chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "Irratable bowl" (unspecified if ongoing); "Emphysema" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 18Nov2022 to 22Nov2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231) on 23Dec2020 07:15 PM via unknown route of administration (vaccine location: Left arm), at single dose (first dose) for COVID-19 immunization. Medical history was reported none. Concomitant medications included ibuprofen. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not use other vaccine in four weeks. Patient experienced Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in her left hand/fingers and the left side on her lip on 25Dec2020. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
Altered mental status. DX Acute encephalopathy. States forgetting to do things and care for himself that he normally does. Couldn't remember name or address.
Redness on arm; Sore arm; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on arm), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness). On 05-Apr-2021, the patient experienced ERYTHEMA (Redness on arm). On 25-Mar-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) had resolved. On 12-Apr-2021, ERYTHEMA (Redness on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-081867 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information received on 20-MAY-2021 contains non-significant information (Email updated).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081867:For Second dose
4cm red, raised, warm area at site of DTaP injection. Right deltoid muscle.
Patient came to the pharmacy to get Pfizer 5-11 pediatric Bivalent booster, but received Pfizer 5-11 pediatric Monovalent booster
Feels like the vaccine is stuck in his system; Dose past 36 days; Chills; Clogged his brain/brain fog; Closed his stomach/stomach closed up; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Closed his stomach/stomach closed up), FEELING ABNORMAL (Feels like the vaccine is stuck in his system), CEREBRAL CONGESTION (Clogged his brain/brain fog), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose past 36 days) and CHILLS (Chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12H2OA) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included PARACETAMOL (TYLENOL) and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Closed his stomach/stomach closed up) and CEREBRAL CONGESTION (Clogged his brain/brain fog). On 01-Apr-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced FEELING ABNORMAL (Feels like the vaccine is stuck in his system) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose past 36 days). At the time of the report, ABDOMINAL DISCOMFORT (Closed his stomach/stomach closed up), FEELING ABNORMAL (Feels like the vaccine is stuck in his system) and CHILLS (Chills) outcome was unknown, CEREBRAL CONGESTION (Clogged his brain/brain fog) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose past 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events, included paracetamol. Patient reported that he took Tylenol and after 14 days took Aleve for his Multiple Sclerosis.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow up information was received on 04-APR-2021, which included patient date of birth and home address are provided. Patient's age is also updated ( from 71 years to 70 years). Additional event, Inappropriate schedule of vaccine administered is provided. Treatment drug  was provided which included Tylenol( paracetamol). Patient reported that he will not have second dose On 14-Apr-2021: NNI; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Pt reports of immediate symptoms of L arm soreness (at site of injection), body aches, headache, chills, shortness of breath, and palpitations for the past 2 days (since the vaccination was administered). Pt has been taking Motrin and Tylenol for pain control and it seems to be helping. Pt was afebrile, non-toxic appearing, in no acute respiratory distress, with normal vital signs. No abnormalities noted on exam. Recommend continued fluid hydration and symptomatic management. Strict return precautions discussed. Pt was d/c with recommended close follow up with PCM as needed.
cold; felt extreme fatigue; body ache mainly in joints; body ache mainly in joints; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), FATIGUE (felt extreme fatigue), MYALGIA (body ache mainly in joints) and ARTHRALGIA (body ache mainly in joints) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), FATIGUE (felt extreme fatigue), MYALGIA (body ache mainly in joints) and ARTHRALGIA (body ache mainly in joints). At the time of the report, NASOPHARYNGITIS (cold), FATIGUE (felt extreme fatigue), MYALGIA (body ache mainly in joints) and ARTHRALGIA (body ache mainly in joints) had not resolved.            No concomitant and treatment medicine has been reported by reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.
There were no adverse effects of the vaccination. This is to report that patient received a 3rd dose of Hepatitis A vaccine, unknowing that she had already received 2 doses prior to that day. No treatment necessary. Parents are aware of the event.
