chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported feeling tingling at tip of his tongue.  also tasted a metallic taste at tip of tongue. no swelling of face or throat. no other symptoms. patient closely monitored for 30 minutes. vitals stable. upon discharge patient reported symptoms improving. patient notes he has had this occur to him in the past.
Participant woke up with fever of 104 F, muscle aches, headache and fatigue. She took Tylenol and Motrin to alleviate symptoms. She had to stay in bed for a few days and continue to take Tylenol and Motrin throughout those few days.  Symptoms improve after 4 days. Participant sought care from a colleague (doctor). No tests or medications prescribed.
This spontaneous report as received from a pharmacist refers to a 76 years old female patient, with none drug reactions/allergies, who was vaccinated with 0.65 ml ZOSTAVAX (lot# not reported) SQ, on 18-MAY-2012. No other concomitant medications. Pharmacist reported that a patient stated "ZOSTAVAX didn't work" and recently in the past month, in approximately November 2012, on an unspecified date, patient developed shingles. As a treatment VALTREX was given. The outcome of patient was reported as recovering/resolving. The relatedness for ZOSTAVAX didn't work and shingles were not reported for ZOSTAVAX by reporting pharmacist. Additional information is not expected.
Left deltoid area was described as hot to the touch and firm, was stated that patient had a fever. Advised to give patient ibuprofen or TYLENOL, may give BENEDRYL if has any swelling or redness. Informed to continue to monitor, if symptoms ie, fever, redness or swelling get worse to call clinic and be seen, if has SOB go to ER.
Sudden rapid heart rate , sweat , nausea, light headed , almost passed out . Ems was called . vitals returned to normal  while in ambulance . No further heart fluctuations.  A month later tinnitus has begun . I?m currently being checked by an ENT to find out why . No previous tinnitus issues .
I have  shingle like skin rash on my neck for more than 13 days. it is itching all over my body and tingling kind of pain on my neck and back. I have been using 10% benzoyl peroxide but not getting improvements. I am planning to go to dermatologist next week.
Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 28-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day beyond use date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 28-Jul-2022).    No concomitant medication was reported by reporter.  Total 35 vials were affected. Vial was initially stored in refrigerator on 04-Jun-2022 and did not undergo temperature excursion. Manufacture code for the lot was MOD. Patient was administered with half dose.  No treatment medication was reported by reporter.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 14-year old female patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 25-FEB-2014 at 2:20 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient declined to repeat vaccination. No adverse event was reported for the patient. The outcome was reported by the reporter as recovered on 25-APR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case was received.
Onset 03/30/2003  Chest discomfort, short of breath, slight fever - Seen in ER  Rx with tylenol  04/03 Complained of heavy chest, Apprehension, Temp 101.9, Increased heart rate on exertion
2 hrs after Anthrax, hives, itching in axilla and groin with erythema. Given Benadryl, celestone, ep, Tx with prednisone and Benadryl with flu in AM.
Pt received dose #1 Moderna COVID19 Vaccine Observed x 15 mins Left and went to his office where he exhibited "pounding chest & cold hands" Came back to clinic about 30 minutes after vaccine BP increased 180/100 HR 145 EMS called
High fever, dizziness, shortness of breath, sweating, fainting/collapsing, nausea, fast heart rate, pain in joints, and severe headache.
