chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the office manager referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. Between the dates of 27-OCT-2016 through 30-MAR-2017, the patients were vaccinated with improperly stored doses of M-M-R II (dose and route unknown, lot # L026551, expiration date 16-JUL-2017; lot # L026551, expiration date 16-JUL-2017; lot # M016234, expiration date 31-MAR-2018; lot # M015930, expiration date 29-MAR-2018) for prophylaxis, which were exposed to temperature excursion, a total time in the range of 47°Fahrenheit (F) to 77°F, for a time frame of 8 hours. There was a previous temperature excursion, the total time in the range 47°F to 77°F for 8 hours. The call was due to a "data logger". No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013739: US-009507513-1703USA013740: US-009507513-1703USA013741: US-009507513-1703USA013742: US-009507513-1703USA013155:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Aug2021 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 27Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and on 11May2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Common variable immunodeficiency" (unspecified if ongoing); "ehlers danlos syndrome" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "autistic" (unspecified if ongoing); "Known allergies: Sulfa drug" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Positive; (23Jun2022) Negative, notes: day 6; (24Jun2022) Negative, notes: day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with ritonavir (PAXLOVID), from 12Jun2022 to 17Jun2022 for covid-19 treatment.  Clinical course: The patient had adverse event Rebound COVID. Symptoms largely alleviated early in Paxlovid course. By day 6, tested negative on RAT (rapid antigen test), negative again on day 7. Then symptoms returned day 8 and tested positive with mild symptoms through day 14.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
body temperature changes; Headaches; Tiredness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE FLUCTUATION (body temperature changes), HEADACHE (Headaches) and FATIGUE (Tiredness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE FLUCTUATION (body temperature changes), HEADACHE (Headaches) and FATIGUE (Tiredness). At the time of the report, BODY TEMPERATURE FLUCTUATION (body temperature changes), HEADACHE (Headaches) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
Uncontrolled crying from 8:30 PM to 12 midnight. Would not eat from 8:30 PM to 2 AM. Would suck but quit nursing as soon as milk flowed as if it hurt to swallow?
Vaccine vial was not properly reconstituted and patient was ultimately getting only the diluent ( Sodium Chloride 0.9% ) administered. Patient was contacted later same day about incident and was given the properly reconstituted vaccine dose. No adverse reactions were reported by patient when they returned to get the satisfactory vaccination dose.
Shingles...began approximately June 28.  On Right arm.   Have had 2 prior cases of Shingles
This case was reported by a consumer via call center representative and described the occurrence of pemphigus vulgaris in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a month after receiving SHINGRIX, the patient experienced pemphigus vulgaris (serious criteria GSK medically significant), injection site pain, itchy upper limbs, dry skin and rash. In October 2018, the patient experienced soreness gum. The patient was treated with AQUAPHOR and prednisone. On an unknown date, the outcome of the pemphigus vulgaris was not recovered/not resolved and the outcome of the injection site pain and itchy upper limbs were recovered/resolved and the outcome of the soreness gum, dry skin and rash were unknown. It was unknown if the reporter considered the pemphigus vulgaris, injection site pain, itchy upper limbs, soreness gum, dry skin and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the left deltoid. The patient experienced itching down her left arm and soreness at the injection site which lasted about a week. In September 2018, the patient went to the doctor for spots on her skin and her physician mentioned that the patient had dry skin and prescribed AQUAPHOR for her skin. In mid October 2018, the patient started to develop sore gums and at first she disregarded it because she thought that she brushed her teeth too vigorously. The patient reported that then she developed a handful of spots under her left breast, 10 spots on her back and right upper shoulder. The patient's physician biopsied a spot on her back and found Pemphigus Vulgaris. The patient did not remember when this first biopsy occurred. On 9th January 2019, the patient had second biopsy of her midsection and it also came back Pemphigus Vulgaris. In January 2019, the physician prescribed Prednisone on a tapered dose for over a month and again she was taking 5 mg daily at the time of reporting. The patient reported that at the time of reporting, she was having a flare up again and was returning to the dermatologist on the day of reporting. The patient did not consent to follow up. The reporting did not wish to give physician information before speaking with her physician. Lab Comments: On an unknown date, the Biopsy was performed.