Mother noticed swelling and redness 2/7/06. Area of 4 x 5 cm erythema left upper thigh.
pt recv vax 30JAN99 & pt exp localized redness w/vesicles, pruritus down arm, hand, chest area;SOB w/chest tightness 24hr p/vax;
9/8/20 Chills, couldn't sleep until 4:00 am. Fever 101.8 F 8:00 am 9/9, slept most of 9/9 with temperatures above 99.0 F. Sweats and fever night of 9/9/20 100.5 down to 99.5 F.  Slight fever 9/10/20 morning but normal by 12:00 pm.  All symptoms gone by 1:00 pm 9/10/20.  Took Tylenol 2-tabs night of 9/9/20.  Had to use down comforter and sweat suit night of 9/8/2020.
Sedation, Myalgia, Fever, Diarrhea, NauseaVomiting, ARM SORENESS, STOMACH CRAMPS, CHILLS Narrative:
Immediately after reaction patient developed severe headache and photophobia. Slight dizziness.  normal HR and BP. Given ibuprofen 300mg x 1 dose and fluids. Symptoms persisted in office for more than 30 minutes. Pt was discharged home and advised to increase fluids and eats well balance meal.
Left arm pain from neck to wrist.  Unable to move arm at all X 2 days.
NauseaVomiting DELTOID TINGLING, BACK PAIN Narrative:
This spontaneous report was received from a male patient of unknown age regarding himself. The patient's medical history and concurrent conditions were not provided. On 17-SEP-2015, the patient was vaccinated with ZOSTAVAX, subcutaneous route in the arm. The patient reported that after receiving the injection, he noticed some bruising at the injection site, which was painful to touch. The patient also reported that "hair on his arm also fell off" around the injection site. The patient did not seek medical attention (did not see his physician). No treatment was given for the adverse events. The outcome of the events alopecia, injection site pain and injection site bruising was reported as not recovered/not resolved. No further information was provided. The reporter did not provide the causality between the events and the suspect therapy. Product quality complaint (PQC) was not reported. Additional information is not expected, no contact details were provided.
Never had hurt that bad; Arm has been hurting ever since I got the shot; Headache; Lot of anxiety; Anxious; Nauseated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Never had hurt that bad; Arm has been hurting ever since I got the shot"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; ANXIETY (non-serious), outcome "unknown", described as "Lot of anxiety; Anxious"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated".  Additional information: When enquired about reason for no lot number of COVID 19 Vaccine response was "No, it was the vaccine which was not with the patient because second dose was due on the April 1st and patient was not going to get it because the reactions patient have had with the first dose have been worse than actually have COVID ". Patient had the first dose of vaccine the last Thursday. Patient had to stand in line about an hour and a half, that was to get an appointment first of all, out in cold and then when patient finally got the vaccine and everything, it really hurt. Patient have never had hurt that bad and patient have got a high pain tolerance and patient arm had been hurting ever since patient got the shot and patient had been having headaches, patient have a lot of anxiety and patient normally was not that anxious. But it had made patient nauseated, it was horrible and patient was telling everybody patient know not to get the vaccine, that was ridiculous.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported that she had not received the vaccine.  Pfizer vaccine given.  Patient was asymptomatic.  Patient then asked for RN to put her vaccine card with her other card. Patient did receive the vaccine at the local hospital and failed to tell the RN.  MD made aware.
Tiredness; Thyroid count  Very low; I feel like I'm in a hazy/Lifeless; I find it difficult to wake up in the morning; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHYROIDISM (Thyroid count  Very low) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event, Prostate cancer on 05-Jan-2013 and Heart attack on 05-Jan-2014. Concurrent medical conditions included Barrett's esophagus (Check every 3 months) since 03-Jan-2019. Concomitant products included LISINOPRIL from 01-Jan-2019 to an unknown date for Blood pressure, GABAPENTIN from 01-Jan-2016 to an unknown date for Pain, PANTOPRAZOLE from 01-Jan-2017 to an unknown date for Stomach pain, TESTOSTERONE from 01-Jan-2019 to an unknown date and TADALAFIL (CIALIS) from 01-Jan-2017 to an unknown date for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced FEELING ABNORMAL (I feel like I'm in a hazy/Lifeless) and SOMNOLENCE (I find it difficult to wake up in the morning). On 01-Mar-2021, the patient experienced HYPOTHYROIDISM (Thyroid count  Very low) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, HYPOTHYROIDISM (Thyroid count  Very low), FEELING ABNORMAL (I feel like I'm in a hazy/Lifeless), SOMNOLENCE (I find it difficult to wake up in the morning) and FATIGUE (Tiredness) had not resolved.            No treatment information was provided by the reporter.  Both doses were given in the right, non dominant arm.  Company comment: This case concerns a 73-year-old male with a serious unexpected event of hypothyroidism, and non-serious feeling abnormal, somnolence and fatigue. Event latency within 24 hours after second dose mRNA-1273. Events ongoing. Based on 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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received and added patient information, medical history, suspect product first dose Batch/lot number, concomitant medication and new events.; Sender's Comments: This case concerns a 73-year-old male with a serious unexpected event of hypothyroidism, and non-serious feeling abnormal, somnolence and fatigue. Event latency within 24 hours after second dose mRNA-1273. Events ongoing. Based on 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.
