chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness, redness, warm to touch just below injection site, affecting the bottom half of the R deltoid muscle. Started the day after the vaccine and has persisted x 5 days. Using ibuprofen for discomfort. The primary concern is that the same exact reaction occurred in sibling who received the same vaccine the same day. Question of possible contaminated batch of vaccines?
12 Jul 05, One day after immunized with Dtap, IPV, MMR, Prevnar, child developed a rash starting on R leg and progressing over the whole body.  Was seen in clinic on 16 Jul 05, cx for strep, and started on amoxicillin.  Cx negative.  22 Jul 05 seen in clinic, rash remains.
It was reported that a 34 year old male pt received a TD Adult vaccination on 09/05/2000. Reportedly that same day the pt experienced nausea, vomiting, diarrhea and light-headness. he also experienced pain at the injection site with numbness and weakness of the left hand. The pt was evaluated by a nurse practitioner not physician. From additional info received on 12/05/2000, additional pt and responsible physician info was provided.
Pt began to experience heart palpitations and shortness of breath a few months after vaccine received.
On Sunday 03/14 at 1am. I woke with chills and a terrible headache that felt like pressure on both sides of my head. I checked and had a fever of 102.3. My joins and bones were hurting and I could barely walk.
Patient developed SAH due to ruptured aneurysm requiring ICU stay and neuro IR intervention
Immune Mediated Bulbar Myasthenia Gravis; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYASTHENIA GRAVIS (hospitalization, medically significant), outcome "recovering", described as "Immune Mediated Bulbar Myasthenia Gravis". The patient underwent the following laboratory tests and procedures: Antibody test: non-reactive; without explanatory pathological findings; CSF test: without explanatory pathological findings; anti-MuSK serologic studies: non-reactive; without explanatory pathological findings; AChR binding and blocking antibodies were, notes: ultimately detected; Magnetic resonance imaging head: without explanatory pathological findings; Nerve stimulation test: decrement in facial nerve-nasalis CMAPs with low f, notes: repetitive stimulation, consistent with a post-synaptic neuromuscular disorder; post-exercise and, notes: repetitive stimulation-induced decrements in median-abductor policus brevis and spinal accessorytrapezius CMAPs, confirming a systemic post-synaptic neuromuscular disorder. Therapeutic measures were taken as a result of myasthenia gravis.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Immune Mediated Bulbar Myasthenia Gravis. 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,Linked Report(s) : US-PFIZER INC-202200966563 Same article/ drug/patient and different event;
Information has been received from a physician concerning a female who was vaccinated with three doses of GARDASIL (Lot # not reported). The patient experienced headaches after all three doses of GARDASIL. The outcome was not reported. It was reported that the patient sought unspecified medical attention. This was one of several reports from the same source. Additional information has been requested.
A report had been received from a Health Professional concerning a 11 year old male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 02-DEC-2014. It was reported that inadvertently expired FLUMIST administered on 02-DEC-2014. The outcome of the event of inadvertently gave expired FLUMIST to three patients was unknown. The report was considered to be non-serious.
administered Boostrix, Engerix-B to patients that was stored at 12.6degree Celsius; This non-serious case was reported by a consumer via call center representative and described the occurrence of product storage error in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Boostrix and Engerix B. On an unknown date, an unknown time after receiving Boostrix and Engerix B, the patient experienced product storage error (Verbatim: administered Boostrix, Engerix-B to patients that was stored at 12.6degree Celsius). The outcome of the product storage error was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 09-Aug-2023 Wholesaler reported that the health care professional (HCP) administered Boostrix, Engerix-B to patients that was stored at 12.6 degree Celsius for 28 days. Wholesaler reported that 4 doses of Boostrix and 1 dose of Engerix-B were administered after the 168 hours stability window.  Specialist advised wholesaler to have HCP call into Information to provide more specific details of excursion. No additional details was available as healthcare professional was not available to provide additional granularity to the adverse event and storage issue. The temperature excursed Engerix-B and Boostrix was administered, which led to Product storage error. The reporter did not consent to follow-up.
