chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave the PNEUMOVAX 23 instead of the PREVNAR 13 by mistake; gave the PNEUMOVAX 23 instead of the PREVNAR 13 by mistake; 4 month olf patient received PNEUMOVAX by mistake; No additional adverse effect; This spontaneous report has been received from a patient's mother and refers to a 4-month-old female patient. No information regarding patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies was provided.   On 27-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S029916; expiration date: 12-JUN-2021) (exact dose, route and site of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). Pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) is not indicated for children less than 2 years of age. The nurses "missed it was not the right thing" and gave pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) instead of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). No adverse event was reported.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 17-MAR-2008, the patient was vaccinated with a first  dose of VARIVAX (Merck)(lot number, expiry date and route was not reproted). On 29-MAR-2012, the patient was vaccinated with a second dose of VARIVAX (Merck), (lot number, expiry date and route was not reported). No adverse effect was reported. Additional information has been requested.
Pt. reports receiving flu vaccine in (L) DM 10/3/13. On 10/4/13 pt complains of (R) arm irritation with rash from wrist to elbow. Pt experienced hot/cold flashes 10/4-10/5/13. On 10/5/13, pt reports feeling of increased anxiety with possible rapid heart rate lasting till 10/6/13. Both rash and anxiety reaction resolved 10/6/13.
Pt received 1st Dose of Moderna Vaccine 7/21/21.  Became ill on 8/12/21, runny nose, SOB.  tested positive for covid.  received monoclonal antibodies on 8/13/21 and then presented back to the ER later that evening for SOB and was given supplemental oxygen.  DC home on 8/15/21 in stable condition
This spontaneous report was received from a certified medical assistant (C.M.A) refers to a patient of unknown age and gender. On 07-NOV-2012 the patient was vaccinated with a dose of 0.5 milliliter (ml) MMR II (lot # (667964/1508Z, expiration date 02-NOV-2012) subcutaneously. No concomitant medications were reported. The reporter stated that a patient was administered MMR II that was expired. No adverse effects reported. No further information is available. Medical attention was sought. Additional information has been requested.
1 week after vaccination, itching, redness, inflamed warm area at injection site. No temperature or other symptoms.
2 episodes of vomiting, malaise, chills, numbness in rt arm last noc;localized reaction w/consultation sx p/inj;
On Saturday I started to congestion in my upper respiratory area with a sore throat and a headache. On Sunday I had a fever of about 99. I had a raspy voice, sore throat with severe headache and a cough. I tested positive with 2 home COVID-19 test on Sunday. I left a message for my doctor and received a call back on Monday morning. I had a screening with another doctor and was prescribed PAXLOVID. I started the medication on Tuesday. On day 2 I started feeling much better. On Saturday November 5t, I tested negative. I still have a light headache, but I am about 90% recovered.
Initial and follow up information has been received from a health professional concerning a 25 year old female with hypertension and protein in urine who on 20-MAR-2007 was vaccinated with Gardasil (lot#655849/0263U).   There was no concomitant medication.  The nurse reported that the patient was pregnant.  The patient's last menstrual period was 27-FEB-2007 with an expected delivery date of 04-DEC-2007.  In follow up telephone call to the doctor's office the Licensed Practical Nurse (L.P.N.) reported that the patient was still pregnant with a due date of 06-JUN-2008 and she mentioned that "everything was on track with patient's pregnancy, looked like a big baby."  She mentioned that patient continued to have problems with her hypertension and protein in urine which existed before her pregnancy.  When the reporter was called back to clarify/confirm patient's information she reviewed her chart and reported that patient had a ruptured ectopic pregnancy on 17-APR-2007.  No other information regarding the last menstrual period (LMP) dates were provided.  It was confirmed that the patient had not received any additional doses of the vaccine since the March 2007 dose.  Upon internal review ruptured ectopic pregnancy was determined to be an other important medical event.  Additional information has been requested.
