chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Max/Low Temperature reached and for what period of time 52F for 1 hour and 37 minutes with no reported adverse event; 3 different patient's were administered the IPOL (opened) after the excursion with no reported adverse event; Initial information received on 20-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who was administered IPOL vaccine (poliomyelitis vaccine (inactivated)) which had reached max/low temperature reached and for what period of time 52f for 1 hour and 37 minutes with no reported adverse event and 3 different patient's were administered the ipol (opened) after the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Immunisation; and Hepatitis A vaccine INACT (havrix) for Immunisation.  On 19-Dec-2022, the patient received a dose of suspect poliomyelitis vaccine (inactivated) Suspension for injection lot V1A021M via intramuscular route in unknown administration site for immunization expiry date- 17-Feb-2024.  On an unknown date max/low temperature reached and for what period of time 52f for 1 hour and 37 minutes with no reported adverse event (product storage error) and 3 different patient's were administered the ipol (opened) after the excursion with no reported adverse event (circumstance or information capable of leading to medication error) (unknown latency)   Action taken: not applicable  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
administered 2 liquid conjugate vaccine components; administered 2 liquid conjugate vaccine components; This case was reported by a nurse via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMX417A, expiry date 31st August 2022) for prophylaxis.   On 19th July 2021, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 19th July 2021, unknown after receiving Menveo, the patient experienced wrong technique in drug usage process and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong technique in drug usage process and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Age at vaccination was not reported. Nurse reported that they administered 2 liquid conjugate vaccine components of Menveo to a patient, which led to wrong technique in drug usage process and inappropriate dose of vaccine administered. Nurse mentioned that the patient had no reactions after vaccination. HCP had no patient data. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
A dose of Moderna Covid19 Vaccine Bivalent Booster 3-5 LOT 215K22A, Exp: 8/19/2023 (0.2 ml) was administered to patient on 6/23//23. It was noticed after the administration of the vaccine that the beyond use date was not recorded on the vial when it was stored in the refrigerator after removing from the freezer, indicating that the vial was stored in refrigerator for more than 30 days.
Unsure if this was Adacel or Boostrix (only know "Tdap")  - great pain in arm, difficulty moving for a couple days - nausea, chills, headache, weakness
The patient presented to a event at the school where our organization was administering Well Child Exams.  Family member with child stated she was scheduled to receive her 4 year old "school shots" the upcoming week with her pcp. However, she wanted to get them at the event since available.  The nurse on duty had pulled a record that exemplified that the shots were due. However, after administration it was brought to the attention that the record was not a match to the patient therefore discovery that the 4 year old patient had received Kinrix and Proquad June 21st according to state website if placed accurately by PCP which had recorded the vaccines in April and June of this year.  No adverse immediate reaction was noted.
Arms/hands and legs/feet feeling tingly, weightless or as they?re falling asleep.
This spontaneous report was received from a 73 year old male consumer with no known allergies referring to himself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. "In approximately 2009" (reported as 7 or 8 years ago), the patient was vaccinated with ZOSTAVAX, 0.65 ml., once for prophylaxis (lot # and expiration date were not reported).  "In approximately 2010" (reported as 6 or 7 years ago), the patient developed shingles a year after being vaccinated with ZOSTAVAX. The patient reported that he was currently "on the tail end" of recovering from his shingles. Causality assessment was not reported. Additional information has been requested.
Red maculopapular rashes form on face trunk, extremities BENADRYL 12.5/5 1 tsp 3 x a day.
Loss of 75% vision right eye, vision still deteriorating. 3/16/06 Received medical records from PCP which included opth. reports.  PMH: HTN, dyslipidemia, nephrolithiasis.  Dx:P anterior ischemic optic neuropathy related to Viagra use; high hyperopia./ss3/28/06 Received medical records from opth.  No new information found/ss
Information has been received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 27-APR-2016 the patient was vaccinated with the second dose of VAQTA (route not reported, lot # L045713 and expiration date 14-JAN-2017) inadvertently (Extra dose administered). Concomitant therapies included M-M-R II and VARIVAX. No adverse effect was reported. Additional information has been requested.
