chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling under her left armpit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling under her left armpit) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling under her left armpit). At the time of the report, PERIPHERAL SWELLING (swelling under her left armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Patient received her first vaccine on January 16th; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received her first vaccine on January 16th) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 16-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 PRODUCT DOSE OMISSION ISSUE (Patient received her first vaccine on January 16th). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received her first vaccine on January 16th) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: This report refers to a case of missed dose for mRNA-1273, lot # unknown with no associated AEs.
Episodes of malaise and nausea and fatigue, initially occurred at dance class after getting vaccine, occurred on a daily basis, mainly in afternoon, soreness at injection site which lasted approx. 1 week. Felt feverish with hive-like reaction 5 nights after vaccine. Evaluated in our office 12/15- nonfocal exam except for some tenderness at injection site, right deltoid muscle. Sx's appeared to resolve several days after office visit on 12/15.
Nausea, headache, fever, diarrhea - symptoms went away on their own after three days
Pediatric dose inadvertently given to client by a volunteer at clinic.  Error discovered while client was present, discussed with patient and gave an adult dose of Pfizer vaccine.  No ill effects or issues observed during the clinic.
sore arm at the injection site; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site) and FATIGUE (extreme fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm at the injection site) and FATIGUE (extreme fatigue). At the time of the report, INJECTION SITE PAIN (sore arm at the injection site) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
Tired. Aching. Left arm broken out from shoulder to elbow on top side of arm. Arm is hot to. Touch. Itches. Stings. Hurts.
temp to 101 w/stomachache began 4AUG98;still has 5AUG98;mom resistant to running pt to MD;mom sure it's from the immun & thinks pt will be ok;
A medication error was discovered resulting in the patient receiving a 2.5mL dose of the Moderna COVID-19 booster dose. The patient was notified as soon as it was discovered and monitored daily by staff for new or worsening complaints. He previously reported no complaints or complications. during daily contact calls.
My reaction began typically enough, with a sore arm and chills.  The chills subsided by the evening, but symptoms continued and migrated from there.  The arm remained sore for 3 days and then began to itch.  This itchiness continued on and off for the next 2 days.  My neck and shoulder were also sore.  The shoulder continued to be sore for about 4 days.  I had an intermittent headache, also  for 4 days.  The worst part though, is the nausea, which also comes and goes.  But it can last for many hours and now, even after 8 days, I am still experiencing this.  I can find nothing in the writings about this vaccine to corroborate this side effect and I am therefore worried about the second shot.
Patient given 5 immunizations as stated below. Mom came out of room and said child did not look right. Took baby who appeared yellow, ashen, had decreased heart rate down to 80, and pulse pressure and decreased respiration rate with pulse oximetry of 84%. Baby required O2, continuous stimulation until EMS arrived and sent to PICU at hospital. 08/23/06-Records received for DOS:06/29-07/03/06 from Hospital. DC DX: apparent life-threatening event,  status post immunizations,  probable adverse reactions to immunizations,  seizures ruled out,  arrhythmia ruled out. HX of Symptoms: presented to hospital on day of vaccinations, she did well immediately after the immunizations and then 15 minutes after immunizations she appeared ashen, yellow and shallow breathing. Heart rate of ~100, shallow respirations, appeared mottled and poor perfusion. Initial pulse ox 88 and after administration of oxygen pulse ox 97. EMS transported to ER.  Past Medical HX: 40 week gestation, C section, in thought to be septic which was ruled out, treated with seven day course of  IV antibiotics.  No further episodes after DC. Hospital Course: Admitted to PICU, color remained slightly off and a little yellow but lips were more pink and she was more active. Received IV sedation for MRI and had probable hypoglycemic episode. Patient die well over  3 day stay.  pH probe: no evidence of reflux, 15 hour study several short episodes of gastroesophageal reflux, on prolonger (greater than 5 minutes). Fraction pH of reflux 4.4% Echocardiogram: patent foramen ovale with restricted left to right shunting, otherwise normal.
This spontaneous report was received from a pharmacist referring to a 22 year old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 22-MAY-2018, the patient was inadvertently vaccinated with one dose of Oka-Merck) PROQUAD for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). No adverse effects were reported.
Muscle aches, fever, cold sweats, chills, fatigue, and diarrhea over a 72-hour time period.
