chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore at injection site/to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on Saturday and he said that it was sore at the injection site.  The whole region where he received the injection was sore to the touch. The reporter did not consent to follow up. The patient declined answering further questions.
rashes; swelling on the mouth; swelling on the lips; swelling on the face; Streaks on arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 01Apr2021 at single dose for COVID-19 immunization. Medical history included diabetic and high blood pressure; both diagnosed long before, probably 20 years before. Concomitant medications were not reported. Patient said that after receiving the first dose of the Pfizer-BioNTech Covid-19 Vaccine, she developed rashes, and swelling on the mouth, lips and face on 01Apr2021. She was told not to receive the second dose but called to confirm if it was true. Patient waited the 15 minutes she was told to after the vaccine. Then an hour after the vaccine her face swelled, mouth swelled, lips swelled up over her nose, she had a rash, and streaks down her arms. She went to the emergency room on 01Apr2021 and was given a steroid and was told to take diphenhydramine hydrochloride (BENADRYL) every 6 hours.  She was not admitted to the hospital. She recovered completely as of 03Apr2021. Patient read the papers that she was given and they said if you had reactions like this you should not get the second shot. She went to the doctor and they told her it was up to her whether or not she got the second shot. She wanted to know whether or not she should get it. She was leaning towards not getting it because it was the same recipe as the first shot and she felt she would have the same reaction. Outcome of the events was resolved.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Mild facial swelling and rash 2 hours after vaccine. Rash self resolved.
Pt. had six month well check 06/25/08. Mom elected not to do immunizations that day related to having "plans" for the weekend, but agreed to return in one week.  Pt. did not return until 9 month appt., but was not feeling well. Physician suggested returning to clinic in one week for immunizations.  Parent returned to clinic 10/08/08 for a "nurse care visit only" for vaccinations.  A new hire looked up last well visit to try and find order for immunizations.  Something wrong with computer system and 9 month well visit was not displayed.  She looked at the 6 month well visit and saw the recommendation to return for Pediarix, Hib, Prevnar and Rotateq.  She went ahead and gave all the mentioned and entered them into the system.  When they appeared on Dr.  workload to be signed off on, Dr. realized the child had exceeded the recommended age for the Rotateq vaccine.  She refused to sign off on the order.  I contacted Merck for direction on any concerns, have not heard of any yet.  Still awaiting final answer. To contact Parent to let them know this was given, should not experience adverse effects and they will not be charged for this.  I will file report to Risk Management/ Quality Safety. Discussed with new hire.  Will implement new policy for patients returning for vaccinations only (nurse care visits).  We will not give vaccinations without an order, either written and signed or entered in scheduler notes as an order.
That evening after getting both injections patient started feeling unwell.  Patient was fatigued and dizzy the next day following immunizations. Mild fever for about 6 to 8 hours. Vomiting and diarrhea was also present. Patient went to emergency room on wednesday. Discharged with anti-nausea and anti-diarrhea medications.
Measle like rash on left arm (Injection site), leg, stomach and chest. Itchy but otherwise tolerable
Patient developed a swollen ball (soft ball size per report) on the bottom (tricep) area of the arm, pain in elbow, stiffness of the arm, stomach upset, headache, dizziness, sweating, loss of appetite, fever, itching. Referred patient to EMS, was on his way to urgent care.
Description: 1/21/05- received primary FLUMIST- no problems. 1/23/05- "felt run down". 1/24/05- c/o n/v, diarrhea, fever (temp not taken), chills and night sweats- was seen by PCM- states no diagnosis given- received quarters x2 days. 1/26/05- above sxs improved- started to notice back pain- "felt like I pulled my muscle in the middle of my back"- woke up at midnight with "severe chest pain (pressure-like, sharp and dull, 9/10)," left arm numbness, worsening back pain, and dyspnea- alleviated by sitting- aggravated by lying down- pain similar to pericarditis he had 2 years ago- no c/o f/c, malaise, fatigue, n/v or diaphoresis. 1/27/05- went to ER- was admitted to medical center- over two days, telemetry was at NSR- given dx of acute pericarditis. 1/28/05- was discharged in stable condition with INDOCIN 25mg 1 tab TID x2 wks- f/u scheduled with clinic in 1 week with his PCM- states still had intermittent cp and dyspnea (3/10) at rest at discharge- other sxs resolved. 2/2/05- pt. seen by his Case Manager- states currently has no cp or dyspnea at rest- however still experiences mild (2/10) cp and dyspnea with excessive talking or with increased physical activities. Pt. has a h/o acute pericarditis 2 years ago- pt. unsure if sxs appeared before or after receiving a flu vaccine- was hospitalized- sxs completely dissipated- no reoccurrence of sxs until recent episode. Discussed case via phone with pt's PCM, algorithm review- f/u cardiology referral recommended. Symptom: Flu-like symptoms< 96 hours Start: 01/23/2005 End: 01/26/2005. Symptom: Chest Pain Start: 01/26/2005 Comment: Initial (9/10, at rest), Present (1/10, with increased activity). Symptom: Dyspnea (shortness of breath) Start: 01/16/2005 Comment: Initial (9/10, at rest), Present (2/10, with increased activity). Symptom: Muscle Pain Start: 01/26/2005 End: 01/28/2005 Comment: Back pain.  6/23/09 Medical records recieved DOS 1/21/05 to 2/22/05. Assessment: Acute pericarditis. Records received support previously submitted information. No additional coding.  ICD-9 Codes: 420.90, 786.0, 786.5, 722.52, 477.0
Roughly six hours after receiving the vaccine, I began to get the chills, and I couldn't stop shaking. Roughly an hour to an hour and a half later, the chills/shaking stopped, only to be replaced by a fever. My temperature shot up, my ears began to ring, and my head began to pound. When I tried to eat, I felt sick to my stomach.   My fever lasted for the entire evening, and I spent most of the night alternating between chills and heat flashes. My head continued to pound, and whenever I tried to sit up, I felt dizzy. At around 4am, I awoke with an upset stomach, diarrhea, and further dizziness.   By around 8-9am, my fever had subsided, and I was beginning to feel a bit better. However, I have been feeling physically drained and a little achy today (03/26).