Swelling at injection site, hives that began spreading and eventually covered full body, took antihistamines and went to urgent care where they prescribed a steroid pack to get rid of hives.
She was a Pfizer trial for Vaccine/Caller had the Pfizer COVID-19 Vaccines and tested COVID positive; She was a Pfizer trial for Vaccine/Caller had the Pfizer COVID-19 Vaccines and tested COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: She is a cancer survivor 10 years back.; "Blood pressure" (unspecified if ongoing), notes: Indication for Use in Case: Blood pressure. Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; BENAZEPRIL taken for blood pressure abnormal; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She was a Pfizer trial for Vaccine/Caller had the Pfizer COVID-19 Vaccines and tested COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: had to take because COVID positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She takes a Probiotic every day for her stomach. She was a Pfizer trial for Vaccine. She was on trial for Vaccine and vaccine didn't create any side effects. She got her COVID-19 Vaccines through Pfizer. Caller had the Pfizer COVID-19 Vaccines and tested COVID positive. Caller declines to provide details regarding her vaccinations. She states she never had any side effects with the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
approx. 2 hours after receiving flu vaccine injection to left deltoid, arm very sore.Continued pain all evening, required vicodin. 18 hours after injection, entire arm sore. Fingers feel tingly and weak. Relates previous history of arm injury- unknown details.
sore arm; injection site pain; extreme fatigue/Exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; sleepy; feel like they have Covid all over again; feel achy; feel lousy; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248) via intramuscular in left arm on 28Jan2021 at single dose for COVID-19 vaccination. The patient medical history included Covid. Concomitant medications were not reported. On 29Jan2021 the patient was experiencing a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall. It was reported that she and her husband both received the vaccine yesterday and stated that they feel like they have Covid all over again on 29Jan2021. She stated that they had Covid already and stated that they have chills and are achy 29Jan2021. Caller said that they are also having that Covid exhaustion. Their arms were quite sore too from the shot, but they did not expect to feel lousy on 29Jan2021. They have been sleepy all afternoon and stated that they sat down and just passed out, caller clarified that they went to sleep on 29Jan2021. Yesterday they were ok. The outcome of the events sore arm, injection site pain, a little headache was unknown, extreme fatigue/exhaustion, muscle pains which makes them a little achy overall, sleepy, feel like they have Covid all over again, feel achy, feel lousy was recovering, chills was resolved on 29Jan2021.  No follow-up attempts are possible. No further information is expected.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 12/30/2020, 01/27/2021, and 11/01/2021. The individual became symptomatic for COVID-19 approximately 01/15/2022 and tested positive on 01/18/2022 at the assisted living facility at which they were a resident. The individual was brought to emergency department on 01/22/2022 with primary complaints of hypoxia and shortness of breath. They were admitted to hospital on 01/22/2022. They were found to have had a myocardial infarction and an acute kidney injury. The individual refused any further lab workups and treatment and was transitioned to comfort cares only. The individual died on 01/23/2022. The hospital discharge notes indicate that no autopsy was performed.
No AE; received 3 doses of GARDASIL 9. The first dose 4/12/2023, the second dose received 4 weeks later, and received the third dose too early on Friday August 11, 2023.; This spontaneous report was received from a pharmacist and refers to a 12-year-old male patient who was immunosuppressed and had a bone marrow transplant. Concomitant therapies were not reported.  On 12-APR-2023, the patient was given the first dose of human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, frequency, strength, lot #, expiry date, and route of administration were not provided). On 10-MAY-2023 (also reported as 4 weeks later), the second dose of the vaccine was administered. The third dose was given too early on Friday 11-AUG-2023 (Inappropriate schedule of product administration). No additional adverse events were reported.
