chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was brought in with a 3 by 4 cm. induration and erythema on right thigh. The patient was presribed Bactrim 40/200/ per 5ml. Patient to be given 7.5ml. orally two times a day for 7 days. A follow up appt. is scheduled in 3 days to recheck the cellulitis.Mother also stated child had 2 episodes of diarrhea yesterday along with a fever of 102 (orally- per mom ) and cough.On examination patient was found to have mild phartngeal erythema.
Pt received his vaccines and on 7/20/01. On 7/21/01 pt had large area of redness and swelling on right arm spreading below the right elbow. Due to the area of redness being so large, hot and painful, pt was placed on antibiotics for treatment of cellulitis . Pt recovered on antibiotics and redness was resolved by 7/24/01.
After 11 days patient experienced a red, bubbly rash near the injection site. It was not itchy. It went away after about 28 hours
Fever up to 101.7 with myalgias and extreme left arm pain. Fever lasted for 12 hours and resolved without medication.
20MAR pin-sized dots on abdo in AM; by afternoon cheeks red & felt warm to touch; 21MAR felt like fever higher (out-of-town & no thermometer); 22MAR evening temp close to 102;23MAR some facial puffiness; clumsy; took to MD later in day
I got my last dose of Covid Pfizer vaccine  January 22.  Wednesday March 03 I started to feel, more tired than usual, intense body aches and headaches. And my temperature was still in normal range, but was getting higher and higher, the next day around 3 PM my temperature was 100. And by the time I was ho the temperature was 101.4 and stayed high even after taking ibuprofen 800mg. I had fever all night, so I went to get Covid tested the next day.   On the third day I noticed pain in my face, I had wrinkle filler 2 years ago in 3 different areas: forehead, crow's feet and nasolabial. This area turn red, tender to the touch and painful. This last for 5 days,  The fever lasted for 4 days. My doctor suggested as a late reaction to the vaccine.  It was cases of reaction to Moderna vaccine towards wrinkle filler, so It might be a reaction to Pfizer in my case
Red, warm, itchy and swollen injection site. Hives to left shoulder and upper back.
Patient received Pfizer vaccine on 3/14/21 at 15:29, she was observed for 30 minutes was feeling fine and left.  She returned to the clinic an hour (or so later) reporting feeling flushed and "off".  We had patient sit back down and began observing again.  Patient developed a cough which became progressively worse.  We monitored her O2 sat, pulse and BP.  At  3:30pm Patient received epinephrine 0.5mg IM and Diphenhydramine 50mg IM.  EMS was called.  Patient's cough subsided.  She refused transport to the hospital AMA.  Patient left the clinic on her own, accompanied by her husband. ;"
This infant had a fever of 103 in one ear and 105 in the other ear. He had a febrile seizure (star mode) 10-15 minutes. The baby was rushed to the ER. Return to his doctor the next day had a reaction to the shots.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. During the timeframe from 04-JUN-2015 to 07-JUL-2015, the patients received (Oka/Merck) VARIVAX (lot # L004652 and expiry date of 11-FEB-2017; lot # L006386 and expiry date of 25-FEB-2017 and lot # L005299 and expiry date of 17-FEB-2017) (unknown strength, route and dose), which was improperly exposed to -10.5 degree centigrade for 23 hours. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was product quality complaint involved. This one of the several reports received from the same reporter. Additional information has been requested.
I have had horrible Tinnitus ever since the first injection of the vaccine, that I never had before.  It came on approximately 3 hours after my injection.  Day 2 and I am expediting a horrible headache and dizziness. At this time, I am notifying my primary to see what can be done!
Day p/vax pt became extremely irritable, screaming & holding his head, finger nails digging into his face & eye where he attempted to hold his face; Was bothered by noise; Also could not be comforted;
stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and life threatening). The patient was hospitalized from 12-Apr-2021 to 17-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown. Not Provided          No medical history and concomitant medications were provided. No treatment information provided.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded
This case was reported by a consumer (patient's mother) via call center representative and described the occurrence of fever in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 1st December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st December 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site erythema, injection site pain and injection site swelling. SHINGRIX was continued with no change. On an unknown date, the outcome of the fever, injection site erythema, injection site pain and injection site swelling were recovered/resolved. It was unknown if the reporter considered the fever, injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received both injections (doses). The adverse events experienced after 1st dose of SHINGRIX were more intense compared to 2nd dose. This case has been linked with case US2019GSK048457, reported for same patient by same reporter.
Tingling pain in left ear start 5 minutes after vaccine, spread to left side of face 10 min after vaccine & subsided within a couple hours
Anaphylaxis, facial edema, diff swallowing.  11/10/09 Medical records received for DOS 11/3/09. ED Assessment: Allergic Rxn to H1N1 vaccine. Anaphylaxis s/p vaccine on way home. Facial swelling. Swollen lips, cough, itching, rash. Facial pain.  ED visit, epi, steroids. Benadryl.
