chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness immediately after the vaccine; severe joint pain; tinnitus; I could barely walk; My bones started hurting me a lot and they still hurting me today; got like tired; shortness of breath; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EW0158) via an unspecified route of administration on 02May2021 as single dose for covid-19 immunization. The patient's medical history included covid-19 from an unknown date in Jan2021 to an unknown date. She was am recovering from severe Covid she had in January and was hospitalized so she would say that's the main thing. Concomitant medications included albuterol [salbutamol] (ALBUTEROL). On an unspecified date in May2021, the patient experienced dizziness immediately after the vaccine together with severe joint pain and also tinnitus. She got the first dose of vaccine on 02May2021 and she was scheduled on 23May2021 for the second dose. It was confirmed that the patient administered Pfizer Covid-19 Vaccine. On an unspecified date in May2021, the patient stated well she had dizziness immediately then and after she could barely walk and then after she don't know for how long but her bones started hurting her a lot and they still hurting her today and her ear started ringing. The patient also got like tired and had more shortness of breath on an unspecified date in May2021 than usual but that went away. The patient was seeking for an advice whether she should take the second one or not. The patient did not receive any treatment for the adverse events experience by her. The outcome of the events my bones started hurting me a lot and they still hurting me today was not recovered, got like tired and shortness of breath was recovered on an unspecified date in May2021 while, the outcome of remaining events was unknown.  Follow-up attempts are needed. Additional information has been requested.
None. Called parent and pt is doing well. Received vaccines in error - not needed at this visit. Vaccines already given at previous visit.
Fever, weakness, fatigue, body pain, so much so that I was bed-bound for about two days. Recovered with rest and just waiting for it to pass. Additionally, I had a rash near the vaccine site that grew to a size roughly larger than a quarter. The rash began about 1 week after vaccination. The rash was red, hot, raised, and itchy. The rash lasted for about a week.
This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a 70-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 29th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX and less than a year after receiving SHINGRIX, the patient experienced generalized muscle aches, weakness, tiredness, tingling sensation, sleepiness, difficulty sleeping, generalized joint pain, hand swelling, swelling, hot flashes, stomach pain, difficulty breathing, injection site pain, headache, thinking slow and condition aggravated. On an unknown date, the outcome of the generalized muscle aches, weakness, tiredness, tingling sensation, sleepiness, difficulty sleeping, generalized joint pain, hand swelling, swelling, hot flashes, stomach pain, difficulty breathing, headache, thinking slow and condition aggravated were unknown and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the generalized muscle aches, weakness, tiredness, tingling sensation, sleepiness, difficulty sleeping, generalized joint pain, hand swelling, swelling, hot flashes, stomach pain, difficulty breathing, injection site pain, headache, thinking slow and condition aggravated to be related to SHINGRIX. It was unknown if the reporter considered the generalized muscle aches, weakness, tiredness, tingling sensation, sleepiness, difficulty sleeping, generalized joint pain, hand swelling, swelling, hot flashes, stomach pain, difficulty breathing, headache, thinking slow and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st and 2nd dose of SHINGRIX in the left arm. The patient stated that less than a year after the 1st dose of SHINGRIX, she experienced muscle pain all over the body, headache, weakness, tiredness, tingling in the muscle, sleepiness, fogginess in thinking, joint pain all over the body, swelling of hands and body, hot flashes all day and night, stomach pain and difficulty breathing. The patient was also having trouble laying on the back and sides. After the second shot of the SHINGRIX all the symptoms experienced previously with the first dose had gotten worse. The patient also experienced pain at the injection site with the 2nd dose of SHINGRIX, which lasted for total of 5 days. The patient visited her doctor after the second shot of the vaccine and was then referred to an orthopedic and neuro-surgeon. She had MRI for the lumbar region, along with right side hip and knee. She also went through x ray for lumbar spine and right side knee. All results were negative. The patient was currently undergoing physical therapy. The patient was referred to her health care provider. The patient gave permission to contact her healthcare provider and provided his contact details. No further details were provided.
Pharmacist gave vaccine to 9 patients which looks like the lots were expired/ Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired/ Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired/ Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired/ Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired/ Expired vaccine used).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that there were no specific dates when administration occurred, but they had the lot number, and it was before 13-Jul-2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. All vials were 5mL adult bivalent Moderna COVID-19 vaccine. The patients were fine. It was unknown when the vial was initially stored in the refrigerator. The vial did not underwent any temperature excursions. Unable to confirm what the date of first thaw was.  Dosage text for suspect product was reported as unknown.  No concomitant medications were provided. No treatment medication was provided.  This case contains information about patient 5th out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2023: Follow up received, age group updated, event verbatim added  and I narrative have been updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
This spontaneous report via field representative refers to a female patient of unknown age who is also a pharmacist (reporter). On 26-AUG-2013 the patient was vaccinated with ZOSTAVAX vial in the right arm for vaccination by her husband, also a pharmacist. Dose, lot and expiry date were not reported. Concomitant therapies included influenza (manufacturer unknown) administered in opposite arm. Post vaccination, on the same day, the patient developed pain and redness at the injection site, which cascaded down her right arm to below her right elbow. No rash was reported. The patient was fine at the time of report. The outcome of events was reported as recovered/resolved. No treatment was given for events. Additional information has been requested.
