chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness / redness all above the upper arm; there was a little bruise at the site where injected; she has swelling on her upper arm, near the injection site about two inches by 2 inches; a little tired; sore arm; she received the booster dose on Sunday, 26Sep2021; she received the booster dose on Sunday, 26Sep2021; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Sep2021 (Batch/Lot Number: 301358A) (at the age of 70 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 04Feb2021 (Lot: EL9269, Expiration: Unknown) (at the age of 69 years old) via an unspecified route of administration, administered in left arm for Covid-19 immunisation and experienced a little tiredness and soreness in arm. The second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 26Feb2021 (Lot: EN6203, Expiration: Unknown) (at the age 69 years old) via an unspecified route of administration, administered in left arm and experienced a little tired and had little bit like had the flu. The patient also had a second dose of Pneumonia vaccine 2 years ago for immunization and arm became swollen. The patient's concomitant medications were not reported. The patient received the booster dose on Sunday, 26Sep2021 and felt a little tired and had sore arm. On 29Sep2021, the patient experienced she has swelling on her upper arm, near the injection site about two inches by 2 inches. There was also some redness. Redness all above the upper arm and there was a little bruise at the site where injected. She noted that she just started experiencing this today (29Sep2021). She had taken Benadryl to reduce the swelling. The patient recovered from tiredness on 27Sep2021. Outcome of the other events was unknown.    No follow-up attempts are needed. No further information is expected.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient had pneumonia around the time of 02/17/2021, receiving care through medical source. No other notes documenting symptoms. Patient has a PMH significant CAD, HTN, AF, Hyperlipidemia.
patient came at pharmacy at 11/19/19 at 11:13am and he mentioned that his arm is painful when he got shingrix shot at 9/26/16 and he went to doctor office at 11/16/19 and he got pain medicines but he came here to report adverse reaction because his doctor told him
The shot is like flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza like illness (Verbatim: The shot is like flu). The outcome of the influenza like illness was not reported.   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.     It was unknown if the company considered the influenza like illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and stated that the shot is like the flu and it was horrible. Follow-up would not possible as no contact details were available.
100.8 degree fever, shivering followed by hot flash and sweating, dizziness, nausea, chest pain.  Following day had all over body pain and fatigue.
On 11/16, started with chest congestion, non productive cough and low grade temperature of 100.7 F. Taken to ER on 11/23 with shortness of breath and diagnosed with pneumonia. Discharged from ER on Z pack and had 1 nebulizer treatment.  As of 11/30 still with wheezing and seen by doctor who prescribed nebulizer treatments and oral steroid.
Severe chills. Shaking on night of injection date, dizziness and passing out several times the next morning, severe fatigue, right breast and axillary pain persisted until 4/10/21.  Also had hardened itchy lump a few days after injection near injection site with a few red bumps.
Received a Shingles vaccination at 2:30 PM last Friday (06/19/09) and am STILL experiencing headaches today, Tuesday (06/23/09).  I was told at the time of the vaccination I my experience a slight fever (I did NOT) but nothing was mentioned about a possible headache.  The paperwork stated a headache is experienced in 1 out of 70 patients.
Skin around injection site bright red and warm to the touch. Onset within 3 hr of injection w/ redness peaking at 48 hr with a duration of 4 days. No treatment.
Within two (?) to eight hours after the first two doses of the vaccine (AM)- evacuative diarrhea (nothing left to come out); after last two doses of vaccine (AM) - milder diarrhea within two (?) to eight hours of taking the pills.
First symptoms were a rash from head to toe, feet, legs area, it lasts 1 1/2 week and it moved to the lungs which started to get bad, I had trouble breathing, up to this day I am still in oxygen. On 12/26 I was in hospital the diagnosed was COVID pneumonia, but it was incorrect. On Jan 4 oxygen my saturation was very low, pulse was on the 70, admitted to hospital and I was diagnosed with vaccine induced interstitial illness (Jan 6). I was in hospital until the 9th. Came back and had black out and passed out. On Jan 14 I had abdominal pain and vomiting, I had a clout in my Aorta, and the kidney and splint were affected. I was for 8 days in the hospital. On Feb 18, I went back to hospital, my lungs were very bad, difficulty breathing, until the 26. I am at home with short term disability.
I felt very hot (no fever) and was dehydrated due to the heat in my body.  It lasted through the day on Saturday (5/8/21) with a lot of fatigue.  On Sunday (5/9/21) the feeling of being hot disappeared yet the feeling of "mild" fatigue continued.    It was at that time on Sunday (5/9/21) that I noticed my eyes were very red and I had eye muscle pain in the eye socket when I moved my eyes.  It has continued today on Monday (5/10/21).
