chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient given MENACTRA Sub Q instead of IM as prescribed.  By next morning, 24-36 hours, area of arm was swollen and red, warm to touch. Cellulitis was diagnosed by patient's primary care MD.  Advised to rest arm and keep compresses on it along with antibiotic orally.
General malaise with burning sensation inside the body, no fever registered; inflammation of right arm and hand/wrist, migratory joints pains, muscle pain, stabbing pains sudden, neuralgic pain in the extremities. Pain was so severe that cause limitation for walking around the house. The last event on the 7th  day  was inflammation of the right foot and ankle with severe pain  with no history of sprain or trauma.
Approximately 5 weeks pregnant, estimated due date December 11, 2021. Symptoms after vaccine include; pain at and around injection site through right shoulder, tiredness and fatigue, chills, headache, nausea, intense dizziness and feeling faint. Pain symptoms started within 1 hour after injection, all other symptoms approximately after 8 hours.
itching all over body; This case was reported by a nurse via call center representative and described the occurrence of generalized pruritus in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was recovered/resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. Four months before the reporting date ago, the patient received Shingrix. Within 24 hours of receiving the vaccination, the patient experienced itching all over her body which resolved within a day. The reporter was a nurse with the health department. She would not provide any additional details. She was going to have the physician call Glaxosmithkline to provide the details.
Patient administered vaccine on Monday, however the vaccine was drawn up the previous Friday. Note - it was kept refrigerated since it was drawn up.
Initial report received on 13 June 2013 from a healthcare professional, medical assistant. A 23 year old female patient was vaccinated on 21 May 2013 with ADACEL batch number C4365AA intramuscularly into the left deltoid. The patient had a history of allergies to chicken feathers, cockroaches and pollen. The patient's prior tetanus doses were not on file. According to the reporter, the patient did not have an illness at the time of vaccination. On 22 May 2013, the patient experienced a shooting pain down the entire left side of her body from her face to her feet. The patient was admitted to the hospital on 22 May 2013 and was evaluated by a neurologist and an infectious disease specialist on an unreported date who were unable to determine the cause of the shooting pains. The patient had a CT of the brain, lumbar puncture/spinal tap, CSF and blood cultures which results were negative. The patient was discharged on an unreported date with the discharge summary: vaccine reaction. The patient is recovering and will follow-up with the neurologist, ID specialist and PCP. The patient outcome was reported as unknown. Documents held by sender: None.
Information has been received from an office manager concerning a 76 year old female who on 03-DEC-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) mistakenly instead of ZOSTAVAX (Oka/Merck). It was unknown if the patient sought medical attention. Follow-up information was received on 17-DEC-2008 via phone call from the office manager who confirmed that VARIVAX (Oka/Merck) was given mistakenly instead of ZOSTAVAX (Oka/Merck). The office manager stated that this was a human error. The vaccines were in the freezer and somebody had written on the box "not ZOSTAVAX (Oka/Merck)", but you could not see the "not". The nurse pulled the box thinking that it was ZOSTAVAX (Oka/Merck), but instead it was VARIVAX (Oka/Merck) and did not look at the vial and administered the vaccine. There had not been any adverse events. The lot number of VARIVAX (Oka/Merck) was 661013/0604X. Further information has been requested.
Redness and itching to right arm below injection site.  Diphenhydramine 25mg orally administered.
Swelling at injection site was size of dime next morning. Swelling continued each day. Today it is 5x6 measured by doctor. Headaches since Wednesday and pain down leg since Wednesday night.  Doctor said celulitis or hematoma that has gotten infected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: antibiotics" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) negative; (2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 28Jun2022 to 02Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 53-year-old female patient who received Shingrix for prophylaxis. On 19th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 20th September 2018, 1 days after receiving Shingrix, the patient experienced general body pain, headache, pain in joint involving hand, fever and chills. On 25th September 2018, the patient experienced shoulder pain. On an unknown date, the outcome of the general body pain, headache, pain in joint involving hand, fever and chills were recovered/resolved and the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the general body pain, headache, pain in joint involving hand, shoulder pain, fever and chills to be related to Shingrix. Additional details were provided as follows: On 19th September 2018 at 16:30 hours , the patient received Shingrix on left arm. After receiving Shingrix, the patient experienced severe body aches, severe headache, fever, chills and joint pain in her fingers. The headache only lasted about 1 day and the other symptoms resolved after 3 days. The patient experienced pain in her right shoulder and it had been getting worse. The patient could not move her arm without pain.