Pt was dx with covid 1 week prior 9/27/2021 , and getting more sob, went to urgetn care and was sent to ED because her sat was in the 80's on room air - Currently in ED 10/4/2021
Caller states a 6 year old patient was administered Vaxelis in order to get the patient caught up on vaccinations.; This non-serious spontaneous safety report, with Case Number: 2023SA223339 (Inquiry Number: 01699146), was received by partner, on 20-JUL-2023 and forwarded on 21-JUL-2023 from other health professional.  The causal relationship between Vaxelis and the reported event "Caller states a 6-year-old patient was administered Vaxelis in order to get the patient caught up on vaccinations" was assessed as not applicable due to the nature of the event.  No further information is expected.
a little sore; injection site was red; mild reaction; a dark pink blotch at the injection site; arm bacame more swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little sore), VACCINATION SITE REACTION (mild reaction), VACCINATION SITE DISCOLOURATION (a dark pink blotch at the injection site), PERIPHERAL SWELLING (arm bacame more swollen) and VACCINATION SITE ERYTHEMA (injection site was red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (a dark pink blotch at the injection site) and PERIPHERAL SWELLING (arm bacame more swollen). On 25-Feb-2021, the patient experienced VACCINATION SITE REACTION (mild reaction). On an unknown date, the patient experienced PAIN (a little sore) and VACCINATION SITE ERYTHEMA (injection site was red). At the time of the report, PAIN (a little sore), VACCINATION SITE REACTION (mild reaction), VACCINATION SITE DISCOLOURATION (a dark pink blotch at the injection site), PERIPHERAL SWELLING (arm bacame more swollen) and VACCINATION SITE ERYTHEMA (injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.
Patient admitted with cerebral vascular accident. The patient had investigations and was found to have subacute left thalamic and left basal ganglia infarcts on MRI.  Stroke neurology was consulted and he started PT/OT. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of the patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that multiple patients had reported that after receiving SHINGRIX, they experienced soreness at the injection site, described as similar to soreness after the tetanus vaccine. The lot numbers and patient identifiers were not obtained. This case has been linked with case US2018051271and US2018051274, reported by same reporter.
I did not have any complications after receiving the vaccine.  On 12/27/2022 I began not feeling well with a sore arm and by the afternoon the swelling and heat started. It was difficult to put on deodorant. The swelling lasted for five days, and it was difficult to carry anything in my right hand. I could use my right hand, but it was painful. I contacted the clinic, and they recommended alternating heat and cold packs. I also took acetaminophen about three times to help with my symptoms. I had a similar reaction to the dose 3 in 12/2021 and I had bruising too.
10/31/12 @ 1530 was given booster TDAP vaccination in (L) deltoid IM. Could not remember last tetanus vaccination. Given instructions for OTC anti-inflammation use and arm movement. Awoke 11/1/12 @ 0300 with lest arm discomfort/aching and headache. 11/2/12 & 11/3/12 noted night sweats, loss of appetite, dizziness and swelling in left upper arm with lump formation where injection was given. 11/4/12 noted further swelling in fingers (L) hand and (L) arm. Presented to hospital emergency department 11/4/12 @ 1319 for evaluation & treatment of left upper arm cellulitis. Given IV Doxycycline 100mg and VICODIN p.o. for pain. Sent home 11/4/12 with script Doxycycline 100mg p.o. twice daily for 10 days and ULTRAM p.o 50mg as needed for pain every 6 hours. Recovering.
Pt vaccinated with b capsa and developed occult bacteremia - positive blood culture for H influenzae type b
Pt c/o swollen both hands and feet when she woke up this morning. Burning sensation, fingers stiff with pain, redness noted.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 10-NOV-2014 the patient was inadvertently vaccinated with PROQUAD (dose, frequency and lot # were not reported) and VARIVAX (dose, frequency and lot # were not reported) instead of VARIVAX. No adverse effects were reported. No product complaint was reported for PROQUAD and VARIVAX. Additional information has been requested.
