chrisvoncsefalvay/vaers-outcomes huggingface dataset:
serum sickness; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SERUM SICKNESS (non-serious), outcome "unknown," described as "serum sickness."  Additional information: The reporter was asking for any information on serum sickness with Prevnar 13. The reporter had a patient, who experienced this, but did not have any patient information right now. The reporter was just gathering information and had the website to report online.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
IMMUNE DISORDER; This spontaneous report received from a consumer via a company representative concerned a 21 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced immune disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immune disorder was not reported. This report was non-serious.
Right shoulder pain, developed approx 1 week after 2nd dose of vaccination, still present on 5/24/2021 left shoulder pain, developed approx 1 month following 2nd dose of vaccination, still present on 5/24/2021 bilateral foot pain, developed approx 1 month following 2nd dose of vaccination, still present on 5/24/2021
Loss of taste; Cough; Loss of smell; congestion; Muscle aches; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), COUGH (Cough), ANOSMIA (Loss of smell), NASAL CONGESTION (congestion) and MYALGIA (Muscle aches) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 038c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced AGEUSIA (Loss of taste), COUGH (Cough), ANOSMIA (Loss of smell), NASAL CONGESTION (congestion), MYALGIA (Muscle aches), PYREXIA (fever) and FATIGUE (tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 11-May-2021, COUGH (Cough), ANOSMIA (Loss of smell), NASAL CONGESTION (congestion), MYALGIA (Muscle aches), PYREXIA (fever) and FATIGUE (tired) had resolved. At the time of the report, AGEUSIA (Loss of taste) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Body temperature: 103 (High) 103F. On 04-May-2021, Body temperature: 101 (High) 101F. On 05-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient reported that he tested positive six days after first dose. On 02-May-2021 patient experienced symptoms. He experienced COVID-19 symptoms like fever, lost taste, cough, congestion, tired. Patient did not seek medical care for the events. Patient rested at home to recover. Patient stated that possibly he caught COVID-19 at clinic while being vaccinated and no other place he could have got it. Patient recovered on 11-May-2021 and still had lost of taste as of 19-Jun-2021.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Additional information received on 19-Jun-2021: Patient demographics were updated; Lab data was updated; second dose details added and additional events of fever and congestion were added.
I had a ache in my left jaw and my neck, aches in my left chest after taking deep breathes.
First adverse event was my son's temperature rising to 106.3 and being in the ER to be told he was dehydrated. The following day 5/23/2010 my son had what was described to us as a seizure that caused him to go from being normal to being lifeless and not breathing with his eyes rolling in his head.  The ambulance transported us to the ER where we were told he had a seizure.
had smells of burning and gasoline; This is a spontaneous report from a contactable consumer (patient's sister) received via agency. This consumer reported similar events for two patients. This is the 2nd of two reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had smells of burning and gasoline. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187152 same reporter and drug, similar event, different patient
This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age and ethnicity received PREVNAR on an unspecified date to an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms, bad cough, fever reaches to 102, chills, uncontrollable shaking, and felt sick on an unspecified date with outcome of unknown. Follow-up (12-MAY-2016): Follow-up attempts are completed. No further information is expected.
Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's concurrent medical conditions, concomitant therapies, and medical history were not provided. On an unknown date, the unspecified patient was administered the second dose of ZOSTAVAX (dose, frequency and route were unknown, lot# M036297, expiration date 14-NOV-2017) "one year" after his first dose for prophylaxis (unapproved dose administered). No adverse effects were reported. Additional information has been requested.
reddish; rash about a size of an orange; very itchy; hot to touch; swelling of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE SWELLING (swelling of the left arm), VACCINATION SITE ERYTHEMA (reddish), VACCINATION SITE RASH (rash about a size of an orange) and VACCINATION SITE PRURITUS (very itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    No Medical History information was reported.   On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE SWELLING (swelling of the left arm), VACCINATION SITE RASH (rash about a size of an orange) and VACCINATION SITE PRURITUS (very itchy). On 28-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (reddish). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE SWELLING (swelling of the left arm), VACCINATION SITE ERYTHEMA (reddish), VACCINATION SITE RASH (rash about a size of an orange) and VACCINATION SITE PRURITUS (very itchy) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included Cold compress.   The patient was administered Moderna booster shot on same day together with her flu shot same arm, left side.  So it was reported that the patient was not sure whether the reaction for the Moderna booster or the flu shot.   This case was linked to MOD-2021-398893, MOD-2021-398894 (Patient Link).
