chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner referring to an unspecified number of patients. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot#, expiration date, dose and route unspecified, data logger) for prophylaxis. No adverse effects were reported. The vaccines were stored during 47 fahrenheitto 77 fahrenheitto for 2 hours and 30 minutes, during 32 fahrenheitto to 35 fahrenheitto for 60 hours and 20 minutes. No previous temperature excursion. This is one of the reports received from the same source.
Pain on left arm shoulder, tired, lack of energy, fain feeling, swollen left upper arm, warm to the touch low grade fever.
Information has been received from a nurse referring to an 18 year old female patient with negative pregnancy status. Information about concurrent conditions and medical history was not provided. On 28-MAY-2015 the patient was vaccinated with a 0.5ml dose of PROQUAD (Merck) (lot # K025759, expire date 08-JUN-2016, subcutaneous, dose# unspecified). No information regarding concomitant therapy was provided. On 07-JUN-2015 the patient developed swollen lymph nodes and a 102F fever. On 07-JUN-2015, the patient visited an urgent care center. The fever resolved after one day (recovered on 08-JUN-2015). The swollen lymph nodes persist (not recovered). Additional information has been requested.
PATIENT WAS GIVEN 0.2ML OF UNDILUTED VACCINATION OF PFIZER-BIONTECH 5-11YO  BIVALENT BOOSTER. COUNSELED POTENTIAL SIGNS AND SYMPTOMS AND RECOMMEND SEE DOCTOR RIGHT AWAY IF SYMPTOMS SUCH AS CHEST PAIN, SHORTNESS OF BREATH, SEVERE FLU-LIKE SYMPTOMS, OR ANY OTHER SEVERE OR UNUSUAL SYMPTOMS
Seizure/eyes went back in head/convulsions; weepy; headache; runny nose; tired; slept a lot; prev dose brand: Johnson & Johnson; prev dose brand: Johnson & Johnson; prev dose brand: Johnson & Johnson; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Jan2022 (Lot number: 331308A) at the age of 46 years as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "personality disorder NOS" (unspecified if ongoing); "obesity" (unspecified if ongoing); "nerve pain in foot" (unspecified if ongoing); "congenital deafness" (unspecified if ongoing); "seizures" (not ongoing). Concomitant medication(s) included: VITAMIN D3; IODINE; METAMUCIL [PLANTAGO OVATA]; SAPHRIS; FISH OIL; DEXILANT; IBUPROFEN; VIIBRYD; PROBIOTICS; SELENIUM; LACTAID. Vaccination history included: Johnson & johnson (Dose Number: 1, Batch/Lot No: 201A21A), administration date: 07Apr2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Jan2022, outcome "unknown" and all described as "prev dose brand: Johnson & Johnson"; SEIZURE (medically significant) with onset 21Jan2022 12:30, outcome "recovered" (21Jan2022), described as "Seizure/eyes went back in head/convulsions"; FATIGUE (non-serious) with onset 17Jan2022 12:30, outcome "recovered" (Jan2022), described as "tired"; HYPERSOMNIA (non-serious) with onset 17Jan2022 12:30, outcome "recovered" (Jan2022), described as "slept a lot"; CRYING (non-serious) with onset 21Jan2022 12:30, outcome "recovered" (Jan2022), described as "weepy"; HEADACHE (non-serious) with onset 21Jan2022 12:30, outcome "recovered" (Jan2022), described as "headache"; RHINORRHOEA (non-serious) with onset 21Jan2022 12:30, outcome "recovered" (Jan2022), described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of seizure, fatigue, hypersomnia, crying, headache, rhinorrhoea. Clinical course: After booster on Monday (17Jan2022), the patient was tired and slept a lot. On Friday (21Jan2022), the patient was tired, weepy, slept a lot, had headache, runny nose, and then a seizure. Seizure further described as eyes went back in head. She had convulsions for less than a minute. The patient has history of seizures but hasn't had one in several years. No follow-up attempts are possible. No further information is expected.
This patient was reported to have pancreatitis, fatty liver, pharyngitis, and vomiting. Information has been received from Glaxo Smithkline regarding information previously reported by a physician and the patient's mother concerning an 11 year old female who on 12/04/97 was vaccinated with a dose of Hepatitis B vaccine recombinant (yeast) (lot # 622792 / 0312E). It was reported that the patient developed pharyngitis, and was seen by her physician on 01/10/98. The patient's mother reported that the patient was treated with Amoxicillin / Clavulanate. Subsequently, she developed vomiting and was seen in the emergency room on 01/14/98. She was hospitalized with a diagnosis of pancreatitis. After 2.5 weeks, she was transferred to a tertiary care center for placement of a central venous catheter and total parenteral nutrition. It was reported that the patient has been hospitalized due to pancreatitis several times since, most recently from 10/06/00 to 10/09/00. The patient's mother reported that the patient currently has a fatty liver. The patient's mother attributed to the development of pancreatitis to the administration of Hepatitis B vaccine recombinant (yeast0. No further information is available. Other reference number is EB2001000505-1.
