chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 34 years old female patient who experienced numbness and tingling in her handwhile she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Details of concomitant medication was not provided. On 15-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT630JA via intramuscular route in the right arm. On 16 Oct-2018, The patient developed a non-serious event of numbness (paraesthesia) and tingling in her hand (hypoaesthesia) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Final diagnosis was numbness and tingling in her hand and numbness and tingling in her hand. Details of lab date was not provided. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for numbness and tingling in her hand.
Patient  reported on 08-19-22 8:00pm  that he lost his voice 1 hour after received the COVID dose 2 vaccine on 08-17-22 at 5:15pm.. He has had difficulty talking and sore throat   after vaccine administration.   Patient has current health condition of esophageal dysmotility.
PT REPORTED LARGE AMOUNT OF SWELLING AT SITE MAKING THE MUSCLE AREA VERY LARGE AND PAIN THE NEXT MORNING UPON AWAKENING, FELT FINE PHYSICALLY. AFTER FOLLOW UP ON DAY 3 PT REPORTED NO PAIN AND SWELLING HAD GONE AWAY.
chills, body aches and migraine beginning on 1/4/21 and lasting until 1/6/21.
Starting feeling like her legs were weak. Within a couple days couldn?t walk without a walker. Eventually got so weak broke her hip and is now living a nursing home. Before injection was living alone and walking fine .
Information has been received from a registered nurse concerning a 13 month old male with an allergy to nuts and described as healthy who on 02/17/2005 was vaccinated with a dose of varicella virus vaccine live.  Concomitant vaccination that day included a dose of hepatitis b virus vaccine rHBsAG Hib conj vaccine.  On 03/02/2005 the patient developed 10 red raised fluid filled lesions, random over body.  Unspecified medical attention was sought.   There was product quality complaint involved.  Additional information has been requested.
Arm tingling/numb after shot; site red and has knot under skin; severe fatigue lasting 14-16 hours.
Increasing fatigue from June 2021 onward. Sudden onset. Muscle aches and joint pain, up and down the spine (June). Throughout July, really heavy fatigue.  Would need to nap when fatigue hits. can occur multiple times per day.
Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   6 patients received dose from affected vial. No concomitant product reported by reporter. Vial did not undergone any temperature excursion issue. The vial was first put into refrigerator on 16 Jun 2022. No treatment medication reported by reporter.
The day of the vaccine I had a red quarter size spot raised around where the vaccine was given. The next day it got larger and two days from administration it is the size of a baseball. Raised, large lump red and warm. Called hospital and they said to put ice on it and take Tylenol.
never received another dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in July 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received another dose of Twinrix, which led to incomplete course of vaccination. The reporter was asking if they would need to restart the vaccine series. The reporter did not consent to follow up.
2 days later nausea, vomiting, diarrhea, palpitions, tachycardia, fatigue, general malaise. Still have occassional palpitations.
Narrative:  A 37yo female with PMH of H - Pylori GI tract infection, Cervicvaginal Cytology - high grade Intraepitheleal Lesion or Carcinoma and Adjustment Disorder Per NP/Nursing documentations - she received Pfizer Covid - 19 vaccine per policy and protocol without complication, first dose on April 8, 2021 and the second dose on April 29, 2021 On May 6, 2021, the attending physician reported, she had Pfizer Covid - 19 vaccine induced reaction of unilateral wrist swelling and erythema which started several days after the vaccine and symptoms improved with antihistamine May 4, 2021 Women's Health documentation included the patient reported having left wrist swelling on May second after she had the Covid -19 vaccine and took Claritin. The shots were administered on the right but the swelling occurred on the left wrist
2 days after receiving flu injection, pain down left arm; Tried heat, elevation, also started getting discomfort in neck, Osteopathic treatment to cervical area
Continual mild to moderate pain at site of injection in left shoulder. Difficulty lifting heavy objects. Taking daily naproxen.
Shortness of breath, low blood oxygen  which gotten increasingly worse the days following first vaccine.  Went to ER two days after vaccine as symptoms continued to get worse and was placed on oxygen  full time.  Had a portable oxygen  machine. Was also placed on hospice care March 18, 2021; 3 days after 1st vaccine. He had a stable bill of health on Feb 4,2021. Dizziness, fainting and falling down days after second vaccine on March 8 2021.  Was in and out of urgent care, ER and assisted care as symptoms and health rapidly deteriorated.  He died May 1, 2021
spoke w/ an employee before taking vaccine due to  reaction before that was not documented. She said to  come back if reaction. Thursday took vaccine after  a few hours started to feel weak, tired, low grade  fever, hives. Took Benadryl and symptoms were away by  Sunday.
A report has been received from a Health Professional concerning a 5 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 11-Nov-2014. Child received FLUMIST quadrivalent on 14-Nov-14 and tested positive for flu A on 06-Dec-14. The outcome of the event of two children vaccinated with FLUMIST quadrivalent tested positive for influenza A is unknown. The report was considered to be non-serious.
