chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore in the arm; one of them received only the adjuvant of Shingrix; received only the adjuvant of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) and (batch number 453s4, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd August 2019).   On 31st January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 31st January 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: A couple was administered with the 2nd dose of Shingrix but one of them received only the adjuvant of Shingrix, which led to preparation of medication and inappropriate dose of vaccine administered. The patient experienced sore in the arm after the 2nd dose of Shingrix. The reporter consented to follow up. This case has been linked to US2020019073 (wife's case), reported by the same reporter.
19 yo male received Moderna vaccine 1 month ago, Has felt progressively unwell with multiple near syncopal episodes since vaccination.  today patient had syncopal episode and was found to have cardiomyopathy/myocarditis and a decreased ejection fraction by cardiac echo, dilated RV and global hypokinesis
BLACK AND BLUE ARM IN VACCINE INJECTION SITE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included strawberry allergy/peach allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0424214, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced black and blue arm in vaccine injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black and blue arm in vaccine injection site on APR-2021. This report was non-serious.
Administered expired Moderna COVID 19 vaccine to 6 patients this morning; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 vaccine to 6 patients this morning) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 vaccine to 6 patients this morning). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 vaccine to 6 patients this morning) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Pt recvd series of 3 Hep-B vax in 1986 (brand unk); does not know if titers were checked in 1986; in 1988 MD recommended that pt receive booster dose p/having blood drawn; titer may have been checked; booster dose recvd in 1988 (brand unk);
ACUTE NON ST ELEVATION MI 2/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt got up to walk out of the room several minutes after vaccine, he fell forward onto carpeted floor striking his right ear. He awoke within 10 seconds. Was lead into room to lay down for about 15 minutes.
Suspected vaccination failure; still had shingles afterwards; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still had shingles afterwards). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 08-NOV-2023 The field representative send via source that the physician requested information on how to treat a patient that completed Shingrix series and still had shingles afterwards. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Patient had injury. Was seen as walking due to no PMo. Received Td booster 12/22/02. States approximately one week later developed joint pain-worse in shoulders but some pain in knees, ankles also muscle pain in groin. No improvement by 1/27/03. Due to new medication ? wanted to see a doctor on that list - gave copy of vaccine at his request to show what doctor he see. To call back with diagnosis - treatment etc.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included fexofenadine hydrochloride (Allegra (Fexofenadine Hydrochloride)) and atorvastatin calcium (Atorvastatin). In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain and shoulder pain. On an unknown date, the patient experienced lymphadenopathy cervical. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the shoulder pain was unknown and the outcome of the lymphadenopathy cervical was not recovered/not resolved. The reporter considered the injection site pain, shoulder pain and lymphadenopathy cervical to be probably related to SHINGRIX. Additional details were provided as follows: The reporter is an Infectious Disease physician and was also the patient. The reporter first said he received the vaccine 5 weeks before the reporting date further describing about 5 weeks before the reporting date sometime in May 2018. The patient received the vaccine in the left deltoid. The left upper arm pain started the day after he received the dose. The left upper arm pain was described to be at the injection site and also generally diffused in the shoulder girdle area. The tender left neck gland in the left lower neck region started about 2 weeks after receiving the first dose. He did not know the exact dosing details but thought it was the standard dose. The reporter indicated time constraints and said he needed to answer a page from the hospital. He was referred to his healthcare professional (HCP) before the call ended, and it was discussed that his HCP might contact the GSK Medical Information team to discuss his inquiry of whether or not he should have the second dose in the series and could his symptom be considered lymphadenitis or not. He described the symptoms as being bothersome but not disabling. It was unknown if he granted permission to be contacted, due to time constraints no further information beyond what was reported. He was not able to provide the specific pharmacy address or phone number. He provided his alternate cell phone number also. This reporter did not at first say he was an HCP. He called on behalf of himself as the patient. He said the address he had first provided was his office address. He did not provide a suite number and said there was no practice name.