Bad muscle cramp in L leg (calf area) and L tricep. Vaccine given on 7/31/13. Symptoms started 8/6/13. Also started volleyball camp on 8/5/12. Pt to call back in 72 hrs.
Pt claims severe muscle pain to the point of unable to be able to walk up the stairs, loss of balance, headache, and confusion starting almost immediately the day after the vaccination. Pt reported similar adverse effects after her first dose as well.
Information has been received from a physician referring to a 24 year old female patient. The patient was not pregnant and had Ewing's sarcoma. On unknown dates (reported as "while she was a teenager") the patient was vaccinated with all three doses of GARDASIL (intramuscular; dose unknown). Concomitant therapy was not provided. On an unknown date in 2016 (reported as recently) the patient was diagnosed with cervical cancer, type 16 and was being treated. The outcome of the event was unknown. The causality was not provided. Upon internal review, cervical cancer was considered to be medically significant. Additional information has been requested.
Vaccine (Flu) IM received Monday 10/26 PM. Awoke with Left leg (Injection limb) twice the size, painful, and red. Hives began in early afternoon. Seen at facility and given Prednisone and BENADRYL.
red raised hive-like rash on pts back mom states rash first noticed 24-36 hrs p/vax; rash extended to pt's chest 48 hrs later; pt examined in ER;
Reported: Didn't feel good, shaky, anxious, palpitations, frequent urination, fecal evacuation.
Pt received the vaccine and stated he didn't feel well and went white, he said it had happened in the past when he got blood drawn. He then went unresponsive and stiffened up. I laid the patient down from the chair to the floor and grabbed the EpiPen to administer. Simultaneously I told the technician to call 911. As I was uncapping the epipen the pt came too and was confused why he was on the ground. The pt then got up, we called his wife over and he sat down in the chair. The wife and him were talking and I left the IMZ room, once I got back into the pharmacy the wife called me to come back over because he was unresponsive again. I got the epipen out again and was ready to administer and he came to again. Pt was still white and now very clammy and w sweaty.  The EMS came and took his BP and HR. Pt refused to be transported, so the EMS left and the pt stayed seated a bit then left.
within minutes of receiving the vaccine patient started feeling weak and like he was going to pass out. His skin coloring visibly lightened. We took him outside, removed his mask, had him sit down. His parents authorized giving him 50mg of liquid Benadryl. Within a few more minutes his normal coloring returned and he started feeling better. His parents wanted to take him home. I advised they call his MD immediately. They did and had a telehealth visit. By the afternoon patient was completely back to normal.
This case was reported by a healthcare professional to a sales representative and described the occurrence of "got sick" in an adult male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  The healthcare professional reported on 26 April 2007 that she, "had heard from another practice" that a subject received unspecified dose of Twinrix "last year."  At an unspecified time after vaccination with Twinrix, the subject "got sick."  The healthcare professional also reported that this dose of Twinrix was "administered with the accelerated dosing schedule."  At the time of initial reporting, 26 April 2007, the outcome of the event was unspecified.  The healthcare professional considered the event to possibly be related to vaccination with Twinrix.
This spontaneous report was received from a company representative via a physician refers to a 83 year old female patient. No pertinent medical history and drug reactions or allergies were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 dose 1 (strength, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. On an unknown date, approximately one month after receiving the PNEUMOVAX23 the patient was diagnosed with bacteremic pneumococcal disease (hospitalization). The patient was hospitalized on an unspecified date, where she recovered after an unspecified period of time. Sought medical attention was reported as no (though patient was hospitalized). There was no PQC involved. The outcome of bacteremic pneumococcal disease was reported as recovered/resolved. The causality of the event in relation to therapy with PNEUMOVAX23 was not reported. Additional information has been requested.
Parent states that since the patient was adminstered the Gardasil vaccines she has been dx with Chemical Depression. I am not sure about the date above.
Bp high  and head aches everyday since the shot. Didn?t have high bp before.
This was not an adverse event, it was a vaccine error. The nurse reconstituted the yellow fever vaccine with sterile water instead of sodium chloride. According CDC and Sanofi Pasteur, the vaccine is inactive. Patient notified and aware.