Had a "histamine reaction" -   Nose, mouth, eyes started itching and watery  - all within 1.5 hours of receiving the vaccine.    This resolved the next day except itching in sensitive areas (lips, nose, eyes, folds of skins, behind ears, inside ears).  Patient started taking Pepcid and Zyrtec twice a day.  The symptoms resolved with this treatment through 2/4/21.  All symptoms resolved as of 2/6/21.  She is taking Pepcid once a day.  Never had any redness, rash, bumps at all - just itching.
patient presented to ED with chest pain, gone upon arrival to ED, dyspnea on exertion, shortness of breath. no congestion, no cough. Nausea present. patient tested for covid and found to be positive. Received 2nd covid vaccine on 2/3/21
No symptoms have been reported.  She didn't disclose that she had receive d J&J vaccine on 3/8/2021.
Itchiness feels like burning on lips anf face; lips feels swollen underneath; Rashes on face mostly on the right side; This spontaneous case was reported by a consumer and describes the occurrence of LIP PRURITUS (Itchiness feels like burning on lips anf face), LIP SWELLING (lips feels swollen underneath) and RASH (Rashes on face mostly on the right side) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced LIP PRURITUS (Itchiness feels like burning on lips anf face), LIP SWELLING (lips feels swollen underneath) and RASH (Rashes on face mostly on the right side). At the time of the report, LIP PRURITUS (Itchiness feels like burning on lips anf face) and LIP SWELLING (lips feels swollen underneath) outcome was unknown and RASH (Rashes on face mostly on the right side) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported she was not taking any concomitant medications prior to vaccine or at present.  The patient reported treatment of events was with diphenhydramine (Benadryl) as advised by the pharmacist for the itchiness, the patient  but only took it once.
One week after COVID-19 vaccine my blood pressure started to rise; Called doctor and had it closely monitored and trying to find out why; Five months later had a TIA Stroke and was hospitalized; Hospitalized for 6 days; Released and doctor prescribed losartan and hydroxyzine.
I administrated a nasal H1N1 vaccine to an 18 month old by accident. Pt should have received injectable 0.25ml. No adverse effects.
This spontaneous report as received from a healthcare worker, (medical assistant (M.A.), also reported as registered nurse (RN)) refers to a patient of unkonwn age and gender. Medical history and drug reactions or allergies were not specified. On 08-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K007158, expiration date 12-NOV-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 73) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same source. Additional information has been requested.
4:00 pm, 03/05/21: Felt a burning shooting pain from my lower back down my leg. Found out this is sciatica- had never experienced sciatica before (or since) the vaccine. Starting to feel fatigued and nauseous. 8:00 pm, 03/05/21: Felt extremely fatigued, started running a fever, and extremely nauseous. Still had sciatic pain. Went to bed. 11:00 pm, 03/05/21: Woke up and started vomiting violently. Still running a fever, still fatigued, still had sciatic pain. 11:00 pm 03/05/21 - 6:00 am 03/06/21: Hourly bouts of intense vomiting. Fever, fatigue, and sciatic nerve pain all still present. Developed a headache. Uncontrollable diarrhea began.  6:00 am - 11:00 am 03/06/21: Went to ER for liquids to treat dehydration and vomiting control. 11:00 am -4:00 pm 03/06/21: Vomiting ceased. Bouts of uncontrollable diarrhea continued. Headache, fever, fatigue, and sciatic pain still present. 4:00 pm, 03/06/21: Almost all symptoms completely disappeared. Still very fatigued but everything else stopped.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD, M026879 27-NOV-2017, M031944 27-DEC-2017, M032497 02-JAN-2018, M017335 05-OCT-2017, M031945 27-DEC-2017. No adverse symptoms reported. Additional information has been requested.