Evening of 3/29 feeling of body "tingling all over". Morning of 3/30 10am (24 hours after shot) significant shaking and chills, lasted 2 hours 11am headache, body ache, and skin sensitive to touch 11am took 800mg ibuprofen 1pm mild fever (99.8) I am usually 97.1 with the same thermometer 2pm medium fatigue 5pm fever broke (98.8) 5:30 took 800mg ibuprofen 6pm all symptoms disappeared.  It was like a POOF all gone. 6pm - 10pm feeling tired but no symptoms except lingering mild headache 3/31, 9am 100% symptom free with full energy
Traumatic fracture of ribs of right side with pneumothorax - chest tube placement. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Sore arm; This is a spontaneous report based on the information received by Pfizer, (LRN: LRN4238523). A contactable other HCP reported for a 64-year-old male patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 64-years, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included ongoing multiple sclerosis. Concomitant medication was not reported. On unknown date, the patient experienced sore arm. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The pt received the vaccines on 10/4/00. Symptoms began on 10/5/00 with a fever. The pt was presented to an urgent care facility on 10/8 and diagnosed with bilateral otitis media. The pt was treated with Zithromax. Pt still has a fever of 103 per mom on 10/10/00. Visit to the pediatrician on 10/10 and the antibiotic was switched. On 10/11, the pt is improving somewhat.
pt called around 12pm. stated she started getting welts all over her body which started around 9am 11/6/20. Advised to take Benadryl got to ER/urgent care. Called back @ 245pm and pt stated she was having laboured breathing. Advised call 911/go to ER STAT. Some welts were going down but more were emerging.
From faxed info received at manufacturer on 12/3/02, it was reported that a 5 y.o. male PT was vax'd with Daptacel, IM as dose #5, Ipol, SC as dose #4, MMR, SC as dose #2, and Varivax SC as dose #1 on 11/19/02 at 6 p.m. On the morning of 11/21/02, the PT experienced swelling at the inject site w/erythema, warmth, and pain going up to the elbow. PT is recovering.
11/08/2021 at 5PM severe pain left arm 11/08/2021 at 9PM migraine type headache and severe nausea began  with sone episodes of vertigo and weakness that lasted through the night. Migraine and severe nausea lasted until 2 AM on 11/10/2021. I was unable to care for myself.  11/10/2021 exhaustion.   GI discomfort and watery diarrhea began and continued until evening of  11/12/21 Night sweats began 11/10/2021 and have continued .
On 01/14, I started my morning being nauseous, very dizzy (feeling like I was going to pass out). Later that day I had moderate body aches, headache, extreme fatigue, and hot flashes.  The fatigue and hot flashes lasted all the way until 01/16. And I was back to normal by 01/17.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL1283), in right arm and on 23Aug2021 as dose 3 (booster), single (Lot number: FA6780) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism, high cholesterol, osteopenia; "high cholesterol" (unspecified if ongoing), notes: Other medical history: Hypothyroidism, high cholesterol, osteopenia; "osteopenia" (unspecified if ongoing), notes: Other medical history: Hypothyroidism, high cholesterol, osteopenia. There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: The patient vaccine received. The patient took other medication in 2weeks. The patient received Antiviral for COVID 19 Treatment. The treatment start date was reported as 02Jul2022 and stop date was 07Jul2022. It was reported that the patient finished full course of Paxlovid on 07Jul2022 (a.m.). Had been symptom-free since 05Jul2022. Symptoms returned 11Jul2022.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 24Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 23Aug2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient took any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient experienced Recurrence of COVID symptoms.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
After pt waited the required 15 minutes after vaccination (around 11:35am), pt left with husband (and child) to car, after about a minute or two, pt's husband came back to the pharmacy and notified us that the pt was experiencing a severe headache and asked what to do. We advised the husband to have the pt come back inside (from the parking lot) so we can further assess the pt. As the pt came back to the pharmacy area, she informed us she was beginning to have blurry vision (note: pt had us read out the questions on the vaccine form because she did not have her glasses and was unable to see). The RPH on duty proceeded to check the pt's blood pressure at around 11:50am and recorded the reading at 178/87, the RPH then advised the pt to continue to sit and rest for a few moments more and will check blood pressure again. At about 11:52am the pt's blood pressure lowered slightly to 160/80, however this is still a high reading so the RPH told the pt to visit an urgent care or get immediate medical attention. The pt agreed to go to an urgent care and left with husband; At around 2pm, the RPH on duty called the pt to follow up on how they were doing. The pt told the RPH that she did not go to an urgent care nor seek medical assistance, but rather went home. Pt said she still had a headache, but no blurry vision and her blood pressure was now at 134/80 which was her "normal", however, was now tired and with aches. The RPH told the pt to continue resting and and if any new or worsening symptoms appear to call us back and/or seek immediate medical assistance. Again, at around 4:00pm, the RPH tried to reach out to the pt to follow up, however pt did not answer and a voicemail was left. We have not heard back from the pt since the date of occurrence 02/04/2022. Today 02/08/2022.