fatigue lasted 2-3 days max; soreness lasted 2-3 days max; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness lasted 2-3 days max) and FATIGUE (fatigue lasted 2-3 days max) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness lasted 2-3 days max) (seriousness criterion disability). On an unknown date, the patient experienced FATIGUE (fatigue lasted 2-3 days max) (seriousness criterion disability). At the time of the report, PAIN IN EXTREMITY (soreness lasted 2-3 days max) and FATIGUE (fatigue lasted 2-3 days max) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided. No treatment medication information was provided.  Company comment: 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.   This case was linked to MOD-2021-286678 (Patient Link).; Sender'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.
Excessive soreness of injection site; Chills; Sore joints and muscles all over body; Sore joints and muscles all over body; Fever; Headache; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 22-years-old female non pregnant patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 13Feb2021 07:30 am (age at the vaccination 22-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication includes Birth control pills. Patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. 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 experienced excessive soreness of injection site, chills, sore joints and muscles all over body, fever, and headache on 13Feb2021 19:00. The patient did not receive any other treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
For the first 3 days, intermittent chills and muscle aches in legs.  On the 4th day, I felt back to normal.  On the 5th day, I noticed a  distinct  increase in the volume of tinnitus in both ears, day and night.   It sounds like constant high pitched white noise.
C/o "extreme pain" @ injection site, limited ROM in left arm, and tingling in fingers of left hand which began approx. 2 hours after Tdap shot. Denies symptoms when shot received. Recommended massage and ice pack and ibuprofen. Spoke with employee 8/18-stated arm is fine now, symptoms were gone by Sat. 8/15.
Sensation of swelling in neck and left deltoid area, tingling and sharp pain in left foot. Tingling in right hand. Referred to neurologist today.
pt recv vax 29JAN97 & on 20FEB97 pt devel chickenpox consisting of 6 lesions;
Began with runny nose like a cold, then felt weak all over, unable to walk 30 feet without a rapid heartbeat of 100-120 bpm and shortness of breath, loss of appetite, this lasted over a month.
Swelling (L) upper lip with palpable tender hip about 1 cm2. BENADRYL 25mg po given with water partial relief within 5 min. Total resolution by end of visit 3:36pm.
Narrative: 86yo male died on 9/24/2021 at home. No information in agency records. Pt did see multiple other providers outside of agency. Pt had received covid vaccines on 1/14/2021 & 2/11/2021. Likely his death is not related to covid vaccines given patient's advanced age and long length of time between date of vaccines and date of death.
I had my vaccination on 10/20/2022. I started to have symptoms on 12/25/2022 to feel unwell. On 12/27/2022 I started to have fever chills fatigue loss of taste. I tested COVID-19 Positive on 12/28/2022 and stayed COVID-19 Positive for 18 days. I was prescribed Paxlovid but did not take. I currently feel ok and getting better each day. Still have some fatigue. I follow up and annual appointment with my physician on 01/27/2023.
Severe pain swelling and redness at administration site. Malaise, headache, upset stomach, myalgias, sweats.
She got her vaccine around 11:00 AM, she did not have any reaction at first.  Her and her husband ran around all day, she was tired and she sat down.  Then on the right side on the middle of her back she was having stabbing type of darting pains that were severe in nature.  She has OA on the left side lower of her back, this was on her right side in the middle of the back on the right side.  The pain took her breathe away and she thought she would end up in the ER.  The only thing that they could think of causing the pain was the vaccine.  She has had the flu shot in the past, and she believes it was the RSV vaccine that she got.  She got up slowly, had a hernia over a year ago and has a binder, and put the binder on and then took it off to sleep and it helped.  The next morning after she slept, she had pain again on that side but not as bad.  She took Tramadol for her pain which helped, but resting on it helped.  Every so often she gets pain in the back on the right side, which she has never had that before.   She has an appointment with her PCP on 9/28/23 and is going to tell him about this.    She took the vaccine as she saw a commercial about it and due to her age she decided to get the vaccine.    She has had the COVID vaccines with no reactions.