Flutter atrial; Feeling anxious; Blurred vision; Eyes red; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), OCULAR HYPERAEMIA (Eyes red), ATRIAL FLUTTER (Flutter atrial) and ANXIETY (Feeling anxious) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B219) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VISION BLURRED (Blurred vision) and OCULAR HYPERAEMIA (Eyes red). On an unknown date, the patient experienced ATRIAL FLUTTER (Flutter atrial) and ANXIETY (Feeling anxious). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (DECONGESTANT [OXYMETAZOLINE HYDROCHLORIDE]) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) at a dose of 1 dosage form. At the time of the report, VISION BLURRED (Blurred vision), OCULAR HYPERAEMIA (Eyes red), ATRIAL FLUTTER (Flutter atrial) and ANXIETY (Feeling anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: New events added
This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced serious and permanent neurological injuries which were attributed to toxic mercury exposure. The following information was received via medical records: The subject received hepatitis B vaccinations on 5/20/95, 6/20/95, and 3/22/96. On 8/6/96, the subject fell off a wagon and presented to the emergency room the following day after his mother noted that he was holding his head to the left side and would not turn his head to the right side. She also noted that he was sleeping a lot. He was diagnosed with cervical strain without fracture or dislocation. The subject's initial development was normal. Approximately six months after the third hepatitis B vaccination, in approximately 9/95 at 16 months of age, the subject began to experience developmental regression. Beginning at approximately two and a half years ago, the subject exhibited behavioral problems included noncompliance with parental requests, aggression, tantrums, body rocking, and head banging (to fall asleep or when he gets upset). On an unknown date, the subject was diagnosed with attention deficit hyperactivity disorder which was treated with a trial of Ritalin. However, the subject's difficult behaviors were exacerbated, and Ritalin was discontinued. In September 1998, the subject was enrolled in preschool and exhibited significant difficulty with the demands of a structured preschool setting. On 12/4/98, at the age of three years seven months, the subject underwent a neuropsychological evaluation for concerns including delays in speech and language development, and difficulty in managing the subject's behavior including irregular sleep patterns. The subject's achievement of other developmental milestones was within normal limits. Evaluation findings included delay in overall development. The subject's reasoning abilities and ability to understand and use spoken language fell within the sixteen to eighteen month developmental level. The subject's socialization skills were at approximately the fifteen month developmental level. The evaluating neuropsychologist noted that no indication of ADHD or depression was found. On 1/28/99, the subject's level of functioning was assessed as developmentally delayed, mental retardation. During evaluation, he exhibited aggression including hitting his mother and pushing. He also hit is head on the treatment room door. An emergency room note dated 7/23/00 indicated that the subject had been diagnosed with autism on an unspecified date. This case was assessed to be medically significant (OMIC).
Pale white skin, raspy slow breathing (almost like hiccups), rash down back, limp when picked up, not responsive to touch or sound, shaking legs almost like seizures.
fatigue; blistering around left arm, waistband; rash around left arm, waistband; This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date unknown) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Shingrix. On 18th July 2019, less than a day after receiving Shingrix, the patient experienced fatigue, blister and rash. On 21st July 2019, the outcome of the blister and rash were recovered/resolved. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue, blister and rash to be related to Shingrix.  Additional information received were as follows: The patient believes that the side effects were related to Shingrix. The patient experienced blistering and rash around left arm and waistband, which persisted for 2-3 days. The patient experienced fatigue on first day and still persisted on the day of reporting.
First day 10 mins after injection my left ear popped then at 10PM I started to feel body aches and had a low grade fever of 99.8 at 10:09PM. At 10:28PM my temperature went up to 101.5. Took Tylenol and fell asleep woke up at 3AM fever of 102.3 . Fell asleep and woke up again with a fever of 102.6. I had chills nausea weakness body aches headache. Took Tylenol again and fell asleep only to wake up again at 6:30Am  still with a fever of 102. Nothing was making it go away I had no appetite extremely fatigued and nauseous it felt like I had covid again. I also felt swollen lymph nodes under my arm. By Sunday I was feeling way better and my fever was gone. Monday my ear popped again lasting a minute that?s never happened before. Monday today 01-05 still having headaches and now chest pain. I felt so bad I wanted to go to the hospital but did not it really did feel like I had covid all over again I would not want to put my self through that again.  Also I did have covid back in October I believe just wanted to put that out there.
Pt reports arm started hurting the morning after the vaccine was give. Today 9/16/2010 area is approx 50mm induration/raised and warm to the touch. Encouraged to seek care with M.D.
