chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Losing eyesight in one eye; Has scratched cornea; She developed Bell's Palsy; She developed shingles; A spontaneous report was received from a relative concerning a  91-year old,  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed shingles, Bell's Palsy, losing eyesight in one eye, and scratched cornea.  The patient's medical history included blind in one eye after laser surgery. Concomitant medications include vitamin d, equate arthritis medicine, losartan potassium, and eye vitamins.  On 30 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly  for prophylaxis of COVID-19 infection.   On 09 Feb 2021, the patient developed shingles and Bell's Palsy. The patient was in the process of losing eyesight in one eye, on the side affected by the Bell's Palsy. The patient also has a scratched cornea. The patient went to the emergency room on 12 Feb 2021.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship with the events of shingles Bell's Palsy cannot be excluded.  However, causality with scratched cornea and losing eyesight in one eye is unlikely.  The scratch is most likely due to a trauma and can impair vision. No further information is expected and follow up consent was denied.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 61 years old patient (gender not reported) who received vaccine FLUZONE HIGH DOSE (lot UJOO6AB) via intramuscular route in the left deltoid on 11-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. The patient did not have any adverse event at the time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
Kinrix given to pt on 5/30/2023, it expired on 5/26/2023, no symptoms, no reactions.
Diplopia and headache, found to have ring enhancing lesions on MRI brain. Ddx broad right now, but given proximity to vaccination reporting in case this is an adverse event. May be CNS lymphoma vs infection vs autoimmune.
Residents left arm from injection site to elbow on the outer aspect of her arm is red, warm, inflamed and painful. APRN has ordered keflex po 3 times a day for 5 days.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: EW0162) at the age of 53 years as dose 1, single and administered in arm left, administration date 01May2021 (Lot number: EW0172) as dose 2, single for covid-19 immunisation; influenza vaccine (FLU), administration date 22Oct2021 (Batch/Lot number: unknown). Relevant medical history included: "chronic headache" (unspecified if ongoing), notes: chronic headache, Has had the last 20-30 years; "migraine" (unspecified if ongoing), notes: Has had the last 20-30 years. The patient's concomitant medications were not reported. Vaccination history included: Shingles shot (AE(s) following prior vaccinations: , Felt bad after getting the shingles shot. It was after the second shot. Felt like had 24 hour flu with it. , Does not have any details to provide a lot/exp date. , This was three years ago.), for felt bad; Shingles shot, for Felt like had 24 hour flu with it.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Apr2021, outcome "recovered" (02May2021), described as "sore arm".  Additional information: Patient reported that she was fine with the first 2 shots, she had a sore arm those two times. She thought that the arm soreness began later on the day she had the vaccine and it lasted maybe 24 hours.  Follow-up (29Nov2021): Follow-up attempts are completed. No further information is expected.
Patient complained that she still feel pain at the site of injection after a month of getting flu shot (FLUZONE HD).
Light Headed/Dizziness, chest pressure, elevated pulse rate, this lasted for two days before subsiding. I called my medical physician and was advised to go to the hosiptal if it continued.
Information has been received from a physician concerning a 15 year old female patient who on 26-AUG-2009 was vaccinated with the first dose of GARDASIL.  On 29-AUG-2009 the patient experienced back pain, joint pain, generalized injection site pain, fatigue and knee pain.  At the time of the report all the patient's symptoms persisted.  No laboratory tests were performed.  The patient sought medical attention by a phone call.  Follow up information was received from a Certified Medical Assistant.  It was reported that the 13 year old patient with skin disorder and no known drug allergies on 26-AUG-2009 was vaccinated with a dose of GARDASIL (Lot # 0558U, valid for rotavirus vaccine live (human-bovine) vaccine); no other vaccines were administered on the same day.  Concomitant therapy included BACTRIM and EPIDUO.  There were no labs/diagnostic studies performed.  The patient was treated symptomatically with rest, fluids, and OTC analgesics.  The patient could not go to school due to her fatigue and received a physician's note which excused her from school until 14-SEP-2009.  Although the office had not seen or heard from this patient since 02-SEP-2009, the Certified Medical Assistant assumed the patient had recovered as no school absence extension was requested.  Fatigue was considered to be disabling.  No further information is available.