Client received first dose of Moderna in the COVID 19 series of vaccination despite her age. She was given the second dose of Moderna to complete her primary series. She was advised to notify her primary care provider about the vaccines given. There were no adverse side effects or events reported.
started to get a little bit of fever; Inappropriate schedule of vaccine administered; Tiredness; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), FATIGUE (Tiredness), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (started to get a little bit of fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL and PROGESTERONE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), FATIGUE (Tiredness) and VACCINATION SITE PAIN (vaccination site pain). On an unknown date, the patient experienced PYREXIA (started to get a little bit of fever). The patient was treated with IBUPROFEN for Fever, at a dose of UNK dosage form. On 19-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, FATIGUE (Tiredness), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (started to get a little bit of fever) outcome was unknown.
1 MIN AFTER VACCINE ADMINISTRATION, PT REPORTED NOT FEELING WELL TO PHARMACY TECH WHILE SITTING IN VACCINE WAITING AREA. PT THEN STOOD UP TO WALK TO PHARMACY COUNTER AND FAINTED AGAINST WALL. SECONDS AFTER HITTING THE WALL PT REGAINED CONSCIOUSNESS AND PARAMEDICS WAS CALLED. PARAMEDICS ARRIVED 10 MIN LATER AND ASSESSED PT.
Narrative:  Timing ERROR only, 2nd dose given 46  days after 1st
Bleeding when passing bowels; Worst belly ache; Gut is the problem area; 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 HAEMATOCHEZIA (Bleeding when passing bowels) in a  patient of an unknown age and gender 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 information was reported.    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 HAEMATOCHEZIA (Bleeding when passing bowels) (seriousness criterion medically significant), ABDOMINAL PAIN (Worst belly ache) and ABDOMINAL DISCOMFORT (Gut is the problem area). At the time of the report, HAEMATOCHEZIA (Bleeding when passing bowels), ABDOMINAL PAIN (Worst belly ache) and ABDOMINAL DISCOMFORT (Gut is the problem area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication information provided. No relevant treatment medication information provided.  As per report due to this event patient could not take certain vitamins.  Very limited information regarding these events has been provided at this time.; Sender's Comments: Very limited information regarding these events has been provided at this time.
This spontaneous report as received from a Vaccines For Children (VFC) consultant refers to numerous unspecified patients of unknown ages and gender. The VFC consulted reported that PEDVAXHIB and GARDASIL may have been administered after going through unsupported temperature excursions on 05-MAR-2013 and 06-MAR-2013. There was no adverse effect reported. Additional information has been requested.
Had shingles after getting the shots/ suspected vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles after getting the shots/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that his or her friend as suggested received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR054617:Same reporter US-GSK-US2023AMR054618:Same reporter
No additional AE reported; Patient was administered expired VAQTA; This spontaneous report was received from a consumer (Healthcare Business Professional) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 17-JAN-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W007382, expiration date: 16-JAN-2023, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (expired product administered).  No additional adverse event reported.  This is one of 2 reports regarding the same reporter. ; Sender's Comments:  US-009507513-2301USA007085:MSD
Client received second dose of Covid vaccine @3:39pm, complained of tingling feeling in chest and blurred vision.  Client was vaccinated in zero-gravity chair, given water to drink.  Vital signs stable.  At 4:14pm  client complained of internal itching, dizziness, blurred vision.  Vital signs stable, denied shortness of breath and difficulty breathing.  At 4:24 pm client offered Benadryl, she declines, reports less tingling , no itchiness, complains of headache, sore arm, less tingling.  At 4:30pm, client attempts to stand up, would like to go home.  Client reports dizziness.  Back in chair and observed.  Vital signs are stable.  Client able to go home @4:35 pm with steady gait and support person, client reports only headache and sore arm at injection site.
Patient complains of shooting pain at the throat on one side, and pressure/pain in the chest one day after receiving second dose of Pfizer covid-19 vaccine.
patient was exposed to someone with COVID on 07/17, he was asymptomatic, tested positive for COVID on 07/20/21.
