chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to case 2019SA062350 (for 8 year old child). This case involves a 19 month old patient who received first dose of vaccine QUADRACEL (lot C5500CA and Exp. Date 16-Aug-2020) via unknown route in the left thigh (left vastus lateralis). The patient's medical history not reported and no any concomitant medications received at the time of vaccination. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient experienced any adverse event. 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 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. List of documents held by sender: none.
Dizziness, Sweating, Tingling in fingers Onset was approximately 35 minutes after administration Effect was transient lasting 1-2 hrs. No treatment needed
pt recvd vax; high pitched crying > 3 hrs; severe local rxn; seen by MD, told to contact ofc for evaluation of further pertussis
Constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included LEVOTHYROXINE, GLIPIZIDE, DULOXETINE HYDROCHLORIDE (CYMBALTA), CITRIC ACID, SODIUM CITRATE ACID (SODIUM CITRATE/CITRIC ACID), INSULIN ASPART (NOVOLOG), DOLUTEGRAVIR SODIUM, RILPIVIRINE HYDROCHLORIDE (JULUCA), GEMFIBROZIL, ROSUVASTATIN, FINASTERIDE, FOLIC ACID, LOSARTAN, ALLOPURINOL and INSULIN DEGLUDEC (TRESIBA) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Constipation). At the time of the report, CONSTIPATION (Constipation) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood glucose: 65 (Inconclusive) 65.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.    This case was linked to MOD-2021-059977 (E2B Linked Report).; Sender's Comments:  MOD-2021-059977:Second dose of Vaccine case of same patient.
6/17/02 mother calls states child given varicella 6/6/02. Child now has red spot on leg  it did not have last week. States did have child ran out in high grass day prior (6/16/02). Advised child to be seen , child not brought in. 6/18/02 child seen by the MD. 6/19/02 mother calls with insisting report be filed. Spoke with MD and advised to use Benadryl if still present child to be seen.
Arm hurts after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurts after receiving the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurts after receiving the vaccine). At the time of the report, VACCINATION SITE PAIN (Arm hurts after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
patient had been screaming and crying inconsolably all night long. In morning during diaper change he would not put his legs down, so patient's father held legs straight and patient had a seizure. Arched back, eyes glazed and rolled back in head, all limbs stiff and stretched outward, shaking all over, drooling excessively, head turned to side, jaw clenched shut, tongue sticking out in fixed position, trying to cry out but unable to. Lasted about a minute, 911 was called.
Patient presented to the emergency department with ileo-ileocolic intussusception with perforation of the bowel wall requiring exploratory laparotomy and ileocecectomy with primary anastamosis
Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-338604 (Patient Link).
Pt given 2 doses of Dtap accidentally, I picked up wrong syringe when doing Immunizations on pt and brother. 8/17/06 2:00pm spoke with mom, she states that pt had slight fever last pm and some crying mom states doing good today.
chills; fever; body aches; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), PAIN (body aches) and MYALGIA (muscle aches) in a 29-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever), PAIN (body aches) and MYALGIA (muscle aches). At the time of the report, CHILLS (chills), PYREXIA (fever), PAIN (body aches) and MYALGIA (muscle aches) had resolved.            No concomitant medications were provided.  Treatment medications were not provided. Action taken with mRNA-1273 in response to the drug was not applicable.
2-3 day p/had sore throat, weak, dry cough, blood shot eyes w/white drainage, dizziness, h/a, nausea; sinusitis, rhinitis;
Syncope with cold clammy skin, Bradycardia 46 with Glucose 132 and low B/P 80/60 and 1/2 hour of unresponsiveness.
A lingering and recurring soreness in left shoulder and arm.  Occasionally, it was almost to a debilitating extent. The past few days my left chest or pectoral area is feeling odd. I have inquired with several different nurses from several different agencies/offices and the consensus is possible nerve damage from the injection. It is because it is recurring that I am reporting this.
for one day only felt like had the Flu: body aches, low-energy, head ache and left arm sore. By morning of 29th felt better
Soreness of the injection site reoccurred after previously going away after initial injection. Same day itching started to occur, followed by swelling around the injection site (photo for reference if needed). This felt like an allergic reaction to me (I have had allergy shots in the past for preventative).  Swelling and soreness have been off and on since.  Started googling and seems to be a similar reaction as ?covid arm?