Punctured vial stored for 20 hours; A patient was administered their first dose of the Moderna COVID-19 vaccine from a vial that had been punctured and stored for 20 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered their first dose of the Moderna COVID-19 vaccine from a vial that had been punctured and stored for 20 hours) and PRODUCT STORAGE ERROR (Punctured vial stored for 20 hours) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered their first dose of the Moderna COVID-19 vaccine from a vial that had been punctured and stored for 20 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial stored for 20 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered their first dose of the Moderna COVID-19 vaccine from a vial that had been punctured and stored for 20 hours) and PRODUCT STORAGE ERROR (Punctured vial stored for 20 hours) had resolved.        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.   No Treatment medications were provided No  Concomitant medications were provided
Had nodules around left ankle; They hurt; They need to get removed; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Had nodules around left ankle), PAIN (They hurt) and MASS EXCISION (They need to get removed) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20a) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced NODULE (Had nodules around left ankle), PAIN (They hurt) and MASS EXCISION (They need to get removed). At the time of the report, NODULE (Had nodules around left ankle), PAIN (They hurt) and MASS EXCISION (They need to get removed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant: Blood pressure meds.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: report contained no new information
HAIR LOSS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair loss was not reported. This report was non-serious. This case, from the same reporter is linked to 20211001154.
I tested positive for COVID on 01/01/2022. After that, I was diagnosed with bronchitis. I went to see a pulmonologist after the bronchitis and he told me to use the inhaler. About two weeks prior to having my stint put in, June 2022, I felt like I was struggling to breathe. I started feeling nauseous and could hardly move. My co-worker called 9-1-1 and the ambulance came. They checked my heartrate, and it was 21BPM. They said that they had to keep bringing me back on the way to the hospital. There was a heart cath. done and there were 2 blockages. One was at 99 percent and one was at 70 percent. They used IVP dye and I had a severe reaction to it. I had to stay in the hospital for a couple of days. I was released and went home. I tried to go back to work, but I was having trouble doing my regular duties. I had to retire early because I was having trouble keeping up. On October 31st, I had feelings throughout the day of feeling like I was cold and having brain freeze like symptoms in my neck. Around 2AM, 11/01/2022, I woke up and realized I was having a heart attack. My husband drove me to the hospital and they had to perform a triple bypass. Since then, I have been taking ELIQUIS, furosemide, ondansetron (for nausea), clopidogrel bisulfate, folic acid, nitroglycerin, metoprolol tartrate, albuterol inhaler and atorvastatin. As of today, I feel that I'm getting better, but I do not have any stamina to do anything. When I am walking or even just going to the grocery store I get exhausted, I feel like everything wants to shut down. Other than that, everything has been good since the surgery.
Nausea severe muscle aches from head to feet waking me up from sleep in middle of night. Stiff feeling very weak next day, sweating but no fever - lasted 3 days - also sore arm where administered.
developed myalgia, neck and knee pain, perioral paresthesia, lower extremity (knee) weakness
Saw a black dot on patient's left arm after administration of Varivax #2 using VanishPoint 5/8" syringe.
Patient developed general pain and fever. On (R) arm site administration developed pain, redness and swelling. Pt is taking APAP and ice for the (R) arm pain.
Patient had fever of 104 approximately 4 hours after vaccine was administered. High fever lasted 48 hours; Tylenol did not reduce fever. Patient now has autism. Follow Up: Mom reports child seemed to scream a lot the day after vaccinations. iN general, he began to experience chronic colds and other minor illnesses, speech delays, tantrums and delay in walking since that time. He was diagnosed at age 3.5 with autism. Records are not available to obtain lot number. Medical Records received on 1/26/2005 states pt is lactose intolerant. Follow up 02/25/05: Patient has a permanent disability- Autism. His language and social abilities are severly impaired. Information from annual follow-up report states: Autism - severely impaired communication, socialization, cognition, sensory intergration disorder.
This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over) and DYSKINESIA (My body moves uncontrollable like someone is moving my body) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over), DYSKINESIA (My body moves uncontrollable like someone is moving my body), FEELING ABNORMAL (I feel like worm are moving around in my stomach and body/ I still feel like something is wrong with my body), BACK PAIN (Feel my back hurts), MIGRAINE (Migraines) and MYALGIA (Muscle aches). At the time of the report, GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over), DYSKINESIA (My body moves uncontrollable like someone is moving my body), FEELING ABNORMAL (I feel like worm are moving around in my stomach and body/ I still feel like something is wrong with my body), BACK PAIN (Feel my back hurts), MIGRAINE (Migraines) and MYALGIA (Muscle aches) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Normal. On an unknown date, SARS-CoV-2 test: (Negative) Negative. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. It was reported that the patient had been experiencing weird symptoms. The patient not had any runny nose symptoms or fevers. It was reported that the patient had migraines when the patient passed the 5g towers on the highways. The patient had been to the hospital and the patient  test results came back normal, but still felt like something was wrong with the patient's body. The patient got denied disability as well. No treatment medication was provided.
