chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a case of Urticaria; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed a case of Urticaria) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt tired). On 13-Dec-2021, the patient experienced URTICARIA (Developed a case of Urticaria) (seriousness criterion medically significant). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and HYDROXYZINE at an unspecified dose and frequency. On 05-Dec-2021, FATIGUE (Felt tired) had resolved. At the time of the report, URTICARIA (Developed a case of Urticaria) outcome was unknown.            No concomitant medications were provided. Treatment medication also included unspecified steroids.  The patient received his Moderna Booster Dose on 03 Dec 2021. The patient felt tired for 2 days after receiving the booster dose. and developed a case of Urticaria on 13 Dec 2021. The patient went to see his Physician and was prescribed steroids and antihistamines. The patient received a Dexamethasone injection and Prednisone tablet. The antihistamine that the patient's Physician prescribed is Hydroxyzine.   This case was linked to MOD-2022-440621, MOD-2022-440662 (Patient Link).
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 21-AUG-2014 the patient was vaccinated with an expired dose of M-M-R II (0.5 ml, subcutaneous, lot # H014977, expiration date: 09-AUG-2014). No adverse effect reported. Additional information has been requested.
About 1 hour after vaccination, patient reported dizziness, lightheadedness and headache. Later reported anesthesia-like feeling of her tongue. Discovered patient unconscious and unresponsive but breathing a few minutes later.
This spontaneous report has been received from a pharmacist. The pharmacist stated that he was aware that ZOSTAVAX was being administered to people younger than 50 years of age, and that insurance would pay for the dose of ZOSTAVAX administered to people under the age of 50. At the time of report, she did not have any specific patients or situations to report. The information was not available on any specific patient. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Redness & swelling to site.  Doctor visit.  Dx cellulitis approximately Tx AMOXIL 500 T TID X 7 days.
NO AVERSE REACTION/EFFECT NOTED DURING THE 15MINUTES WAIT. THE PT/MOM WAS LATER CONTACTED AND THERE WAS NO ADVERSE REACTION/COMPLAINT VOICED. PT'S MOM STATE " HE'S FINE AND I'M FINE TOO. THANK YOU FOR CHECKING ON US"
Day 1 Pain Both Shoulders, Neck Only Day 2 Pain Hips, Spine Only Day 3 Pain Both Knees Only Day 4 Pain Both Ankles Only Remainder Time, Ankles Only Second Shot Reaction: Week 1 Very Little Reaction Week 2 Pain Right Ankle, Difficulty Walking, Low Energy Then pain Left Ankle, less Right Ankle Then Significant Pain Left Ankle, Calf Muscles Then Pain Both Ankle, Calf Muscles, Some Thigh Muscle Pain In Legs Would Wake Me up From sleeping One Advil 200 mg Pill Would Reduce pain in 15 minutes, Max 4 pills per day
too much bile; acid stomach/digestion sped up/food not Digesting; acid reflux; stomach pain; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 13:15 (Lot number: EP7533) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number=EW0169, administration time=01:15 PM, dose number=1, vaccine location=Right arm), administration date: 14Apr2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: BILE OUTPUT INCREASED (non-serious) with onset 05May2021, outcome "not recovered", described as "too much bile"; DYSPEPSIA (non-serious) with onset 05May2021, outcome "not recovered", described as "acid stomach/digestion sped up/food not Digesting"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 05May2021, outcome "not recovered", described as "acid reflux"; ABDOMINAL PAIN UPPER (non-serious) with onset 05May2021, outcome "not recovered", described as "stomach pain"; HYPERHIDROSIS (non-serious) with onset 05May2021, outcome "not recovered", described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of bile output increased, dyspepsia, gastrooesophageal reflux disease, abdominal pain upper, hyperhidrosis.  Additional information: Adverse event: too much bile, acid stomach, acid Reflux, digestion sped up, food not Digesting, stomach pain, sweating. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient did not had covid prior vaccination. Patient was not covid tested post vaccination. Patient did not had covid test post vaccination. Patient had no known allergies. Patient did not had other medical history.  Follow-up attempts are completed. No further information is expected.
Cut; Product Complaint; exposure via skin contact; Pharmaceutical product complaint; This case was reported by a pharmacist via call center representative and described the occurrence of laceration of finger in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) and (batch number AH992, expiry date 18th March 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced laceration of finger, occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger, occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of finger to be related to Shingrix.  Additional details were provided as follows: The reporter was an experienced user of the product.He pulled out an adjuvant suspension from the carton to prepare a dose to administer to a consumer.When he pulled out the vial, he went to remove the label and was cut on his left middle finger by what he discovered to be a damaged adjuvant suspension vial filed related adverse event, which led to laceration of finger, occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint.  The base of the vial was missing a piece of glass and the rest of the base had branching cracks.The product was not administered to a consumer. No damage was noted to the package or carton at the time it was received but the carton was not opened until the user needed to obtain a dose. The box was not inspected at the time the shipment was received.No evidence of leakage in the package carton.There are glass pieces still in the carton.No product is left in the vial.The reporter would email a picture of the suspect vial to GlaxoSmithKline. The reporter would return the suspect adjuvant suspension vial and the corresponding lyophilized powder vial to GlaxoSmithKline.Please provide credit for one dose of the Shingrix vaccine. The reporter consented to follow up. The reporter was a pharmacist and gave permission for his physician to be contacted.