I have experienced headache for a week and on and off body aches,excessive unexplained tiredness.
13-yr old patient received an adult dose; 13-yr old patient received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2022, the patient received the 2nd dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 14th September 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-Sept-2022 Reporter's comment: The reporter consented to follow-up via mail. Additional supportive information: The patient received an adult dose of Havrix 1440, which led to overdose and adult product administered to child.
I requested child be given his DTaP immunization. Later I updated to a Tdap w/o crossing out the written order for DTap.
Pfizer vaccine was given accidently given in place of Pfizer as the patients 2nd dose of the primary series. Per Pfizer medical was advised not to repeat dose.
Left side of my face tingled after the first shot starting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tingling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 45 min after receiving Shingles vaccine, the patient experienced tingling (Verbatim: Left side of my face tingled after the first shot starting). The outcome of the tingling was resolved.   It was unknown if the reporter considered the tingling to be related to Shingles vaccine.     It was unknown if the company considered the tingling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023 The case was received from the patient via interactive digital media. The reporter stated his/her left side of face tingled after the first shot of Shingles vaccine. It started about the 45 minutes afterwards until he/she woke up the next day. Patient stated it was not super bad and might not be related but his/her doctor advised against the second dose.
Information has been received from a physician concerning a 16 year old female patient who on 14-AUG-2008 was vaccinated with the first dose of GARDASIL (lot# 660612/0229X) 0.5 ml intramuscularly.  After receiving the first dose patient experienced bad cramps and heavy bleeding during her menstrual period.  Patient sought unspecified medical attention.  Patient informed physician about this experience when she came back to receive her second dose of GARDASIL 24-NOV-2008.  Additional information has been requested.
Progressive back pain ascending up the spine, 3 day history of bilateral hand swelling and pain in multiple joints.
Patient experienced syncope several minutes after receiving these three immunizations. Lost consciousness for several seconds before coming back into consciousness. Nurse recognized pt. was getting pale and not feeling well before syncope occurred, so patient was sitting at time of incident and no falling injury occurred. Emergency services were called and paramedics dispatched to assess patient before releasing her to leave with her parents. Pt. was alert and oriented after regaining consciousness and blood pressure and pulse were within normal range.
pt recvd vax & exp lightheadedness, burning @ inject site, nausea, SOB, tingling, pain in lt leg, rigidity, soreness; Reporter noted that other pts recvd same lot# around same time & had no reactions;
This spontaneous report was received from a medical assistant concerning a 8 weeks old female patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On 07-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673:
Almost immediate itching followed by heat. The following morning large uneven red bump. The pain began about an hour after injection
PATIENT STATED THAT HE HAD A DELAYED ADVERSE REACTION LOOKS LIKE A RED CIRCLE BELOW WHERE THE SHOT WAS GIVEN IN HIS ARM, HE ALSO STATED THAT HE STARTED TO FEEL A NODE AFTER HE GOT THE VACCINE SAME DAY AND THEN IT FEELS BETTER WITH TIME, WAS ADVISED BY ME TO CHECK WITH HIS DR TO MAKE SURE HE IS OK AND IF THE DR MAYBE WOULD CONSIDER SOME MEDS TO HELP HIM HEAL BETTER
Missed to receive the dose of the vaccine past 8 weeks; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed to receive the dose of the vaccine past 8 weeks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed to receive the dose of the vaccine past 8 weeks). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed to receive the dose of the vaccine past 8 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The patient is 15 years old and came for the booster, so she should have received the Pfizer vaccine for the age of 12 years or older and was given the Pfizer vaccine for 5-11 years.