NEXT MORNING ON ARISING TACHYCARDIA = 164, POSSIBLE Afib for several hours.  KNOWN problem/dx but NEVER SO SEVERE.   Next day fatigue - went to bed 3:30.  today, 2 days after = baselines NO MEDICAL CARE REQUIRED. WILL REPORT TO MD
I immediately had an increase in heart rate to 110 bpm.  after getting the injection.  I sat for 30 minutes instead of the 15. My heart rate still continued to stay high.  I drove home and continued to monitor my heart rate.  My heart rate stayed elevated for the remainder of the evening.  The lowest was around 99 bpm when I retired to bed.  Woke the next morning with a heart rate in the 80's.  Normally my resting heart rate is around 62 bpm. Within 24 hours, my heart rate was back to normal. As of today, my heart rate is back to normal.    I have a slight cough, but I believe that is due to my sinus allergies.
1 week after covid booster: vertigo, dizziness, nausea, headache. Still ongoing as of 10/09/2021.  Been treated by primary doctor, express med doctor, and neurologist. Received numerous medications with no relief.  Also have been evaluated by a physical therapist.  Have had MRI and CT to rule out other causes. PT to be scheduled.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/23/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Left messages on 5-9,5-10, and 5-11 for patient to call pharmacy back.
Patient reported painful/tender nipples after receiving the vaccine. He said the symptoms are still there but subsiding.
p/vax pt started to have swollen inj site, redness & pain;pt took unk chinese herbs OTC by self & claimed that dec swelling;seen at clinic;lt upper arm swelling, red, pain & warm to touch;
After  5 min, patient experienced sharp left deltoid area to left neck with ?fuzzy headache?
This spontaneous report was received from a nurse via a company representative refers to an young adult female patient of unknown age. It was reported that the patient was not pregnant. The patients medical history, current conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with first injection of VARIVAX injection (dose, lot # and expiry date were not reported) for prophylaxis (reported as because of no history of varicella disease). On an unknown date after receiving the VARIVAX, the developed a rash from the shoulder down to the injection site. The patient stated that she might not go back for the second dose. The event outcome and causality were not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sore arm for several days.   Upset stomach and nauseous for several days,  two days of watery stool. Weak in general for a week.
Full body rash that developed over a period of two days; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK8733) via an unspecified route of administration in the arm left on 06Apr2021 at 09:00 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to scallops and bee venom. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. On 09Apr2021, the patient experienced full body rash that developed over a period of two days. On 15Apr2021, the patient underwent SARS-CoV-2 test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and included treatment with benadryl (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event rash was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Fever, Rash on Chest, Abdomen, Almost entire Back, Itching Fatique, Smell Sensitivity - Skin sensitivity Extreme illness for one week - Rash visible for over 30 days - Prescribed Steriods 11-07-2020 Areas on Back are still slightly visible
57 year old male patient inadvertently administered an expired dose of Typhim Vi with no reported adverse event; Initial information received on 18-May-2021 regarding an unsolicited valid non-serious case received from a physician via other health care professional.  This case involves a 57 year old male patient who was inadvertently administered an expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included YELLOW FEVER VACCINE (YELLOW FEVER) for Immunisation; and POLIO VACCINE (POLIO VACCINE) for Immunisation.  On 17-May-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A25 and expiry date: 11-May-2021) (prefilled syringe) via an intramuscular route in the right upper arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report no adverse event was reported.   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.
this is 1 of 2 hosp employees to deven an injs ite rxn characterized by redness, swelling & warmth, following vax;vaccine was administered between the shoulder & elbow areas but below the deltoid;
Developed 104-105 degree fever; severe aches and chills; low O2 SATS; very high heart rate.