Systemic: She states the now has genital herpes-Severe, Additional Details: Patient believes she developed genital herpes from the shingrix vaccine.
This spontaneous report was received from a healthcare worker and refers to multiple unspecified patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients' were vaccinated with improperly stored doses of M-M-R II lot # L024267 with expiration date 01-JUL-2017 (dose, strength, and route unknown (incorrect product storage). The vaccine was exposed to temperature of 71.2 Fahrenheit )F) for 7  hours and 31.8 F for 106 hours. Data logger was involved. It was unknown if there was any previous temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
The patient received their first dose of COVID vaccine on 12/31 at Facility as a healthcare worker. Her employment terminated and she obtained employment at Hospital. She scheduled for her second dose of the series through the Hospital vaccination clinic. She contacted employee health in advance of scheduling her appointment that she should receive her second dose of Moderna. At the time of scheduling, as well as at the time of appointment check-in, she stated that it was her first dose.  Through a breakdown in communication, she received Pfizer as her second dose instead of Moderna in error.
fainting after receiving a dose of Bexsero; This serious case was reported by a nurse via sales rep and described the occurrence of fainting in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced fainting (Verbatim: fainting after receiving a dose of Bexsero) (serious criteria GSK medically significant).  The outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-OCT-2023 The nurse called to ask if there were instances of fainting after receiving a dose of Bexsero.  She stated she had several in the past year. She would also like to know was if there was there any data on increase of adverse events with Bexsero being given with another vaccine, especially Meningitis ACWY. The reporter consented to follow up. The case is linked with US2023140658, reported by same reporter.; Sender's Comments:  US-GSK-US2023140658:same reporter
I had sore throat, congestive, coughing, loss of voice, headache, and low-grade fever. I also had nausea and vomiting. My ears also hurt as well. The sore throat and coughing lasted for about 3 days. The nausea and congestive are still ongoing. I went to a walk in clinic for a COVID-19 test, which came back positive. They did the a flu test also but came back negative.
Slightly sour and ache after vaccinate, the symptoms continues all the time and the symptoms became gradually more serious, will feel painful if put for my strength on the left arm. Went to my family doctor on June 03 for treatment but so far the symptom continues.
Injection site little itchy; Injection site swelling and raised area (size half dollar); Arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE PRURITUS (Injection site little itchy) and VACCINATION SITE SWELLING (Injection site swelling and raised area (size half dollar)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site little itchy) and VACCINATION SITE SWELLING (Injection site swelling and raised area (size half dollar)). At the time of the report, PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE PRURITUS (Injection site little itchy) and VACCINATION SITE SWELLING (Injection site swelling and raised area (size half dollar)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 34-year-old (non-pregnant) female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0161), at the age of 34, via an unspecified route of administration, in left arm, on Apr 16, 2021, at 10:15, single dose, for COVID-19 immunisation. Medical history: none. The patient has no known allergies. The patient's concomitant medications not reported. The patient previously took the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection), on an unspecified date, single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not tested for COVID-19 since the vaccination. On Apr 27, 2021, at 08:00, patient had a very big inflammation in her left armpit. It hurts and she was worried about it, since she will most likely need a mammogram to study the case. She read it might be linked to COVID-19 vaccine effects and wanted to report it in order to make the right diagnosis and treatment. No treatment received for adverse events. She was asked for further studies to identify the reason for the bump and if is a reaction from the vaccine or something else. Reportedly, the event took place after use of product. The outcome of events: not recovered. No follow-up attempts needed. No further information expected.
8 days p/receiving vax pt had generalized tonic clonic seizure; seen by MD; hx febriel seizure; pt recvd 1st & 2nd doses of vax 20OCT92 & 17DEC92;
Patient nervous about vaccine with parents present. Upon completion of vaccine, patient tried to stand and pass out. Patient then had a jerking like motion x2 of head and came to. Patient has loss of consciousness for a brief 10 seconds. Paramedics were called and assess patient. Patient able to go home with parents.
