chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the excursion, some of the vaccines were given to different consumers/no AE; Initial information was received on 12-May-2021 regarding an unsolicited valid non-serious case from a other health professional (MI Inquiry number: 00598570).  This case is linked to case 2021SA161603(CLUSTER).  It was reported that different patients of unknown age and gender received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) after the excursion on an unknown date for prophylactic vaccination (product storage error).  It was a case of actual medication error due to incorrect product storage.  At the time of report, 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 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 available on batch number for this case.
High Fever - 102.0 to 103.5 Extreme body aches Shortness of Breath Headaches - Extreme Rash
18:10- patient vaccinated and at 18:14 patient states that he got a rush feeling to the head, hearing is going out, and shaky. At this time we laid out the yoga mat and transferred patient from chair to mat and immediately elevated his legs. Vital signs at 18:15 SP02 98%, HR 55, BP 100/62, diaphoretic. He couldn't respond for the first 20 seconds, but then said he felt much better and can see and hear fine again. Water bottle provided. At 18:20, vital signs: SP02 99%, HR 65, BP 114/60 RR 16. At this time he states he feels like he can sit on a chair, but we had him sit against the wall on the yoga mat. He stated he could use a snack and small bag of gold fish provided. He requested to sit on a chair, so we slowly stood him up and sat him on a chair. He said he felt "normal again" and we requested to stay an additional 15 minutes after to ensure he did not experience another adverse reaction. 18:30 Vital signs at 18:30, SP02 99%, HR 88, RR 18, BP 118/75. 18:35, patient requested to go home since he feels fine.
On Jan 23 (the 6th day after receiving her COVID vaccine) the patient developed severe nausea and vomiting. She had started a new medication 1 day prior to her symptoms (Jan 22) so assumed it was due to that. She stopped the medication after 2 doses.  Her vomiting continued with only minimal improvement. On Feb 4 she was seen in the office and diagnosed with acute hepatitis. She has already had her vaccines for Hep A and B.
Breakthrough Covid-19 infection; Breakthrough Covid-19 infection; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Nov2021 (Lot number: PAA173696) at the age of 27 years as dose 3 (booster), single, administration date 04Apr2021 (Lot number: ER8729) as dose 2, single and administration date 06Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 15Nov2021, outcome "unknown", described as "booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Breakthrough Covid-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
This spontaneous report was received from a medical assistant referring to a 74 year old patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 14-SEP-2011, the patient was vaccinated with 1 dose of PNEUMOVAX 23 intramuscularly (lot# and frequency were unspecified) for prophylaxis. Then, the patient received a dose of PREVNAR 13 on 05-JUL-2016. The patient then received another dose of PNEUMOVAX 23 intramuscularly, lot# N010105 (expiration date: 15-NOV-2018) for prophylaxis on 16-OCT-2017. No adverse effects were reported.
Neck pain & pain w/ swallowing on 8/19/23 AM went away 8/21/23
This is a spontaneous report from a contactable Nurse reporting for herself. A 65-year-old female patient received PREVNAR 13 at single dose at right upper arm on an unspecified date in 2017 (2 months before this report) at 12:00 pm for immunization, at physician office. The patient stated she had 2 vaccines that day. She did not have any medications, medical history or investigations to add to this report. Sher did not have any vaccines in the previous 4 weeks, any medical history that was relevant or previous reactions. The patient experienced swollen and discolored, half of her arm in Aug2017 with outcome of recovering, tingling feeling in 2 fingers in Aug2017 with outcome of not recovered, skin is rashy and flaking / her skin was rashed in Sep2017 with outcome of recovering, they are still kind of numb feeling on an unspecified date with outcome of unknown. The shot discolored her arm, caused swelling, and her skin was rashed and skin was dark. She did not know when the events started.  She stated that she has pictures. She states that it looks kind of like her arm was burned. She states that her arm is still discolored and flaking. The AEs required a visit to  physician office: at that time there was fluid draining from it. She had to go back to the doctor and who gave her a steroid cream for her arm. She states that the rash and flaking started three weeks after the swelling went down. She had the tingling in two fingers and they are still kind of numb feeling. The swelling was gone. She didn't read in the pamphlet that it was normal.  The Nurse considered events of swollen and discolored, half of her arm, tingling feeling in 2 fingers are serious due to medically significant.  The reporter assessed the events skin is rashy and flaking, swollen and discolored, half of her arm and tingling feeling in 2 fingers related to PREVNAR 13. Sender's Comments: Based on a drug event temporal association,  a causal association between administration of PREVNAR 13 and the onset of "swollen and discolored, half of her arm, tingling feeling in 2 fingers" cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
fever, nausea, and diarrhea and arm pain night one, nausea day 2. since then day3-9 joint pain, tired, restless at night
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Other medication in 2weeks: No. The patient received COVID 19 Treatment of Anti-Viral from 13Jul2022 to 18Jul2022. It was reported that patient had covid again on 23Jul2022 and for which no treatment was received with outcome as not recovered. The patient had no Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After the vaccination there was the typical side effects:  fatigue, fever, pain at injection site.  There was also worsening diarrhea and stomach pain that has not abated as of September 26, 2022.  I have Ulcerative Colitis and this has worsened since taking the vaccine two days ago.