Back pain; This is a spontaneous report received from contactable consumer from License Party. Other Case identifier: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-123164 (Bristol-Myers Squibb Company).  This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN in 80-year-old female patient who received apixaban (Eliquis) tablet for an unknown indication. On an unknown date, the patient started Eliquis (Oral), 5 milligram twice a day. On an unknown date, the patient experienced BACK PAIN. The action taken with Eliquis(Oral) was unknown. At the time of the report, BACK PAIN outcome was unknown. For Eliquis(Oral), the reporter did not provide any causality assessments.  Apixaban (ELIQUIS) is under agreement with Bristol-Myers Squibb.  Follow-up (06Jan2022): This is a spontaneous follow-up report received from a contactable nurse from License Party (Bristol-Myers Squibb). Other Case identifier: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-123164 (Bristol-Myers Squibb Company).  This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BACK PAIN in 80-year-old female patient who received apixaban (Eliquis) tablet for an unknown indication. CO-SUSPECT PRODUCTS included COVID-19 Vaccine for COVID-19 immunisation. On an unknown date, the patient started Eliquis (Oral), 5 milligram twice a day and Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced BACK PAIN. The action taken with Eliquis (Oral) was unknown. At the time of the report, BACK PAIN outcome was unknown. For Eliquis (Oral), the reporter considered BACK PAIN to be not related. Most recent follow up information was received from a nurse in response to query incorporated above includes: 06Jan2022: New reporter, co-suspect added, event attribute updated.  Apixaban (ELIQUIS) is under agreement with Bristol-Myers Squibb.
Extremely high heart rate - 140 beats per minute at rest and high blood pressure - ended up in the ER
On 09/02/2021- Aggravated pain in the left chest.  Pain radiating from my chest to my left arm.  Irregular heartbeat sometimes slow, sometimes fast. Tibia joint pain, elbow, knee and wrist and my back and I still have that.  Swelling of my knee, both knees and extreme fatigue that it continues. It has improved a bit. The fatigue is a normal issue when you are feeling pain in your chest. I think it is associated with it.  I did not have any fever. Inflammation and joint pain have not completely subsided. The chest pain although the intensity has infused, I still feel it off and on at twice a week. And the fatigue is still there. When my son's school reopened at the end of August 2021 one of his class friends was diagnosed with COVID-19 and as a precaution we all tested for PCR test-COVID-19 test and the results were negative. None of my family members I interacted had COVID-19 or COVID-19 symptoms. I have not suffered from any COVID-19 symptoms during the whole pandemic.
Case number PHEH2012US003969 is an initial spontaneous report received from a pharmacist on 14 Feb 2012, with a follow up received from pharmacist on 29 Feb 2012. This case refers to a female patient (age not reported). She was vaccinated with MENVEO vaccine (batch number: M11042) intramuscularly on 09 Feb 2012. After vaccination she experienced flu-like symptoms which began 2-3 days before the time of this report. She had been feeling weak since the symptoms began. The outcome was not reported at the time of this report. The reporter stated that a direct causal relationship could not be determined since it was at the peak of the flu-season when everyone around seemed to have the flu. However a relationship between the flu-like symptoms and MENVEO could not be denied since the symptoms developed shortly after the patient received the vaccine. No further details are available. Follow up report received on 29 Feb 2012: Updated pharmacist's comment about causality of events.
pt recv vax & pt titers were taken & pt was considered to be equivocal, meaning that they did not necessarily seroconvert, but they were not negative either;
Complaints of shoulder pain after flu shot and couldn't sleep due to pain. Also complained of limited ROM. Rx for Medrol dose pack for relief. Rx for PT 2 times weekly and Bextra for relief. Referred to neurologist; ordered more PT and Prednisone. Thinks its frozen joint. Referred to orthopedist. Giving cortisone injections. Also getting iantophoresis in PT. Thinks shot was given too high.