A non-serious report of two doses of FluMist given on same day has been received from a nurse in the USA concerning a child of unknown age.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical history nor concomitant medications were provided.  The patient received FluMist on an unknown date.  The school age child received one full dose of FluMist in each nostril.  No adverse events were reported.  No outcome was provided by the reporter.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to MEDI-0006239 and MEDI-0006240 which were all from the same reporter.
Soreness and erythema with edema at injection site that started 10/30/2011. Presented to office on 10/31/2011 - wheal measuring 17 x 10 x 0 cm to right posterior upper arm.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, less than a day after receiving Flu trivalent vaccine, the patient experienced general body pain, headache, exhaustion and sickness. On an unknown date, the outcome of the general body pain, headache, exhaustion and sickness were recovered/resolved. The reporter considered the general body pain, headache, exhaustion and sickness to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. About 11 years before the reporting date, the patient received an influenza vaccination of unknown manufacturer. Within a day of being vaccinated, the patient was sick and bedridden with symptoms of body aches, headache, a feeling of being totally exhausted like she was going to die for at least one day. Then she felt like she really tired recovering from the flu, and all the symptoms were eventually resolved. The patient did not recall the exact timeline for symptoms or any further specific product dosing details. The patient thought that, the flu vaccine caused all of those symptoms and decided not to have any further flu vaccinations since. This case has been linked to case US2018070982, reported by the same reporter.
Fever, Diarrhea, fever of 101, chills, body aches, diarrhea, loss of appetite Narrative: Day 2 soreness to injection site; day 12-14 fever of 101, chills, body aches, diarrhea, loss of appetite; use of OTC tylenol to help with symptoms: resolution of symptoms afterwards
Began having upper chest pain when taking deep breaths and when lying down. Chills Night sweats Fatigue Body Aches and pains
Patient was waiting the required 15 minutes after and became light headed. Patient was placed in supine position with legs elevated until patient felt well again. After patient felt well, water and sugar was given. Patient waited another 15 minutes to be monitored and exhibited no further symptoms
Blood clots in nose 10/16.  Shingles like rash on torso since 10/16.  Nausea on 10/16 and 10/17.  Extreme fatigue on 10/16 and 10/17.
Client reported he developed oval blotches on his skin on 08Nov06, the day after receiving FluMist (first time), he was in NYS and went to ER (Cortland Regional Medical Ctr) and was DX with erythema multiforme advised this clinic of event 27Nov06. Oval patches persist has F/U appt with his MD 13Dec06.
evening of 4JUL had T104.8 R, had diarrhea;gave APAP didn't break temp, do alternated w/advil which broke temp;noticed rashes today 6JUL, however not bothering child;
Fever (low grade) starting five days after administration, following by rash to face/neck/torso on ninth day after shots.
Day 1 post vaccine: 1) arm pain 2) tired and achy Day 2 post vaccine: 1)full body aches 2) weak 3) one dizzy spell lasting briefly
Pfizer #2 covid immunization. In that afternoon, developed unexpected nosebleed. Has never had this in past.
SEVERE CHILLS; FEELING WEAK; NAUSEA; VOMITING; EXCRUCIATING TIGHTNESS BETWEEN HER UPPER CHEST RADIATING AROUND TO BILATERAL SHOULDER BLADES AND BACK; MUSCLE SPASM; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetic - diet controlled, arthritis, high cholesterol, penicillin antibiotics allergy, and sulfa antibiotics allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced vomiting. On 28-MAY-2021, the subject experienced excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back. On 28-MAY-2021, the subject experienced muscle spasm. On 28-MAY-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 10/10. On 29-MAY-2021, the subject experienced severe chills. On 29-MAY-2021, the subject experienced feeling weak. Treatment medications (dates unspecified) included: acetylsalicylic acid, and loperamide hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back, muscle spasm, severe chills, and feeling weak on 29-MAY-2021, and nausea on 28-MAY-2021, and the outcome of vomiting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non-serious.