Patient was waiting 15 minutes post vaccination and began coughing. Staff noticed her coughing and asked how she was feeling. She described her throat at closing and difficulty breathing. She was vaccinated at roughly 9:40 am on 4/4/21 and at 9:46 am she reported these symptoms. The staff alerted the pharmacist on duty, and the patient was moved to a private area with a pharmacy technician as the translator. Pharmacy clerk was directed to call 911 at this time. She assessed patients symptom and patient said she had difficulty breathing and felt her throat closing and was coughing continuously. The patient had history of an allergic reaction to bee stings and had used epipens in the past. She felt that her symptoms were similar to what she had experienced in the past. It was determined to use the Epipen. The epipen was administered at roughly 9:50am. Patient was told to remain calm. The fire medic showed up at this point. The pharmacist then got a BP reading (205/193 and pulse of 95). The patient complained of feeling really cold and was visibly shaking. She did say that she was beginning to be able to breathe better. Her husband showed up about 2 minutes later. The paramedics arrived at about 9:55am and took a BP, pulse, and pulse ox reading. She was able to walk with assistance to a gurney and taken to the ambulance where she was transported to the Hospital.
This  all happened after the second shot I felt nothing except a sore arm after the first shot. I immediately felt dizzy and nauseous.  Nausea continued for days--intermittently for 3 weeks.  Severe headache, muscle and joint pains, fatigue.   Very very cold the fist night.  slight fever.  In the morning my nightgown was soaking wet.  Headache persisted for a few days.  Eventually loss of tast but that returned. The only thing that persists is intermittent fatigue and nausea.
Patient is 4 years old and received a vaccine for ages 5-11 year old. Patient waited in room with nurse for 10 minutes and no adverse reactions noted at this time.
92 year-old male with PMHx of vascular dementia, BPH, MDD, sleep disturbance , basal cell carcinoma of neck, osteoarthritis, BLE edema, Guillain-Barre syndrome 30 years prior, s/p COVID positive on 1/11/21 and received IV Bamlanivimab.  Sent to hospital on 2/2/21 for altered mental status, generalized weakness with inability to lift bilateral UE and difficulty moving his BLE.  He was treated for UTI with 7 days of Cefepime for Morganella Morganii.  He was followed by neurology with MRI of the brain and CT of the spine without acute findings.  Lumbar puncture unable to be obtained.  He received 5 day course of  IVIG for presumed Guillain-Barre .  EMG showed generalized sensory motor polyneuropathy both axon loss and demyelinating type severe in degree.  However, he did not recover from his GBS symptoms, was transferred back to the nursing home and died on 2/15/2021.
Headache & Myalgia Narrative:  Emp did not seek any medical help, states that she took Motrin and is now improving.
Information has been received from a certified medical assistant concerning a 14 month old female who on 29-JUN-2005 was vaccinated with a first dose of VARIVAX (Merck) (lot# 648934/0828P) (route and administration site not reported).  On 03-AUG-2005 the patient developed chickenpox.  Subsequently, the patient recovered from chickenpox.  The patient sought medical attention by contacting the office.  Additional information has been requested.
had a sudden severe sugar drop to 38; close to passing out; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: 59267-1000-01), via unknown route of administration on left arm on 05Feb2021, at 17:00 at the age of 73 years old at a single dose for COVID-19 immunization administered at Pharmacy or drug Store. Medical history included hypoglycemia. Concomitant medications included diltiazem, lansoprazole, cimetidine, acarbose and omeprazole (ZOL). Past drug event included allergy to doxycyclene. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient stated, "I have hypoglycaemia", "On 05Feb2021, about 4 hrs after vaccine I had a sudden severe sugar drop to 38. No warning signs like I usually have. Followed normal process of bringing sugar back up with Glucose tablets, boost and protein bar. Was close to passing out and just wanted to make someone aware that this could happen. I did call and talk to the pharmacist about it". The patient assessed the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021.
ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 21 year old female. 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: 211A21A and expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced administered 2.5ml of the vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220129, 20211220146, 20211220152, 20211219681, 20211165041, 20211165041, 20211200723, 20211200752, 20211200769, 20211201046, 20211201228, 20211201963, 20211202193, 20211202207, 20211202246, 20211202250, 20211202371, 20211165041, 20211200675, 20211200717, 20211200723, 20211201082, 20211200994, 20211201168, 20211201179, 20211201286, 20211201304, 20211201351, 20211201392, 20211201443, 20211201450, 20211201963, 20211202161, 20211202193, 20211202199, 20211219871 and 20211220301.