MODERNA WAS GIVEN ACCIDENTALLY PRIOR TO HER 18TH BIRTHDAY. NO ADVERSE EVENTS REPORTED TO US
pt recv vax 20OCT97 & came to the Er on 21OCt97 w/a thick tongue, little difficulty breathing, some hives, gen pruritus;
Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue, chills, pain inj site, rynny nose, sore throat Narrative:
Rash, itching, pain. Patient also described the area around the injection site as being "hard" and "tight." Symptoms were almost resolved by 10/1/14. There was sill a quarter-sized rash on 10/1/14 around the injection site. Unknown if any attempts were made to treat the reaction.
Pt. has redness, warm to touch & itching at injection site - tx w/ topical corticosteroid by dermatologist (happened to have appt 5/30/12).
On 9/19/22, I had an annual physical and they noticed that my platelet count was a little high. I met with a Hematologist on 11/11/22, and they ran more tests. The determined that I have a gene mutation and my bone marrow is overproducing platelets and they are going to try to control it with medication. I was prescribed Hydroxyurea 3 days a week at first and now I am taking it 5 days a week. I am also taking a Baby Aspirin. No other medications were prescribed.  I am still dealing with this at this time.
Metallic taste in mouth. Tingling in fingers/toes. Feeling faint.
04/16/2021 around 1:00AM in the morning nausea, hear loss, fatigue. It continued  till November. menstrual cycle was off to 7 days. It was bleeding heavy. I had a lot of pain. I stick  with my regular diet. My doctor didn't help much. I followed my usual things till November. It  got better slowly by slowly.
Pain left armpit, swelling left armpit. Started in January. Didn't initially associate it with the vaccine.  Got  progressively worse. Went to doctor when it became painful. Visited doctor on March 23, ultrasound at the Hospital, March 31. Second ultrasound and diagnostic mammogram at the clinic April 14. Given all clear by the clinic.
Initial report was received from a health care professional on 01 Dec 2009: This patient (21 month old) inadvertently received a dose of S-OIV FLUVIRIN intramuscular on 03 Nov 2009. The dose volume was not specified. No adverse events were reported.
The left side of my face swelled a bit, became red and numb.  By the next day, the redness and swelling has mostly disappeared, but the numbness is still there.  I can feel it in my ear, my eye, my teeth, lips, and whole left side of my face just aches.
Medication Error:  the Moderna Covid-19 vaccine was administered off label to this 17 year old individual.  No adverse side effects reported.  This error was noticed when the individual returned to receive the second dose.  The second dose was not administered.  Reached out to Moderna help line to receive guidance.
Patient presented to the ED for COPD with acute exacerbation within 6 weeks of receiving COVID vaccination.
Patient experienced a reaction post COVID vaccination  Vaccine brand PFIZER Lot # FD0809 Type of reaction TINGLING  Symptoms Patient had vaccine and was in the observation area.  She experienced tingling of her lips and tongue.  Patient felt like her tongue was beginning to feel swollen.  Denied trouble breathing or difficulty swallowing.  No swelling noted.   Vital signs:  BP 149/76  | Pulse 71  | Resp 16  | LMP  (LMP Unknown)  Interventions (Fexofenadine 60 PO given per standing order) Was a code blue called -No How long was patient monitored in observation area -30 minutes after the Fexofenadine was given Final outcome - Tingling subsided.  Instructed to call PCP for further instructions and to proceed to nearest ER or call the emergency line for difficulty breathing or swallowing.
Started with pain in arm at injection site, heaviness  and pain in chest-hurts to touch, sweating, dryness of mouth, fatigue Taken Ibuprofen and Tylenol
menquadfi administered post excursion with no reported adverse events; Initial information received on 10-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA082418.  This case involves a 11 years old male patient and reporter reported Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] was administered post excursion with no reported adverse events.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On 10-Jan-2023, the patient received 0.5 mL  dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (frequency- once (1x), lot U7449AB, expiry date - 23-Sep-2024, strength - unknown) via intramuscular route in unknown administration site for immunization post excursion with no reported adverse event (poor quality product administered) (Latency: same day).  Action taken: not applicable.  Outcome: Unknown for the reported 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.
