chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm and headache overnight; sore arm and headache overnight; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (right arm), on 11Feb2021 10:00, at single dose, for covid-19 immunization. Medical history included celiac disease. Concomitant medication included bupropion. The patient experienced sore arm and headache overnight on 11Feb2021 18:00. The patient recovered from the events on 12Feb2021. The patient took ibuprofen (ADVIL) as treatment for the events (self-prescribed). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.   No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Gave FluVac at 8:30 on 2/11/04.  On 2/12/04 at 8:15 am mother of patient called.  Noticed "bumps" on upper extremities 2/11/04, slowly progressed to cover entire body.  No difficulty breathing, no fever, no irritablility.  Advised to call pediatrician.
Patient presented to Hospital on 8/23/21 complaining of shortness of breath  and coughing and chest discomfort.  Elevated Troponin and leukocytosis.   Admitted  with myocarditis, viral syndrome and pneumonia.
1618 vaccine given 1625 nausea onset followed by "feels like I'm on laughing gas", then started seeing sillhouettes but unable to see faces. b/p 118/82, hr-107, 0s sat 92% ra. 1636 starting to feel better b/p 118/82, hr-103, 02 sat 96% ra. 1646 all issues have resolved. Instructed to f/u with MD as needed. Discharged with grandpa to home.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a pediatrician regarding a patient who received a dose on an unspecified date and experienced more pain from the Prevnar injection than from other immunizations. Event Details:The pt experienced more pain from the Prevnar injection than from other childhood immunizations. Manufacturer Comment: The reporter was unable to specify the number of pt;s who experienced this event. Additional reports will be generated as identifying information is provided. No additional information was available at the time of this report.
30 sec seizure UE + LE (L>R) with nl exam w/i 1 hr after 52. Witnessed by family (with extensive experience with sz D/0).
T99.3, sl redness below inj site;swelling in lt chest, sl pale rash on abd 13MAy-14MAY;tx w/celestone & Claritin;17MAy99 mom reported fine now;
Fussy, 2 1/2 x 3 cm red inflammation right thigh, diarrhea.
Had moderna vaccine 1/9/21 at 2pm. Around 3pm started getting chills/low grade fever /headache/swollen right armpit node. Called supervisor and was told i could not come in with these symptoms. I was out of work for 2 days. Went back to work. Developed a non-productive cough/severe headaches lasting all day. Even if i took tylenol. Week of 1/18/21 Still had severe headaches/ cough/ chills/ no fever/ but started having a bad sorethroat/ chills and difficulty talking and  swallowing. My throat lymph nodes were swollen. couldn't even swallow water but breathing was okay. Was sent to an ENT that same day.  Had nasopharynscopy. Had slight swelling inside throat.
Pt recv vax on 4/15/99; on 4/16/99 pt exp fever, sleepy, LA pain/ swelling, chest pain; tx=warm compress
A report has been received from a Health Professional concerning a 63 year old, female subject, who had been receiving FLUMIST (Intranasal). Concomitant medications included ADDERALL and cycidrine. FLUMIST (Intranasal) started on an unknown date. It was reported that the patient had fever and headaches which started on 21-oct-2013, no appetite, generalized aching, tired and accidental exposure while administering drug was considered as an event. The outcome of the event of fever, no appetite, headaches, generalized aching and tired is unknown and the patient recovered from the event of accidental exposure while administering drug/patient was not administered FLUMIST-This would be secondary contact on 27-Oct-2013. The report was considered to be non-serious. The event of generalized aching, tired and no appetite has been identified by the company physician from the source documents and added as adverse event and considered it as non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 28-Oct-2013 from Health Professional:New events of generalized aching, tired and no appetite were added. The outcome of the event accidental exposure while administering drug/patient was not administered FLUMIST-this would be secondary contact was changed to recovered and stop date added. Corrected report 17-Nov-2013: Reporter's added. Action taken with FLUMIST was changed to not applicants.
