a home care patient through our public health agency and one of our home care nurses assigned to this patient administered a flu vaccine on 10/9/2015 at this patients home.  It was reported to the immunization nurse  on Thursday October 22, 2015 that patient was in a Burn unit with Steven Johnson Syndrome.  Nurse reported patient had Steven Johnson Syndrome a long time ago, but the doctor's may have felt the flu vaccine could have contributed.  Patient take antipsychotics and antiepileptics daily.
Pain at injection, formed a knot and moves up to shoulder. Shoulder pain for 2 days. At 4am on sept 6. Violent vomiting, diarrhea, chills, back pain, sweats, shortness of breath, intense stomach cramps.
21DEC92 pt recvd vax 21DEC92 & 4JAN93 devel chicken pox; 10JAN92 pt devel mumps & 22JAN93 mom notified MD also reported that brother had mumps w/MMR;
Pt reports pain, heat and swelling at injection site. Body aches Fri and Sat night. Pt called today 4/20/15 to report arm is better but still slightly warm and sore.
Initial misuse report received from a healthcare professional on 03 OCTOBER 2013. The patient had received FLUZONE. Patient's age was less than 3 years. The patient received 0.5 ml dose instead of 0.25 ml. No adverse event was reported. List of documents held by sender. None.
5 minutes after receiving COVID vaccine, the patient reportedly had a seizure like event.  Patient was monitored and rapid response was called. The patient was transferred to the ED where VS monitoring, EKG (normal sinus), and labs were collected. blood glucose was elevated, patient received fluids.  Patient's glucose appropriately decreased following crystalloid administration the patient was feeling improved and no labs were of concern. Patient was discharged from the ED.
Pt had lip and tongue swelling as well had rash on her upper body. The patient denied SOB. Patient also had swollen left upper arm at site where vaccine was given. BENADRYL, prednisolone given and follow up next day. Patient is being sent to allergist.