Dizziness right after and felt a numb feeling - felt like he could not hear - sweaty .  Feeling better now - was initially very hypotensive but better after laying down.  Feeling better now after sitting again
Her left upper eyelid become droopy and cannot open fully..it lasted for about 5 days.  A warm compress was applied to the eye.
This spontaneous report was received from a currently 62-year-old male patient reporting on himself. The patient was thyroid cancer survivor with allergy to regional anesthesia. On 12-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for shingles prevention (dose, lot # and expiration date were not reported). Concomitant therapies included mirtazapine (manufacturer unknown), alprazolam and hydrogen peroxide. On an unknown dates, the patient experienced severe gum pain with inflammation, sore throat, crust illusion in his right ear, hearing loss also in the right ear, changing in the hearing in his left ear, and he was also starting to go deaf. The symptoms occurred at different unspecified time. The patient contacted his physician and would meet with her on the reporting day. The patient received unspecified treatment for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The patient considered the events to be related to ZOSTAVAX as he reported the events as adverse events for ZOSTAVAX. Upon internal review the event of deafness was determined to be medically significant. Additional information has been requested.
local rxn of induration enlarging daily sicne administration of vax;10JUN97 the area measured 9" x 3" extending down the lt arm fromt he shoulder;warm to touch;
Information has been received from a physician concerning three female patients who were vaccinated with Gardasil. Subsequently the patients passed out after receiving the vaccine. Subsequently, the patients recovered from passing out. Additional information has been requested.
Vaccine administered that went under temperature excursion; Vaccine administered that went under temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     The patient was not sick or had no fever on the day of vaccination. The patient did not have an allergic reaction to polysorbate, polyethylene glycol or a previous dose of COVID-19 vaccine. The patient did not have a serious allergic reaction (anaphylaxis) to another vaccine or any injectable medication, foods, venom, environmental oral medications. The patient had no bleeding disorder and was not on long term aspirin therapy or did not took other blood thinners. The patient did not have Guillian-Barre syndrome (a type of temporary severe weakness) after receiving the vaccine. The patient did not receive any dermal fillers. The patient had no history of blood clots or risk factors for developing blood clots,  myocarditis or pericarditis, heparin induced thrombocytopenia (HIT) and multisystem inflammatory syndrome. The patient was not immunocompromised.     On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received booster dose.  Date and time vial was first punctured was on 15-Jun-2022 at 9.15 AM, the vial undergo temperature excursions of plus 1.9 degrees C to plus 6.4 degrees C for 15 mins.   Storage condition at the time of the excursion was Refrigerator.  Vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022. The proposed desired use by date provided was on the afternoon of 15-Jun-2022  No treatment medications were reported.
She feels that vaccine had done permanent damage to her heart; constantly dizzy; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (She feels that vaccine had done permanent damage to her heart) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE/SALMETEROL) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). On an unknown date, the patient experienced HEART INJURY (She feels that vaccine had done permanent damage to her heart) (seriousness criterion medically significant) and DIZZINESS (constantly dizzy). At the time of the report, HEART INJURY (She feels that vaccine had done permanent damage to her heart), DYSPNOEA (shortness of breath) and DIZZINESS (constantly dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Blood pressure measurement: 177/107 mmhg (abnormal) blood pressure increased. On 08-May-2021, Troponin: increased (abnormal) troponin level raised.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment given with Prednisone tablets for 5 days and Doxycycline.  Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: added with new event information and reporter details; Sender's Comments: Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product.
Vaccine administered 1/26/2015. Discussed events with patient on 3/16/2015 following inquiry about whether to get a second dose of MMR. Patient recovered at the time of report. On 1/27/15, following 1/26/2015, patient reported having very sore arms, high fever and chills; unable to go to work for 3 days due to symptoms. Also reported fatigue, lack of appetite. Improvement for 'several days' then experienced onset of extreme fatigue and rash development. "Rash was all over body and very itchy", and "started on chest." Rash resolved after three days. Total course of "not feeling well" approx. two weeks. No doctor visits or assessment of rash at time of symptoms. Wife with previous record of MMR vaccination, reported a small rash following patient rash onset, 3 days later.
flu-like sx, aches in all bones & joints, fever, nausea, dizziness;
Info has been received from a woman in a doctor's office concerning a 56 year old female who on 05/14/2002 (also reported as 05/23/2002) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641115/1159L). "The next day", on 05/15/2002, or 05/24/2002, the pt developed local redness, local soreness, and local swelling. Subsequently, the pt recovered. Unspecified medical attention was sought. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also noted that similar experiences occurred with other patients from the same source (WAES #s 0206USA00883 and 0206USA00271). No additional info has been requested.
