chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt a lump in my left armpit; I had gotten shortness of breath feeling; I had gotten feeling tired; I had gotten feeling weak; I felt hot; Sides felt like it had getting tight; I felt dizzy; My body had tensing up; Feel my body or hardly breath.; Through out the day I was getting worse; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8736) via an unspecified route of administration in the left arm on 24May2021 at 16:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The relevant medical history was not reported. The patient had no allergies to medications, food or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25May2021 the patient experienced felt a lump in left armpit, worse, shortness of breath, feeling tired, feeling weak, felt hot, sides felt like it had getting tight, felt dizzy, body had tensing up and feel body or hardly breath. It's reported that the patient had a lump in left armpit throughout the day had worse, shortness of breath feeling tired, and weak. He felt hot so drinking Gatorade then a couple of minutes later sides felt like it had to get tight and felt dizzy then when an inside body had to tense up and he couldn't feel the body or hardly breath. No therapeutic measures were taken as a result of reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of felt a lump in left armpit, worse, shortness of breath, feeling tired, feeling weak, felt hot, sides felt like it had getting tight, felt dizzy, body had tensing up and feel body or hardly breath was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
No adverse event, vital signs assessed, f/u 3/6 with no complaints of adverse effects.
Patient did not have an adverse reaction. This report is being submitted because patient received a dose that was kept at room temperature beyond the 6hr expiration time.
Rash under breast; eyes were puffy; itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under breast), PERIORBITAL SWELLING (eyes were puffy) and PRURITUS (itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH (Rash under breast), PERIORBITAL SWELLING (eyes were puffy) and PRURITUS (itchy). At the time of the report, RASH (Rash under breast), PERIORBITAL SWELLING (eyes were puffy) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
The patient is a 22 yo male with a history of asthma who reports onset of dermatitis limited to the vaccinated arm, one day after receipt of COVID vaccine #1 (lot #ER8730). He denies any immediate reaction symptoms to suggest IgE mediated reaction (e.g. oral/face/throat swelling/wheezing etc). He reports he awoke with a highly pruritic tender dermatitis limited to his vaccinated arm from axilla to wrist. No  lesions to hands, other extremities, trunk or face. Lesions were papular, discrete, varying in size, and all in the same stage of development. He denies confluence, targetoid appearance, vesicles or pustules. He denies oral or other mucosal lesions, fissures or cracks.  He reports the local injection site was tender and erythematous. He denies systemic symptoms such as fever, chills, malaise, cough, CP, HA, n/v/d. He denies illness symptoms prior to vaccine receipt. He denies any history of AE after vaccine receipt.  He has no photos, but reports residual discoloration suggestive of post-inflammatory hyperpigmentation. He did not seek care.
19 y/o male ADSM is referred from clinic to FBVHC for evaluation of skin rash eruption in temporal relationship with the receipt of Smallpox vaccine.  Symptom: Pruritus Start: 04/24/2008 Comment: Related to skin rash.  Symptom: Rash, diffuse Start: 04/24/2008 Comment: See summary for description.
This spontaneous report as received from a healthcare worker refers to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient received the first vaccine on 7/25/21 and developed visual disturbances on 7/27/21. Her mother noticed her squinting and trying to use just one eye to look at something. Patient states that her right eye has double vision that started as persistent on 7/27/21, but now seems to come and go. She states if she is looking at her teacher in class, she can see two heads. She was seen in our office today for an exam and vision screening which was WNL. She has been referred today to opthalmology for a dilated eye exam.
pt recvd vax; 24-48 hrs following vax, pt devel diffuse arthritis/arthralgia in knees, ankles, feet, shoulders & mid back;
Patient complained of her heart racing. Pt was taken by wheelchair and helped to a stretcher. BP 149/82, HR 114, RR 22, O2 sat 99% RA. Patient complained of chest pressure and patient taken to ER. Pt also reported with her first covid vaccine she experienced heart racing. Found to have sinus tachycardia.
Headache; Rash is currently like all over my stomach and back; it is not really a rash but like red dots all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; RASH MACULAR (non-serious), outcome "not recovered", described as "Rash is currently like all over my stomach and back; it is not really a rash but like red dots all over my body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients had been administered unspecified doses of GARDASIL 9, (lot number, strength, route of administration and dose were not provided), that underwent temperature excursions. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Mom states child entire lt leg became swollen 1 day post vax; Child not seen by Family MD or by hlth dept;
Mom called on 3/14/01 and stated child broke out with chickenpox, on axilla area, head, arms and legs; 12 to 15.
literally having blood in my stool; Black stools; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunisation. Concurrent medical history included that the patient can hardly hear. Concomitant medications were not reported. On an unspecified date the patient was literally having blood in stool, black stools. The patient got the vaccine and experienced things no one else did and now was having more issues. The patient needed to make sure that blood in stool and black stools were rare side effects. Events outcome was unknown. Information on the Lot/Batch number has been requested.