Information has been received from a nurse concerning an 8 month old male baby. The baby's 23 year old mother was vaccinated intramuscularly in the left deltoid with one 0.5 ml dose of GARDASIL (Lot #660618/0572X) on 21-OCT-2008. The mother's LMP was 22-SEP-2008. Estimated date of delivery was 29-JUN-2009. On 16-JUN-2009 the mother had a repeat scheduled Cesarean section, and delivered the male baby, weighing 7 pounds, 6 ounces. There was "no indication of any problems with the baby." The mother had no significant medical history, prenatal complications, and was not taking any concurrent medication according to the nurse. However, in February 2010, at about 8 months of age, the baby died of sudden infant death syndrome (SIDS). The nurse had no further information on this. A lot check was initialized. The mother's experience was captured in WAES #0811USA00264. Additional information is not expected.
Throat closing, tongue swelling, vomiting. IV BENARYL, SOLUMEDROL, epinephrine.
lymph nodes under the arm, neck, chin, at the back of the head; sore arm; could hardly lift her head up; had a knot under; stomach hurt really bad; worst migraine; have 40 fever blisters on her lips; fever at the injection site; body aches; fever; severe chills for over 24 hours; joint pain; red around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes under the arm, neck, chin, at the back of the head), PAIN IN EXTREMITY (sore arm), HEAD DISCOMFORT (could hardly lift her head up), RASH MACULAR (had a knot under) and ABDOMINAL DISCOMFORT (stomach hurt really bad) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LEVOTHYROXINE, PROPRANOLOL and VITAMINS NOS for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes under the arm, neck, chin, at the back of the head), PAIN IN EXTREMITY (sore arm), HEAD DISCOMFORT (could hardly lift her head up), RASH MACULAR (had a knot under), ABDOMINAL DISCOMFORT (stomach hurt really bad), MIGRAINE (worst migraine), ORAL HERPES (have 40 fever blisters on her lips), VACCINATION SITE REACTION (fever at the injection site), MYALGIA (body aches), PYREXIA (fever), CHILLS (severe chills for over 24 hours), ARTHRALGIA (joint pain) and VACCINATION SITE ERYTHEMA (red around the injection site). At the time of the report, LYMPHADENOPATHY (lymph nodes under the arm, neck, chin, at the back of the head), PAIN IN EXTREMITY (sore arm), HEAD DISCOMFORT (could hardly lift her head up), RASH MACULAR (had a knot under), ABDOMINAL DISCOMFORT (stomach hurt really bad), MIGRAINE (worst migraine), ORAL HERPES (have 40 fever blisters on her lips), VACCINATION SITE REACTION (fever at the injection site), MYALGIA (body aches), PYREXIA (fever), CHILLS (severe chills for over 24 hours), ARTHRALGIA (joint pain) and VACCINATION SITE ERYTHEMA (red around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included paracetamol and ibuprofen, ice bags on head
hours after taking the vaccine tongue started to swell throat started to swell, started sweating and felt real weak. Went to the clinic and was dx with pneumonia
This spontaneous report as received from a female consumer refers to herself of unknown age. The patient was vaccinated SC with a dose of 0.65 ml ZOSTAVAX (lot# not reported) in approximately February 2011 (reported as over 2 years ago). Concomitant medications included: acyclovir. On an unspecified date however the consumer still had two cases of shingles since receiving the ZOSTAVAX. The consumer stated that she also had Ramsey Hunt Syndrome however she did not mention if the Ramsey Hunt Syndrome occurred before or after the ZOSTAVAX was administered. At the time of reporting, the outcome was unknown. Additional information has been requested.
Patient reported a large area of redness and swelling on arm where vaccine was administered.  It started appearing at some point today.  She said she was going to put ice on the area and take benadryl as she did before when she had a similar reaction to the vaccine.  I also faxed the reaction info to the primary care doctor to notify them as well.
unavailable to get the third dose for about two weeks.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose on unknown date) and Engerix b (received 2nd dose on unknown date).   On an unknown date, the patient did not received the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: unavailable to get the third dose for about two weeks.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 25 Oct 2023 A pharmacist reported that a patient who had received the first and the second dose of Engerix-B. Today was the sixth month after the first dose. However, the patient would be unavailable to get the third dose for about two weeks, which led to incomplete course of vaccination. The HCP asked what the max interval between the second and third dose is in order to not re-start the series.
