chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). Subsequently the pt experienced a severe local reaction. It was noted that the physician did not feel comfortable using the remaining doses in the vial and would like an investigation into Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Malaise; Headache; joint pain; received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise), HEADACHE (Headache), ARTHRALGIA (joint pain) and EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 041L20A and 037K20A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for Vaccination.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021). On 30-Oct-2021, the patient experienced ARTHRALGIA (joint pain). On 30-Oct-2021 at 8:00 AM, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) had resolved. At the time of the report, MALAISE (Malaise), HEADACHE (Headache) and ARTHRALGIA (joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related. No further causality assessments were provided for ARTHRALGIA (joint pain) and EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021).    No treatment information provided.   This case was linked to MOD-2021-382061 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received- New event added : Joint pain On 09-Nov-2021: Significant follow up appended - updated patient demographics, added concomitant medication VLAURIX and added events. On 09-Nov-2021: Significant Follow up received and Added event.
pain in the arm; soreness in the arm; is also getting the chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), MYALGIA (soreness in the arm) and CHILLS (is also getting the chills) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), MYALGIA (soreness in the arm) and CHILLS (is also getting the chills). At the time of the report, PAIN IN EXTREMITY (pain in the arm), MYALGIA (soreness in the arm) and CHILLS (is also getting the chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by reporter No treatment medication were provided by reporter
Sick; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a patient of unknown age and gender who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's vaccination(s) included Influenza vaccine as prophylactic vaccination. The patient's medical history, past medical treatment(s), concomitant therapy and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from the event.  There will be no information available on batch number for this case.
My husband stated that he did not feel good after the vaccine the next morning, later he went to pick up hay and died on someone's property from the acute coronary syndrome.
This case was reported by a other health professional and described the occurrence of pain in arm in a adult female patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). On 4th September 2014 14:00, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and pain in shoulder. On an unknown date, the outcome of the pain in arm and pain in shoulder were unknown. The reporter considered the pain in arm and pain in shoulder to be probably related to FLUARIX QUADRIVALENT. Additional information received on 06 October 2014: The caller was a nursing student. Her nursing class received FLUARIX QUADRIVALENT vaccine on the same day about a month ago. A few of them experienced side effects subsequent to the vaccine.
Pt came in to Walgreens on 10-5-09 stating her left shoulder joint hurt since receiving the vaccine. It was given on her back left shoulder instead of in the arm muscle per pt. She was going to see her physician the following week.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Apr2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had Paxlovid Treatment from 03Aug2023 to 07Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278910 Same patient, different drug/AE.;
Information has been received from a registered nurse concerning a 75 year old male with diabetes, atrial fibrillation, glaucoma, hypertension and codeine allergy who approximately in November 2006 was vaccinated with Pneumovax 23.  On 27-FEB-2007, the patient was vaccinated, intramuscularly with a 0.5 mL dose of Pneumovax 23, (Lot # 651399/0486F).  Concomitant therapy included COUMADIN, ACTOS, DIOVAN, CARDIZEM, AMARYL, NEURONTIN and PROSCAR.  It was reported that within 24 hours, approximately on 28-FEB-2007, the patient reported that he wasn't "feeling good" and had a cough.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2007. In follow-up it was reported by a health care professional concerning a 75 year old, male, whose reported weight was 230 pounds and whose reported height was 72 inches with diabetes, atrial fibrillation, glaucoma, hypertension and codeine allergy who approximately in November 2006 was vaccinated with PNEUMOVAX vaccine. On 27-FEB-2007, at 10:00 a.m., the patient was vaccinated intramuscularly into the right deltoid muscle with a 0.5 mL dose of PNEUMOVAX vaccine (Lot # 651399/0486F). It was reported that the patient stated that on 05-MAR-2007, he had a heaviness in his chest, no shortness of breath, but described a slight head cold (possibly unrealted). It was reported that the patient did not have any related serious event. The patient went to the physician and reportedly recovered on 15-MAR-2007. It was reported that the patinent's physician informed him that nothing would be done unless the patient had a significant change in health status. Additional information has been requested.
increased blood pressure; A spontaneous report was received from a consumer concerning a 74-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced increased blood pressure.  The patient's medical history included high blood pressure and cholesterol. The concomitant medications reported were unspecified cholesterol medication and blood pressure medication.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 25/Feb/2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 003A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient went to the Emergency Room because of high blood pressure, she was admitted overnight for monitoring but they did not find a cause. She had a follow up appointment next week with her doctor.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of event, increased blood pressure, was unknown.; Reporter's Comments: The event was consistent with increased risk of complications associated with history of high blood pressure confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
Patient had first vaccination on 3/3/21 and developed diffuse body rash on 3/5/21 which again flared after second shot and persists.