Patient received 2nd dose of the Pfizer vaccine.  Within 12 minutes patient began to complain of dizziness and nausea.  She complained of dry mouth and sweating.  Patient was placed supine onto gurney.  Her BP read 162/101.  PO2:94%.  MD stat was notified and patient was later escorted to the ER.  She was received per ER staffing for treatment and evaluation.
no adverse event; During temperature excursion case, customer reported that improperly stored vaccine was administered to 10 separate patients. No additional AE reported, No PQC reported.  Names of vaccines involved (including lot/exp) PEDVAX HIB T042013 exp 07/22/202; This spontaneous report was received from an office manager and refers to a 9-month-old patient of unknown gender.  The patient's medical, concurrent conditions, and concomitant therapies were not reported.  On 18-APR-2022, the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) vaccine (lot # T042013, expiration date 22-JUL-2023) presented a temperature excursion of 11.43 Celsius degrees for 4 hours and 45 minutes (there were no previous temperature excursion). On an unknown date in 2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #T042013, expiration date 22-JUL-2023, (route of administration was not reported) administered for prophylaxis (product storage error). No additional adverse event was reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2205USA003131:
Frequent dizziness, no nausea. Feeling like the room is spinning. I had a CT scan ordered by Dr., scanned Jan 25, 2022 at local Hospital.
Doctors think that this caused blood clots in my left leg from my groin down to my toes.  Had 5 surgeries in order to try to clear them, but had to have a 6th surgery to amputate below the knee.
The patient presents to the ED today with concern for viral symptoms (fever, congestion, cough, fatigue) and worsening weakness. Over the last few weeks he has been weak, he now says that he has a hard time walking with his walker. Over the last 3 days he has experienced fever with a max of 102 degrees at home, cough, and congestion. He was worried about COVID infection, although he has been vaccinated with both doses of Pfizer. He saw his primary physician assistant today at the urgent care in maple grove, where he was swabbed for COVID and discharged with return precautions.   He presents today with concerns for worsening of his weakness and continuation of his cough and congestion. He denies chest pain, shortness of breath, abdominal pain, or changes in bowel or urinary habits. He has some swelling in both of his legs, which is always present in his left leg, but it may be worse in his right leg today.
Client verbalized feeling lightheaded followed by vomiting.  Client was evaluated by Broward Fire Rescue and treated.   Per Fire Rescue client is stable, no further evaluations needed, symptoms resolved after 20 min.  Client exit the facility at 1:35pm accompanied by relative.
less than 10 minutes after receiving the Pfizer shot, I started feeling lightheaded, dizzy, and unwell.  My scalp became itchy first, then my whole body became itchy.  I was sitting in the 30 minute area.  There was no one around me to tell that I was not feeling well other than cleaning personnel.  I got up and went to a person sitting at a table and she took me across the facility to EMT personnel against the wall.  They took my blood pressure (197/102).  I do not have high blood pressure, it's normally 110/70.   They repeatedly asked me if I took my blood pressure medication today.    They told me that they are seeing many panic attacks.  I told them that I have never had a panic attack.  they did not believe me.  I told them that I have strange reactions to medicine, I gave them a sheet with them listed.  heart rate was 99, and I was itchy all over.  they gave me water and told me that I could go home.  chest tightness at home, asthma acting up
The patient had Back Ache; nodule on Injection Site; The patient had Chills; This spontaneous case was reported by a nurse and describes the occurrence of BACK PAIN (The patient had Back Ache), VACCINATION SITE NODULE (nodule on Injection Site) and CHILLS (The patient had Chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 03-Feb-2001, the patient experienced CHILLS (The patient had Chills). On 03-Feb-2021, the patient experienced BACK PAIN (The patient had Back Ache) and VACCINATION SITE NODULE (nodule on Injection Site). In February 2021, BACK PAIN (The patient had Back Ache), VACCINATION SITE NODULE (nodule on Injection Site) and CHILLS (The patient had Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication provided.  No treatment drugs were provided.   This case was linked to MOD21-058711, MOD21-058703, MOD21-049015, MOD21-058136, MOD21-058280, MOD21-058698, MOD21-058281, MOD21-058340, MOD21-058388, MOD21-058415, MOD21-058427, MOD21-058427, MOD21-058450, MOD21-058692, MOD21-058465, MOD21-058488, MOD21-058505, MOD21-058616, MOD21-058625, MOD21-058638, MOD21-058654, MOD21-058666, MOD21-058676 (E2B Linked Report).; Sender's Comments:  MOD21-058711: MOD21-058703: MOD21-049015: MOD21-058136: MOD21-058280: MOD21-058698: MOD21-058281: MOD21-058340: MOD21-058388: MOD21-058415: MOD21-058427: MOD21-058427: MOD21-058450: MOD21-058692: MOD21-058465: MOD21-058488: MOD21-058505: MOD21-058616: MOD21-058625: MOD21-058638: MOD21-058654: MOD21-058666: MOD21-058676:
Within 5 hours of receiving Anthrax pt was awakened with nausea, diarrhea, HA (worse than migraine), Diaphoresis, Fatigue and Febrile
The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating into both arms approximately 23 days following her second dose of the Pfizer vaccination.  She was taken to the cardiac cath lab after negative troponins and a negative stress test.   Two coronary stents were placed in the setting of single vessel disease.  She suffered a mild myocardial infarct during angioplasty.  The patient was transferred to the facility where I work due to persistance of bilateral arm/hand dysesthesias/numbness/tingling which did not resolve following angioplasty/stenting.  She demonstrated a poorly-definted mid-thoracic sensory level described as abdominal numbness extending to the legs.  She demonstrated widespread hyperreflexia, including crossed adduction with bilateral knee jerk reflexes.  Her presentation was consistent with acute transverse myelitis.  As of outpatient follow-up on 4/12/21 the patient had continued dysesthesias and a subjective sensory level similar to presentation.