Patient reported to Urgent Care with Left sided chest pain with Left arm weakness. Patient evaluated by Dr., called emergency number and sent to hospital via ambulance. Follow-up appontment scheduled.
Systemic: Ringing of the ears, slurred speech-Severe, Systemic: Tinnitus-Severe
PATIENT HAD SORE ARM DAY AFTER INJECTION, AFTER A FEW DAYS GOT A LITTLE BETTER AND NOW PATIENT SAYS IT HAS GOTTEN WORSE. TO THE POINT OF HAVING DIFFICULTY LIFTING ARM
She initially had arm swelling and pain over the next few months she has lost mobility and can only move her arm 45 degrees up and down and still experiencing pain and discomfort. limited mobility.
immed p/receiving a DPT, pt stopped breathing; pt became limp, turned blue; attempts were made to stimulate pt resp response; w/in a few minutes, pt began to respond slowly; pt MD was informed of incident & will see MD this PM
Swollen lip (I've had lip fillers before) and hot and itchy Covid arm at the injection site. Felt as though I had the flu for the past 48 hours. No fever although I did wake up sweaty on night 2.
Patient received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date).    This case included information of patient 45 out of 190 reported patients.  No concomitant product reported by reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 190 patient received a vaccine past the beyond use date from 9 different lot number vials.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:case
Sore Arm after injection; Nausea; Muscle Aches; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received first dose of BNT162B2, via an unspecified route of administration (vaccine location=left arm) on 01Feb2021 at a single dose for Covid-19 immunization at a workplace clinic. Medical history included unspecified allergies to medications, food, or other products. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She was not pregnant at the time of vaccination. The patient experienced sore arm after injection, nausea, muscle aches, headache, and fatigue on 01Feb2021. No treatment received for the events. The events were reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Information has been received from a pharmacist concerning a female pt who was vaccinated IM with a 2nd dose of Hep-B and subsequently, the pt experienced a headache which lasted for 4 days. Unspecified medical attention was sought. Additional information has been requested.
1 day after receiving vaccine, fever and body aches. 6 days after-injection site redness and hot to touch, up shoulder and down to elbow, continued to have fever and body aches.
Injection obtained on 10/8/2021 in the right deltoid.  The following morning, woke up with swelling in the right neck, anterior chest wall,  left arm, left shoulder and axilla area.  Soreness at injection site.
Pt exp sx similar to pts who were dx w/fibromyalgia; details of these sx @ time of the report were unk; no further details were provided;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 2nd February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, feeling unwell, incomplete course of vaccination and product availability issue. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved and the outcome of the feeling unwell, incomplete course of vaccination and product availability issue were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad reaction to the first dose of SHINGRIX that was extreme, painful swelling at the injection site that lasted 2 weeks. The patient felt ill the day after injection, and so felt strongly that she should receive the injection at least one week before departing for travel. On 16th July 2018, the patient had a scheduled and appointment for and showed up for her second dose. And she called only to be informed that there was no available product. SHINGRIX on backorder, which led to incomplete course of vaccination and product availability issue. The patient was traveling soon and need to get the second dose as soon as possible, before the 6-month window closed. The patient was very upset that there was a shortage of the product, and she was worried that by not getting the second dose within the 2 to 6 month window of the first dose, her immunity and health would be put at risk. The patient requested that; please send a dose of SHINGRIX for her and any other patients in urgent need as soon as possible and no later than 20th July 2018.