Within hours, developed a debilitating headache and nausea. Chills followed, headache continued for 2 days, over the counter pain drugs and hot compress did not help.
The shot was at 8:00, I proactively took an extra strength tylenol because I had adverse reactions with the first shot.  By 2:00 I could not lift my L arm up.  I took another tylenol.  I ate a light dinner and fell deep asleep for about an hour.  I woke up went to bed at 8:15 but could not fall alseep.  at 12:45 I had a HA, My hands and feet were freezing cold and my legs were so hot they were sweating. I had the chills.  I took another tylenol and a sleep aide and finally fell asleep for 4 hrs.  I woke up with a HA and my whole body felt "charged"  like eletricity was going through it.  When I touched my back it was like free nerve endings were charged up (I am a PT and an athlete). This went on most of the day.  The second night I went to bed my hands and feet were tingling.  In the morning I went swimming and while doing my pool exercises I got a severe muscle cramp in my entire L leg (I have never had that and I have been an athlete my whole life) It took about 10 min for me to get out of the water. once I started walking on it subsided.  Presently, I am one wk out, my blood pressure has been all over the place, I am fatgued, I have had a hard time working out, with my muscles feeling awful, my gut hurts!
a practice that i oversee gave a act-hib vaccination after the expiration date with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15-months-old and unknown gender patient who got a HIB (PRP/T) vaccine [ACT-HIB] vaccination after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2023, the patient received unknown expired dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ784AAA; expiry date: 07-Oct-2023) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (same day latency).  Reportedly, A practice that reporter oversee gave a Hib vaccination after the expiration date and reporter was hoping you could tell me if the dose should be repeated or if it will count as valid  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  No additional details.   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.
I had Lymphedema, rashes on my stomach and legs, sore muscles, aching joints, extreme fatigue and lethargy, headaches, diarrhea, and Fever. These symptoms started to develop about 5 days after receiving the vaccine.  They got progressively worse on the 6th and 7th day and then started to get better on the 8th day.
Received the 2nd vaccine 4/15/21 I had fever, muscle aches, chills, fatigue, headache for 2 days. On 5/9/2021 I had a Bell?s palsy episode never had any issue like this before. I did go to my local er expressed my concerns this was a reaction to the vaccine but that was blown off.
Injection site swollen to size of a softball. Red, warm to the touch and increasing in size every day.
Patient suffered 3 TIAs while in ER with son for son's issues, 4 days after receiving his second dose of SHINGRIX. Patient interested to know if there is a connection to having received the vaccine?  Patient spent 3 days in the hospital.
From history and physical on 1/1/22: "patient is a 66 y.o. female with progressive weakness over the past few days. Today she became so weak that she fell and hurt her L knee and her L knee is sore and difficult to flex. She isn't quite sure how she fell. EMS was called and she was found to have hypoxia with oxygen saturations in the 80s. She notes progressive weakness, with cough/congestion/SOA. Denies f/c. Decreased appetite. Has feeding tube, on chronic tube feeds.  She has a history of esophageal motility from radiation for non-Hodgkin's lymphoma AND a history gastric sleeve in 2015 making adequate nutrition problematic and requires TF. " Acute hypoxic respiratory failure Cough/congestion COVID+
about 8 hours after shot I stated getting the chills, I went bed with a an electric blanket to warm up. I got teeth chattering cold and curled up to try to get warm. Then I witnessed electrical waves and thought I was witnessing the booster migrating into my system I did not want to lose the the connection with the waves so I started to count them but they got going to fast.I was able to save the data that I witnessed to download later and anylize it. After a while there was a load pop like a bag of air being popped and the hallucination stopped. The next morning I was lethargic and tired so I slept most of the day. It was about 30 hours before some type of norm returned.
Diagnosed with shingles 4/14/2010 - Vaccinated with VARIVAX 9-9-2008.
administrating a full undiluted vial (purple cap) of the Pfizer-BioNTech COVID-19 vaccine as a single dose; administrating a full undiluted vial (purple cap) of the Pfizer-BioNTech COVID-19 vaccine as a single dose; sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team.  A 26 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Jan2022 (Lot number: 33130BA, Expiration Date: Feb2022) at the age of 26 years as dose 2, 1.8 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 13Jan2022, outcome "unknown" and all described as "administrating a full undiluted vial (purple cap) of the Pfizer-BioNTech COVID-19 vaccine as a single dose"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "sore arm".  Additional information: The patient received a full vial of the vaccine that was undiluted. It was reported that the patient came in for 2nd dose and only reported have a sore arm after the overdose. The pharmacist provided an alternate contact for the weekly check in phone call in case she is not in the store.   Follow-up (16Feb2022): This is a follow up spontaneous report from a contactable consumer. This consumer reported in response to HCP letter sent via telephonic follow-up activity which included that:  Updated field: New reporter added, historical vaccine added, dose number and dosage updated, event sore arm added, and additional information updated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200065429 same reporter, same drug, similar event, different patients.;US-PFIZER INC-202200064592 same reporter, same drug, similar event, different patients.