soreness of the arm and headache; soreness of the arm and headache; tenderness around the site of the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 82 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "soreness of the arm and headache"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "tenderness around the site of the shot".  Additional information: Patient was not sure if it was the first or second shot or what it was, but that was the only thing. It might have been in the evening that she had tenderness around the site of the shot. That's all that she said anything about. She had medical issues but don't ask because caller had no idea what they are, but she definitely had some issues.  Caller Stated a lot of the people have received the vaccine (not sure if that was Pfizer or not) and experienced  soreness in the arm but no other problems, including her mothers sister 94 years old female, another 83 years old female who has other medical problems experienced soreness of the arm and headache. A different (young and old) age group of people experienced chills, did not feel right but it did not last long.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough case admission after two vaccines; PATIENT EXPIRED ; Pfizer 4/23/22 Lot# FK9894;  Pfizer 5/24/22 Lot# FN2908
I had regular bloodwork done on February 18th. I had an appt on the first of April to get my results back.  My platelets had dropped to 134,000 and they are normally over 150,000; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 08Mar2021 at 13:45 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient received unspecified concomitant medications and also received shingrix (MANUFACTURER UNKNOWN) on 20Feb2021 in left arm for unknown indication. 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 received other vaccine within four weeks prior to the vaccination. On 18Feb, the patient had regular bloodwork done. She had an appt on the first of April to get her results back.  Her platelets had dropped to 134,000 and they were normally over 150,000. On an unknown date, the patient underwent platelet count and the result was her platelets had dropped to 134,000 and they are normally over 150,000. Therapeutic measures were not taken as a result of the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event platelet count decreased was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Child presented with cardiopulmonary arrest per parents previously health with negative PMH. Found apneic and unresponsive, medics called and child intubated and resuscitation attempted in route. Child apneic and unresponsive upon arrival at ED. Resuscitation was not successful. Per parents child received vaccine, 1 day DTP.   5/8/06 Received ER medical records which indicate patient arrived at ER in full arrest & was unable to be resuscitated.  5/19/08 Autopsy states COD as sudden death associaated with a hypotonic-hyporesponsive episode due to recent vaccinations.  Autopsy states patient & twin well on day of vaccination.  Then developed fever, vomited & developed severe diarrhea.  Became limp with diaper change, caregiver started CPR & was transported to ER.
Starting mid-afternoon (after getting the vaccine at 8:25 am 2/14/19), developed a very strong headache, very sore, red, swollen L arm (around the injection site) muscle soreness (especially in shoulders and neck) extreme fatigue, mild nausea. Symptoms intensified at night to the point where I got little sleep owing to the pain. Felt terrible--all the same symptoms plus a little bit of wooziness and shiveryness the morning of 2/1,; wentto work that morning only because I had 2 critical meetings that morning. Left work mid-day and went home to bed, still feeling the same symptoms, but somewhat abated. Exhausted but that night was able to sleep. On Day 3, (Saturday, 2/16/19), felt better though still not fully well. By that evening felt more or less back to normal. Note that this is the 2nd shot in the 2-shot SHINGRIX for me. I got the first shot in September, 2018, (from the same provider--my regular PCP's practice) and also had similar symptoms for 2-3 days after the shot, but they were not quite as pronounced and I did not have to miss any work.
Patient had swelling in (L) arm and itching. She had a slight fever and headache and upon movement felt short of breath. As of 10/4 rash still present swelling slightly reduced and patient was prescribed steroids and diphenhydramine for itching.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Shingrix (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 26th April 2018, the patient received the 1st dose of Shingrix (intramuscular). In April 2018, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. Around 3 days after vaccination, the patient developed shingles. The patient was seen by her doctor and was prescribed unknown treatment.
I started will swelling in left arm. After I few days I lost range of motion. I have severe pain and loss of ROM in L shoulder/ rotator cuff area.
Information has been received from a nurse practitioner concerning a 9 year old female with NKDA and a history of varicella exposure and lice exposure who on 09/10/1997 was vaccinated SQ in the right arm with a first dose of varicella virus vaccine live. There was no concomitant medication. On 07/10/01, 2 wks after being exposed to varicella at camp, the pt experienced chicken pox. The first lesions were noted on the abdomen and on 07/11/01, she was seen in the office with 100s of lesions, covered top to bottom. It was noted that just her face had 40 lesions and that all the lesions were itchy. Her fever on 07/11/01 was 102 degrees F. Follow up information has been received from a nurse practitioner who reports the child's vesicles scabbed in 3 days and started to fade. When the patient's mother called the office on 07/14/22, the vesicles had almost disappeared. Additional information has been requested.
about 1 1/2hrs p/vax pt started crying & cried 7-8hrs, w/o stopping;MD ordered ped DT to be given instead of DTP
I HAD A 2ND DEGREE BURN ON MY RIGHT FOOT DUE TO HOT WATER AND WENT TO THE EMERGENCY ROOM. I GOT A TETANUS SHOT( I DON'T KNOW WHICH KIND TETANUS SHOT) ON MY RIGHT ARM AND OMNICEF FOR THE INFECTION AND HYDROCODONE  FOR THE PAIN. AFTER ONE WEEK MY RIGHT ARM SWOLLEN WITH REDNESS AND A LOT OF PAIN. I HAVE NO IDEA WHY I GOT THE PAIN AND THE SWOLLINING AFTER A WEEK. MY RIGHT ARM IS STILL SWOLLEN AND I CAN'T DO ANYTHING USING MY RIGHT ARM.
A few days after 1st vaccine, noticed extreme dryness inside the nostril opening on both nostrils. Over next few days experienced periods of redness/tightness on the face, particularly across the forehead, the upper cheeks and around the nose and mouth. Redness often accompanied by sense of itchiness, tightness or mild burning. Symptom severity varied day to day, but did not stop after initial event.