I came to this immediate care clinic on 11/8/2022 to receive the newest COVID booster. I filled out paperwork indicating my age and other information, including dates of previous COVID vaccinations. I also brought my vaccination card. The nurse met me and led to a room. I was vaccinated, she filled out my card with the date and "Pfizer Bivalent Booster," as well as the lot number. Later, I looked at the MyChart portal to see my visit summary. The visit summary says the lot number and that I received the pediatric dose for ages 5-11 years. I am 53 years old. There's no reason that the nurse/assistant should have given me a pediatric dose. I assume this means I am unprotected and that the dose is invalid.
Arm numbness extending to wrist, immediately after injection.  48 hrs. later patient states experienced "upper body" swelling, "heart racing", "throat swelling", "lymph nodes" swelling, "trouble swallowing", "kidney pain"
Woozy feeling about 5-10 minutes after vaccination. Lasted but getting better for about an hour. Able to walk and drive after staying 30 minutes in clinic
over the last three to four weeks I have lost send of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (over the last three to four weeks I have lost send of taste) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced AGEUSIA (over the last three to four weeks I have lost send of taste). At the time of the report, AGEUSIA (over the last three to four weeks I have lost send of taste) outcome was unknown.            No relevant concomitant medications were reported.   Treatment information was not provided.  The patient stated that she changed one of her medications, she is not sure the medication or the vaccine caused the side effect.
Pt recv vax on 10/10/98; on 1/15/99 pt exp uveitis
1. Lethargy 2. Intense Migraine 3. Joint pain 4. Foggy Brain 5. Heavy Chest 6. Chills
Patient Received covid pfizer vaccine orange cap for age 5-11years, but he is 13 years,
dizziness, tachycardia, sore throat, globus pharyngeus, epigastric pain, cramping, nausea
Pt had a ventricular fibrillation cardiac arrest that required CPR, epinephrine and external defibrillation. Pt has no history of chronic health issues or heart issues and is an athlete. Pt found to have a prolonged QTc and is being worked up for long QT syndrome. Will get an ICD implant prior to discharge.
Parent brought child in the office and reports the rich arm below the vaccination site and the elbow is swollen, the arm was warm and tender to the touch. Child didn't appear to be in any distress. Around the vaccination site was a small half circular area approximately 0.5cm in diameter, slightly lighter in color than the surrounding skin.
Passed out about 1 minute after injection. Sent for ER only as a precaution. Per EMT, pt stable.
The patient experienced no symptoms.; on 6/12/2020 a patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, concurrent conditions and previous drug reactions or allergies were not reported.      On 12-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, subcutaneously administered, lot number S031496, which has been verified to be a valid one, and expiration date reported and validated as 07-OCT-2021 (dosage schedule and frequency were not reported) as prophylaxis (product storage error). The vaccine was reconstitued with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot number reported and validated as T000494, expiration date on 06-JUL-2022). It was exposed to a temperature between 6 degrees Fahrenheit (F) to 14 degrees F for a timeframe of 15 minutes and another one between 15 degrees F to 46 degrees F for a timeframe of 29 hours and 15 minutes. There was no previous temperature excursion. Digital data logger was involved. The patient experienced no symptoms (no adverse event).