Temperature on Monday-1 week later per mom 3-8-04. Rash-face, trunk and extremities on wednesday, 3/10/2004
This non-valid spontaneous report as received from a pharmacy intern refers to a patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On 05-DEC-2017, the patient was vaccinated with PNEUMOVAX23 intramuscular injection in a deltoid muscle (dose and expiration date were not provided) lot # N003993 for prophylaxis. On an unknown date in December 2017, the patient began to experience shoulder pain. The outcome of the event was unknown. The relatedness between PNEUMOVAX23 and the event was not provided. Follow-up information has been received from a physician on 19-DEC-2017. This report refers to a 38 years old female patient. The patient's concomitant therapies included azathioprine, AMITRIPTILYNE and topiramate. The patient received PNEUMOVAX23 vaccine to her left deltoid on 05-DEC-2017. The patient's concomitant therapies included azathioprine, AMITRIPTILYNE and topiramate. With in few hours, she experienced pain and weakness to the left shoulder and had difficulty raising her left arm more than 20-30 degrees and went to the urgent care. They noted that the injection appeared high on her shoulder and suspected it may have entered the sub acromial space. They placed a sling and gave her a prescription for hydrocodeine. The physician saw her for follow-up on 07-DEC-2017 and she couldn't abduct the arm past 20-30 degrees. She contacted the physician again on 10-DEC-2017 and was not improving. She was now scheduled for EMG (electromyography) (on 10-JAN-2018) to rule out motor nerve palsy, possibly an axilla nerve dysfunction. The outcome and causality of the event pain and weakness to the left shoulder were unknown. The event pain and weakness to the left shoulder was considered to be serious due to disability.
Symptoms include skin bumps and skin redness, but do not include pruritus. Located on left side of face, left buttock, left leg, right side of face, (L) buttock and leg. Onset was sudden 12-20-15. Treated with ZYRTEC Children's allergy.
He had a cough, but no fever. We took him to the doctor, and he was diagnosed with Strep Throat.  They prescribed Cephalexin and we have been giving him Zyrtec. We also gave him Albuterol when his cough was bad. He is feeling better now.
patient administered open IPOL post excursion with no adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA419841(CLUSTER), 2022SA422655(CLUSTER), 2022SA422419(CLUSTER), 2022SA422653(CLUSTER), 2022SA422151(CLUSTER), 2022SA421782(CLUSTER) and 2022SA422846(CLUSTER).  This case involves a 4 years old male patient who was administered open IPV (VERO) [IPOL] post excursion with no 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 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR)  and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 26-Sep-2022, the patient received 0.5 ml dose of suspect open  IPV (VERO), suspension for injection (lot V1A022M; Exp.date: 17-FEB-2024) via intramuscular route in the left thigh for Immunisation post excursion with no adverse event (poor quality product administered) (latency on same day).  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.
Upon checking with patient on 10/14/2020 still massaging, still swollen But did not seek MD care. Self treating. MD office contActed, pt did not contAct MD.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 73-year-old female patient who received Shingrix (batch number YE9YL, expiry date 6th February 2021) for prophylaxis. On 7th August 2018, the patient received Shingrix .5 ml. In August 2018, less than a month after receiving Shingrix, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the rash and pruritus to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix vaccine on right arm. The patient reported a rash on both arms and legs with an itchy feeling. The onset date was unknown. The dose number in series was unknown. The pharmacist said he did not have a record of her receiving another dose but could not confirm this one as the first dose. The vaccine was given in the afternoon. Upon call back to health care professional, health care professional stated he found out patient had a computed tomography scan on Monday and received IV contrast medium. He thought  the adverse event could be related to the IV contrast medium.
The patient is a healthy 4-year-old who received influenza vaccine #5 and 26 October 2018. MOP reports he had complained his head hurt to receipt of vaccine about 1 hour prior and had been given TYLENOL. States he received the vaccine without immediate incident and they waited the required 15 minutes and then left. A few minutes later he complained of GI pain. At about 20 minutes post vaccine receipt they were at store, and he continued to complain of GI pain he was given a snack of a 'lunchable' at about 40 minutes post vaccine receipt. About 60 minutes post vaccine receipt she had him in a warm shower and he experienced an episode of emesis, gagging, choking, spitting, and facial flushing and complained of cold. She denies noting facial swelling pruritus, urticaria, or dyspnea. She did state he was 'blue at his lips' and his eyes were 'blotchy'. They returned to clinic where he was very distressed, crying, voice very soft, anxious, and refused to speak or open his mouth. He was treated with BENADRYL and IM steroid and went to sleep. He was discharged to home and continued his GI pain complaint for another 1-2 hours. He had an episode of diarrhea at some point during this event, but MOP does not recall exactly when. About 3 PM his father came home and he immediately perked up and was at baseline. He had no further symptoms, no fever no urticaria no pruritus, ate well, took fluids and was playing normally. Provider note reports positive erythema and edema to eyelids, eyes, throat pain, and refusal to talk or eat. Physical exam notes tachycardia heart rate at 158 and hypertension 147/95. Lung exam clear to auscultation and no urticaria is documented.
