chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported in the patient; a patient received a dose of GARDASIL-9 in November 2018 (lot/exp unknown), and a second dose in July 2019.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.  On an unknown date in November 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (exact dose, site of administration, lot# and expiration date was not reported) for prophylaxis. On an unknown date in July 2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (lot# N019103, expiration date 03-FEB-2020) (site of administration was not reported). No adverse effects were reported.
On sat 12/4, I suddenly had a stroke on the left side of my brain which affected the right side of my body. I can walk assisted, my right arm lost some strength and coordination. I was taken to the ER. I was originally at local Health Center but now at the local Rehabilitation Center.
I had a pericardial effusion, pleural effusion and had a liter of fluid drained from my lungs. I was hospitalized twice first time 1/30-2/3 and second time 3/31-4/2 at hospital in city, state.
Guillain-Barre-like syndrome with progressive weakness/multiple falls for 3 weeks. Recent vaccine history shows that pt received their influenza and tetanus together. Suspicion that it might be one or both vaccines causing the reaction. Pt also stated that she is a recovering alcoholic and has PMH significant for childhood Hodgkin lymphoma. CSF culture was unsuccessful and pt was discharged with IVIG x5 days.
headache worse after booster dose,It was like a throb in the front of her head.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache worse after booster dose,It was like a throb in the front of her head.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 017B21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Headache and Migraine. Concurrent medical conditions included Blood pressure. Concomitant products included GABAPENTIN for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced HEADACHE (headache worse after booster dose,It was like a throb in the front of her head.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and LIDOCAINE at an unspecified dose and frequency. At the time of the report, HEADACHE (headache worse after booster dose,It was like a throb in the front of her head.) was resolving.            Other concomitant medication included blood pressure medication.  Treatment medication included gabapentin.   This case was linked to MOD-2021-406267, MOD-2021-406269 (Patient Link).
Huge red circle where shot was given.  The after the shot I had chills, fever and the arm where the shot was given hurt.
Beginning a day after the vaccine, I had a burning sensation along the sides of my face on both sides. Over the past seven months, the pain has continued in the same spot off and on and now traveled down into my neck. I have also been exceptionally fatigued during that time.
Chief Complaint: Shortness of breath      Situation/Background: Patient with a history of COPD with COVID pneumonia that was discharge on 09/20 is in the clinic today d/t shortness of breath. Referring provider notes that patient was unsure of meds upon discharge and patient has not been taking his Lasix properly.  Today, patient is short of breath
Stroke 2-3 weeks after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke 2-3 weeks after second vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke 2-3 weeks after second vaccine) (seriousness criterion medically significant). In 2021, CEREBROVASCULAR ACCIDENT (Stroke 2-3 weeks after second vaccine) outcome was unknown.            No treatment information was provided. Lab details were not provided. No relevant concomitant medications were reported.  Company Comment: This case concerns an 85 year-old female patient, who experienced the unexpected event of Cerebrovascular accident. The event occurred 2-3 weeks after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an 85 year-old female patient, who experienced the unexpected  event of Cerebrovascular accident. The event occurred 2-3 weeks after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a physician's office concerning a 15 year old female patient who on 28-AUG-2007 at 10:30 AM was vaccinated IM into right upper arm with a first dose of GARDASIL lot # 658556/1060U) and on 14-NOV-2007 she was vaccinated IM into left upper arm with a second dose of GARDASIL (lot #658488/1264U).  It was reported that patient got nausea and vomiting for two days after each vaccination of GARDASIL.  She was reported to be recovered on an unspecified day.  Additional information is not expected.
May 2- vommitting and low grade fever and migraine  May 3- migraines joint pain and stomach pain May 4- went to the ER My white blood cell count dropped to 2.7 My ketones were 15 my labs were not good. Moderna sent my entire body into a lupus flare I was treated with 2 bags of fluids, torodol, pepcid and prednisone  May 8- I've now lost 4 lbs my sinuses are so swollen I can't smell, but have a negative covid test  The next week I feel better May 13- I get a tattoo, didn't know that falls under the "procedure" umbrella My body starts adversely reacting to my tattoo. The nurse says it's because of the vaccine.. Painful red rashes spread it's hot my arm is hot. Also the same arm I got the moderna in. May 18- put on more steroids and antibiotics   The "free and safe" vaccine has now cost me over $400 and 2 days of work. Er- copay $300 Urgent care- copay $45 Meds- $30  Work- $110 Tattoo- $100 that will need to be redone
Patient stated that her injection site and site is warm. Patient received both vaccines listed at same time in same arm. Patient had nausea, fatigue, fever, couldn't eat, chills.