10/9/2018 @ ~2:08pm: Approximately 30 minutes after receiving the PNEUMOVAX-23 vaccine, patient began to experience tingling in her fingers & slight muscle aches in her arm. Patient went to the Dr.'s office. Dr. did not prescribe any antibiotics or pain medications. 10/9/2018 @ ~7:00pm: Patient's arm was very painful. Patient described the pain as feeling like a ton of bricks & could not move her arm without pain. Patient said, she felt like biting her arm off. The pain lasted all night long. Patient's arm had blisters. 10/10/2018 @ ~7:00am: Patient felt better, but still could not move her arm; it was painful with movement. 10/11/2018: Patient went back to Dr.'s office because she experienced blisters all night long & woke up with redness & blisters at the injection site. Dr. diagnosed as cellulitis & prescribed Cephalexin 500mg 1 capsule 3 times daily x10 days. 10/13/2018: Patient still had a couple blisters, but the pain is gone.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date in 2015 (reported as "since 13-JUL-2015"), the patients were vaccinated with an unspecified number of improperly stored doses of PROQUAD (Merck) (lot # reported as K002752, expiration date 30-APR-2016) (dose, strength and route of administration were not reported). There was no concomitant medication reported. Additionally, no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Itching/burning/tingling/numbness in left arm -- pinky and ring finger especially affected. Itchiness spread to neck, chest, other arm, and head. Dissipated after about 30 minutes.
shortness of breath; heart palpitations/my heart is pounding to my chest; chest pain; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right (reported as Right upper arm) on 07Oct2021 (Batch/Lot Number: FF8841) as DOSE 2, SINGLE and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: FF8841) via an unspecified route of administration, administered in Arm Right on 07Oct2021 at 17:00 as DOSE 1, SINGLE both doses taken at age of 31-years-old for COVID-19 immunisation. The patient was not pregnant at time of vaccination.  Medical history included Right bundle branch block, allergy to Shellfish, adhesive, iodine. Past Drug included Iodine and Reglan and experienced allergy. Patient took no other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. On 09Oct2021, the patient reported that she had shortness of breath, heart palpitations/my heart is pounding to my chest, chest pain and Inappropriate schedule of vaccine administered. Patient had heart palpitations at night. During the day being weekend like her heart was pounding to her chest, she had chest pain, she had the same symptoms three days after she received the vaccine. The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. As a treatment she was prescribed prednisone it had not helped, had been taking her inhaler for three weeks straight and it has not helped. Other treatment included for adverse events which the patient took was with Steroid. Outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the event dyspnea and suspect drug BNT162B2 cannot be 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.
Child was taken to daycare 7/25/17, mother received phone call that child was running around and became very lethargic and collapsed to ground, was very hard to arouse. 911 was activated, EMS reports approximately 5 seizure episodes back to back on transport to Hospital. Tx received in ER, notes include "we reviewed that the immunizations are not related, but may have lowered the threshold in someone who is already risk for having a seizure." referred to Pediatric Neurology at another facility.