VACCINE WAS GIVEN IN ERROR. PT RECEIVED PEDIATRIC VACCINE UNDILUTED
Information has been received from a healthcare worker referring to unknown number of patients (unknown age and gender). The patients were vaccinated with improperly stored PEDVAXHIB (dose, dose #, lot #, route and application site were not reported), since 01-OCT-2015. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
No heart issues prior. On 4/16/21 my Apple Watch notified me that my heart rate had been under 50bpm for 10 minutes. I have had my Apple Watch since 10/2019 with no warnings prior. After checking my watch I saw my EKG reading on 3/14/2021 began showing abnormal readings. Prior to that, I have data back to 10/2019) nothing had been abnormal. I have had heart flutters, racing and pauses ever since 3/14/21. I made an appt. (4/29/2019)with my family dr.  and she ran an EKG and saw the same thing. Stating it was PVC. She prescribed Atorvastatin 20mg and metFormin 500mg. She told me to make an appointment with a referred cardiologist  and I saw him on 5/18/2021. He has diagnosed PVC, Left bundle branch block with an ECG abnormality. He prescribed that I wear a Halter heart monitor for three days. I did that and have just returned that device for reading.
Administered an expired Pentacel to a patient with no reported adverse event; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case from other healthcare professional and a consumer/non-healthcare professional via Medical Information (under reference number 00862209).  This case involves a patient (unknown age and gender) who was administered an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Caller stated she called yesterday because they administered an expired Pentacel to a patient and would like more information. Caller provided a case number that did not populate: 00862739. Perhaps the correct inquiry number is 00861739. The caller states that she doesn't have time to provide additional Adverse event (AE) information but she accepts a call back or paperwork from regulatory authority. This is all the information she provided at the time of her call."  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
patient received ACT-HIB which was reconstituted with expired diluent/no adverse event; Initial information regarding an unsolicited valid non-serious case was received on 06-Apr-2021 from a health care professional (medical assistant) (Reference number- 00550125) and transmitted to Sanofi on 07-Apr-2021.  This case involves a 6 month-old male patient who was vaccinated with 0.5 mL HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with expired diluent (batch number UJ143AA; expiry date 03-May-2021 and expiry date of diluent 22-Mar-2021) via an unknown route at an unknown administration site on 07-Apr-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was also reported that "MA(medical assistant) also asked if all of the Act-HIB vaccines they had in that box with the expired diluent would also be considered not viable. MA confirmed that the Act-HIB and diluent were from the same brand new box, and vial used was the first vial taken from the box. MA was requesting letter stating different expiration dates should be expected for the Act-HIB and the diluent. MA suddenly had to go saying they had patients in the middle of the call. Attempted to call back MA for AE(adverse event) information but the front desk stated that she was still assisting patients and just asked a number she can call back". Additional description of event Adverse events: "MA explained that the expiration date for the Act-HIB itself and the diluent were different. The expiration date for Act-HIB in the vial was 03-May-2021 and the expiration date for diluent was 22-Mar-2021. Initial Response: It was discussed with MA that it was not atypical for the expiration dates to differ. It was discussed, dose administered was not considered valid as Act-HIB was reconstituted with expired diluent. MA also asked if having the expired diluent means all Act-HIB vaccines in the same box were no longer viable for use and use of alternate diluent was discussed. MA requested to her information that it was not atypical for the expirations to differ".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event information was obtained from the consumer who received the vaccine.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Patient received the second dose of SHINGRIX on 8/16/18. She called on 9/14/18 stating that she experienced pain in the injection site (left arm) following the injection until now. The pain has not gotten any better, and she has not tried any pain medications. There were no redness or swelling reported. She also stated that she felt the needle went in twice. The syringe used had auto retracts after the shot is given. Pharmacist does not recall double poking any of her patients so is unsure what was the sensation the patient felt. Pharmacist contacted the company's patient care pharmacist right after the phone call with employee and was advised to advise patient to see a doctor in case of any infection. The patient states she will see her primary care provider.
Case number PHEH2013US015037 is an initial spontaneous report received from a nurse on 12 Jul 2013, and with a follow up report received on 06 Aug 2013. This report refers to an 18-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with an intramuscular dose of MenCYW-135 liquid  conjugate component of MENVEO (batch number: M12094) without being reconstituted with MenA lyophilized conjugate on 12 Jul 2013. No adverse events were reported following the maladministration. Follow up report received on 06 Aug 2013. Updated batch number.
Giving 2nd  dose Pfizer vaccine and patient threw up after 5 minutes of giving 2nd dose Pfizer