Phone call from Mom, reporting that patient's arm is red, hot to touch and swollen from shoulder to elbow. Advised ice to arm, MOTRIN or TYLENOL and to monitor.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Brugada syndrome" (unspecified if ongoing); "Known allergies: Penicilin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (07Jul2022) Unknown results, notes: Covid rebound 6 days after finishing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Redness 5 cm X 5 cm; Swelling + Pallor 8X8 cm; tenderness.
Pharmacy staff drew up the 0.3 mL dose without first diluting the Pfizer suspension. The dose was administered at 0919 on 7/28/21. The error was not identified until pharmacy attempted to draw up a dose for another patient at 1300 on 7/28/21.
2nd dose at less than recommended interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number JH25S, expiry date 4th November 2021) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 25th May 2021, the patient received the 2nd dose of Shingrix. On 25th May 2021, unknown 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 patient received 1st dose of Shingrix on 1st May 2021. The pharmacist reported that a patient received 2nd dose of Shingrix at less than the recommended minimum interval of 2 months after the first dose, which led to shortening of vaccination schedule. The reporter consented to follow up.
Patient is 17 years old but accidentally received Flublok which is approved for 18 and over.
Leg and body aches, recurrent rashes, "cap" headaches, dizziness or weakness, eyesight deterioration (rapid), eye pain, diarrhea, nausea
Patient developed redness and swelling around the area where she received a ZOSTAVAX about 10 (ten) minutes prior. She well advised to take BENADRYL and go to the ER - no problem breathing.
brownish discolored spot on arm/ lower down on his arm than the injection site; soreness/ achy; tired; fever; This case was reported by a consumer via call center representative and described the occurrence of depigmentation spot in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced depigmentation spot, pain, tiredness and fever. On an unknown date, the outcome of the depigmentation spot, pain, tiredness and fever were recovered/resolved.   It was unknown if the reporter considered the depigmentation spot, pain, tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix in left deltoid and less than a day after vaccination, it was sore afterwards. The next day, the patient noticed a brownish discolored spot on his arm lower down on his arm than the injection site. The patient also felt a little achy and tired and was running a fever, less than a week after vaccination. The spot took a long time to resolve, but the other symptoms resolved with 3 to 4 days. The patient noted that when he got a tetanus vaccine, he had similar symptoms. The reporter consented to follow up.
This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX injection, lot# L005299, exp. date: 17-FEB-2017 and lot# L041326, exp. date: 13-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. had a seizure after 1st DPT on 6/1/99 as reported by parents to MD.
Itching, swelling and elevated temperature at the injection site 7 days after the injection.  Benedryll improved symptoms (50mg for two days) 9 days after injection most of the swelling is gone and itching is diminished.
Shot given 9-11-13. Patient presents back at pharmacy 9-13-13 with red swollen left upper arm. Patient complaint of heat, swollen, rashy appear at injection site, also dazed "drugged feeling".
A non-serious spontaneous report of pregnancy was received from a health professional concerning an adult female. Neither relevant medical history nor obstetrical history have been reported for this patient. No concomitant medications have been reported for this patient. On 27-Oct-2011, the patient received FLUMIST. Later, on an unknown date, she found out that she was pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
After the vaccine, I have been very itchy at the vaccine site. I have had, chills, extreme fatigue, headaches, dizziness, stomach cramps. I have even blacked out while driving which caused me to get in a MOTOR VEHICLE ACCIDENT, I could have died, or hurt someone.
feeling sick; had a temperature; headache; fatigue; pain carrying over to her chest; weird pain in her armpit; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (pain carrying over to her chest), AXILLARY PAIN (weird pain in her armpit), MALAISE (feeling sick), PYREXIA (had a temperature) and HEADACHE (headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MALAISE (feeling sick), PYREXIA (had a temperature), HEADACHE (headache) and FATIGUE (fatigue). In March 2021, the patient experienced CHEST PAIN (pain carrying over to her chest) and AXILLARY PAIN (weird pain in her armpit). At the time of the report, CHEST PAIN (pain carrying over to her chest) and AXILLARY PAIN (weird pain in her armpit) outcome was unknown, MALAISE (feeling sick) had resolved and PYREXIA (had a temperature), HEADACHE (headache) and FATIGUE (fatigue) was resolving.            No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
Initial and follow-up information has been received regarding a case in litigation from a 78 year old male with osteoporosis and no allergies who on 08-JUL-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX by subcutaneous injection (lot number and injection site not reported). Concomitant therapy included alendronate sodium (MSD). On approximately 11-JUL-2008, also reported as three or four days after receiving the vaccine, the patient developed fever, headache, dizziness, nausea, pain in the ankles and blood spots on his left arm. The patient's events persisted. The patient did not seek any medical attention. Follow-up information was received from the patient which reported that he continued to have headaches and he developed blood spots on his left arm. The patient did not seek any medical attention. Additional information is not expected.