expired dose of PENTACEL was administered with no reported adverse event; Initial information received  on 28-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old female patient to whom expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient's concomitant medications included hepatitis A vaccine (Hepatitis A) for Immunisation.  On 28-Dec-2022, the patient received an expired 0.5 ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, suspension for injection (frequency - once, strength - standard, lot - UJ590AAA and expiry date - 18-Dec-2022), with no reported adverse event (expired product administered) (latency: same day) via intramuscular route in the left thigh for immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Patient is a 10 year-old male vaccinated 12/19/2021 at 1241pm for his 2nd dose of the Child Pfizer 5-11 vaccine (Lot# FK5618). Patient was vaccinated by RN in his Left Deltoid. Per responding post-vaccination observation staff member RN written and verbal report to this documenting Charge RN, the patient complained to his parents shortly after vaccination while he was waiting with them in post-vaccination observation area that he had a ?bad headache and dizziness?. Post-vaccination RNs immediately responded following parent notification to patient complaint, and the two RNs safely escorted patient to private medical cot area with both parents and minor brother present.   One RN stayed with patient while the second RN notified this documenting Charge RN who immediately responded to medical cot area to support patient/family and the two other RNs. Patient laid down supine safely on medical cot with head slightly elevated on pillows for a few minutes. Patient assessed and appeared pale to this documenting Charge RN. Patient reported to RNs that he felt better after lying down for a few minutes and then sat up safely at side of medical cot to drink some apple juice following parent consent. RN took patient sitting vital signs at 1259pm with Blood Pressure: 90/60 Pulse Rate: 96 and Pulse Oximetry reading: 99%. Patient parents stated the blood pressure is baseline to normal for the patient. After drinking juice patient stated that he felt better and had less headache. Patient parents present with minor child throughout the entire medical incident. Patient reported to RNs that he did not eat much that day before receiving 2nd vaccination. Parents confirmed that child did not have much of an appetite before vaccination because he was nervous and anxious about getting his second COVID-19 vaccination. Patient stated he felt less nervous than he did for his first dose, but he still was very anxious. Both of patient?s parents verbally confirmed that he was nervous for both doses.   Patient verbalized again that he felt better, RNs assessed patient skin color return, less pale. Patient parents provided education that if the headache and dizziness return to follow-up with their medical provider as soon as they can and get emergency assistance as needed. Parents verbalized understanding. At military time 1315pm patient safely stood at side of medical cot, denied any further headache or dizziness, patient verbalized he felt better. Patient safely ambulated in care of both parents with his brother present also out of the clinic, stable gait with ambulation noted by RNs.
Information has been received from a medical assistant concerning a 9 week old female with no pertinent medical history and no known drug allergies who on 13-MAY-2009 was vaccinated orally with a dose of ROTATEQ (lot # 663461/0285Y).  There was no concomitant medication.  On the same day, after receiving ROTATEQ, the patient vomited 5 minutes.  No lab tests were done.  The patient recovered on the same day.  Unspecified medical attention was sought.  Follow-up information was received from the medical assistant which reported that the white baby had no illness at time of vaccination.  On 13-MAY-2009 the baby was in the office for well baby exam and was vaccinated orally with the first dose of ROTATEQ (lot # 663461/0285Y).  No further information was provided at this time.  Additional information is not expected.
immun was given 12MAY94 & 13MAY94 the mom called & stated pt arm is reddened; arm of shot feels warm & is sore;
Between my first and second vaccine, I experienced 10+ non-consecutive days of vertigo. I have never experienced vertigo in my life. I have no indication to believe my vertigo was caused by anything other than the vaccine. The vertigo was extreme including spinning walls and tipping ceilings, only to be consoled by sleep and bed rest. I also experienced a general feeling of unwellness for three weeks.
Pneumonia and empyema caused by streptococcus pneumoniae serotype 19 in an immunized child (x/p Prevnar x 3) 2/24/03. The discharge summary received on 1/28/04 states bacterial infection, thrombocytopenia, hemolytic anemia and hemolytic uremic syndrome.
Patient started feeling dizzy, hot, and vision became blurry  while monitoring  post vaccine. Patient was provided with water, and laid down.  Symptoms resolved within 10 minutes.
Initial report received on 19 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; dose one on 21 September 2011, dose two on 22 November 2011 and dose three on 02 February 2012 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 30 June 2012, approximately 4 months after the last dose. On 02 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea. Laboratory testing included positive PCR on 02 July 2012. Culture date 02 July 2012 with negative results. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 16 July 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 17 days. No investigator causality assessment as per protocol. Documents held by sender: None.
Non-ST elevations MI, Acute systolic heart failure, CAD, ischemic cardiomyopathy
My right arm started to get tingly/My arm tingled down to my fingers and it went numb; My right arm started to get tingly/My arm tingled down to my fingers and it went numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 15:30 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 24Aug2021 21:00, outcome "unknown" and all described as "My right arm started to get tingly/My arm tingled down to my fingers and it went numb". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional information: Facility type vaccine was Pharmacy or Drug Store. patient did not receive other vaccine in four weeks. prior vaccination, patient was not tested for Covid. Post vaccination tested for Covid. Patient was worried about getting second dose.   Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101238398 same reporter/drug/AE, different patient