chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure/Got the vaccine, two/ three years later got the shingles; Got the shingles; It does hurt; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine a few years ago and about three years after that he/she got the shingles. The patient stated that it did hurt for sure. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As this case was received from interactive digital media page and follow-up could not be performed, therefore in worst approach, the case was processed based upon the latest comment depend upon time hours of post.
3 by 3 inch circumference rash with swelling, pain and 3, 3 inch long stripes of redness radiating from the rash site.
Headache; Vomiting; Sore Throat; coughing; missed 2 days of school.
pt administered morning of 1SEP92 @ 11AM afternoon of same day pt seen @ ER dx crying synd; pt cried for 3 hrs per mom;
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 46 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
This morning I still felt bad but not as bad, felt exhausted; Still feel drained right now and sore, achy; Having aches; Chills; Passed out, became unconscious; Generally not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, became unconscious) in a 69-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.     No medical history was provided by the reporter.  Concomitant products included DRONEDARONE HYDROCHLORIDE (MULTAQ), RISPERIDONE, METOPROLOL, APIXABAN (ELIQUIS), TEMAZEPAM and TOPIRAMATE for an unknown indication.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out, became unconscious) (seriousness criterion medically significant), MALAISE (Generally not feeling well), MYALGIA (Having aches) and CHILLS (Chills). On 13-Jun-2021, the patient experienced FATIGUE (This morning I still felt bad but not as bad, felt exhausted) and MYALGIA (Still feel drained right now and sore, achy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Jun-2021, LOSS OF CONSCIOUSNESS (Passed out, became unconscious), MALAISE (Generally not feeling well), MYALGIA (Having aches) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (This morning I still felt bad but not as bad, felt exhausted) and MYALGIA (Still feel drained right now and sore, achy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include fluids.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
13-year-old received the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13-year-old received the Moderna COVID-19 vaccine) in a 13-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13-year-old received the Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13-year-old received the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
4 y/o vaccines Dtap, MMRV, IPV given to 3 y/o by mistake. No vaccine reactions noted.
I woke up on the 18th and I sat up in bed and I started coughing, and I could not catch my breath, and got distressed. Coughing and wheezing. I talked to the pulmonologist who sent me to the. Later, the symptoms did not improve, I called my PCP who recommended me to go to the ER, several tests found nothing. I followed up with a cardiologist and later with pulmonologist who prescribed Symbicort inhaler and it has helped tremendously.
Developed headache, then severe vertigo, nausea, vomiting. Fairly severe over the course of several hours, then diminished by the following day. (Still with intermittent vertigo and nausea the following day, at the time of a phone visit with the patient.)
Summary narrative including initial information received from a healthcare professional (nurse) on 10 May 2012 and follow-up information received on 14 September 2012. A 24-year-old female patient had received 3 dose of IMOVAX Rabies vaccine (batch number: G10761) first dose on 18 April 2012 intramuscularly in the right arm, second dose on 25 April 2012 intramuscularly in the left arm and third dose intramuscularly in the right arm on an unspecified date. Concomitant medications were none. On 05 May 2012, the patient developed dizziness, headache and nausea. The lab investigations were none and treatment medications were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: None.
Temperature of 100.6 on 07/28/18, increasing fussiness and stumbling when walking. 07/30/18 right thigh warm to touch, 07/31/18 mother took to ER and was told to massage area while also applying warm, moist, heat to right thigh. Per mother on medical record.
Soreness on right side of throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Dec2022 at 12:00 as dose 5 (booster), single (Lot number: GJ6743, Expiration Date: 31Jan2024) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). Concomitant medication(s) included: MAXZIDE taken for hypertension. Vaccination history included: BNT162b2 (Lot number: EW0156 as dose 1, single), administration date: 09Mar2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Lot number: EW6207 as dose 2, single), administration date: 30Mar2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Lot number: EW0217, Exp Date: 21Dec2021 as dose 3 (booster), single), administration date: 26Oct2021, when the patient was 62-year-old, for COVID-19 Immunization; Bnt162b2 (Lot number: FN2908, Exp Date: 21Jun2022 as dose 4 (booster), single, ), for COVID-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 22Dec2022, outcome "recovered" (Dec2022), described as "Soreness on right side of throat". Therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: Patient was calling to report side effects she had from Pfizer booster which was sore throat, it was only on one side of her throat. It is not with her first shot, the third one (booster), she mentioned she have gotten every shots (unspecified Booster). It was soreness on right side of her throat, the day after she got her shot (yesterday's evening, 22Dec2022) and she got her shot on Wednesday afternoon (21Dec2022). It was reported that she took some paracetamol (TYLENOL) the day before.