The morning after the shot I woke up feeling achy and sore all over. I had muscle cramps throughout the day. Also, I was extremely tired for the entire day.
Approximately nine months post vax pts laboratory results indicated that the pt failed to seroconvert.
Fever 102 for 24 hours, severe neck and shoulder pain, headache, increased shortness of breath, arm pain and weakness, stomach ache.
This spontaneous report as received from a healthcare professional refers to a 13 month old patient of unknown gender. On unknown date in June 2014 (reported as within the last week or so) the patient was vaccinated with first dose of (Oka/Merck) VARIVAX 0.5 ml, subcutaneous (lot # J014228 and expiry date 08-NOV-2015). Concomitant therapies included PREVNAR 13 and dose of ACTHIB given on the same day in June 2014. On unknown date in June 2014 the patient experienced raised, large area, red, 1.5 inch by .75 inch wide. The outcome of the events was unknown. The relatedness between the events and (Oka/Merck) VARIVAX was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Half circular red area approximately 3" below injection site. Circular arch is approximately 6" wide.
PT REPORTED GARBLED SPEECH, HEADACHE, ISSUES WITH DIZZINESS SAYING IT WAS "LIKE I WAS DRUNK" THAT STARTS A COUPLE HOURS AFTER GETTING VACCINE ON 10/17/23 AND SYMPTOMS RESOLVED THIS MORNING 10/19/23.
Headache, weakness, extreme nausea, and diarrhea for 12 hours. Sore throat started 12/17/2009 & weakness continued.
I have started to have increase muscle pain in my legs, sides and shoulder to the point that it is affecting my sleep, rest and daily activities. I went to my doctor finally after trying at home changes, who prescribed me muscle relaxers and has put me into physical therapy.
Within 2 min of vaccine, experienced tingling over back of hands and nose, with cold sensation on back, and face itching. Then 30 min later, had itching in throat. Administered Benadryl 50 mg and within 30 min, patient reported resolution of symptoms.
now I have a red rash on my hand; rash; I got the 2nd shingles shot Friday and had chills Friday night and also ached like the flu; I got the 2nd shingles shot Friday and had chills Friday night and also ached like the flu; This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 2nd dose of Shingrix. On 15th November 2019, less than a day after receiving Shingrix, the patient experienced chills and flu-like aching. On 19th November 2019, the patient experienced red rash and rash. On an unknown date, the outcome of the chills and flu-like aching were recovered/resolved and the outcome of the red rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the chills, flu-like aching, red rash and rash to be related to Shingrix.  Additional details were reported as follows: The patient received  2nd Shingrix shot Friday and had chills Friday night and also ached like the flu,  The patient reported now (day of reporting) 4 days after receiving vaccination he had red rash on hand. All the event was recovered, except the worst was the shivering Friday night,slept in a coat long pajamas and socks. No further information was available.
Large welt (over 2 inches in diameter) formed at flu vaccination site within 24 hours, welt began declining and red itchy rash began to spread, mostly across upper arms, chest, abdomen. Patient self treated with oral Benadryl and OTC antihistamines. Four days post vaccination, rash persisted and spread to lower arms & upper thighs- patient was prescribed prednisone & topical ointment.  Two weeks post vaccine rash has persisted and worsened despite completion of oral prednisone regimen, patient consulted with allergist and is beginning Allegra am, Pepcid + Zyrtec pm daily to treat itch/rash that is believed to be a viral reaction to the vaccine.
Tested positive for COVID though vaccinated; Tested positive for COVID though vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14-year-old male patient received BNT162b2 (BNT162B2), on 12May2021 as dose 1, single (Lot number: EW0179), in left arm, on 05Jun2021 as dose 2, single (Lot number: EW0185), in left arm and on 20Jan2022 as dose 3 (booster), single (Lot number: F71611) at the age of 13 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known Allergies: Peanuts" (unspecified if ongoing), notes: Known Allergies: Peanuts. Concomitant medication(s) included: QVAR; FOCALIN XR ER. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022 at 20:00, outcome "not recovered" and all described as "Tested positive for COVID though vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Tested positive for COVID though the patient was vaccinated. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. Device timestamp: 07Jun2022.  No follow-up attempts are possible. No further information is expected.
first dose 2019, second dose not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 30-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix vaccine, which led to incomplete course of vaccination.