Developed a red, non-puritic rash in axilla and neck on same side as vaccination.; This is a spontaneous report from a non contactable consumer.  A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) (age at vaccination 48-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unknown date (lot number: not reported) as dose 1, single for COVID-19 immunisation. The patient experienced developed a red, non-puritic rash in axilla and neck on same side as vaccination, the patient had no discomfort, described as 'looks a little funky' on an unknown date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Arm has been hurting/Pain did not get worse, but did not stop; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm has been hurting/Pain did not get worse, but did not stop) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 097c21a and 025c21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included COLECALCIFEROL (VIT D3), ASPIRIN [ACETYLSALICYLIC ACID] and VITAMIN E NOS for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced PAIN IN EXTREMITY (Arm has been hurting/Pain did not get worse, but did not stop). At the time of the report, PAIN IN EXTREMITY (Arm has been hurting/Pain did not get worse, but did not stop) had not resolved.            Concomitant drugs reported included ingestion pill and blood pressure pill.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395864 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Event date added, Event Outcome updated - Not Recovered/Not Resolved
Mouth is sore on left side; Fever of 101.2; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Mouth is sore on left side) and PYREXIA (Fever of 101.2) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ORAL PAIN (Mouth is sore on left side) and PYREXIA (Fever of 101.2). At the time of the report, ORAL PAIN (Mouth is sore on left side) and PYREXIA (Fever of 101.2) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Initial information received on 12-Jun-2018 regarding an unsolicited valid serious case received from a non-healthcare professional via other company (Mylan). This case involves a patient who experienced Guillain-Barre syndrome, while he/she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Sanofi-Aventis' flu vaccine) produced by unknown manufacturer (batch number, expiry date, dose, dose in series, route and site of administration was not reported). The patient developed a serious the patient reportedly experienced Guillain-Barre syndrome, following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. No Lab data was reported. It was not reported if the patient received a corrective treatment. Final diagnosis was Guillain-Barre syndrome. Outcome of event was not reported. List of documents held by the sender: None. Sender's Comments: This is poorly documented case which involves a 11 years old patient who received INFLUENZA vaccine (unknown manufacturer) and developed Guillain-Barre syndrome. Latency is unknown. Additionally, patient's medical history, medical condition at the time of vaccination, lab tests ruling out alternate etiologies and medical confirmation of the event were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
1 day post vacc pt developed a severe headache, 2 days post - soreness/achey joints, 3 days - tightness in chest, 7 days - knot appeared at site of vaccine.
Pt developed a red, indurated, tender area around vaccination site antoroluturol right thigh but mother only reported it today.  Today area is dark, red, irregular, indurated, not tender no nodes.  6x5cm.
This case was reported by a healthcare professional and described the occurrence of bleeding from cut in a 52-year-old female subject who was vaccinated with HAVRIX 720. Concurrent medications included LEVOTHYROXINE. On 27 October 2008 at 11:00, the subject experienced bleeding from cut from broken vial of HAVRIX 720 (pharmaceutical product complain). The healthcare professional reported that when the medical assistant removed a vial of HAVRIX from the box and placed it on the counter, the bottom of the vial cracked and completely came apart from the vial. (pharmaceutical product complaint). Then when the reporter picked it up, she cut her right and left thumb. It is currently bleeding sporadically. At the time of reporting, the events were unresolved.
1st shot was given April 1st . On April 6-8th he began with low grade fever, chills, body ache. April 14th began to complain about chest pain went to hospital in and was told he had environmental pneumonia on right lung, was given antibiotics. April 17 went to the emergency room as fever and chill were high and had difficulty breathing.  Was admitted and transfer to Hospital.  Was given antibiotics Zithromax, iv fluids. Discharge on the 21st.  Later that night we notice bumps that hurt on in front of his legs.  Went to the doctor they indicated he had  erythema nodosum was prescribed prednisone 2 a day for 5 days.  At the end of treatment bumps had almost gone away.  Took an x-ray that showed he had  hilar lymphadenopathy and will go see a pulmonary specialist in June.  Was told ok to take 2nd does of pfizer .  2nd does was taken 4/28th .  On May  1st bump re appeared however only on ankle and heel.  Went to the doctor and was put on another prednisone only 5 days once a day.  Medicine did not help. On May 15 began with new symptoms and began  to complain about wrist and ankle pain, heel pain. Not able to walk or stand correctly went to go see the doctor 5/19 and order a tb test and other blood work.  Suggested to report to the cdc since symptoms appear after getting vaccine. PT is not feeling good, indicates his body feel different since the vaccine.  weak , tiered, sweats from not doing anything. Waiting for results.
22mins post vaccination, pt reported Nausea and dry heaves to observation nurse. Pt was taken to triage area. Charge RN onsite provider notified. Pt denied CP, SOB, headache.  Vitals: @12:21 BP 153/88, HR 66, RR 20, O2 Sat 100% -- > @12:29 140/86, 62, 18, 99% -- > @12:45 139/91, 68, 16, 99% After sitting in a recliner chair for ~20mins, pt reported that nausea subsided and was able to tolerate drinking water.  The patient was able to ambulate out of the chair w/o assistance. Patient was educated to seek further ER services if sxs worsen. Pt verbalized understanding. Pt stable and released from the vaccination site.