chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received anthrax series between Dec 2006 and June 2008. Diagnosed with T1DM in August 2009. Presented on 4 August 2009 with weight loss and 1-2 month history of polyuria and polydipsia. At the time of diagnosis, the pt blood glucose level was > 700 and his A1c was 11.8. He was anti-body positive for GAD65 and antibody negative for pancreatic islet cells. Pt is now taking bedtime LANTUS 20units, with NOVOLOG 2-4 units prior to meals, taking 1 unit for every 50 > 150 and 1-2 units per meal. No diabetes-related complications.
having difficulty breathing; chest is heavy; This is a spontaneous report from a contactable consumer (patient). An 82 year old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 29Jan2021 as unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 29Jan2021 approximately one and half hours of vaccination had difficulty breathing, and states chest is heavy. She had concerns and asks what she should do. The outcome of the events is unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pt was 18 weeks pregnant at the time of the vaccine. Second pregnancy. Pt is a physician.  Pregnancy was entirely normal up to that time. On 1/18/2021, she began to have heavy vaginal bleeding probably due to a placental abruption and subsequently delivered  at 18 weeks.  Baby was stillborn. Ultrasound done 1/15/2021 normal.  Lethal event for the fetus.  The patient did well.
fever-temp between 98-102, chills, sweats; MD dx could be a virus so stopped taking VIVOTIF; Spoke to pt again on 17OCT90 & said that MD said might be mono;
Chills; Sickness; I got the soreness/I am achy, the achiness; upset stomach; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 AVCCINE; lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, sickness, got soreness/had achy, the achiness and upset stomach on an unspecified date. The patient just wondering what can she do about it. The outcome of these events was unknown at the time of report.    Information about batch/lot number has been requested.
A report was received from a health care professional on 10/30/03 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 10/29/03. On 10/29/03, a vaccinee under 4 years of age inadvertently received Fluvirin vaccine. The vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/02/04: Further information was received from a health care professional on 01/02/04 indicating that the vaccinee did not experience any adverse reaction. No follow up pending, all information received. See Ref.: PJP200300952.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 2013, the patient was inoculated with the ZOSTAVAX vaccine by a pharmacist and/or physician at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In or around June 2013, the patient was treated for the onset of a vesicular rash, which was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Telephone call to clinic 11/8. Client states at 11:00 PM she experienced nausea and difficulty breathing. Complained of feeling achy all over. Awake off and on all NOC. In AM, continued to complain of achiness; had trouble getting going. Stayed home from work. Had also complained of abdominal pain and syncope in the NOC. Abdominal pain relieved after stool. Had increased pulse at 112/min and decreased BP at 88/58. Had taken a dose of Trazadone at HS (Med is not new). Eating/Drinking FLDS. 11/10/05 Telephone call follow up states felt ok. 11/9 returned to work. Complained of light soreness at injection site. Did not go to doctor. No history of previous injection reactions. Continued to be fine today. Client states I wonder if the Trazadone made me feel this way.
5/10/2021 Patient died.  5/3/2021 Patient is a 91 y.o. female with a history of afib, PE/DVT, hypothyroidism, GERD, htn, colon resection 206 and HTN who presented to the ED with AMS and difficulty breathing. Patient unresponsive in the ED and was intubated for airway protection. CTA chest with extensive acute pulmonary embolism with findings of right heart strain. Patient intubated and sedated, information is obtained from her son, medical staff and medical records. Patient was hospitalized with Covid 2 weeks ago, following discharge she seemed to slowly be improving until Saturday prior to admission Per son was more tired but she had worked with physical therapy and HH on Friday. Sunday she was having difficulty breathing and was brought to the hospital.  4/17/2021 Altered mental status, unspecified altered mental status type; Pneumonia of left lower lobe due to infectious organism; Atrial fibrillation with rapid ventricular response (HCC); Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC); Acute hypoxemic respiratory failure (HCC); Chronic respiratory failure with hypoxia (HCC); Pressure injury of sacral region, stage 3 (HCC); SOB (shortness of breath); Palliative care encounter; Shock (HCC); Chronic atrial fibrillation (HCC); Acute respiratory failure with hypoxia and hypercapnia (HCC)
This medically confirmed report (initial receipt 06-Jan-2014) concerns a 60 year old female patient with a medical history of morphine allergy. On the 01-Nov-2013, the patient received AFLURIA (batch number R53307A) 0.5mL via the intramuscular route. On an unspecified date, the patient developed excruciating pain and numbness in the entire arm in which AFLURIA was injected. These symptoms lasted approximately three days. The patient went to see the pharmacist and reported her symptoms to the pharmacist about two weeks after AFLURIA was administered and at that time she had recovered. On an unspecified date (in December 2013 or January 2014), the patient returned to the pharmacy and stated that the nerve was damaged. Outcome was not reported. The events of pain and numbness in the entire arm were reported as recovered.
hives on trunk of body appeared approx. 20-30 min. after H1N1 flumist was administered/took 25mg Benadryl fastmelts PO and the hives started improving soon after. The father called the childs Dr. who suggested watchful waiting, go to ER if symptoms escalate. List of symptoms to watch for given to parent.For the rest of that night and the next day every tiime the benadryl wore off the hives would reappear-so they gave him benadry till Sunday 11/01/2009-then he was asymptomatic.He never had any respitory symptoms.