Can't use arms or legs because they are hurting so badly; Can't use arms or legs because they are hurting so badly; Sounds very weak; This is a spontaneous report from a contactable consumer (caregiver). A 48-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization, at the age of vaccination of 48 years old. The patient's medical history and concomitant medications were not reported. The patient experienced can't use arms or legs because they are hurting so badly (non-serious), sounds very weak (non-serious), both on 08Apr2021 with outcome of unknown. Caller was calling for her 49 year old daughter, who received her 1st Pfizer COVID Shot this morning and was experiencing a terrible reaction. She mentioned that her arms and legs were so sore that she cannot get out of bed. She already took Tylenol for it but it did not help. She mentioned that her daughter was healthy and does not get sick often. She was asking how long these side effects may last. Caller reported that she called the patient earlier, and the patient said that she can't use her arms or legs because she was hurting so badly and that all she can do is lay down. Caller reported that the patient was supposed to be traveling to downsouth this weekend to visit the caller.  Caller reported that she called the patient to see if she needed anything and that the patient sounded really weak.  The patient reported to the caller that she was in bed, her arms and legs hurt so badly, and that was miserable. Caller stated that she is very worried about the patient.  Caller inquired if what the patient was experiencing was a common reaction, and how long the side effects will last. Treatment received included the patient took Tylenol.  Follow up information completed. No further information is expected. Information about lot/batch number cannot be obtained.
Fainted (muscle spasm similar to seizure), concussion, abrasion and bleeding on hand and knee, swelling on hand and knee from fall. Code called along with EMS call for EMTs. Nausea, headache, grey pallor, very tired.   Follow up apptmt 1/28/22 for full check up
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. The healthcare worker reported that the patient received their GARDASIL doses outside of the Prescribing Information (PI) recommended schedule. In May 2011 the patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular. In January 2013 the patient was vaccinated with the second dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular), intramuscular. In January 2014 the patient was vaccinated with the third dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular. No adverse effects reported. Additional information has been requested.
Swelling around shot, painful, headache, back ache, chills, legs and muscle and leg pain.
fever, pancreatic pain, rapid heart rate and breathing.  (pancreatic pain was the main symptom that resulted in the patient going to and staying overnight in the hospital)
Patient came to ED with shortness of breath.  Patient admitted to hospital with acute respiratory failure and Covid positive.  Patient treated with remdesivir.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Confusion-Medium, Systemic: Hyperventilation-Medium
Patient contacted location supervisor. Reported about 2 hours after vaccine she began itching from top of head and spread to rest of body. Client states no rash, hives, fever or any other sx. Client contacted PMD who told or any other sx. Client reports taking 25 mg BENADRYL q 4 hours-nurse suggested increased dose to 50 mg q 4 hours after client checks with PMD.
developed a severe tachycardia (SVT) that did not react to shots given to me by the Personnel. Urgent care called emergency and had me transferred to the Emergency room for treatment. I am now on Metopropol 50 mg and Amlodipin 5 mg every day and still suffer from an irrational blood pressure and puls, when for years before I only had mild spouts of VT every 6 or 8 months. It is now a regular, every day problem. So I know that it developed negatively.
Patient received Johnson & Johnson COVID 19 vaccination on 3/31/21. Follow up telephone call made to screen patient for warning signs of blood clots. Patient reports new onset symptoms of severe headache that started occurring on 4/2/21 at 4:pm. Patient was given the recommendation to seek medical attention at the nearest emergency department for medical evaluation for blood clots due to reported symptoms. Patient denies any abdominal pain, leg pain or swelling, or shortness of breath. Patient states he does not plan to be evaluated in emergency department but will make an appointment to be seen by primary care provider. Patient educated and informed that the severe headache symptom is a warning sign of a blood clot and should seek medical evaluation at the nearest emergency department. Patient verbalizes understanding. Patient also given Nurse COVID line number.
12hours after vaccine developed headache, chills, and body aches. Within 24hours also developed severe fatigue. Symptoms resolved within 48 hours except for continuing fatigue and recurrent headache.