A non-serious spontaneous report of two patients were administered FLUMIST was received from a health professional concerning an adult male. Neither past medical history nor concomitant medications were reported for this patient. The product expired in 22-Dec-2010. On 03-Jan-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Mild fever; slight chills; tired; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021. The most recent information was received on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever), CHILLS (slight chills) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fatty liver, Diabetic, Overweight, Adrenal disorder NOS, Arthritis (no cartilage on her knees at all), Poor peripheral circulation, Renal cyst (left kidney), Eye disorder NOS and Cancer (NOS).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (slight chills) and FATIGUE (tired). On an unknown date, the patient experienced PYREXIA (Mild fever). The patient was treated with LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) on 08-Mar-2021 for Adverse event, at a dose of 1 dosage form and LORATADINE (CLARITIN [LORATADINE]) on 08-Mar-2021 for Adverse event, at a dose of 1 dosage form. On 02-Mar-2021, CHILLS (slight chills) and FATIGUE (tired) had resolved. At the time of the report, PYREXIA (Mild fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  The patient subsequently realized that the events of skin irritation all over her body; her right arm was itchy, she scratched and looked and she had like 5 or 6 bumps in a row; and bumps on her arms, fingers and left side of her body, toes, stomach, chest and above her right breast, forehead, down hairline, face, neck, even palms of her hands were due to bed bug bites (events removed). The only adverse reaction she had to the vaccine was slight chills, mild fever, and tiredness.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: F/U-1 : Patient initials updated. Event added; some adverse events removed.
Initial unsolicited report received from physician on 20-Dec-2017. This case was linked to 2017SA264640-1 (same reporter). This case involves adult patient (age and gender not reported) who was vaccinated with 0.5 ml dose (once) of FLUZONE QUADRIVALENT (Batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 01 Dec 2017. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced anaphylactic reactions described as "very unusual". Patient had not seen reactions of this type. Lab data and corrective treatment were not reported. The patient's event outcome was unknown. Upon internal review, the company decided to consider the case serious because of important medical event anaphylactic reaction. List of documents held by sender: none.; Reporter's Comments: Patient experienced anaphylactic recation after vaccination. Exact time to onset is not mentioned. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, role of the vaccine cannot be assessed.; Sender's Comments: Patient experienced anaphylactic recation after vaccination. Exact time to onset is not mentioned. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, role of the vaccine cannot be assessed.
Woke up crying, had stiff extremities and shaking extremities for about 5-10 second, would resolve spontaneously, then reoccur approximately 8 times. Eyes did not roll back, no post ictal period. Dad called 922, by the time EMS arrived, episodes resolved. Parents drove her to the ED.
pt recvd vax; cyanosis, dyspnea, weakness,"went limp"; on 26nov94 then cardiac arrest while en route to hosp; sz,heart failure on hosp, coma, in intensive care;
Patient presented  to clinic 2 days after vaccine administration with redness, swelling and weakness on arm where injection was administered.
Dehydration; Vomiting; Fever; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DEHYDRATION (Dehydration), VOMITING (Vomiting) and PYREXIA (Fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR) and INSULIN ASPART (NOVOLOG) for Type 1 diabetes mellitus.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting) and PYREXIA (Fever). On 02-May-2021, the patient experienced DEHYDRATION (Dehydration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-May-2021, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved. On 02-May-2021, DEHYDRATION (Dehydration) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Body temperature: 102 (High) fever, 102..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Broke out about 9 days after 2nd vaccination with dark red spots/rash throughout my body-I have pictures; This is a spontaneous report received from a contactable consumer, the patient. A 72-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 24Feb2021 at 19:45 (at the age of 72 years), as a single dose for COVID-19 immunisation. Medical history included High blood pressure controlled, high triglycerides controlled and essential tremor controlled on an unspecified date. Concomitant therapies included lengthy-3 prescriptions and many supplements. The patient was allergic to pain killers-codeine. Past drug history included CoQ10 supplements (taken but heard other experienced these hives as well). Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 02Feb2021 at 03:45, as a single dose for COVID-19 immunisation. The patient had not received 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 had not been tested for COVID-19. The patient experienced red spotty rash on 05Mar2021 at 16:00. (Broke out about 9 days after 2nd vaccination with dark red spots/rash throughout body). The patient mentioned that he had pictures with him. The patient received treatment for the reported events with antihistamine-generic and unspecified steroid treatment.   The clinical outcome of red spotty rash was resolving.   Information about lot/batch number cannot be obtained. No further information is expected.