Excessive fussiness and crying followed by leg episodes of jerking/stiffening in the third day after administration of shots. Patient admitted to hospital for observation after NL work up. The suspected seizures were not associated by a fever.
experiencing diarrhea; experiencing chills; experiencing tiredness; experiencing muscle pain; experiencing joint pain; experiencing nausea; Not feeling well at all; This is a spontaneous report received from a Program. A contactable consumer (patient) reported for herself. A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FW0161, Expiry date: unknown) on 14Apr2021 via an unspecified route of administration as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose last 14Apr2021. The second dose was scheduled tomorrow 05May2021. The second week after getting the first dose, she was experiencing diarrhea, chills, tiredness, muscle pain, joint pain, and nausea. She was still experiencing this until now and not sure if she can take the second dose tomorrow on 05May2021. She was notified as well that there was no available second dose from the facility where she gets the first dose. Patient reported that the first week after the vaccine she felt fine, but that the last 2 weeks she has not been feeling well at all. Patient reported that she was supposed to go back tomorrow, 05May2021, to have the second dose of the Covid-19 vaccine. Patient stated that she thinks that with every vaccine, when patient don't feel well, she don't go, and get vaccinated. Patient inquired if that was true because she doesn't think that she should get the second dose of the Covid-19 vaccine if she isn't feeling well. Patient was recommended that to reach out her primary care physician for further guidance. Patient reported that she tried to reschedule the appointment for her second dose of the Covid-19 vaccine that was scheduled for tomorrow, 05May2021. Patient reported that when she tried to reschedule the appointment, the website said that there was not going to be any more vaccines in her area. Patient inquired if she was supposed to have the second dose of the Covid-19 vaccine within 6 weeks of the first dose. Patient declined to complete safety report, stating that she was not feeling well on unspecified date in Apr2021 and didn't feel up to it. She had side effect from the vaccination, and she called her doctor. He said that she felt fine the first week, so this was not side effects. He said if she doesnt feel well she should not get the second dose because she was supposed to go tomorrow. If patient didn't had the side effects immediately does that mean that it's not side effects from the vaccine. She got side effects from the flu vaccine. Patient was having chills, nausea, diarrhea, muscle aches, and pains. Outcome of event Not feeling well at all was unknown and all other events was not recovered.  No follow-up attempts are needed. No further information is expected.
R-Arm = red, swollen, itching 2-3" round 2/5-18 gone NoTe- I never had any reacTions To shoTs For- Flu Pneumonia Shingles TeTanus *Second Vaccine given 2/26/21 11AM reactions - Sat 2/27 - 101 all day, but 8AM was 100.1 L arm - red + sore + itchy + swollen- tired - stayed in bed all day - didn't eat much slight headache Sun 2/28 - OK temp 98.7 L arm - still sore, swollen, red + itchy (2 wks) otherwise feel fine *Moderna OU3A2 (OVA)
Patient was febrile to 102, unresponsive, atonic and screaming for 4-5 hours. 20 minutes after she stopped screaming, had a generalized seizure lasting 45 seconds which resolved spontaneously.
Dizziness, Headache, Myalgia, Rash, shaking, pale, diaphoretic, dyspneic, pain at injection site Narrative:
Swelling in Lymph Nodes; Pain at Injection Site; Dry mouth sensation; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth sensation), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swelling in Lymph Nodes) and INJECTION SITE PAIN (Pain at Injection Site) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced DRY MOUTH (Dry mouth sensation), DIZZINESS (Dizzy) and INJECTION SITE PAIN (Pain at Injection Site). On 17-Feb-2021, the patient experienced LYMPHADENOPATHY (Swelling in Lymph Nodes). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, DRY MOUTH (Dry mouth sensation), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swelling in Lymph Nodes) and INJECTION SITE PAIN (Pain at Injection Site) outcome was unknown.            No concomitant medications were provided by the reporter.   Patient also used ice pack to treat the events.   This case was linked to MOD-2021-015805 (Patient Link).