Patient began menstruation early despite being on BCP.  Patient was due to start menstruating on 4/18/2021. However, the patient started cramping and menstruating on 4/13/2021. This has never happened to patient.
Information has been received from a female consumer reporting on herself who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown) and "shortly after receiving the vaccine" she experienced her arm to swell and she felt aches and pain. It was unspecified if the consumer sought medical attention. At the time of the report, the consumer's outcome was unknown.  Additional information has been requested.
Initial misuse report received from a healthcare professional on 11 October 2013. This case is a part of 1 cluster cases and is linked to case number 2013SA103895 (same reporter, events after FLUZONE ID, lot number: UT4725AA). A 66 year old received FLUZONE ID (batch number: UT4725AA, expiry date: 19 April 2014) on 11 October 2013. After received FLUZONE ID, immediately afterwards, patient reported itching at site spreading to face and neck, and eyes. Patient was outside of age indications for FLUZONE ID. Patients received therapy with BENADRYL or ranitidine. The event was resolved. List of documents held by sender: none.
This spontaneous report as received from a physician refers to an unknown number of patients of unknown age. On an unknown date, the unknown number of patients might have been vaccinated with doses of GARDASIL (lot # not reported) that were improperly stored. It was reported that the doses of GARDASIL were exposed to temperatures of 33F for 120 hours. No adverse effect reported. Additional information has been requested.
Reporter states pt did not seroconvert p/receiving Engerix-B series; all injects were administered IM;
Nurse drawing up Moderna doses administered 0.3mL doses instead of 0.5mL. Patient notified 10/06/2021 and offered to received the additional 0.2mL to receive the full dose.
A large red area developed in the area of the vaccine, Also. my lymph nodes in the groin on the same side as the injection became enlarged and very tender over night and have still not gone down.
Pt. stated "I felt a hot flash and lightheaded 10 minutes after getting vaccinated."  "It started on my arms and it wend down to my legs."  At 10:25am vital signs taken.  BP 130/70, HR 54, O2 Sat 100%, R 16.  Pt. stated her HR is usually low.  At 10:38am pt. stated light headed is going away and I only feel the hot flash in my legs.  At. 10:49am, pt. stated I feel so much better and refused to go to the hospital.  At 10:51am pt. went home.
I am not sure if this is related to the cover vaccine but about 10 days after vaccination I started with hives and allergies.
c/o problems swallowing despite drinking water. Sat pt in chair, VS taken and monitored. Epinephrine IM given when pt c/o problems swallowing worsening. 9-1-1 called and responded but pt declined escort to ED because he stated he was feeling better after Epi  so instead I and patient transport escorted pt to ED via wheelchair.
Patient called and then came into store to show a bruise the size of about an inch. The bruise was purplish and surrounded by a yellow circle. The bruise is on right arm the same arm that FLUVIRIN was given.
Arm hot to touch; Chills; Muscle and arm aches; Redness at vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Arm hot to touch), CHILLS (Chills), MYALGIA (Muscle and arm aches) and VACCINATION SITE ERYTHEMA (Redness at vaccine site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE WARMTH (Arm hot to touch), CHILLS (Chills), MYALGIA (Muscle and arm aches) and VACCINATION SITE ERYTHEMA (Redness at vaccine site). At the time of the report, INJECTION SITE WARMTH (Arm hot to touch), CHILLS (Chills), MYALGIA (Muscle and arm aches) and VACCINATION SITE ERYTHEMA (Redness at vaccine site) had resolved.            Details reported by phone on follow-up: patient said all AE's dissipated within 2 weeks, that she is feeling fine now and has nothing else to report.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: No specific follow-up information recorded.
Information has been received from a health professional concerning a 4 year old female with no medical history or allergies who on 13-SEP- 2002 was vaccinated with Varivax (lot# 642680/0379M). There was no concomitant medication. On 01-MAR-2006 the patient experienced red, itchy spots that were treated with Aveeno bath. Medical attention was sought but no labs were done. The patient recovered. Additional information has been requested.
lst and 2nd day:  sore arm 3rd day:  shortness of breath, fatigue, body aches, headache one week later:  arm itching , red and blotchey and warm Time Course:  symptoms lasted 4-5 days