Lots of discharge from eyes; Fever; Severe headache; Muscle aches; Joint pain; dose number=3; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 15:45 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE; VIT C; VIT D [COLECALCIFEROL]; ZINC; MG [MAGNESIUM SULFATE]; CA [CALCIUM]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Pcp has record, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Jun2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Pcp has info, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27May2021, when the patient was 35 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 15:45, outcome "unknown", described as "dose number=3"; PYREXIA (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Severe headache"; MYALGIA (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Muscle aches"; EYE DISCHARGE (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Lots of discharge from eyes"; ARTHRALGIA (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Joint pain". Therapeutic measures were not taken as a result of pyrexia, headache, myalgia, eye discharge, arthralgia.  Additional information: Patient had no known allergies. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination,the patient was not tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a physician via company representatives and support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications were not provided. On 20-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 200 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash all over body; Itchy; Injection site got infected; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site got infected, rash all over  body, itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, 1 week after vaccination, the patient experienced Injection site got infected and 2 1/2 weeks after vaccination, the patient experienced  rash all over my body and itchy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, injection site got infected, rash all over my body,  itchy was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Information has been received from a medical assistant referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 30-JUL-2015 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot# and expiration date were not reported). The second and third doses were vaccinated on 02-OCT-2015 and 18-NOV-2015 respectively (strength, dose, route, lot# and expiration date were not reported) for the same indication. No adverse effect was reported for the patient. This is one of two reports received from the same reporter. Additional information is not expected as the physician is not allowed to be contacted.
Child sitting in IZ chair. Mother with child throughout visit. After giving Flu shot child bent over in chair and appeared to lose consciousness for approx. 5-10 seconds. No injury. Child recovered quickly and was answering questions and talking. Child appeared pale for approx. 1 minute. Legs elevated. Child stayed in Clinic with mother for approximately 1/2 hour. Upon leaving Clinic, child stated she felt fine.
Received first covid vaccine on 3-26-21, had my first ever seizure on  4-5-21, second covid vaccine was given on 4-17-21, second seizure occurred 5-1-21.
I was told to report that I am now positive for covid 19. I am asymptomatic and received positive test results on 2/5.
I had a sinus and ear infection, severe headache, swollen lymph glands. I took a home COVID-19 test that came back negative, I called my doctor but was unable to get in as they were very busy. I went to a local Urgent Care. Upon examination I was given Z-pack and Prednisone for the sinus and ear infection. It did take a couple of days for the medication to start working.
Developed swelling at site on right deltoid, redness, hard, very tender to touch. Swelling contiune to get worse and went to the ER on 07/04/2011. ER MD I & D'd site and packed. Was placed on oral antibotics of Doxycycline Hyclate 100mg twice daily for 10 days & Bactrim DS twice daily for 10 cays and pain medication of hydrocodone 5mg every 4-6 hours prn pain.
fast heartbeat, dizziness, headache, severe pain in back of neck, Joint pain,  Fever, vomiting, diarrhea, and arm pain
Initial misuse report received from a healthcare professional on 27 September 2013 and on 21 March 2014 at agency. A pregnant woman of unknown age had received FLUZONE 1 ml. No adverse event was reported. The list of documents held by sender: None. Addendum: 24 April 2014 upon second internal review a significant correction was made in the case to add the no adverse event detail in the as reported event.
Student c/o facial itching/feeling hot and mouth feeling warm. Rested and flushing increased. 1410 given BENADRYL 30 mg PO elixir and uncle called to pick her up. 1432 no change, still "feels hot", but able to swallow/speak. 1438 T 98.4, uncle picked up.
Moderna vaccine was administered outside - reported by patient? NO LOT NUMBER WERE SUPPLIED. ------------------------------------------------------------------------------------------------------------------------------ I95.9 HYPOTENSION 5/21/2021 NONTRAUMATIC ACUTE KIDNEY INJURY; J96.00 ACUTE RESPIRATORY FAILURE 5/21/2021 NONTRAUMATIC ACUTE KIDNEY INJURY; J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/21/2021 NONTRAUMATIC ACUTE KIDNEY INJURY.
patient, a 26yo male, was presenting for a 2nd dose Pfizer COVID vaccine. Client reported that approximately 3 days following his 1st dose he began to have transient chest pain lasting a few minutes, resolving and then returning 20-30 minutes later. He stated the transient chest pain has been occurring intermittently since his 1st dose and noticed the pain mostly at night when he would lie down. He reported being borderline hypertensive and denied any other pertinent medical conditions. Client stated he did not have any allergies to medications/environment/foods however, is lactose intolerant. Lead RN  took client's blood pressure 158/108 and HR: 60. Client stated he did have periodic palpitations, denied any shortness of breath, dizziness, headache or numbness and tingling. Lead RN  consulted with operations Lead RN to approve delaying 2nd dose and recommendation of referral of client to ED or Urgent care to rule out myocarditis. Operations Lead RN approved ED referral and delay of 2nd dose Pfizer COVID vaccine. Lead RN  educated client on myocarditis, elevated BP and recommendation to go directly to ED or Urgent care. Client denied any current chest pain, dizziness, palpitations and declined EMS transport to ED. Client agreed with plan and stated he would proceed to nearest ED. He left the site on his own accord with a steady gait.