Swelling of the face; Swelling of the mouth; Swelling of the throat; Broke out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in upper arm left, administration date 02Sep2021 12:30 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was none. concomitant medications were not reported.  The following information was reported: SWELLING FACE (non-serious), outcome "not recovered", described as "Swelling of the face"; MOUTH SWELLING (non-serious), outcome "not recovered", described as "Swelling of the mouth"; PHARYNGEAL SWELLING (non-serious), outcome "not recovered", described as "Swelling of the throat"; URTICARIA (non-serious), outcome "not recovered", described as "Broke out in hives". The events "swelling of the face", "swelling of the mouth", "swelling of the throat" and "broke out in hives" were evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling face, mouth swelling, pharyngeal swelling, urticaria.  Additional information: It was reported that three weeks ago patient received the first dose of the covid 19 vaccine.The patient experienced a terrible reaction. Swelling of the face, mouth, throat. Broke out in hives. He continues to have all these symptoms. His purpose for calling, any compound or compound that could be causing the reaction. Basically the ingredients since he has not had allergies. He stated that, he have never had any allergies or an allergic reaction. He have had multiple surgeries. He did have a reaction once to anesthesia in an emergency situation.  He did not know if there was a particular compound, chemical within the vaccine that you could tell me to avoid that could be exacerbating this reaction.  Patient was almost sent to the ER for intubation. Since then he continues to have all the symptoms. He was calling to report and ask what compound or chemical could be causing his reaction since he has no allergies and has never been allergic to anything else. Even just last night he broke out really bad. His doctor prescribed Xyzal which he takes in the evening and it seems to help pretty well and seems to subdue the symptoms. Prior vaccinations medical history was none. There were no family medical history relevant to adverse events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253599 Pfizer
Initial information received on 06-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a nine-weeks-old female patient who received 0.5 mL dose of vaccine PENTACEL lot C5516AA, expiry 15-Sep-2019 Administered via unknown route in the left deltoid On 31-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccinations included ROTATEQ for Immunisation; PREVNAR 13 for Immunisation; and HEPATITIS B VACCINE for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that child was administered the DTaP-IPV component of PENTACEL ( 0.5ml dose), without reconstitution of the HIB component. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This spontaneous report as received from a physician refers to an unspecified number of patients. On an unknown date the patients might have been vaccinated with GARDASIL (lot #, expiration date, route and dose unspecified) that was exposed to temperature conditions that Merck cannot support. NO PQC. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Headache, nausea, chills, fatigue, soreness at infection site, sore throat
Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of PROQUAD (Merck) (lot # L010141 with expired date 24-SEP-2016, lot# L023113 with expired date 24-SEP-2016; dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
The pt was seen on 5/7 with 3 day hx of a loose productive cough and marked nasal congestion. This was thought to be a URI. Cough persisted in spite of inhalation therapy and steroids. Pt was seen on 5/16 and started on Biaxin with improvement.
This is a spontaneous report received from a non-contactable reporter(s) (Physician). A 79-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 79 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot No.: EN6198, Intramuscular, Arm Left), administration date: 26Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot No.: EP6955, Intramuscular, Arm Left), administration date: 19Mar2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "Leukopenia", "Neutropenia". The following information was reported: SPLENOMEGALY (hospitalization, life threatening) with onset 20Jan2022, outcome "not recovered". The event "splenomegaly" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy bone marrow: (unspecified date) Unknown result; Computerised tomogram: (20Jan2022) Splenomegaly; Labs: (29Jun2021) he had leukopenia and neutropenia, notes: for the first time and this has been persistent since; SARS-CoV-2 test: (08Sep2022) Negative; Ultrasound scan: (unspecified date) Unknown result, notes: diagnosis being confirmed and then treatment will be discussed. Therapeutic measures were taken as a result of splenomegaly included bone marrow biopsy and ultrasound; diagnosis being confirmed and then treatment will be discussed. Clinical course, on labs from 29Jun2021 he had leukopenia and neutropenia for the first time and this has been persistent since. He had his third dose of Pfizer COVID vaccine 18Oct2021. Computerized tomogram 20Jan2022 showed splenomegaly. He had his 4th dose of COVID vaccine 02May2022. On 08Sep2022 he presented to the ED for an unrelated injury and was found to have worsening leukopenia and neutropenia and new blast cells. This patient is scheduled for bone marrow biopsy to confirm leukemia diagnosis. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 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. Linked Report(s): US-PFIZER INC-202201150632 Same patient, same drug, different dose; US-PFIZER INC-202201156108 Same patient, same drug, different dose.