56 adults patients received doses after its expiration date Jul 13, 2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the event with Humira and assessed the event as not related to Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Headache, body aches, nausea and vomiting, chills, fever, and pain/soreness at injection site. All started day of vaccination; and, continued through next day.   Increased fatigue started day of vaccination; and, is still ongoing. Is getting better every day.
Initially redness amd swelling. resolved on 12/29/20, redness, swelling and pain reocurred on 1/3/21, Better on 1/5/21
About 14 hours after receiving the first injection I started to feel chilled and nauseous.  I started vomiting.   I also developed a throbbing headache.  I continued to feel nauseous with a headache for another 14 to 18 hours.  I took Tylenol to help minimize the symptoms.
Elevated liver enzymes: before vaccination 4/15/ test ALS 28, ALT 31.  After vaccination test 5/3 ALS 208 ALT 165  the others: nausea, let's arm pain ,headache , fatuque
Day #1 after vaccine - fever Day # 3 after vaccine - clingy/fussy Day #4- 8 after vaccine - irritable, angry, biting - very abnormal behavior for child by both family and longstanding daycare provider.  Will have improved behavior at times.
April 3 injection site itched. No other symptoms noted. April 7 injection site itched like a mosquito bite. April 8 injection site felt like a good bruise and the swelling felt hard, muscle hard. April 9 mild pain and limited mobility of arm, but not inconvenient at all. April 10 injection site slightly itching. Discomfort nearly gone.
Started to feel nauseous, weak with body aches. The entire left side of my body felt paralyzed and hot. The pain went into my chest and was tingling. My bones felt like they had stabbing sharp pains. The injection site then became red and almost the size of a golf ball and tender to touch.  Overnight I could not fall asleep as I felt immense pain in my arm and over my entire body.
This case was reported by a pharmacist via call center representative and described the occurrence of exacerbation of pain in a 68-year-old female patient who received TWINRIX adult (batch number 925P2, expiry date 22nd March 2016). Previously administered products included TWINRIX adult (doses 1 and 2). On an unknown date, the patient received the 3rd dose of TWINRIX adult 1 ml. On 12th February 2015, unknown after receiving TWINRIX adult, the patient experienced exacerbation of pain and contusion. On an unknown date, the outcome of the exacerbation of pain and contusion were unknown. It was unknown if the reporter considered the exacerbation of pain and contusion to be related to TWINRIX adult. Additional information received: The patient developed increased pain with 3rd injections vs dose 1 and 2. The bruising did not go away and remained for 2wks. No additional information available at the time of reporting.
received his first dose of V ARlV AX at 15 months second at 10 years old.; No additional AE reported; This spontaneous report was received from a registered nurse, referring to her son, a 24 years-old at the reporting time, male patient. The patient's concurrent conditions, pertinent medical history, concomitant medication, drug and allergy reaction were not provided.  On an unspecified date (approximately between 1198 and 1999 and reported as "at 15-months old"),  the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX). Also, it was reported that On an unspecified date (approximately between 2006 and 2007 and reported as "at 10-years old"), the patient received the second dose on varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration).  No additional adverse event reported.
Chills/Fatigue/Fever/Headache/Muscle Pain/Nausea/Pain at the injection site
From shoulder to elbow red, itchy, pimply rash noticed about 24 hours after vaccine. Benadryl cream applied after consulting with MD. Rash disappeared in 3 hours.
Interchange of vaccine products; Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Grass" (unspecified if ongoing); "known allergies: cats" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Heart rate elevated 15-20 bpms higher 12 hours after injection. Chest right or strained
Received vaccine 10/17 onset of symptoms following day started getting ill feeling 21:00 10/18, then ill with fever of 102 10/18 PM - 10/19,20,21.  MD help 10/24 saw MD for recovery.  Follow up on 01/08/04: "Unable to get lot # or manufacturer.  Information from vaccine administrator."