Vomiting and diarrhea; no fever. She was seen in ER and treated and released. Symptoms resolved by 6/4/2017; developed fever 6/6/2017, diagnosed with pyelonephritis 6/9/2017, treated.
Information has been received from a licensed practical nurse referring to an 11 year old patient of unknown gender. On 10-OCT-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M021407 with expiration date of 30-APR-2018; dosage, frequency and route of administration were unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA009046.
Information has been received from a healthcare worker concerning a patient (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (651401/0619F).  Subsequently, on an unspecified date, the patient developed redness all over the injection site down to the elbow.  The patient sought unspecified medical attention at the emergency room, was treated and released.  At the time of this report, the patient had recovered.  No product quality complaint involved.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
states she had immediate migraine, nausea. Note she was observed for 20 minutes following this injection an reported no complaints.
Tachycardia HR 160, numbness and tingling in left side of face and down left arm and chest pain and tightness. I was sent to ER for evaluation of aflutter on telemetry monitor.  Abnormal EKG in ER and persistent tachycardia despite NSS bolus. Recommendations to F/u with cardiology, outpatient 2D echo and zio patch x 2 weeks
Beginning around 9 days post vaccination, I started to experience extreme itching on all parts of my body including scalp. In these areas of extreme itching, I experienced hives, red skin, and dermatographic uritcaria. This is the second time this has happened - these effects also happened with the second COVID vaccine, but we did not think the dermatographism was related to the vaccine at the time. Last time the symptoms lasted about 2 months and subsided with taking four (4) Zyrtec daily, and one (1) Benadryl at night, while also using topical Benadryl.
Patient reports that his arm, chest, and stomach are all numb.  I recommended that he presents to an ER, but he refused.   I emphasized to him that it's possible that he is having a serious event, but he still refused.
Rash/Redness/Swollen/hardness on arm near injection site that got as big as 3 inches long and 2 inches wide
Within 2 hrs both pt and wife (also same vaccine) describe fever with pain, swelling at injection site
Day following vaccines attended school during first hour of school had intermittent episodes of H/A described to mother as throbbing.  Lasting several seconds to a few minutes.  During second hour of school no c/o of H/A and felt good, during third hours of school H/As returned but now continuous, nauseated, no emesis, just felt weak and "legs like rubber", child then "passed out"; regained consciousness within a few minutes without intervention.  H/A still present and felt pulse racing. Sent to ER, per mom EKG, Urine, lab (CBC) all within normal limits, Temp 99.9 H/A remained, pulse in ER regular, ER physician noted "ear infection and nasal drainage", sent home with antibiotics and mom to observe for other s/s.
20 mins after injection my face and ears became red hot, had tingling on my left side and a slight scratchy throat. I immediately took Benadryl 50 mg and after 30 minutes symptoms subsided. Extremely sore arm today. No other symptoms on 1/16/21
Child develops upper resp. infection and given antibiotic after receiving Hib and HB.  2 mos. later receives DTaP immunization.  1 week later develops upper respiratory infection and ear infection.  Administered antibiotic.  2 weeks after DTaP and 60 days after Hib & HB, develops a spinal lesion causing pneumonia, 103 fever, paralysis, breathing problems, etc.  After 5 MRIs, Xrays, blood tests/cultures (CDC), urine tests, EEG, ultrasound, nasal wash, spinal tap, genetic testing (skin biopsy) Diagnosed w/Transverse Myelitis which is listed as an adverse reaction under Central Nervous System on Comvax vaccination insert. In the last two years, has received ongoing physical/aqua therapy. He has been followed by a neurosurgeon, neurologist, pediatrician, geneticist, urologist, orthopedist, orthotist, seen by a chiropractor, massage/occupational/phsycial/speech therapist, and treatment from different alternative medicines.
Nausea (30mins later, duration: 15 hours), low grade fever (24 hours later, duration: 7 hours), aches and joint pain (5 hours later: duration: 24 hours), arm soreness (15 minutes later, duration: roughly 48 hours)
pt recv vax & exp hives localized @ the inj site;w/in 5 days hives resolved;
Day of vaccine, site with erythema, tender to touch and hard lump under site.  Resolved for the next few days (vanished).  On day 7 the erythema returned to the site of injection, hard lump under skin, erythem is approx half dollar size, and rash to neck and chest appearing pink and sandpaper type rash.  Pruritic to injection site.
administered an expired Engerix; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received HBV (Engerix B adult) (batch number P7294, expiry date 3rd January 2022) for prophylaxis.   On 18th January 2022, the patient received Engerix B adult. On 18th January 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient inadvertently administered an expired Engerix B, which led to expired vaccine used. The reporter consented to follow up.
pt got up 8DEC93 AM & noticed small red & white spots under skin; no other illness noted; pt felt warm; did not take temp had been given APAP; rash gone by 3AM 19DEC93;