I95.9 HYPOTENSION 2/15/2023 NAUSEA AND VOMITING I95.9 HYPOTENSION 2/15/2023 ANEMIA DUE TO CKD I95.9 HYPOTENSION 2/15/2023 CELLULITIS
mind was very foggy; Her arm is throbbing; developed cellulitis at the vaccine site; the cellulitis was traveling down her arm; booster; Body ache; High fever/Temperature went up; This is a spontaneous report from a contactable consumer (patient).  A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm right on 12Nov2021 (Batch/Lot Number: FD0809) (age at vaccination 52-year-old) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Medical history included was reported as no. Concomitant medications included tamoxifen and propanol taken for an unspecified indication, start and stop date were not reported. The patient received other vaccines within four weeks prior to the vaccination included Flu shot an unspecified route of administration, on 04Oct2021 (Batch/Lot Number: not reported) (age at vaccination 52-year-old) for immunization. The patient received historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: 3247) as dose 1, experienced body aches, dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: 3247) as dose 2 single for covid-19 immunisation, experienced body aches. The patient had booster on 12Nov2021, body ache, high fever on Nov2021, developed cellulitis at the vaccine site; the cellulitis was traveling down her arm on 16Nov2021, her arm is throbbing, mind was very foggy on an unspecified date. The patient underwent lab tests and procedures which included blood test: everything is fine on 2021 had blood work done, don't know how recent, in September probably, body temperature: went up this evening 102.5 on 14Nov2021. Therapeutic measures included antibiotics were taken as a result of developed cellulitis at the vaccine site; the cellulitis was traveling down her arm, Ibuprofen for body ache and high fever. The outcome of the event developed cellulitis at the vaccine site; the cellulitis was traveling down her arm was recovering, body ache, high fever not recovered, her arm is throbbing, mind was very foggy was unknown.  Follow-up attempts are completed. No further information is expected.
Developed four red spots on forehead and on one cheek- not raised, noted after giving vaccines, No distress, exam normal except noted above baby was given Benadryl, Rash resolved within a few minutes. Observed here for 30 minutes awake no distress or rash at discharge
Pregnancy history in 2016-2017 with normal pregnancy, vaginal delivery. Bleeding early in pregnancy started on 9/27/2021, test were done and determined bleeding was subchorionic Hemorage. bleeding continued on and off.  first OB appt on 11/8/2021 determined a nonviable pregnancy by US. DnC procedure done 11/12/2021
69 Y male, partially vaccinated (Moderna vaccines x 2, no booster), with history of hypertension, type 2 diabetes, CAD with prior MI s/p PCI, chronic hepatitis C cirrhosis, who presented with progressive dyspnea and was admitted for COVID pneumonia (symptom onset 1/2, COVID positive 1/2). He was transferred to the ICU 1/15 for inhaled nitric oxide.    He completed remdesivir (1/11 to 1/15) and steroid taper (ended 1/25). Hospital course complicated by persistent hypoxemic respiratory failure despite broad spectrum antibiotics (vancomycin, meropenem, caspofungin) and continued trial of inhaled nitric oxide, requiring maximal HFNC since transfer to ICU, then subsequently escalated to BIPAP since 1/28.   His respiratory status continued to decline during the day 1/30 despite on BIPAP, with oxygen saturations dropping as low as 68-70%. Given continued progressive clinical decline on maximal non-invasive interventions, goals of care were again re-discussed with patient and family (via video call) at bedside. He firmly indicated he did not want intubation and declined further escalation of care. Decision was made to transition to comfort care. Patient passed at 11 PM on 1/30/2022. Family was present at bedside.   Complications: None   Diagnoses:   Active Hospital Problems   Diagnosis   ? (Principal) CORONAVIRUS COVID-19 PNEUMONIA   ? ACUTE ON CHRONIC RENAL FAILURE   ? NON-ISCHEMIC MYOCARDIAL INJURY   ? HYPERTENSION   ? DIABETES MELLITUS TYPE 2       DM 2 WO RETINOPATHY Noted: 03/31/2016 Resolved.   Primary Procedures: None   Secondary Procedures: None   Consults: None   Condition on Discharge/Discharge Disposition:  Expired
Administered IV instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 47-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 7th January 2023, the patient received Boostrix (intravenous). On 7th January 2023, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: The reporter did not have lot number or expiration date at time of interaction. The reporter did not confirm that it was the vital formulation. The reporter consented to follow-up via postal. Additional supportive information: The patient received a dose of Boostrix via intravenous instead of intramuscular, which led to intramuscular formulation administered by other route.