On 6th day after vaccine, lymph nodes became swollen under right arm which was the injection arm. They have been swollen for 3 days to date.
redness & swelling from rt arm @ inj site to elbow given 16OCT97 reported to office 17OCT97;rx 17OCT97 w/APAP & DPH;22OCT97 pt on atarax & pred taper;
Pt presented with what appeared to be a red rash with small clustered blister-like lesions in the shape of the previously applied bandage.  Site was assessed by SMO and PCM and dermatologist.  Telfa bandage with paper tape was applied to site.  Pt received Benadryl, Claritin and Naproxen for management of localized symptoms, pt denies ALL other symptoms.  Pt f/u in clinic daily for site assessments.
evening p/vax pt felt hot & devel a high pitched cry; pt was upset all nov despite APAP given; pt OK during the next day but 2nd noc developed the cry & could not be comforted; pt instructed to call PMD;
Was giving injection in left deltoid and syringe came off and leaked some down arm . Sticker was close to needle and safety guard.  Part of the dose leaked out during the injection.  Patient received a partial dose of vaccine.
administration of Pediarix after expiration data; This case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd September 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd September 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported Health care professional reported administration of Pediarix after expiration date, which led to expired vaccine used.  Pediarix was expired by a few months. Non-symptomatic or clinical manifestations present with patient. The reporter consented to follow up.
Information has been from a health professional referring to a 6 month old female patient. On 24-JUL-2015 10:00 AM, the patient vaccinated with oral, ROTATEQ (dose 3, lot number K012457 is an invalid lot number for rotavirus vaccine, however, it is valid for Hepatitis A Vaccine, Inactivated, dose unknown) orally, which was exposed to temperatures outside of the recommended range. Concomitant therapies included PEDIARIX. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because requested follow up information has already been received.
Pt claims he received influenza vaccine at outside hospital 11/23. 11/25 he noted leg weakness and could not walk without assisstance.  He was admitted 11/27 with leg weakness, hand, feet and mouth numb, and difficulty swallowing.  Pt also developed respiratory failure.  Guillain Barre was diagnosed per EMG and nerve conduction studies and pt hospitalized 11/27/07-1/22/08. Pt transferred to outside rehabilitation facility. 2/20/08-records received for DOS 11/27/07-01/22/08-DC DX: Guillain Barre syndrome. Respiratory failure, ventilator associated pneumonia, ARDS. Atrial fibrillation with RVR. Acute renal failure. C-difficule diarrhea. Citrobacter UTI. Anemia. Bilateral lower extremity DVTs. Mild to moderate mixed hearing loss. Type two diabetes mellitus. Stage two decubitus ulcer. Neuropathic pain. Right middle lobe abscess. Two days after vaccination developed progressive bilateral lower extremity and bilateral upper extremity weakness and dificulty standing. Previous exploratory laparotomy for small bowel obstruction 11/07. Trached. Transferred to rehabilitation facility.
vesicular rash occurring on right upper arm, not at the injection site. small groups of nodular bumps that are now occurring on my right hand, left arm, back, and neck. they do itch but are not painful. they do not appear to be fluid filled. appeared about 3 days after initial vaccine.
Started feeling nauseated around 4:00 PM and increased fatigue.  Vomited a total of 3 times starting at 5:00 PM.  No chills or fever noted.  Recovered fully by next day.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 04-APR-2015, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # were not reported). On 14-DEC-2015, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot # were not reported) and on 15-FEB-2016 with the third dose of GARDASIL (dose, route and lot # were not reported), what was off-schedule. There were no symptoms reported. Additional information has been requested.
Swelling, redness and pain for 1 week. Patient reported to pharmacy upon administration of second dose on 09/09/2019.
FATIGUE/TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. 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: UNKNOWN) dose was not reported, administered on 25-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 25-APR-2021, the subject experienced fatigue/tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue/tiredness on 26-APR-2021. This report was non-serious.
Employee reported not feeling well about 60-90 minutes after having TB skin test and Hepatitis B vaccine administered. Skin pale and flushed, complained of weakness, jaw tightness, tingling of extremities, dizziness, respiratory restriction. Employee noted to be hyperventilatory, cool compresses given, allowed to rest, vital signs monitored. Symptoms resolved about 30-45 minutes after start. Employee not noted to have hypersensitivity reaction at injection sites. Employee reports small patch of