Left arm sore to touch; Heavy feeling; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 02Mar2021 at 16:00, the patient experienced left arm sore to touch and heavy feeling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event Left arm sore to touch and heavy feeling was not recovered at time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Drooping of mouth, not able to blink or close right eye. Tearing of right eye, strange feeling on toungue. Diagnosed as Bells Palsy
p/vax pt devel a varicella-like rash which was initially macular, papular then vesicular w/approx 20 lesions on thighs, buttocks, face & back;also exp fever of 100 & felt tired & drained;
legs, arm, abs, back and head was itchy, some raised some dots; Full rash on the body, red rash around injection site; little itchy on the back of her neck and back; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (little itchy on the back of her neck and back), URTICARIA (legs, arm, abs, back and head was itchy, some raised some dots), RASH (Full rash on the body, red rash around injection site) and VACCINATION SITE PAIN (Sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (Sore arm). On 05-Jan-2021, the patient experienced PRURITUS (little itchy on the back of her neck and back). On 06-Jan-2021, the patient experienced URTICARIA (legs, arm, abs, back and head was itchy, some raised some dots) and RASH (Full rash on the body, red rash around injection site). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 06-Jan-2021 for Rash all over, at an unspecified dose and frequency. On 07-Jan-2021, RASH (Full rash on the body, red rash around injection site) had resolved. At the time of the report, PRURITUS (little itchy on the back of her neck and back) had not resolved, URTICARIA (legs, arm, abs, back and head was itchy, some raised some dots) outcome was unknown and VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
pt recv vax & arms was swollen from site to fingertips;referred to MD took APAP & use ice pack;spoke to father 10FEB97 said still had small amount of swelling in fingers but thought was fine;
pt recv vax & 6 hr later pt spiked a temp of 104;tx w/Ibuprofen & dimetapp elixir & saw MD the next day;19JAN96 pt seen again & dx w/touch of pneumonia;tx w/ATB;
Pt not immune p/testing 4DEC90; Anti-HBs-neg; P/4th inject pt tested 27FEB91 still negative for ANti HBs; Testing scheduled for APR91;Given 5 doses 9DEC88, 13JAN89, 16JUN89, 16JAN91, 22MAR91 fr lot#s 1893P, 629A4, 1239S, 1 & 2 dose not give
Date of Admission: 10/10/2022   Date of Discharge: 10/21/2022   Admission Diagnosis: Thigh hematoma, left, initial encounter  COVID  Respiratory failure with hypoxia (CMS/HCC)  Hematoma    Hospital Principal Problem (Discharge Diagnoses): Thigh hematoma, left, initial encounter
This spontaneous report as received from a nurse's aide refers to an unspecified patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (strength, dose, route of administration, lost # and expiration date were not reported). No information on patients concomitant medication was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
4 days p/receiving Td & TIG pt exp swollen tongue, burning sore throat;
This is a spontaneous report from a non-contactable nurse via Pfizer sales representative. A 17-year-old female patient received the first dose of TRUMENBA (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced facial redness and swelling 2 days after receiving the first dose of meningococcal group b rlp2086. No follow-up attempts are possible, information about batch number cannot be obtained.
Pt received Hep A around noon time 7/7/17-Mom called 3:30 that pt had red hives itchy rash to full body. No fever. Tx w/BENADRYL helped. Last 36 hrs.
Bell's Palsy.  Noticed lip felt numb at 9:00 AM.  By noon it was more numb and left eye was dry.  Could barely blink with left eye.  By 4:00 PM facial droop on left side so went to ER.
Information has been receivedc from a physiciaan concerning a 23 month old pt who on 01/02/1999 was vaccinated with a dose of varicella virus vaccine live. On 12/23/1999,  the pt experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no Tx given and no hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. thirty nine other cases (WAES 0407USA01446 and 0409USA01855 to 0409USA01857 and 0409USA01859 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live . Additional information is not expected.
Initial case was received from a health care professional on 21 February 2014. A 71-year-old female patient whose medical history included allergic to latex and concomitant medications were not reported had received an intramuscular FLUZONE HD (batch number U4809AA, dose not reported) in the left arm on 28 December 2013. On 29 December 2013, in the morning the patient had trouble in moving her left arm. On 04 January 2014, she went to an urgent care and was told to put an ice on it and to take anti-inflammatory. On 17 January 2014, she saw her doctor who gave her a cortisone shot and took an X-ray. The event was still not recovered so Magnetic Resonance Imaging (MRI) was planned. No corrective treatment was reported. The list of documents held by sender: None.