This spontaneous report was received from a medical assistant and refers to two unspecified patients of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On 08-JUN-2017, the patients were administered improperly stored doses of VAQTA injection, strength reported as 25/0.5 (units not provided), lot # M047658, expiry date on 25-OCT-2017 (exact dose, dose number and route of administration were not provided). No adverse effect was reported. Administered doses of vaccine experienced a temperature excursion of 78 degrees Fahrenheit or above, which lasted for 200 hours. No previous temperature excursion was reported. The digital data logger was not involved in recording the excursion. Additional information has been requested.
Initial unsolicited report received from a nurse via other company (Pfizer) (Manufacturer Report Number: 2016538687) on 26 January 2017. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of INFLUENZA VACCINE on an unspecified date in 2015 and dose of TRUMENBA (batch number, expiry date, dose in series, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced Guillain Barre Syndrome. Lab data and corrective treatment was not reported. The outcome of the event was not reported. Upon internal review this case was considered as serious due to Important Medical Event: Guillain Barre syndrome. List of documents held by sender: none. Sender's Comments: This case concerns adult patient who received INFLUENZA VACCINE and simultaneously with MEASLES, MUMPS AND RUBELLA VACCINE (LIVE) and MENINGOCOCCAL GROUP B VACCINE developed Guillain Barre syndrome. Time to onset is not provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, reaction to previous vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Information has been received from a licensed practical nurse concerning an 18 year old female student with no pre-existing allergies, birth defects or medical conditions, who was vaccinated with a dose of GARDASIL that was stored as low as 31F.  There was no illness at the time of vaccination.  No symptoms reported.  There was no product quality complaint.  Additional information will be provided if available.  This is one of several reports from the same source.
Information has been received from a physician concerning a male pt with no past medical history or allergies who 6/26/06 was vaccinated SC with a 0.5ml first dose of MMR II/Varicella vaccine (lot 652328/0956R). There was not concomitant medication. Subsequently, on 6/28/06, two days after vaccination, the pt developed a rash and fever. Unspecified medical attention was sought there were no labs performed. At the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested.
Received Pneumovax on 10/17/20.  On 10/19/20, patient reported fever of 101.6, on 10/20/20 patient reported arm was red, hard, warm, and painful to the touch.  Redness, soreness, and warmth began to spread towards elbow and back of arm the next day.  MD diagnosed as cellulitis and prescribed a 7 day course of Bactrim.
This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 60-year-old male patient who received SHINGRIX. The patient's past medical history included herpes virus infection (the patient has a history of herpes flare ups for which he takes VALTREX. Previously administered products included SHINGRIX (1st dose received). Concomitant products included VALTREX. On 21st May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 21st May 2018, less than a day after receiving SHINGRIX, the patient experienced stomach discomfort, influenza-like symptoms, fever, pain in arm and tiredness. On 23rd May 2018, the patient experienced tingling sensation. On an unknown date, the outcome of the tingling sensation was not recovered/not resolved and the outcome of the stomach discomfort, influenza-like symptoms, fever, pain in arm and tiredness were unknown. The reporter consider the tingling sensation to be possibly related to SHINGRIX. The reporter considered the stomach discomfort, influenza-like symptoms, fever, pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient declined to provide address and could not provide demographics for the pharmacy where he received the injection. The patient reported that after the 2nd dose of SHINGRIX he experienced sore arm, tiredness, flu like symptoms, fever, stomach discomfort. The patient reported that today he was feeling tingling like a herpes flare up was about to occur, tingling was above the left knee.
Intense shoulder pain a few hours after getting Pneumovax injection. Made movement of the arm difficult. Severe limitation of range of motion.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 2:16 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were Reported. No Treatments were Reported. Patient had No Adverse Events
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and COVID-19 VACCINE NRVV AD26 for COVID-19 vaccination.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medication information provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient received booster dose of Moderna COVID-19 vaccine.  Action taken was reported as unknown for Humira (Solution for injection in pre-filled pen) (Adalimumab) and action taken was reported as not applicable for COVID-19 VACCINE NRVV AD26.  Reporter causality for Humira (Solution for injection in pre-filled pen) (Adalimumab) was reported as not related and reporter causality for COVID-19 VACCINE NRVV AD26 was reported as Possible.  No treatment medication information provided.
Breakthrough COVID at hospital. Patient is fully vaccinated with booster on 10/8/21. Patient was set to ED from nephrology office for SOB on 1/24/22. The week prior the patient admits to attending a family funeral where six other attendees also ended up COVID+. Patient endorses chest pressure, SOB and dry, hacky cough but denies all other symptoms. Chest XR normal. ED workup included IV steroids, normal Chest XR and routine bloodwork.