4 days after her vaccine she developed urticaria on her knees, legs, arms and elbows.   Seen in the office on Day 5 and treated with steroids.  Rash suspicious for SERUM SICKNESS
I have a rash on the left arm where I had the shoot ,its the inside in my bicept area. the skin is red & itches.
A cyst occurred under the left chin; throat hurt; menstruation period became longer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CYST (non-serious) with onset 12May2021, outcome "unknown", described as "A cyst occurred under the left chin"; OROPHARYNGEAL PAIN (non-serious) with onset 12May2021, outcome "unknown", described as "throat hurt"; OLIGOMENORRHOEA (non-serious) with onset 12May2021, outcome "unknown", described as "menstruation period became longer". Additional information: No treatment received. No covid prior vaccination and no covid tested post vaccination. 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. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had chills and felt achy the same evening.  Pt passed away on 9/14/2023
SEVERE HEADACHE; SEVERE SWELLING OF FACE; WAS TREATED IN EMERGENCY ROOM; RECIEVED BENADRYL--PREDNISONE MORPHINE-FAMOTIDINE-DIPHENHYDRAMINE-HYDROCODONE.
Patient states left arm swelled up from elbow to shoulder.  Patient stated very lethargic/tired/body aches.  Patient states started about 4:00pm and really got worse at 7:00pm.  Patient stated taking acetaminophen and applying warm compresses to area.  Pharmacist suggested diphenhydramine and acetaminophen/ibuprofen.  Contacted patient on 10-15-20 and patient said doing better.  The swelling gone down.  Checked again on patient on 10-16-20.  Patient said a whole lot better.  Swelling all gone.  Just a little tender at actual injection site.
took 2nd capsule & 4PM & 9PM had fever of 101 & stomache cramping; the next day had diarrhea & nausea;
(R) arm vaccine site with redness and swelling within 12 hrs. of vaccine, began resolving by clinic appt. (L) arm vaccine sites with extensive redness, swelling, tenderness from shoulder to elbow-began after 24 h of immunizations. no fevers. treated with Benadryl dx: local hypersenstivity reaction
Patient returned to pharmacy approximately 4 hours after the  immunization complaining of severe arm pain and vomitting.
Daily debilitating migraines paired with photosensitivity and vertigo.  They are now less frequent, occurring once a week, whereas they were first happening every day.   Migraines start with aura symptoms - visual distortions, feeling dizzy and nauseous - and then progress into a piercing pain in the upper left side of my head.  Every since they have started, I have been sensitive to light and patterns in my vision (blinds, stripes, flashing lights, light in between tree branches, etc.)   That hasn't gone away.   I first saw my Primary Care physician, who prescribed me different Triptan medications.  Those didn't help, so he referred me to an Ophthalmologist who saw nothing unusual, only that I was nearsighted (which I wear glasses and contacts for.)   My Primary Care physician then referred me for an MRI, which showed everything was normal.  I then went to an Ophthalmologist who checked my vision, and everything was fine there.  I then went to a Neuro-Ophthalmologist, who also said everything was fine.  I then saw a Neurologist, who suggested I may be having seizures.  I conducted an EEG, which showed no unusual brain activity.
Patient reports feeling slightly dizzy, sweating, shaking and dry mouth. Patient think she passed out and has history of anxiety and passing out with shots.
I tested positive for Covid-19 on December 25, 2022, I experienced upper respiratory infection; coughing; congestion. I was prescribed PAXLOVID for my symptoms.
Severe swelling and effusion in knee. Accompanied by severe pain. Also mobility limitation. While I have very mild age related osteoarthritis, I was in perfect health prior to this episode and with a good activity level. I believe I experienced reactive arthritis after the Covid immunization, as also seen in the articles below.