24 hours post vax, arm became sore red and tender surrounding injection site. Also swollen lymph node.
I have a golf ball size swelling at the site of injection and in my underarm areas of the right arm.
GENERALIZED ITCHING AND BURNING SENSATION. COLD COMPRESS AND BENADRYL 50 MG TABLET WAS GIVEN.
Initial report received from a health care professional on 25 May 2007. A 44 year old male patient (with a history of no known allergies) complained of severe neck pain radiating down the left arm and left axillary area, 4 hours after he received Adacel (lot number C2730AA) intramuscularly in the left deltoid on 24 May 2007. There was loss of sensation anteriorly and posteriorly from the mid forearm to the left hand. He is unable to grasp or lift. He was sent to the emergency room for evaluation. He did not have any illness at the time of vaccination. At the time of the report, he had not recovered. Follow-up information was received from the health professional on 15 August 2007. The patient was referred for a neurology consult, and underwent EMG (electomyogram, NCV (nerve conduction velocity), and work-up for polyneuropathy. Results for these tests were not available.
Localized hive on forehead, underarms and wrists. Pt advised to self administer 50 mg Benadryl PO.
I have had tinnitus for many years. It has always sounded like cicadas and the sound was very consistent in rhythm and loudness. Shortly after my initial vax I started noticing the sound I was hearing was louder and inconsistent in rhythm. It's now distracting and affects my ability to focus and concentrate.
No additional AE reported.; Caller was Physician. Caller reported AE for Nurse. At same call time, Caller reported Separate AE for Patient (See AE Case# 02242794).   Patient was administered a partial PROQUAD dose on 09/08/2022 (See AE Case# 02242794); corresponding Patient was; This spontaneous report was received from a physician and refers to a nurse of unknown gender and age. The nurse's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-SEP-2022, while the nurse was administering measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, for prophylaxis (dose, strength, lot number, expiration date, and route of administration were not provided) to an unspecified patient, it was reported that the patient was "wiggling" and the nurse's eye was exposed to the vaccine (occupational exposure to product). No additional adverse event was reported (no adverse event).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2209USA003013:Same Reporter Link
Bilateral Bells Palsy.  I had vaccine shot on 3/5/21.  I woke up on 3/22/21 with right sided facial paralysis.  Went to  ER.  5 days later I also had paralysis on the left side of my face.  It has been 5 months and I still have left sided paralysis.  I cannot close my mouth, close my left eye, cannot move my eyebrow,, drool, no gag reflex.  I have lost 10 pounds since eating and drinking is difficult.
Very strong metallic taste; feel the tip of the tongue a little numb; feel very thirsty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Aug2021 15:30 (Batch/Lot number: unknown) at the age of 48 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 21Aug2021 23:00, outcome "not recovered", described as "Very strong metallic taste"; HYPOAESTHESIA ORAL (non-serious) with onset 21Aug2021 23:00, outcome "not recovered", described as "feel the tip of the tongue a little numb"; THIRST (non-serious) with onset 21Aug2021 23:00, outcome "not recovered", described as "feel very thirsty". Therapeutic measures were not taken as a result of dysgeusia, hypoaesthesia oral, thirst.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications the patient received within 2 weeks of vaccination. 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 had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
One hour after receiving the vaccine, I started feeling a change in my breathing. I have been experiencing restricted breathing and shortness of breath ever sense then, along with light headedness and fatigue. It has been 5 days and no improvement.
3/27/21 Severe throwing up. 3/30/21 went to urgent care for abdominal soreness - nothing determined. 4/12/21 Follow up with cardiologist.  Bloodwork done - showed slightly elevated liver and pancreatic enzymes.  4/15/21 saw gastroenterologist.  4/19/21 CT scan of abdomen 4/19/21 Diagnosis: Pancreatitis. 4/21/21 repeat blood work.  Amylase and Lipase back to normal. ALT (SGPT) still slightly elevated.  Repeat blood work will done shortly. Repeat CT scan being done in 2 weeks.