Broke out in hives approximately 1 hour 30 minutes after injection. Severe weakness, body aches, fever, and fatigue began approximately 20 hours after injection
Injection side is swollen, red, itchy, burning, and hot. appt set for Friday for PCP
had her first vaccine in January, 2021 / now has COVID; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix (intramuscular). In May 2021, between 3 and 5 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was not recovered/not resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that the patient had her first vaccine and now had COVID. The reporter requested to remain anonymous and did not contribute information. All information was not available. The reporter did not consent to follow up.
9:46 a.m.-vaccine administered and patient had c/o SOB and dizziness. 10:15 a.m.-BP 240/98 10:20 a.m.-BP 229/91 10:25 a.m.-BP 233/98 Sats-97%  EMS assessed patient at 10:40 a.m. Sats-97% BP-238/118 P-55 10:45-EMS transported patient to Hospital.
I was feeling really achy.   I had a hard time breathing.  I had a spikey fever.  I was struggling to breath.  I had flu like symptoms (fever, chills, coughing).  I went to the ER.  They did EKG, chest x-ray, and blood work.  They did a COVID-19 Test, positive result.  The chest x-ray, it shows that my lung was inflamed, fluid, and dark. They diagnosis me with COVID-19 Pneumonia.
Because of the allergies he had and he was not able to take certain vaccination growing up; This spontaneous report as received from a patient's mother via Pfizer Inc. (Manufacturer Report Number: 202200365669) refers to a male patient of unknown age.  Concurrent conditions, medical history and concomitant medications were not reported.  Because of the allergies he had, the patient was not able to take certain vaccination growing up: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot number, expiration date, dose and route of administration not provided); diphtheria vaccine toxoid, hib vaccine, pertussis vaccine, tetanus vaccine toxoid (HIB DPT) (lot number, expiration date, dose and route of administration not provided) and COVID-19 vaccine (lot number, expiration date, dose and route of administration not provided). The outcome of allergy to vaccine was unknown.   The reporter considered allergy to vaccine to be related to the vaccines.
I received the following adverse reactions from the Pfizer vaccine; chest pains, shortness of breath, hand/arm numbness, and dizziness. I went to the ER after my vaccine around 2pm and was diagnosed with HEART INFLAMMATION
Localized warmth at injection site, 2 lumps appeared in armpit area of arm of injection site, patient felt feverish.
experienced reinfection; experienced reinfection; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced reinfection on an unspecified date. The reporter (daughter) reported that the patient (mother)  experienced reinfection after her first dose of the Covid-19 vaccine. Outcome of the event was unknown.   No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Nausea, vomiting, diarrhea, headache, and chills.
About 4 hours after receiving the vaccine, I experienced fever and chills and neck ache. I shook tremendously and felt very hot and was very cold. In the morning I awoke with only a headache - at the top of my head and also forehead.
During care  on 10/17/2020 at  1 am resident found to have intense reddened area covering center and right side of back measuring 15x8 cm with 2 blisters in center of back measuring 2.5x1 cm and 1x 0.5 cm. Right posterior and lateral hip found to have intense red area measuring 12x9 cm with blister measuring 4x2 cm.  Tylenol prn ordered  with Aloe Vesta ointment and nonstick dressing. Followup on 10/19/2020 at 9am revealed an overall decrease in the erythema with rupture of blisters to back with weeping of serous fluid and peeling of skin. Right hip blister intact with clear/light yellow fluid . No oral ulcers or additional blisters noted to any other skin surfaces or membranes.
Initial misuse report received from a healthcare professional on 04 September 2013. This is an invalid case as individual patient identifiers are not reported. It was reported that DTAP-IPV was given from PENTACEL vaccine without ACT-HIB. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
COVID-19; Inappropriate schedule of vaccine administered; sickness; feels bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness), FEELING ABNORMAL (feels bad), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Ulcerative colitis.    Concurrent medical conditions included Ankylosing spondylitis and Ulcerative colitis (Moderate to severe ulcerative colitis).   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. In 2021, the patient experienced ILLNESS (sickness) and FEELING ABNORMAL (feels bad). On 01-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In January 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, ILLNESS (sickness), FEELING ABNORMAL (feels bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and COVID-19 (COVID-19) had not resolved.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of sickness, feels bad and COVID-19 was not reported for Humira.  No treatment information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Immediately after administration patient seemed red and said he could feel it like he was having an anxiety attack. Patient said he felt his throat closing up 20 minutes post administration. Said he didn't think he needed an epi-pen. Was offered oral Benadryl, took 37.5mg liquid diphenhydramine (15ml) or 12.5mg/5mL . After 30 minutes post administration patient said he felt he was ok to go and he said he could feel the Benadryl helping. About 7:15p pharmacist called patient cell number and patient said he could feel the Benadryl working and felt sleepy but better than before. He said he thought that maybe he just got nervous.