Information has been received from a 69 year old female with reflux and no allergies who on 05/02/2001 and on 11/12/2001 was vaccinated with a first and second dose of hep A vaccine, both pediatric doses (0.5ml). This does not comply with the recommended dosage. Concomitant therapy included Prevacid. On 03/08/2002 it was reported that the pt "over the past three months" has had diarrhea. The pt sought unspecified medical attention. It was noted that the pt received both doses from a recalled lot. Additional info has been requested.  A 15-day follow up report received 6/3/2003 adds: Follow-up info received on 07/31/2002 from a registered nurse reported the lot# of the second dose of hepatitis A virus vaccine inactivated, given on 11/12/2003, as 639195/0523L (different from lot# reported by pt). The nurse further reported that the "pt was afraid the 'recalled' doses were 'harmful'." "The pt tested reactive for HAV, AB." And, "the complaint of diarrhea was four months after vaccinationwith Hep A," with onset in March 2002 (different than onset provided by pt). The pt reportedly recovered in March 2002. Further info is not expected.
Initial report was received on 11 March 2011 from a health care professional. A 22 year-old female patient with no reported past medical history, had received a left arm injection of ADACEL, lot number C3728BA (route and exact date of administration not reported) and a left arm injection of Influenza vaccine (manufacturer, lot number, route and exact date of administration not reported) on the same date and an unspecified amount of time later experienced an "arm swollen, red with severe cellulitis". The patient was hospitalized ten days after vaccination. The reporter questions a response to the acellular pertussis portion of the vaccine. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Dx: Angioedema, pruritus Tx: Prednizone, Clairitin, ice Results: Swelling not going down with treatment, itching is now gone.
tested Ag positive for covid; tested Ag positive for covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 58 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via unspecified route of administration, administration date 24Mar2021 (Lot number: EL3247) at the age of 57 years as dose 2, single and administration date 03Mar2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "tested Ag positive for covid". The event "tested ag positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: Ag rapid (nasal swab): (31Dec2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. It was reported that patient went to family gathering on 12Dec and had congestion 30Dec and tested Ag positive for covid after another family member tested positive. It was unknown if patient had other vaccine in four weeks. The patient received the covid-19 vaccine at workplace clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Patient had his 1st dose of the Moderna vaccine & developed commonly reported side effects, sore arm & fatigue shortly after the vaccine was administered. As the week continued past 48 hours post injection period, he was experiencing  extreme fatigue & muscle aches.  On the morning of 3/29 his feet were tingling & his legs were stiff.  When he woke up on 3/30 the stiffness in his legs & the tingling increased to the point where walking became difficult.  Finally on the morning of 3/31 he could not walk without assistance.  His PCP said to take him to the emergency room. Patient was admitted to Medical Center with the suspicion of Guillain Barre Syndrome.  A lumbar puncture confirmed Guillain Barre on 4/1/21 and a 5 day course of IVIG was started immediately after confirmation of diagnosis.
rash is now spreading, swollen, painful and burning.; rash is now spreading, swollen, painful and burning; Small rash; General Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (rash is now spreading, swollen, painful and burning), VACCINATION SITE RASH (Small rash), VACCINATION SITE SWELLING (rash is now spreading, swollen, painful and burning.) and MYALGIA (General Soreness) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010B21A) for COVID-19 vaccination.     No Medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (MICROGESTIN FE) for Birth control.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced MYALGIA (General Soreness). On 25-Apr-2021, the patient experienced VACCINATION SITE RASH (Small rash). On an unknown date, the patient experienced VACCINATION SITE PAIN (rash is now spreading, swollen, painful and burning) and VACCINATION SITE SWELLING (rash is now spreading, swollen, painful and burning.). At the time of the report, VACCINATION SITE PAIN (rash is now spreading, swollen, painful and burning), VACCINATION SITE RASH (Small rash), VACCINATION SITE SWELLING (rash is now spreading, swollen, painful and burning.) and MYALGIA (General Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Per patient the rash is now spreading, swollen, painful and burning. Patient is using cold compress to alleviate her symptoms.  Patient does not have a primary care physician but she provided consent to contact the vaccination facility. Patient provided consent for safety team to contact her on her phone number
Fully vaccinated with Moderna x 3.  Tested positive for Covid 19 on 05/11/2022. Admitted to Medical Center 05/14/2022-05/24/2022. Expired on 06/11/2022.