pt recvd vax w/in 5mins leg became very red, blotchy & warm (hip to knee)-cool compresses applied pt waited 20mins in ofc
Information has been received from a health care professional concerning a 65 year old male patient with no known drug reactions/allergies, cardiac murmur and hyperlipidaemia, who on 15-OCT-2008 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX vaccine (Lot # 660685/0619X). Concomitant therapy included PRINIVIL, Niacin and Aspirin. The health professional reported that the patient on 16-OCT-2008 experienced body aches, fever and slept for a whole day. The patient was at the office for a non-related issue on 06-NOV-2008 and reported his experienced to the office. The patient sought medical attention. ON 17-OCT-2008 the patient recovered. Additional information is not expected.
pt recve vax & had a syncopal or vasovagal episdoe; pt recovered w/o any residual effects; No further details were provided;
Patient had infection at the injection site. Progressively got worse so they ended up going to the emergency room. MD started antibiotic  and will check progress over the next 3 days and decide on further course at that point.
This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 44 year old male patient. The patient had medical history of sulfa allergy. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, three months after vaccination, the patient experienced Bell's palsy. The outcome was not reported. Linked case: 2016059359 (same patient).
Vaccination administered 11/11/09. Reaction noted 11/12/09. Employee noted generalized hives and itching. Sx worsened resulting in tx at ER on 11/14/09.
Information has been received from a licensed practical nurse concerning an 8 week old female with a protein allergy (MPSI") and gastrooesophageal reflux on 09-MAR-2007 was vaccinated PO with the first dose of Rotateq (LOT # 656189/1239F). Additional vaccines administered on the same day included the first dose of Pediarix (Lot# AC21B066AA) IM in right thigh, first dose of hibconjugate, (654677/1124 F) IM in left thigh and first dose of Prevnar (B08681D) IM in the left thigh. There was no illness present at the time of vaccination. On 09-MAR-2007, in the evening the patient developed diarrhea and started vomiting. Prevacid was restarted. On 14-MAR-2007 the patient tested positive for rota stool. The patient was treated with lactinex and recovered on 15-MAR-2007. There was no product quality complaint reported. The licensed practical nurse considered rotavirus to be other important medical event. Additional information has been requested. A copy of the medical record is attached to further document the patient's experience. This is in follow-up to report(s) previously submitted on 4/15/2007. Information has been received from a registered nurse (RN) concerning a 2-month-old female who on 09-MAR-2007 was vaccinated PO with the first dose of ROTATEQ (lot number not provided). Concomitant vaccination administered on that same day included "all the required shots for a 2-month-old." The patient was noted to be asymptomatic on the day of vaccination. The RN reported that, within 24 hours after vaccination, on approximately 10-MAR-2007, the patient developed a fever and diarrhea. On 12-MAR-2007, the patient presented to the office where she tested positive for rotavirus. The RN noted that the patient had been in daycare where Influenza A had been "going around." No further information is available.
Large round (about 10cm in diameter) reddened swollen itchy  wheal at injection site....
With in 24 hours I started to experience a low grade fever, this progressed to a horrendous sore throat and ear ache, and joint and muscle pain.  Now 2 weeks in and it is still taking a toll?
Extreme anxiety since day 3.  Dry sinus since day 2.  Inflamed sinus.  Off and on rapid/hard heartbeat since injection.  Insomnia.  Rapid weight loss.  Dry mouth.  Loss of appetite. Ongoing chills (10 days after shot).  Depression.  Lack of energy.
Short bouts of difficulty breathing during low to mild exertion, without chest pain, beginning about 3 days post vaccination and continuing at a frequency of about one episode per day and lasting for about 2.5 weeks.  No treatment sought at the time of this reporting, and some improvement experienced over time.