Unknown/unable to be identified blood-based autoimmune internal and external reactions causing physical hard pustules skin reaction flare-ups, airborne-based respiratory complications, hyperreactive airborne allergy-based triggers, and no medications resolve the reactions or symptoms.  The primary reaction repeatedly flared no less than five times between October 2021 through March 2022, each cycle lasted three to four weeks with the proceeding flare-up starting approximately one week before the preceding flare-up subsided, so there was no relief for five months.   To date, I am mindful of the known triggers for the autoimmune response and try to reduce exposure to these events. Respiratory restrictions are still evident with unknown triggers. My body does not heal as quickly. When my body is experiencing an episode by a reaction inconsistent secondary and tertiary side-effects occur until resolved.
Narrative:  ER Course: I examined this patient, after I obtained a history. Given that the patient had some similar symptoms when he had his second dose of his COVID-19 vaccination, it was suspected that his symptoms could be due to an allergic reaction to the vaccine. The patient had already been taken diphenhydramine at home. He was given prednisone 40 mg and famotidine 20 mg in the emergency department. The patient was observed in the emergency department and his eft upper extremity swelling improved and his facial swelling almost completely resolved. The patient also noted that the slight chest tightness he had earlier had resolved. Given that the patient was not having any respiratory symptoms, and that he had significant provement, it was felt that he was stable for discharge and outpatient follow-up
nausea, vomiting, diarrhea, dizziness, syncope, fainting, abdominal pain
no additional AE; Improperly stored administered vaccine; This spontaneous report was received from a medical assistant concerning a patient of unknown age. No information about the current condition, medical history or concomitant therapy was reported.   On 13-JUL-2021, there was a temperature excursion on rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and it was administered to the patient (at the dose of 2 ml, lot # 1707585, expiration date# 21-FEB-2022; route was not reported) as prophylaxis (product storage error). The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored improperly at the temperature of 34.5 F for 1 hour and 48.6 F for 30 minutes. The previous temperature excursion was reported as 47 F for 30 minutes. The call was not due to data logger. No additional adverse event was reported.   This is one of several reports received from the same reporter.
Pt presented to urgent care clinic on 3/28/19 with severe herpes zoster rash on left scalp and face, reporting that the rash started on 3/26/19, one day after receiving Shingrix.  Pt has continued to have herpetic neuropathy of left scalp, face and left eye following resolution of rash, requiring multiple urgent care and optometry visits for ongoing evaluation and pain control.
Pt came to ER with SOB, cough, and covid positive, onset 1 week prior.  Fever and chills since 7/4/21.  Covid positive on 7/9/21.
Within 2 days of receipt of the 2nd dose of the vaccine (Shingrix) developed hives. Large red patches lower back to upper buttock, both upper arms and where upper and lower arm meet, both legs upper thighs and lower legs, lower abdomen. The areas became very red, hot and itchy. After 4-5 days the skin started to dry off and within a week, week and a half started to become extremely dry and peal off. It is now a month after and my lower legs are still peeling. I made an appointment with a professional. Took Benadryl for 5 days. Use close to large bottle of body lotion to make the situation bearable.  This was not an expected outcome that was listed on the handout. It was confirmed by the healthcare professional that it was not an episode of Shingles but an allergic reaction to something that was in the serum. Further testing was not ordered.
This spontaneous report as received from a Licensed Practical Nurse referring to an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 06-JUL-2018, the patient was vaccinated with a pediatric dose of VAQTA for prophylaxis (specific dose, route of administration, lot number and expiration date were not reported). The reporter specified that there were no adverse effects.
Right deltoid area was red, hives, warm to touch and painful on 09/10/2018, she was placed on Clindamycin HCL 300 mg Tid, patient returned to clinic on 09/13/2018 the red rash-hives had spread from shoulder to elbow, still warm to touch and painful, prednisone 20 mg bid was added.
About a week after the last vaccine, I became extremely fatigued and it just comes and goes. I still have that fatigue on occasion. It had began to bother me more so after July 6th 2021, that is when I started the Shingles symptoms as well. I thought, I would wait a little while but I went to my DR. I went to the DR on July 2021 sometime, I am not sure of the exact date. Well now it is September and my Shingles are gone. By the time I went to the DR, I did not receive medication for that. Also I have had Hepaticis C for 15 years, I took EPCLUSA in 2018 and have been fine since then. The fatigue I started to experience after the vaccine reminds me of the fatigue I experienced when I had Hepaticis C.
