chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe rigors, to which I suspected I was having a seizure (first time in my life). Loss of motor function and shaking so vigorously that I experienced moderate-to-severe cramping in my neck, lower back, and hips. Unable to walk, difficulty speaking. Blacking out in peripheral vision (experiencing tunnel vision). Was in process of calling an ambulance, but after approximately 5 minutes, symptoms subsided. The following morning, I was sore, but largely asymptomatic.
Pt has black and blue bruising on her outer left arm around the bicep area. Pt states the immunizer gave the injection too low and that it hurt more than usual. She states the bruising appeared on 09/01/10 and is still present at the time of this complaint (09/15/10).
patient receiving second dose / prior to the recommended 2 month minimum time period after receiving the first dose; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received second dose of Shingrix prior to the recommended 2 month minimum time period after receiving the first dose of Shingrix, which led to shortening of vaccination schedule. The reporter did not want to provide any patient demographics and provided only minimum information. The reporter did not consent to follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, fever, fatigue and gastrointestinal upset. On an unknown date, the outcome of the shivering, fever, fatigue and gastrointestinal upset were recovered/resolved. It was unknown if the reporter considered the shivering, fever, fatigue and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and FLUAD into arm. The pharmacist reported that she had given SHINGRIX to many people and followed up with each recipient. Additionally, she had given 2 patients FLUAD at the same visit as SHINGRIX (in opposite arms). The pharmacist stated that, most of the patient's reported shivering, gastrointestinal (GI) upset, fatigue or low-grade fever which was mild and resolve within 24 hours. The pharmacist stated that these 2 people did not report any different or more severe side effects compared to those who did not receive FLUAD and got SHINGRIX alone. The pharmacist said that, she did not feel like these adverse events were worthwhile to report, as they were all mild and self-limiting. The patients that received FLUAD on the same day did not experience worse symptoms. This case has been linked to case US2018172531 and US2018GSK177719 (the cases for the patients who received SHINGRIX and FLUAD both), reported by the same reporter.
Pt. received Vaccines 08/18/2021 and started experiencing symptoms of rash and vomiting. Self-treated with Benadryl and monitor, symptoms have subsided.
approx 3hrs p/vax pt collapsed on to the floor-remained limp for a short time;around mouth was blue tinted, vomited x 2 w/in a 40mins period
"COVID Arm" - red, itchy circle about 5" in diameter on left arm near injection site. Slightly swollen and hot. Has lasted now for 24 hours. Treated with Cortizone cream. Still itchy and hot, but bearable. Just reporting for data collection purposes--I don't believe I need any further intervention.
Myalgias x 3 days - nausea x 3 days - local, skin rx w/erythema, bruising, itching 20x15cm started 4 days later.
Fever & rash. Acyclovir, TYLENOL given. Physician diagnosis of chicken pox. Started 10/5/11.
caller got thse second dose more than 36 days after the first/Got 2nd dose beyond 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller got thse second dose more than 36 days after the first/Got 2nd dose beyond 42 days) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller got thse second dose more than 36 days after the first/Got 2nd dose beyond 42 days). On 21-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller got thse second dose more than 36 days after the first/Got 2nd dose beyond 42 days) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up information received and  Reporter information was added, Patient demographics updated, Suspect product Dose-1 and Dose-2 information was updated and event verbatim was updated
24 hrs after IPV given to right thigh, pt developed fever to 102 degrees, redness/swelling, had 2 febrile seizures.
Vaccine given on 12/17/20 went to ER on 12/18/20 . Started having diarrhea at 4am on 12/18/2020. Came in to work and felt short of breath and heart rate increased. She went  to the ER. She was  given a liter of fluid 0.9% NACL IV, and per employee all symptoms resolved and she was discharged. She reports no further problems.
Patient states fever of 101. arm warm to touch, redness, state swelling size of egg. States she took ibuprofen and BENADRYL. Advised patient to check with MD's office to see if needs to be seen.  Spoke with patient again on 4/22/19 states somewhat better still red and raised.
R hand swelling 2 days after immunizations given, decreased speed of R finger movement.  Strength within normal & capillary refill normal.  Sent to ER to evaluate.  Afebrile.