Patient was 17 at time of initial vaccination. Dr was contacted and verbal order was given to give second dose per off label use. Patient denies any adverse reactions or side effects.
Severe abdominal pain, cramping, and nausea that lasted for 24 hours. The pain was bad enough that I nearly passed out and had a panic attack where my hands got stuck in a strange position and my tongue stopped working for a while, which the ER doctor believed to be caused by hyperventilating.
PT HAD THE SHOT APPROXIMATELY AT 2:15 PM AND BY 4:30PM SHE START GETTING TIRED. PATIENT DESCRIBE SHE MAY SLEPT ON THE RIGHT ARM AT NIGHT. BY THE NEXT MORNING (ABOUT 18 HRS AFTER THE SHOT), THE INSIDE OF HER ARM IS BECOMING PINK ABOUT THE SIZE OF 6x3  AND THE MUSCLE IS REALLY STIFF (NOT AT THE INJECTION SITE). PATIENT TOOK ADVIL TWICE IN THE NEXT 24 HOURS, HER PAIN IS GONE. BY MONDAY, THE PINK IS FADED AND BY TUESDAY IT ALMOST FADED. SHE DID NOT EXPERIENCE ANY FEVER.
This spontaneous report as received from a medical student refers to a 6-month-old patient (gender was not reported). On 12-FEB-2018, the 6-month-old patient was vaccinated with a dose of GARDASIL 9 lot # N020352, expiration date 10-APR-2020 for prophylaxis. No adverse effects were reported.
Arm started getting hot to the touch; Arm started getting a bit swollen; Arm started getting red; Arm started getting rashy; Arm started getting itchy; Arm was sore for two days afterwards; A spontaneous report was received from a consumer concerning a 65-year old female patient who developed a sore arm for 2 days and arm started getting itchy, red, rashy, hot to the touch, and a bit swollen.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of the two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the left arm on 06 Feb 2021 for prophylaxis of COVID-19 infection.   Reporter got the vaccine on 06 Feb 2021 and for the next 2 days her arm was sore. On 15 Feb 2021 she reports arm started getting itchy, red, rashy, hot to the touch and a bit swollen. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event(s) developed a sore arm for 2 days and arm started getting itchy, red, rashy, hot to the touch, and a bit swollen, was unknown.  Based on comment, all event coded Vaccination Site Pain, Vaccination site warmth, Vaccination site Pruritus, Vaccination site swelling, Vaccination site rash, Vaccination site erythema.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced weird taste in mouth on tongue and lips. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird taste in mouth on tongue and lips. This report was non-serious. This case, involving the same patient is linked to 20220145141.
Symptoms were fever (100.8), muscle ache, joint ache, chills, headache (severe), fatigue, soreness at injection site. Symptoms started 8-10  hours after injection.  Symptoms lasted 36 hours.  Took Tylenol for aches and fever.
From time of vaccine administration (approx 10 AM) until at least 1600 (6 hours) inconsolable, "screechy" cry and achy - not typical cry and very uncharacteristic in this happy baby.
High fever of more than 102, chills and body ache and site of injection swollen and hard to touch and painful. Patient did not take Tylenol for fever and pain as instructed and did not apply cool massage over the site.
Sedation, Myalgia & NauseaVomiting Narrative:  Other Relevant History:
Flu; Initial information was received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media..  This case involves adult female patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "no flu shot, no flu".  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
PATIENT WAS GIVEN NEW COVID 19 VACCINE ALONG WITH FLU VACCINE. PATIENT WOKE UP THE NEXT MORNING, FELL OUT OF BED AND WET HIMSELF. PATIENT ALSO HAD FEVER OF 102. PATIENT WAS SENT TO MEDICAL CENTER FOR FEBRIAL SEIZURE WITH CONFUSION AND FALL
Initial report was received from a consumer on 10 May 2013. A 17-year-old female patient had received an intramuscular injection of MENACTRA (lot number, site and date of administration not reported) when she was between age 11 and 12. She never had a booster dose. The patient was currently in the hospital in ICU with meningitis. No amputations were done at this time. She has been in the hospital for about 3 weeks. Past medical history and relevant diagnosis tests were unknown. Outcome was not recovered. Documents held by sender: None.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     No adverse event reported for the patient.  No treatment medications were reported.