Verbally called by RN in influenza vaccination clinic that child was in distress. I came immediately to room and encountered child in RNs arms, having seizure activity consisting of rhythmic jerking of limbs, eyes rolling upward repeatedly, hands clenched. Color normal. Child was placed on exam table in decubitus position and I called for oxygen and emergency kit and asked staff to activate EMS. Child with strong femoral pulse and normal respirations during seizure, no color change. 5L O2 by FM was placed on baby, O2 sat 98-100%, HRs 150s throughout. Seizure lasted approximately 2-3 minutes. Baby was bulb suctioned x 3 during episode to help clear secretions. No vomiting. HR and respirations normal throughout episode. At conclusion of seizure baby remained in post-ictal state for approx 2-3 min at which time EMS arrived. Glucose normal, saturations normal, baby vigorous and crying with normal exam. Baby transported via EMS.  I discussed seizure with parents before transport and let them know I would also communicate with PMD.
Rash all over torso. Rash did not reach arms. Rash stopped at upper thighs.
pt brought to ED via EMS with increasing SOB; found to be positive for COVID and hypoxia; cough; worsening hypoxia; O2 supplementation; Dexamethasone; Remdesivir; pt's condition continued to decline despite measures taken to improve status; ICU; acute renal failure; suffered cardiopulmonary arrest and did not survive
Felt tired over the next day. Sunday onset of pain  and swelling in the Lymph node of the L arm, injection was in the L arm.
This spontaneous report was received from a registered nurse refers to a 61 year old female patient with allergy to PERCOCET, sulfa and latex and a history of Herpes Simplex. On 08-JUL-2013 the patient was vaccinated with ZOSTAVAX, (lot number and expiration date not reported0 (0.65 ml, subcutaneous, once). It was reported that on 09-JUL-2013 (reported as 24 hours after) the patient experienced joint aches all over her body and a fever that "lasted for about a day and then subsided" (10-JUL-2013). It was reported that the patient saw her unspecified primary care provider on 11-JUL-2013 (reported as "today"), and the injection site was red, hot to the touch and itchy. The outcome for joint aches and all over her body and injection site red, hot to the touch and itchy, was reported as  not recovered. No treatment ws given for the above mentioned events. No laboratory diagnostic tests were performed. The reporter did not assess the causality between joint aches all over her body, fever, and injection site red, hot to the touch and itchy. Additional information is not expected.
This is a spontaneous case, initially received from other health professional on 11-Sep-2018, concerning a 55-year-old, adult, male patient. The patient's medical history and concomitant medication were not available. On 10-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: partial dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, at the moment of administration of vaccine from multi dose vial (MDV), the medical assistant removed the cap, inserted the syringe, pressed the plunger and administered the flu shot, therefore, a part of the vaccine had reached the patient's muscular tissue. Then, with the pressure, the needle was detached and separated from the syringe, and the residual vaccine was lost. The reporter assessed this case as non-serious.
Information has been received from a registered nurse concerning a 14 month old female with no known allergies or pre-existing medical conditions who on 08/24/2001 was vaccinated with varicella vaccine. Concomitant therapy included Prevnar. On 10/29/2001, the pt developed chicken pox on her hands, face, behind her ears and trunk, a cough, a temp of 100.4 deg F and a decreased appetite. The nurse reported that she had approximately 30 clear fluid filled vesicles. No lab or diagnostic testing was performed. On that same date, the p sought unspecified medical attention. Subsequently, the pt recovered. Additional info is not expected.