Approx 20 min after receiving vaccine she complained of feeling light headed.  Facial complexion was slightly sweaty Her BP at this time was 94/60 Sp)2 = 98% and pulse 61 R Water was offered and she was agreeable and drank some 10 min after her light headed episode she stated she  felt much better and got up to use restroom Approx 30 min after initial episode she complained of slight headache Vitals at this time wer 110/60 Sp02 = 99% and Pulse 74 R Approx 35 min after initial episode she complained of numbness in jaw and back of throat with tingling in lips; However, just prior to this her friend was also brought in for additional follow-up as she was experiencing some symptoms as well. The challenge was determining how much of the situation was based off of the other since they were in the same room. Vitals at this time were SpO2 = 99% and pulse 74 R She was given Benadryl 25mg po approx. 40 min after her initial complaint of light headed. In approx. 10 min she stated her symptoms had resolved other than the slight headache
10/06/2012 had flu shot at pharmacy. I'm not sure of exact time but it was early afternoon. Roughly 2-3 hours after flu shot was administered on 10/6/2012 I began to suffer shoulder pain in the upper deltoid muscle. 10/07/2012 woke up with low grade fever, body aches and frozen shoulder. Could not move my left arm. Arm was pinned down to my left side. 10/8/2012 woke up, fever and body aches gone. Arm still "pinned down to left side". From night of 10/6/2012 - been unable to sleep on left side. From physical therapy my range of motion has increased considerably but I continue to have symptoms such as: extreme hypersensitivity in my upper shoulder, arm pain and swelling, tingling, weakness, "shooting pain" going down my arm.
Increased heart rate when she walks; Very dizzy; May have received 1.5 dose instead of 1 dose; Heart racing (110 BPM heart rate); A spontaneous report was received from a consumer concerning his wife, a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart racing/ Palpitations (110 beats per minute) on walking/ Heart rate increased, felt very dizzy/ Dizziness, might have received 1.5 dose instead of 1 dose of vaccine/ Accidental overdose.  The patient's medical history was not provided. No concomitant product use was reported.  On 15 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 024M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 15 Feb 2021, an unspecified duration after receiving the vaccine, the patient experienced heart racing (110 beats per minute) on walking and felt very dizzy. The patient reported normal heart rate while resting. It was known that the patient might have received 1.5 dose instead of 1 dose of vaccine.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event received 1.5 dose instead of 1 dose of vaccine was considered resolved on 15 Feb 2021. The outcome of the events, heart racing (110 beats per minute) on walking, felt very dizzy, may have received 1.5 dose instead of 1 dose of vaccine, was not reported.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273, lot # 024M20A with associated AEs of heart racing and dizziness. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
patient presented to emergency department on 10/17/21 with shortness of breath when laying down patient was admitted for further management of acute respiratory failure with hypoxia patient was found to be covid-19 positive on 10/17/21 patient did require treatment for symptoms associated with covid-19 with dexamethasone patient was discharged to home on 10/20/21
A couple days after the vaccine he developed a small, raised half dollar sized whelp on his right thigh that was hot to the touch. It did not seem to bother him; it did take a week to go away. On December 26, 2022, he awoke with a rash all over his body, certain areas were worse than others. We went to the doctor, they took his temperature, looked at the rash. Said it did not look like hand, foot and mouth and it did not look like any of the rashes that were going around. They did prescribe BACTRIM cream to apply the areas to help clear up the areas. It did not seem to bother him at all and as of today the areas appear to be clearing up.
On 4/3/21 about 2 weeks after my 1st dose of Moderna I noticed a raised rash/hives on my left middle back consistent with shingles I?ve had before.  Very itchy but painful to the touch.  While rash stayed localized the itchy sensation grew larger and wrapped around my left side to my left lower stomach.  Itchy, painful to touch and actually also numb.  Situation persists now almost 3 weeks later.  Situation is livable but uncomfortable. Virtual doctor consultation to monitor situation.
Fainted after recieving immunizations.Turned pale. Fell to the floor. Patient passed out for 10 seconds. Stated that she felt dizzy when she came to.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30 days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30 days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 2:02 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 2:02 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30 days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30 days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  It was unknown if patient had acute illnesses and chronic or long standing health conditions. The patient received vaccine past  30 day expiry date on 02-Apr-2022 at 14:02:30. The patient received second booster dose.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Originally I had bodyaches, chills, headaches, and shortness of breath. Some of those cleared up rather quickly, but then either I developed new symptoms: loss of smell and taste, difficulty swallowing, difficulty breathing especially while laying down, sharp pain when sneezing or hiccuping in my midsection, tightness in chest.
rash & itching lt arm;lump in throat, SOB, tachycardia;
Information has been received from a nurse referring to a 12 year old patient of unknown gender. There was no medical history or concurrent condition reported. The patient was vaccinated with 3 doses of PEDVAXHIB (lot#, expiration date, dose and route not reported) on 16-JUL-2003, 23-OCT-2003 and 22-JUN-2004, respectively. On 27-MAY-2015 the patient was vaccinated with a fourth dose of PEDVAXHIB (dosage, strength and route were not reported). There was no concomitant medication provided. At the time of the report, no adverse symptoms were reported. Additional information has been requested.