1/9/21 no pain and no red mark 1/10/21 ? perfect red circle where vaccine was given with pain, hot ? unable to wear sleeve over spot, difficult to sleep, and could feel it even when breathing 1/11/21 ? marked vaccine area with pen line ? see picture below. Shoulder tender with movement above 90degrees 1/12/21 ? redness is spreading outside of pen more medially, slightly laterally ? shoulder tenderness is still the same level
Redness/Itchiness around injection site still present after 1 week of administration.
Localized cutaneous reaction. No evidence of cellulitis. Mild and resolving, through course prolonged (still present 2 weeks after).
Vaccines given on 7-26-13. Athetotic type motion in his lower extremities x 2 days. No treatment. Mother notified MD of this symptom on 9/3/13.
testicular swelling after 2nd COVID shot.  Adverse Event on:  5/14/2021 , 6/13/2021, 9/16/2021, 10/2/2021.  Each event lasted almost exactly 24 hours, start to finish.  Zero allergic reactions from other stuff, nothing out of the ordinary noted.  I saw on social media men reporting this and it seems the same is happening to me!  Testicles swell to avocado  size, penis grossly disfigured during the swelling.  Dissipates within 24 hours.
7/15-  Patient stated that their symptoms started on: 7/15 patient stated he had a headache, mild cough and runny nose. Today he feels better.
Initial and follow-up information has been received from an LPN concerning a 5 year old Caucasian female pt who on 7/16/01, at 14:45, was vaccinated, IM, in the right thigh (also reported as the left thigh) with the 2nd dose of MMRII (lot 636662/0019L). On 7/18/01, the pt was seen by a physician for an injection site erythema (11 X 7cm) and injection site pain (symptoms began sometime in the evening on 7/17/01). It was reported that the pt was treated with amoxicillin trihydrate (+) clavulanate potassium (Augmentin) (400/5ml bid for 10 days) and that on 7/20/01, the symptoms improved. The pt subsequently recovered. No further information is available.
This case was reported by a consumer via call center representative and described the occurrence of tooth infection in a 82-year-old male patient who received TWINRIX. Co-suspect products included TWINRIX. Concurrent medical conditions included prostate cancer (diagnosed 5 years ago). Concomitant products included Atorvastatin, finasteride, Losartan, pantoprazole, Vitamin B12, Probiotics, vitamin d, COSOPT, Coq10, glimepiride, Lutein + Zeaxanthin and Potassium. On 5th May 2017, the patient received the 1st dose of TWINRIX (intramuscular). On an unknown date, the patient received the 2nd dose of TWINRIX. On an unknown date, less than a year after receiving TWINRIX and not applicable after receiving TWINRIX, the patient experienced tooth infection, prostate specific antigen increased and incomplete course of vaccination. The patient was treated with Amoxicillin. On an unknown date, the outcome of the tooth infection, prostate specific antigen increased and incomplete course of vaccination were unknown. It was unknown if the reporter considered the tooth infection to be related to TWINRIX. The reporter considered the prostate specific antigen increased to be unrelated to TWINRIX. Additional details were provided as follows: On 5th May 2017, the patient received the 1st dose of TWINRIX on an unknown arm for trip. The patient did not receive a second dose of TWINRIX, which led to incomplete course of vaccination. The patient wanted to know if it was okay to receive the second dose. The patient was observed without treatment for prostate cancer, which was diagnosed 5 years age until he started radiation therapy on 8th August 2017 because his prostate specific antigen (PSA) kept going up. The cancer did not seem aggressive.
Hives, erythema and wheezing started about 1 hour after Hep-A and Yellow Fever shots.
1st dose May 2019/2nd dose yet not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in unknown arm in May 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The caller only received first dose of Shingrix at the time of call. The caller did not give permission to contact her health care professional. The caller did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Fever 100, sore throat, body aches, warmth, tenderness and redness at injection site, approximately 3", increased in size overnight since onset. Recent hospitalization for CD. Tested negative at hospital discharged 1/19.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a two-months old female patient who received an expired dose of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR, ROTATEQ and HEPATITIS B VACCINE for Immunisation. It was actual medication error due to expired vaccine used. It was not reported that the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.