chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Head bobbing, subsequently diagnosed by a neurologist as tic disorder. Symptoms persist and may be chronic.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No pertinent medical history, drug reaction/ allergies or concurrent conditions were reported. On 29-MAR-2016, the patient was inadvertently vaccinated with an expired dose of VARIVAX (Merck) (which had a lot of K003421 and expiration date of 06-MAR-2016; however, dose, dosage number and route of administration were not reported). This was reported supported. Nonetheless, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Aching became more pronounced; Chills and Aching became more pronounced; bowel movement difficulty; nausea that worsened in 2019; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received in October 2018, Please refer the US2020175334).   In January 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, chills, bowel dysfunction and nausea aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, chills, bowel dysfunction and nausea aggravated were unknown.   It was unknown if the reporter considered the pain, chills, bowel dysfunction and nausea aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated the chills and aching became more pronounced after the second injection in January, 2019.  The patient reported nausea that worsened in 2019, and alleviated May 2020.  She started to feel better in April, 2020.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020175334:same patient
Onset of headache and bilateral upper extremity weakness within 24 hours of receiving vaccine. Progressed to lower extremities, requiring hospitalization.  Working diagnosis is transverse myelitis versus Guillain-Barre Syndrome. Diagnostic work-up still in progress. Treatment course has been acyclovir and IVIG.
Left upper chest discomfort, sharp upper chest discomfort with radiation down her left arm, cough, shortness of breath,  headache.   Patient had a Pulmonary Embolism.  She was sent to the hospital and started on Xarelto 15mg bid for 21 day and will follow with Xarelto 20mg daily.
Slight Fever; she is in bed shivering; feeling lightheaded; Fell to the floor twice; Feeling sick; stayed in bed all day; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 15th January 2023, 1 days after receiving Shingrix, the patient experienced feeling unwell. In January 2023, the patient experienced bedridden. On 16th January 2023, the patient experienced shivering, light headedness and fall. On 17th January 2023, the patient experienced fever. On 17th January 2023, the outcome of the fall was recovered/resolved. On an unknown date, the outcome of the feeling unwell, fever and shivering were not recovered/not resolved and the outcome of the bedridden and light headedness were unknown.   It was unknown if the reporter considered the feeling unwell, fever, shivering, bedridden, light headedness and fall to be related to Shingrix.     Additional Information: GSK receipt date: 17-JAN-2023 Reporter comment: Reporter was the patient's grandson. The reporter states that the patient received her first Shingrix dose on Saturday morning and that she started feeling sick Sunday night.  The reporter stated that the patient had a slight fever and she was in bed shivering right now despite having 6 blankets on and with the heat up in the house and that the shivering started yesterday (16th January 2023) and stayed in bed all day.  The reporter also stated that the patient felt lightheaded yesterday (16th January 2023) and that she fell to the floor twice and that he helped her back up to get to her bed, but he was not sure if she was still feeling lightheaded at this time. The grandson did not consent for safety follow-up with HCP (healthcare professional) and HCP's information were not provided.  The reporter did not consent to follow up. Additional Supportive Information: Outcome date was reporter for event feeling unwell, fever, shivering, light headedness as 17th January 2023, but the outcome was given as not recovered and not resolved for event feeling unwell, fever and shivering and lightheaded outcome given unknown. Outcome was conservatively captured as per description and clarification has been raised.
Muscle aches, fatigue, generalized body aches and weakness. Temp 99.1. Muscular twitching.
It was reported that a male pt received vaccines on 12/11/97. Reportedly, on 9/11/99, a nasopharyngeal swab culture was done and was positive for Bordetella Pertussis.
This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 21-APR-2017, the patient was vaccinated with VARIVAX lot number M024683, expiration date 18-MAY-2018 (dose and route were not reported) for prophylaxis, instead ZOSTAVAX due to human error. No adverse effects were reported. Additional information has been requested.
I had an influenza shot, although I am unsure what type. I had a healthy birth, but now have chronic burning pain in my elbow up to that shoulder. Some days it is debilitating.
Patient given first dose of COVID vaccine today. Patient was well after vaccine and when walking out she felt dizzy. She sat down at a nearby bench. She had no LOC. She has no PMH, no medications. On exam BP 120/80, RR 16, HR 100 Oxygen 98%, Exam Patient appeared flushed and sweaty, she was alert and oriented, Heart: RRR, S1 and S2 normal, no murmur, Lung: clear bilaterally. Patient was given water and a snack. She had not eaten breakfast this morning. Patient also said she felt nervous about getting the vaccine. Patient monitored, patient improved. Patient went home with family that was here to get vaccinated as well.