Shortly after administration of the vaccine, patient began feeling lightheaded and nausea. Patient was crying and had rapid breathing. Patient appeared to be having a anxiety attack. 911 was called. Blood pressure was taken 3 times over the course of ~5 minutes. Emergency response personnel arrived and continued to assess and monitor the patient. The patient eventually left with her father (AMA)
arm was sore; left hand (region of pinky and ring finger) has a tingling and numb sensation; left hand (region of pinky and ring finger) has a tingling and numb sensation; lymph nodes swell up and were very large; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PARAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation), HYPOAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation) and LYMPHADENOPATHY (lymph nodes swell up and were very large) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm was sore), PARAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation), HYPOAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation) and LYMPHADENOPATHY (lymph nodes swell up and were very large). In 2021, PAIN IN EXTREMITY (arm was sore) and LYMPHADENOPATHY (lymph nodes swell up and were very large) had resolved. At the time of the report, PARAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation) and HYPOAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was concerned about it and asked if it was Guillen Barre's syndrome. Patient also has concerns about getting second dose. Patient did not take medication to treat symptoms. Patient does not take any concomitant medication.  No treatment medication were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: follow up received on 08-Nov-2021 contain no new information On 08-Nov-2021: follow up received on 08-Nov-2021 contain no new information
Patient fainted twice after vaccination was administered. Patient fell on end cap in store and hit her head and back.
Reconstituted with sterile water; Reconstituted with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number YCIY7, expiry date 25-OCT-2024) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Shingrix. On 20-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAR-2023 The reporter reported that on 20th March 2023 morning, a Shingrix first dose was reconstituted with sterile water and administered to a patient.  The patient received Shingrix vaccine which was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter was consented to follow up.
Day after injection I felt as if I had the flu. Feverish and chills. The most significant reaction has been the lymph node(s) in my left armpit. Swelling, stabbing pain, pain with movement. This pain increased throughout the day 11/17/2021. Taking acetaminophen and ibuprofen with heat applications has provided little relief.  Today 11/18/2021 pain has reduced from 11/17/2021 but is still having effects on my physical ability to move and rest.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-JUL-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about ,17-FEB-2015 the patient was treated at a health center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. On or about 18-FEB-2015, the patient treated again at the health center for new and ongoing outbreaks of shingles infections. The patient was prescribed acyclovir for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Fatigue) in a 77-year-old female 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.    Concurrent medical conditions included Macular degeneration and Crohn's disease (Moderate to severe).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) had resolved.            No concomitant medication provided. No treatment information mentioned.  Patient had macular degeneration in right eye. Had both COVID Moderna vaccines and after second dose had chills and fatigue for 3 days.   Reporters causality for events with HUMIRA was no reasonable possibility.  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
pain in the arm; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) and BACK PAIN (Back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A. and 025K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm) and BACK PAIN (Back pain). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the arm) and BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided by reporter.
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 24-NOV-2008 was vaccinated with her initial dose of GARDASIL (lot # 661530/0575X) 0.5 mL intramuscularly in deltoid. On unknown date the patient had a severe reaction to the vaccination and went unresponsive. Her blood pressure was recorded at 54/30. The patient was sent to the local Emergency Room via ambulance. She was not admitted to the hospital and recovered from unresponsive. The last menstrual period was 21-OCT-2008 and estimated delivery date was 28-JUL-2009 (reported as "27-JUL-2009"). Upon internal review, went unresponsive was considered to be an important medical event. Additional information has been requested.  2/2/09 ER record received for DOS 11/24/08 with DX: Vasovagal episode. Pt was receiving immunizations when had a single episode of syncope.  PE WNL in ER. D/C to f/u up with PCP.