On 8NOV91 redness & welts appeared 5in in diameter around shot area (rt leg); 99.9 fever; On 9NOV91 had welts on arm where TB skin test was given; size of fifty cent piece, around top area only;
Began experiencing  symptoms similar to influenza in the early morning hours of May19th, 2021. Both chills and systemic warm body temp (felt hot) as day progressed.  Sweated, headache, nausea and general overall malaise.  Did not take temp but suspect fever.  Symptoms subsided by following day (May 20th, 2021).
This spontaneous report as received from a female approximately 34 years old patient with schizophrenia and no allergies refers to herself. On 01-JAN-2013 the patient was vaccinated with one dose of RECOMBIVAX INJECTION 10 (dose and lot # was not reported). Concomitant therapies included SAPHRIS. The patient had tested positive for HEPATITIS B after the administration of RECOMBIVAX. The patient also stated she was not feeling well and was not recovered because she was still testing positive for HEPATITIS B. The patient saw the doctor. The treatment was not given for AE. No lab diagnostics was performed. Additional information has been requested.
acthib vaccine was administered that was later noted to have expired 4 days previously with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves 18 months old male patient to whom HIB (PRP/T) VACCINE [ACT-HIB] was administered that was later noted to have expired 4 days previously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) and Hepatitis A Vaccine (Hepatitis A) both for Immunisation.  On 28-Oct-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml once(lot UJ588AA, expiry date: 24-Oct-2022, expired 4 days previously) via intramuscular route in unknown administration site for immunization.  On 28-Oct-2022 the acthib vaccine was administered that was later noted to have expired 4 days previously with no reported adverse event (expired product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown.   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.
This is a spontaneous report from a non-contactable physician communicated to a Pfizer sales representative. An elderly female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on unknown date. Medical history included that the patient was very sick. Concomitant medications were not reported. Very very very old patient received PREVNAR 13 and the next day, she passed away on an unspecified date. It was not reported if an autopsy was performed. Physician causality assessment: 100% sure that the PREVNAR 13 had nothing to do with the patient's passing. No follow-up attempts possible. No further information expected.
both of his arms right at the biceps are hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (both of his arms right at the biceps are hurting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dislocated shoulder (30 years ago.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (both of his arms right at the biceps are hurting). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (both of his arms right at the biceps are hurting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient stated that the pain was intermittent from 2 to 10 out of 10 and the pain was different everyday.
Severe fatigue/ tiredness; MYALGIAS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jun-2021 and was forwarded to Moderna on 12-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe fatigue/ tiredness) and MYALGIA (MYALGIAS) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021 at 8:00 AM, the patient experienced FATIGUE (Severe fatigue/ tiredness) and MYALGIA (MYALGIAS). On 12-Feb-2021, FATIGUE (Severe fatigue/ tiredness) and MYALGIA (MYALGIAS) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.     No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-019475 (Patient Link).
I was very tired in the mornings even after sleeping all night, waking with a dry mouth, snoring, not feeling very rested. I went to my doctor letting him know I suspected that I had sleep apnea. I was sent for sleep study test on the 22nd of November 2022. It was determined that I did have sleep apnea. I have a dental appliance that has made a huge difference in how I am sleeping, I am waking more well rested, no more snoring.
Information has been received from a woman in a physician's office concerning a 58 year old Caicasian male pt with hyperlipidemia and coronary artery disease and no known allergies and a history of asbestos exposure who on 10/18/2001 was vaccinated in the right arm with a second dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccinations on 10/18/01 included a second dose in the right arm of Fluvirin. Other concomitant therapy included atenol, lisinopril, aspirin and hydrochlorothiazide. Subsequently, the patient developed erythema with 3+ edema. The affected area was from the injection site(deltoid)to his wrist, affecting his upper arm and forearm. It was reported that his arm was so bad that he couldn't touch his head. He was started on prednisone over the weekend (on approximately 10/20/20010. The condition was reported to not be resolving so that patient was started on amoxicillian trihydrate (+)Clavulanate potassium 875 mg twice daily for cellulitis. The reporter indicated that she thought the patient was improving because their office had not heard anything further from him. The reporter expressed a concern with the lot since 3 patients received the vaccine and "have had reaction". FOLLOW-UP information from a physician indicated that the patient developed swelling, erythema, pain of right arm from injection site to wrist, with a fever of 101. The patient was treated with antibiotics with resolutiuon of symptoms over approximately 10 days. No further information is availble.