she feel like a little bad for a couple of days; more harsh, more pain, more everything and it hurts; it has pain again like in ''hand''; today it is going more harsh, more pain, more everything and it hurts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1ST DOSE), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "she feel like a little bad for a couple of days"; PAIN (non-serious), outcome "unknown", described as "more harsh, more pain, more everything and it hurts"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "it has pain again like in ''hand''; today it is going more harsh, more pain, more everything and it hurts".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
this is 1 of 5 hosp employees, out of 280 vaccines, who devel an inj site rxn 24 to 48 hr p/vax;
A few hours after pneumonia booster was given his arm became painful to move and continued to worsen. He couldn't sleep that night and had to skip bowling the next day because he couldn't lift his arm. There was no redness or swelling - just pain. He was better the third day after the injection.
2 mins post vaccination (13:28), pt c/o Flushing/sweating. Vitals: BP 118/82, HR 88, RR 22, O2 Sat 97% -- > 126/80, 76, 96%. Pt VSS but was a little lightheaded when standing.  Pt drank water and walked around.  Pt stable and released from the vaccination site ~50mins post vaccination
Left arm swelling and erythema at pneumococcal injection. Cellulitis, fever, leukocytosis.
?The patient has an itchy papular rash diffusely on her back  approximately 1-1/2 hours after receiving her second Moderna COVID-19 vaccine.   She describes some itching in her throat but no throat swelling or difficulty breathing.   No wheezing, lightheadedness, fainting or vomiting.  Vital signs are stable.  50 mg of oral  Benadryl was administered.?
Noticed itching sensation 4days or so after vaccine,  itching increased and noticed profound redness below injection site, 3 inches wide by 5 inches long,  warm to touch and itchy
At routine doctor's visit, it was discovered that blood pressure was high. Doctor recommended monitoring the blood pressure at that time. This was monitored for a while until participant requested some medication in early December of 2022. Doctor prescribed losartan. This managed the blood pressure well, but there are still days when it spikes. Dizzy, couldn't walk straight and nausea, so participant went to ER January 13 to 15th 2023. Blood Pressure discovered to be in the 200's and so the doctors kept participant for observation. Just treated nausea.
I took Pfizer vaccine on March 20th and I had to go to the emergency room on March 23rd. The diagnosis: shingles which evolve to a severe case. It took three-four weeks to start to get better, but the pain still persists. I am supposed to get the second shot before the 42 days, but not sure if I should take it or not.
I had severe nausea, a low grade fever, aches, chills, and moderate fatigue that prevented me from working or daily activities for two days. By day 1 after the vaccine I also had hives and a rash at the injection site. A week after my second dose, I also had more hives pop up on my face and a bit at the injection site. And every few weeks, I have a few come up at the injection site and on my face, and then they go away.
P.C. from Mom on 8/16/17 to report pt. has temp. of 101 and redness and tenderness R deltoid. Mom states fever started upon awakening 8/16. Pt. reported headache evening of 8/15/17. Mom gave 600 mg ibuprofen Q6 hrs. Pt. has Hx of Danlos syndrome and often gets local reaction with immunizations. Nurse instructed Mom to take child to ER if temp does up and she made an appt. with pediatrician Dr. for 8/17/17. See attached OV from Dr. 8/17/17. 13 year old in with Mom. He had vaccines at clinic on 8/15/17 and has been having joint pain, headache and a fever. Injection sites look a little better today per Mom arms had warmth and minimal swelling over both shoulders. No drainage from sites. He has reacted to vaccines in the past. Fever high 101. Appetite is down. He went to bed without eating.
This spontaneous report as received from a medical assistant (also reported as administrator) refers to a patient of unknown age and gender. On 03-JUN-2016, unspecified doses of improperly stored VARIVAX (lot# 1041204, expiry date: 20-OCT-2017 or 1048466, expiry date: 02-DEC-2017 or M000761, expiry date: 16-JAN-2018) was administered to the patient. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Within 3-4 hours of receiving vaccine, he began with headache, vomiting, diarrhea. These lasted overnight along with low grade fever (about 100). Today he is fatigued and slightly dizzy. They are attempting rehydration with rest.