Child was administered w/wrong vax HPv at 7:00 pm 9/10/05 Right after received Hep A-Since 7:30 pm till dev. fever
This spontaneous report as received from an other health professional refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of M-M-R II for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II).; Sender's Comments: US-009507513-1707USA011791: US-009507513-1707USA011793: US-009507513-1707USA011792: US-009507513-1707USA011201:
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302872. This case involves a 28 months old female patient who was vaccinated with a 0.5 ml instead of 0.25 ml dose of FLUZONE (lot UJ009AA and Exp. Date 30-JUN-2019) via intramuscular route in the right thigh on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine overdose. It was not reported whether the patient experience any adverse event. 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 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. List of documents held by sender: none.
side effect; This spontaneous case was reported by a consumer and describes the occurrence of   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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Patient developed chest pain 5-10 minutes after the first dose requiring hospitalization. I am a hospitalist physician admitting the patient to hospital from the ER.
Fever, nausea, muscle aches and pains, sweating, cold/hot flashes, headache, no taste, fatigue, exhaustion, dizzy, pain in injection site, deep sleep, bizarre dreams, hallucinations when closing eyes (dots and eye spinning sensation)
next day patient felt warm and his arm was red around the injection site and went down to his elbow
Hives on upper left arm: Raised area is 4.5 inches long and 3 inches wide, and has grown in size over last 12 hours About half of raised area is red Hive is itchy, hard to the touch, and hot to the touch
Yesterday I tested positive for covid; Yesterday I tested positive for covid; This is a spontaneous report from a contactable (patient). A 40-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Jan2021 09:45 (Batch/Lot Number: EL1283) and dose 2 via an unspecified route of administration on 28Jan2021 09:45 (Batch/Lot Number: EL9264) both as single dose for covid-19 immunisation.  The patient medical history included exposure to COVID-19. Concomitant medications were not reported. The patient was not pregnant. The patient tested positive for covid on 22Apr2021 with outcome of not recovered. It was unknown if patient received treatment due to the event. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 22Apr2021.  Clinical course was reported as follow. The patient was healthcare worker and received both doses of the Pfizer vaccine in Jan2021. Last week her mother got COVID and the patient was exposed before knowing she was positive. Yesterday the patient tested positive for covid (22Apr2021). The patient was around her for about an hour and probably only briefly within 6 feet.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Pt took pill no. 1 one hour before dinner on empty stomach. Complained of abdominal cramping two hours after dinner. Took pill #2 on 9/5 with no sxs. Tool pill no. 3 on 9/7 one hour before dinner on empty stomach. Developed abdominal cramping two hours after dinner with nausea and vomiting throughout the night. Pt did not take pill no. 4.
Explosive diarrhoea; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 83-years-old female patient received first dose bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: EN9581), via an unspecified route of administration, administered in arm left on 08Feb2021 12:30 (at an age of 83-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at 88 mcg, daily for thyroid mediciene; alendronate sodium (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at 88 mcg, daily for bone building. On 23Feb2021, the patient experienced explosive diarrhoea. The female consumer reports receiving her first injection of the Pfizer-BioNTech COVID-19 vaccine on 08Feb2021. Two weeks later, she started experiencing severe diarrhea, which is continuing. She asked if this explosive diarrhea could be a delayed side effect of the vaccine, if this has been reported with the vaccine. she guessed that is the place that she got it where they sent them through like a herd of elephants, unknown if she is going to get the second dose or not relative to these events. The clinical outcome of the explosive diarrhea was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient has no side effects to report at this time. Patient request bivalent vaccine and was given monovalent vaccine
PATIENT EXPIERENCED SEVERE CHILLS, MUSCLE PAIN AND VERY HIGH BLOOD SUGAR (300+)
NAUSEA, VOMITING, FEVER, JOINT PAIN, DIZZY, DIARRHEA, BLURRED VISION.
Tingling on the Arm, Face, and / or Legs; arm was heavy; Numbness on the Arm, Face, and / or Legs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (Tingling on the Arm, Face, and / or Legs), LIMB DISCOMFORT (arm was heavy) and HYPOAESTHESIA (Numbness on the Arm, Face, and / or Legs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPOAESTHESIA (Numbness on the Arm, Face, and / or Legs). On an unknown date, the patient experienced PARAESTHESIA (Tingling on the Arm, Face, and / or Legs) and LIMB DISCOMFORT (arm was heavy). At the time of the report, PARAESTHESIA (Tingling on the Arm, Face, and / or Legs), LIMB DISCOMFORT (arm was heavy) and HYPOAESTHESIA (Numbness on the Arm, Face, and / or Legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-037928 (Linked Report).; Sender's Comments:  MOD-2021-037928:multiple patient case