Pt contacted our office with sore arm and vomiting 10/16. She declined offer of appt but went to ER that night. Admitted with presumed cellulitis. Treated with abx.
bloody tissue; very thirsty; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TISSUE RUPTURE (bloody tissue), THIRST (very thirsty) and VACCINATION SITE PAIN (pain at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M(N)20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TISSUE RUPTURE (bloody tissue), THIRST (very thirsty) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, TISSUE RUPTURE (bloody tissue), THIRST (very thirsty) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Nexium. Treatment details was not provided.
Pt states early morning 4/27, had pain, some swelling, elevated temp (not taken) and chills next 3 days, the L upper arm began itching with more swelling and moderate to severe pain. The site continued. (over)
On 09/19/20 woke up with severe arm pain. Persisted entire day. Next morning noticed that large (2-3" diameter) welt near injection site. Warm to touch and very painful. Dr. recommended  Benadryl and Advil and ordered allergy panel (blood drawn 9/21). Today welt is gone, but still tender.
joint pain gradual onset on knee-ongoing;wrist pain (sharp) p/vax;serious lung & sinus infect;required periods of long ATB tx;tired;pt exp myocongestion;low grade fever, h/a since 6/99;pt had systemic rxn;
When pt moves arm in backwards swinging motion, pt feels as though there is a needle in his arm. Not sore when he moves his arm in any other direction.
Muscle Pain; Fever 101.4F after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Pain) and PYREXIA (Fever 101.4F after 2nd booster) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced MYALGIA (Muscle Pain) and PYREXIA (Fever 101.4F after 2nd booster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 13-Apr-2022, MYALGIA (Muscle Pain) and PYREXIA (Fever 101.4F after 2nd booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2022, Body temperature: 101.4 (High) Fever (101.4 F).         The consumer confirmed that she did not had any side effects from previous 3 shots (2 primary and one booster). No concomitant medication reported.
This case was reported by a physician to a sales representative and described the occurrence of a false positive laboratory results for human immunodeficiency virus (HIV) in a patient who received hepatitis B vaccine recombinant (Engerix-B).  On an unspecified dates, the patient received the Engerix-B series.  At an unknown time following administration of Engerix-b, results of an HIV test were "false positive".
Burning rash neck & upper shoulders. Reaction lasted one week & was asked to see an allergist. Pt took BENADRYL & Famotidine & was asked to see an MD for steroid Rx.
On October 12, 2022 I started having pain in the upper part of my stomach that has not gone away. I have gone to see my doctor but he cannot figure out what is going on. Doctor scheduled a test in December 2022 for me to do.
have a red ring about where               have a red ring around the area where I received the shot, size of area is 10 inched by6 inches being  treated for cellulitis,but was told to report
Constipation beginning the day after the vaccine. Ongoing constipation problems for months following the vaccine. No prior history of constipation - regular bowels movements since childhood and never needed OTC constipation medication
Pt is a 4 year old with a history of single ventricle status post repair. He is currently on treatment with Lasix, Lisinopril 5mg, and baby aspirin and is heart function has been well compensated. He never had allergic symptoms, such as eczema, asthma or urticaria until he went to his doctor for the 4 year check up on the 11/29/04. At that time he was vaccinated with DTP, hep B and MMR and about 10 minutes after the injection he manifested difficulties in breathing, vomiting, flushing, itchy rash from the waist to his face and lost of consciousness. The family hadn't left the building yet, so pt was taken back to the pediatrician's office immediately. He was administered, after talking with his cardiologist, epinephrine, steroids, oxygen and antihistamine. He regained consciousness quickly, and he was sent home after 1 hour without admission or observation in a hospital setting. Since then he has had no further anaphylactic episodes and he has been doing fine. He is not currently following any diet and regularly eats peanuts. He doesn't like shellfish, and mom is not sure that he has been exposed to treenuts. Prior to the office visit he didn't eat any unusual foods or candy neither did he take any unusual medicine or NSAIDs. Lives with parents and 3 older healthy siblings in a 40 year old house with some wall to wall carpeting. Nobody smokes and the family doesn't own a pet. No family history of allergies. Today he was in good general condition, his weight was 15.2kg and his height 100.7cm. The skin was clear. The HEENT exam was unremarkable. The lungs were clear to auscultation. The abdomen was nondistended, nontender. The cardiovascular exam was within normal the limits. The rest of the physical exam was normal. We reviewed the ingredient of the single vaccines: DTaP vial stopper contains natural latex rubber IPV contains calf serum protein, neomycin, streptomycin, and polymyxin B, MMRII contains neomycin 25mcg, gelatin, human albumin, and bovine serum; produced in chick embryo cell culture. In order to assess his possible allergy to gelatin, latex and treenuts (in the event of unk exposure to nuts), we performed a RAST that showed only a class II sensitivity to bovine gelatin (1.30 NV <0.35 ku/l) porcine gelatine (2.41 nv<0.35). Assessment: Pt had an anaphylactic reaction 10 minutes after the administration of IPV, DTaP and MMR vaccine. Given the time correlation and the absence of exposure to other possible cause of anaphylaxis (food or medicine), we think that one of the vaccines administered caused the reaction. The most likely cause of anaphylaxis is probably the gelatin contained in the MMR vaccine. However we can not completely exclude that allergy to latex was the trigger to his reaction. He never had reaction to latex before, but parents has always tried to keep away from latex.