The evening immun were given pt was inconsolable for >2hrs & was very pale; pt was improved p/24hrs;
arm pain; joint and muscle pain; joint and muscle pain; there was some blue/blackish discoloration; loss of strength in the arm that got the injection; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old male patient received BNT162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 (Anatomical Location: Arm)), administration date: Mar2021, for covid-19 immunisation, reaction(s): "pain in arm"; Bnt162b2 (Dose 2 (Anatomical Location: Arm)), administration date: 2021, for Covid-19 immunisation, reaction(s): "pain in arm". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster dose"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "joint and muscle pain"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "there was some blue/blackish discoloration"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "loss of strength in the arm that got the injection". The events "arm pain", "joint and muscle pain", "joint and muscle pain", "there was some blue/blackish discoloration" and "loss of strength in the arm that got the injection" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient received booster dose about a month and a half ago. The patient had to wear a sling and the patient stated that the arm hurt worse out of the sling.  The blue/blackish discoloration and loss of strength happened in the arm that got the injection, but that it was on the lower bicep, not in the upper shoulder where he got the shot. He also mentioned that his HCP has said other people have had similar side effects.   The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L017407, exp date: 15-AUG-2017). The product was stored in temperature of 50.2 F degrees for 1 hour and 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Pain and swelling at injection site; Pain and swelling at injection site; Chills; extreme tiredness; cold sweats; back pain; rash covering my body; red with almost hive like bumps; red with almost hive like bumps; This is a spontaneous report from a contactable other HCP. A 25-years-old female patient (not pregnant at the time of vaccination) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6206, via unspecified route, in left arm on 05Mar2021 12:30 PM (at 25-years age) as 2 nd dose, single dose for covid-19 immunization. The patient medical history included hypothyroidism and ADD (Attention deficit hyperactivity disorder), Known allergies to Ibuprofen and aspirin. The concomitant drug included Adderall and levothyroxine which was taken within two weeks. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EM9809, via unspecified route, in left arm on 11Feb2021 12:30 PM (at 25-years age) as 1 st dose, single dose for covid-19 immunization. The patient had no reaction for the first 12 hours.  On 06Mar2021, pain and swelling at injection site started at about 12-hour post injection. Chills, extreme tiredness and cold sweats following that. Tiredness and back pain the following 24-36 hours. At 36 hours post injection she woke up to more cold sweats, back pain and then a rash covered her body. It was painless and no itchy. It was however red with almost hive like bumps on 06Mar2021 at 12:00 AM. The facility type vaccine was reported as other. No other vaccines in four weeks. The patient underwent lab tests and procedures which included COVID Test (SARS-CoV-2 test): result Negative (Nasal swab) on 03Mar2021. No covid prior to vaccination. The patient had received the treatment included Benadryl and Tylenol. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected. received the treatment included Benadryl and Tylenol. The outcome of the events was not recovered.
2 days after receiving pneumococcal vaccine pt. noticed erythema and some pain in her (L) upper arm radiating to (L) upper chest. Fasted x 3 days (religious) 5/7, 5/8 and 5/9. On 5/8 developed 104 degree fever w/ chills. Went to ER. Returned to ER after syncopal spell (per ambulance); dx'd viral infection and dehydration. Seen 5/13 today in clinic continues to have pain and erythema.
bump that is swelling.; large bump that was painful and throbbing; its warm to touch; Its growing in size- the width of her arm.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 57-year-old female patient reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced side effects that started with a bump that was swelling. It was a very large bump that was painful and throbbing and it was warm to touch. It was growing in size- the width of her arm. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Felt sick 12 hours after the shot.  I woke up 5/26 with a slight headache but otherwise felt fine, arm was sore.  Thursday morning i woke up with a tingling sensation in my left hand and it progressively spread throughout the left side of my body and into my right foot.  Hand, chest, stomach, left leg and left foot and right foot all have have pins and needles sensation.
second dose was over 42-day window; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was over 42-day window) in a patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was over 42-day window). On 08-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was over 42-day window) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
TB Skin Test Chronin flammatory, pain, swelling and softer toxic infection was traveling throughout my body auxillary lymph-adenopathy in my left breast have enlarged, phlebitis, cellulites are in the injection on 7-29-2014 the Doctor insert a syringe in my arm where I was inject TB Skin test. TDAP swelling shoulders numbness.
had two doses of the Pfizer Covid vaccine - and tested positive for Covid; had two doses of the Pfizer Covid vaccine - and tested positive for Covid; nasal congestion; cold symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had two doses of the Pfizer Covid vaccine - and tested positive for Covid"; NASAL CONGESTION (non-serious), outcome "unknown", described as "nasal congestion"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptoms". It was reported that this is the second time patient has had Covid and event took place after use of product. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.