Repeatedly I have almost passed out when standing quickly.  I notice this because of work, I need to squat or kneel in front of equipment or work on my hands and knees.  When I stand up quickly, I usually start to black out.  I noticed this initially when taking the trash out 34 days after the Booster when I actually blacked out while walking and snapped too a split second alater as I was stepping off the curb.  I steadied myself with the trashcan before I fell over.   Since then on job sites, most recently two days ago every time I stood up which would be six times. I actually had to balance myself against the equipment so that I could stay vertical. It was like a low blood pressure except that almost blacked out.
patient reported to office on 1/26/21 complaining of SOB with lying down. Pain at sternum/shoulders/neck. She felt like she was being squeezed.
This case was reported by a consumer, who was also the subject, and described the occurrence of rash in a 42-year-old female subject, who was vaccinated with HAVRIX (GlaxoSmithKline), ADACEL (non-gsk). A physician or other health care professional has not verified this report. Concurrent medical conditions included seasonal hayfever. Concurrent medications included PRISTIQ, LEVOTHYROXINE and ORTHO TRICYCLEN LO. On 8 June 2012, at 16:00 the subject received 1st dose of HAVRIX (details unknown, left arm). On 8 June 2012 the subject received unspecified dose of ADACEL (details unknown). On 9 June 2012, 1 day after vaccination with ADACEL and HAVRIX, the subject experienced rash, generalized hives all over body, itching and condition aggravated. The subject reported she has had a rash since receiving a HAVRIX vaccination. It started about a day after the vaccination and was generalized hives all over her body. The hives are very itchy, and was still itchy 8 weeks in. She has flare ups of this rash where it is more itchy and she did not feel the rash had really improved since the vaccination. She received a ADACEL vaccination at the time same and was unsure which vaccine had caused the rash. She sought medical attention at the doctor's office. The subject was treated with CLARITIN and SINGULAIR. At the time of reporting the events were unresolved. The vaccination course with HAVRIX was discontinued.
1) Metallic taste  within 30 minutes after shot; metallic taste lasted for about four hours.  This was followed by pain and burning feeling on tongue and burning and stinging feeling on lips, which continues to be a problem as of today?s date.  Tongue also feels swollen but does not visually appear swollen.  2) Feeling of hyperactivity, jitteriness and insomnia immediately after shot, which still persists.  3) Loss of appetite and weight loss immediately after shot, which persists.  Stomach pain developed about one week after second dose on November 26, 2021.  4)  Blurry vision  immediately after shot and remains intermittent.  5) Pain in bones and joints, including knees, elbows, shoulder, hips, feet, which developed about one week after shot and persist today.  Limitation in shoulder mobility developed immediately after second dose and has only improved slightly after two weeks.  6) Intermittent feeling of burning up but no fever.  7) Intermittent headaches, which developed about one week after shot, and persist today.  8) Unexplained bruising, which developed about one week after second dose on  November 26,  2021.  9) General feeling of being unwell within 30 minutes of first shot and persists today.  10) Intermittent diarrhea within one day of shot and symptom continues intermittently.
This case was reported by a nurse and described the occurrence of injection site soreness in a 12 year old subject of unspecified gender who was inadvertently vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the mother of the subject. On an unspecified date in 2005, on or before 14 October 2005, the subject received 1st dose of Fluarix at an unspecified site of administration (lot number not provided). Fluarix is recommended for immunizing individuals 18 years of age and older. At an unspecified time following the administration of Fluarix, on or before 14 October 2005, the subject experienced injection site soreness. At the time of reporting 14 October 2005, the outcome of the injection site soreness was not provided. Follow-up to the case will not be available.
lt arm reddened & sl swollen 2NOV92 from shoulder to elbow; pt c/o pain 20NOV92; mom noticed flushing did not check temp until 21NOV-t99 orally; pt very nervous, excitable 20NOV92 did not eat or sleep well;
Jansen COVID-19 Vaccine EUA  Approximately 12 hours after receiving the vaccine, I began having headache, body aches, and cold chills. 24 hours after receiving injection, most symptoms have gone away, with only a slight headache remaining and soreness at the injection site.
Severe body aches, chills, heachache, fever 99-100, Started feeling bad 4 hours after receiving injection and last for 2 days. Alternated with Tylenol and ibuprofen.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On 19-MAY-2016 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K020215, expiration date 15-MAY-2016, dose, dose# and route unknown). No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.