sore arm; Achy; Fever  99.4-101.4; chills; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (Achy), PYREXIA (Fever  99.4-101.4), CHILLS (chills) and ARTHRALGIA (joint pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (Achy), PYREXIA (Fever  99.4-101.4), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (Achy), PYREXIA (Fever  99.4-101.4), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 99.4-101.4 (abnormal) 99.4-101.4.         No concomitant medications provided.    This case was linked to MOD-2021-089180 (Patient Link).
vomiting starting 5 days p/vax & lasting 2+ weeks (sometimes up to 3X per day);runny nose for 1wk (lasted 1+ wk);diarrhea 3 days p/inj (lasted 2 days;fussiness;
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Seasonal Influenza vaccine. Co-suspect products included VENTOLIN Hfa inhaler for chronic bronchitis and pneumonia. Concurrent medical conditions included chronic bronchitis and pneumonia. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose and VENTOLIN Hfa (inhaled) at an unknown dose and frequency. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine and not applicable after starting VENTOLIN Hfa, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria hospitalization). VENTOLIN Hfa was continued with no change. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Seasonal Influenza vaccine. The reporter considered the influenza to be unrelated to VENTOLIN Hfa. Additional details were provided as follows: The patient experienced flu when she was at home. The patient reported that she was hospitalized in January 2016 and then sent to a rehabilitation center for a month. The patient did not related VENTOLIN HFA to the adverse event experienced by her. This case was considered as suspected vaccination failure since the time to onset for the event and the lab test confirmation for the strain was unknown.
Areas became red, felt warm and hard to the touch.  Very itchy (and still itching 3 days later).  Also initially noticed red streaks down her arms.
VACCINE KILLED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 (Dose series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered 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 patient died from an unknown cause of death after vaccination. It was unknown if an autopsy was performed. The consumer reported as "Your vaccine killed my friend". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause of death on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20211245706- COVID-19 VACCINE AD26.COV2.S- vaccine killed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
ASIA Syndrome with neurologic autoimmunity, cognitive changes, fatigue and acute inflammatory disorder
Aches; Chills; Fever; Headache; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Dec2021 10:00 (Lot number: FF8839) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT, administration date 21Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Mar2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Mar2021, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 10:00, outcome "unknown", described as "Dose number=3"; PAIN (non-serious) with onset 02Dec2021 20:00, outcome "recovered" (03Dec2021), described as "Aches"; CHILLS (non-serious) with onset 02Dec2021 20:00, outcome "recovered" (03Dec2021), described as "Chills"; PYREXIA (non-serious) with onset 02Dec2021 20:00, outcome "recovered" (03Dec2021), described as "Fever"; HEADACHE (non-serious) with onset 02Dec2021 20:00, outcome "recovered" (03Dec2021), described as "Headache". Therapeutic measures were taken as a result of pain, chills, pyrexia, headache.  Additional information: The patient reported aches, chills, fever, headache that lasted all through the night and into the morning until about noon. The patient was treated with Aleve 220 mg / two tabs taken three times. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had received other vaccine in 4 weeks. Patient had no known allergies. No follow-up attempts are possible. No further information is expected.