This case was reported by a consumer and described the occurrence of rash in a 38-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2L752, expiry date June 2015). On 16th October 2014 10:30, the patient received FLUARIX QUADRIVALENT (intramuscular). On an unknown date, the dose was an unknown dose. On 16th October 2014, 10 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced rash and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the rash and hives were recovering/resolving. The reporter considered the rash and hives to be almost certainly related to FLUARIX QUADRIVALENT. Additional information: Caller reports that she received a FLUARIX QUADRIVALENT vaccine yesterday at her local pharmacy. Yesterday evening she started noticing a rash developing on her forearms. She woke up this morning and there were hives on both arms starting a little below her wrist to her elbow. The hives are red, elevated and flat, and they are worse on the arm where she received the injection. She spoke with her HCP and pharmacy, but has not had to go into the office. She took some BENADRYL this morning and the rash does seem to be doing better.
Broke out in hives red, flush, head torso, arm felt hot minus itching, no wheezes, no angiodema or stridor- upper body, face. Benadryl 50 ml IM, Epinepherine 0.3 ml SQ, Prednisone 50 mg tabs.
Mild headache that night so took Tylenol 650mg, slept ok. Got up 5/5 thinking everything was OK, started to do things but very tired. Around 9AM dry heaves and exhaustion, dizziness, extreme weakness, mild headache and whole body aches. Could hardly get out of bed to the bathroom for dry heaves. Unable to keep sips of water down. This lasted until about 9:15 PM when water stayed down. 9:30 I ate a light meal then slept all night. Tired and slightly achy 5/6, rested all day. Better 5/7, and almost back to normal 5/8. Seem to be fine 5/10..
Patient presented to emergency department on 10/13/2021. She was found to be COVID-19 positive but was asymptomatic during admission. She required no treatment. Her husband was also admitted during this time with COVID-19 who is her primary caregiver. She was brought to hospital for facility placement. She was discharged on 10/20/2021 to an acute rehab facility.
As soon as I received the vaccine it felt like I drank a hot alcoholic shot, my throat was thickening and hard to swallow, tingling and numbness on my face I felt hot inside and cold shivering, I was a little out of it, very tired nauseus and I had a really hard time swallowing saliva, 30 mins later I had no feeling in my face, my lips felt huge like I had just had novacaine, my eye felt like it was drooping, I went to employee health I was given Benadryl and I took it for two days and one day I did not take the Benadryl and my face started drooping all over again so I took Benadryl and it went back to normal. I was advised not to get the second vaccine. I fully recovered.
Patient Name:    Patient MRN:    Patient DOB:       Date of Admission: 8/17/2022     Date of Discharge: 8/20/2022     Diagnosis: Vaginal Delivery     Hospital Course                      OB History    Gravida   Para   Term   Preterm   AB   Living    2   2   1   1       2    SAB   IAB   Ectopic   Multiple   Live Births                0   2         #   Outcome   Date   GA   Lbr Len/2nd   Weight   Sex   Delivery   Anes   PTL   Lv    2   Preterm   08/18/22   35w4d       3.162 kg (6 lb 15.5 oz)   M   Vag-Spont   EPI       LIV    1   Term   03/04/21   37w0d       2.829 kg (6 lb 3.8 oz)   F   Vag-Vacuum   EPI       LIV       Complications: Mild preeclampsia, Postpartum hemorrhage             The patient  underwent a Vaginal delivery during this hospitalization.  She is now 2 days postpartum.  She has not had complications since the delivery.  She has not been febrile.  She did not have a surgical sterilization at the time of her delivery.       At the time of discharge, the patient was afebrile and has been tolerating a regular diet.  She has been ambulating and voiding without difficulty.  Denies symptoms of orthostasis.      Plan     She has been given discharge instructions which include the following: No straining, No lifting over 15 pounds, No sex, No tampons, No douche and No tub baths.  Follow up for a postpartum exam in 6 weeks.  Call for any signs of fever, foul discharge, increased bleeding, wound redness or draining, or signs of postpartum depression.     Discharge Medications     Motrin 800 mg one every 8 hours #30        Signed:  MD  8/20/2022  9:36 AM
Patient had a vasovagal response to vaccination. Felt light-headed and dizziness after vaccination, lost color in his face. After several minutes (approx. 5 mins) patient regained color. He was able to walk around and was fine after a few minuted.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 08-FEB-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Client Developed itchy facial skin and swelling and redness on the left side of the face. Facial skin is also bumpy per clients report.