Loss if taste about 6 hours after second vaccine; This is a spontaneous report from a contactable consumer (patient). This 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0181) via an unspecified route of administration, administered in right arm on 15Jun2021 13:30 (at the age of 55 years old) as dose 2, single for COVID-19 immunization. The patient medical history included HLRCC, salivary gland cancer, carcinoid tumor and adhesions from an unknown date and unknown if ongoing. The patient had antibiotics, sulpha, walnuts and hazelnuts allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccine in four weeks. The patient concomitant medications included naltrexone, famotidine (PEPCID [FAMOTIDINE]), Allegra (FEXOFENADINE HYDROCHLORIDE), Benadryl (DIPHENHYDRAMINE HYDROCHLORIDE), ibuprofen and vitamin start dates and stop dates were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ew0178) on 25May2021 13:30 on right arm (at the age of 55 years old) as dose 1, single for COVID-19 immunization. On 15Jun2021 at 19:30, the patient experienced loss if taste about 6 hours after second vaccine. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab) which result was negative on 09Mar2021. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
within 5 minutes of receiving the vaccine,  my left arm became numb & weak & resolved by the next day; 1-2 hours later my legs/feet from the knees down became numb/tingling with tightening muscles; 2 hours later left side entire face became numb with puffy left eye lid which lasted for 8 days;  by the 8th day my symptoms began to resolve only to return with 4 days with left face/throat numbness & left side numbness/tingling with tightening forearm muscles both hands/fingers/arms from elbows down & numbness/tingling/muscle tightening in both legs/feet/toes from the knees down  along with pain in both knees which lasted another 2 days;  I continue to have some residual symptoms of numbness on the left side of my face that comes and goes as well as the same symptoms of numbness/muscle tightening and tingling in both legs/feet that comes & goes.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received Rotavirus vaccine (batch number CT44F) for prophylaxis.   On 08-FEB-2023, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patient's age was reported as 0 years. The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
I received my booster Pfizer boost on 03/28/2022, then tested positive for COVID on 06/29/2022. Breakthrough case.
1/4 vaccine 1/12 Woke up, I had noticed red mark on arm. The rash got bigger and spreading. Felt achy.
Audible wheezing; Retractions o2 sat 80% c/o itchy throat about 15 min post Hep A and Tdap; Re with o prednisone XOPENEX and Epipen.
This spontaneous report as received from a pharmacist via a company representative and refers to 2 patients of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # K003599, expiration date: 13-MAR-2015). On an unknown date these patients experienced a little redness at the injection site. The patient was diagnosed (date unspecified) with cellulitis.  The outcome of event was not reported. The reporter considered event to be related to ZOSTAVAX (reported as adverse experiences related to this lot). The reporter wanted a lot check on #K003599. This is one of several reports from the same reporter. Additional information has been requested.
Psoriatic Arthritis; Hand deformity; Polyarticular Juvenile Idiopathic Arthritis Flare-up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4157318.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 2016 (Batch/Lot number: unknown) to 2021, subcutaneous for juvenile idiopathic arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, Route of Administration: Intramuscular), administration date: 01Mar2021, for COVID-19 Vaccination, reaction(s): "COVID-19"; BNT162b2 (Dose: 02, Route of Administration: Intramuscular), administration date: 01Apr2021, for COVID-19 Vaccination, reaction(s): "COVID-19". The following information was reported: JUVENILE IDIOPATHIC ARTHRITIS (medically significant) with onset 2022, outcome "not recovered", described as "Polyarticular Juvenile Idiopathic Arthritis Flare-up"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic Arthritis"; HAND DEFORMITY (non-serious), outcome "not recovered". The action taken for adalimumab was dosage permanently withdrawn in 2021.  Additional information: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Solicited report by a consumer of a female with events of and non-serious Polyarticular Juvenile Idiopathic Arthritis Flare-up, Hand deformity, COVID-19, and Psoriatic Arthritis with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. Pfizer BioNTech COVID-19 vaccine was also considered suspect. Primary reporter did not have the lot number information, because the packaging was discarded.  The causality for the events with Adalimumab Solution for Injection was not provided. The causality for the events with Pfizer BioNTech COVID-19 vaccine was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.