My arm starting swelling. It was swollen 3x its size. The shot site was red. I developed these red streaks underneath the shot about 3 of them appx 2 inches in length and inch thick. I developed hives all over the upper arm. It hurt to lift my arm the next day. I put alcohol on the site and it was stinging and burning. I had some lumps on my upper arm that were raised and resembled mosquitoe bites, fast heart rate. I was dizzy and passed out 7/15/2016. The next day I had a hard time concentrating on what the teaching was saying in my CPR class. For the next 3 days I put alcohol on the site in the morning and at night. It would sting and I developed a scab over the shot site. Showed arm to co-workers and family members.
had a allergic reaction to the first Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (had a allergic reaction to the first Moderna shot) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (had a allergic reaction to the first Moderna shot). At the time of the report, ALLERGY TO VACCINE (had a allergic reaction to the first Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. Treatment medications were not provided
Pt recvd 3 doses of Hep B vax 30JUL90, 01SEP90, 31JAN91 & following the 3rd dose devell pruritic hives on rt arm, spreading to legs & face; tx DPH & recovered; On 1FEB91, again, pt devel hives;
This spontaneous report as received from a registered nurse refers to an unspecified  number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX, lot # L032399, expiry date 26-NOV-2016 and L037791, expiry date 30-DEC-2016. Temperature 0.2 degree centigrade for 5.5 hours and there was no previous temperature excursion and it was administered. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Symptom of severe headache approx one hour after I got home from being vaccinated - then at approx one hour later I developed swelling of throat/mouth/tongue, huge local swelling, heat, face was red and hot.
Monday morning I woke up feeling tired, but finally on the mend; Body aches; Muscle soreness; Chills; Body was super sensitive to touch; Couldn't sleep; Fever of 102; Headache and neck pain; Headache and neck pain; I had mild nausea and couldn't eat much.; I had mild nausea and couldn't eat much.; Sweating; This is a spontaneous report from a contactable other hcp. A 38-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Em9809 and expiration date was not reported), via an unspecified route of administration in arm left on 05Feb2021 at 14:30 (at the age of 38-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: El8982 and expiration date was not reported), via an unspecified route of administration in left arm on 15Jan2021 at 02:30 PM as dose 1, single for COVID-19 immunisation. The patient had no allergies. Facility type where vaccine was administered was public health clinic/veterans administration facility. The patient did not take other vaccine in four weeks. On 05Feb2021 at 11:00, the patient experienced chills, body was super sensitive to touch, couldn't sleep, fever of 102, headache and neck pain, "she had mild nausea and couldn't eat much", body aches, muscle soreness, sweating, "monday morning she woke up feeling tired, but finally on the mend" on 08Feb2021. Within 10 hours of receiving the second dose, the patient began having chills and almost like his body was super sensitive to touch. She couldn't get comfortable and couldn't sleep all that night. She began developing a fever of 102 and developed a major headache and neck pain. She had mild nausea and couldn't eat much. She was able to drink liquids ok. The fever, chills and body aches lasted from Friday night until Sunday afternoon around noon. Then the sweating started. She was sweating throughout the day and Sunday evening woke up covered in sweat and needed to change his clothes and sheets twice throughout the night. Monday morning she woke up feeling tired, but finally on the mend. She had muscle soreness in her shoulder and neck and a mild headache. The patient did not test for COVID post vaccination and no COVID prior vaccination. The patient did not receive any other treatment for the adverse events. The patient underwent lab tests and procedures which included pyrexia: 102 on 05Feb2021. Outcome of the events fever, chills and body aches were recovered on 07Feb2021 and the outcome of other events were recovering.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Co Tiredness, Nasal/chest congestion and dry cough in the morning and continued to the night with fever, runny nose difficulty breathing and hoarse voice.  Over the course until today cough became moist and productive with thick yellow mucus.  I saw my physician who is treating me with antibiotics.
Month later blood sugar went to hyperglycemia your prior dosage insulin was not working and blood increased to 300-500 range. Prior range was 100-200 blood sugar range. Increase insulin, April/May sugar levels went to hyperglycemia and having to sick insulin. Body swelling leg, foot, and ankle and he is on a lot of medicine and checking to see if in congestion heart failure and upcoming test to check for blood clots.