My 16 year old son can participate in your Covid 19; Received the first moderna vaccine by error of pharmacy; A spontaneous report was received from a reporter concerning a 16-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) by error of the pharmacy.  The patient's medication history was not provided. Concomitant medications none.  On 19 Feb2021 2021, the 16 year old patient received the first of the two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly in the anatomical location in the for prophylaxis of COVID-19 infection.  The pharmacy has shared with them that he can no longer receive his second vaccine due to their error.   The patient's mother seems very interested in him getting his second vaccine and has asked to please let her know how this can be resolved Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was considered as recovered or resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) and vaccination error for mRNA-1273 (lot number unknown) with no associated AEs reported.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. The patients' demographics, concomitant medications, pertinent medical histories and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024252, expiry date 30-JUN-2017; lot # M006729, expiry date 08-FEB-2018; lot # M017292, expiry date 07-APR-2018; lot # M025869, expiry date 24-MAY-2018; lot # M032494, expiry date 06-JUL-2018; dose and route of administration were not reported) for prophylaxis. The doses of the vaccine were exposed to a temperature excursion of -4.8 degrees Celsius for a time frame of 1 hour 20 minutes (date unspecified). A digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA008843.
The patient developed redness at the injection site that began to spread down the arm and torso. She used diphenhydramine and said that she was given an oral and topical steroid
Patient received Hep A #1 4-25-14. Well appearing. T.C. from patient 4 days later 4-29-14 reporting he felt sluggish/fatigued. Said he did not think he should have received vaccine due to adverse response to topical NEOSPORIN age 5 (inflammation at site) denies severe allergic rxn then or now. Appointment offered - he declined. Called pt next day - feels little more rested - offered allergy appoint - let him know GlaxoSmithKline pharmacist consulted.
brain fog; "tipsy", floor appears to move; difficulty standing; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 15Apr2021 10:45 (Batch/Lot Number: EWO169) as SINGLE DOSE for covid-19 immunization. Medical history included vestibular disorder from an unknown date. Concomitant medications included insulin (INSULIN), lisinopril (LISINOPRIL), acetylsalicylic acid (ASPRIN), lysine (LYSINE), ibuprofen (IBUPROFEN) and simvastatin (SIMVASTATIN) all taken for unspecified indications, start and stop dates were not reported. The patient previously took gabapentin and experienced drug hypersensitivity. The patient experienced brain fog, "tipsy", floor appears to move and difficulty standing on 15Apr2021 10:45. It was reported that the events resulted in Disability or permanent damage. Outcome of the events was not recovered.
Ringing in ears. I am not sure what time I noticed it but definitely started the day after I received the vaccination.  I am contacting my doctor today.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable pharmacist (Patient's mother) via medical information team. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 20Sep2021, the patient had tested positive for covid, the event was medically significant and on an unspecified date in Sep2021 she experienced febrile. Patient has not received second dose. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive on 20Sep2021. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events  Drug Ineffective and COVID-19 and the suspect drug BNT162B2.
This nurse did not administer the vaccine. The vaccine was administered. The age of the client was identified as under 18 years of old after the vaccine was given.
recovering from covid / had both shots/ i thought pfizer would want to know that i still got it; recovering from covid / had both shots/ i thought pfizer would want to know that i still got it; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  An 82-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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "recovering from covid / had both shots/ i thought pfizer would want to know that i still got it".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Received Johnson & Johnson vaccine at  pharmacy on Friday April 9, at 8 am.  Injection in left arm.  Mild flu like symptoms Friday night and most of day Saturday.  Symptoms dissipated over the day Sunday.  Monday received my weekly allergy shot and exercised for first time.  Headache returned Monday evening.  Took some Tylenol.  Awoke at 2 am with tinnitus in both ears.  Mostly in left.  Never experienced before.  Scheduling appointment with ENT.  Very concerned.
Patient "near-syncopal" per EMS. Patient stated light-headed, nauseated. EMS stated patient pale. Vitals monitored by EMS in post vaccination waiting area. Patient then stated that he was feeling better. Patient released to go home in personal vehicle with spouse driving.
fatigued; super achy; my first was horrible, still looks awful red; burning; itching; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th September 2022, the patient received the 1st dose of Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced fatigue, pain, erythema, burning sensation and pruritus. On an unknown date, the outcome of the fatigue, pain, erythema, burning sensation and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, pain, erythema, burning sensation and pruritus to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-September-2022 Reporter's comment: This case was reported by a patient via interactive digital media Patient reported that first dose was horrible everyone had shingles recommend even had reactions Patient still thinking whether second would be worse. On Saturday patient experienced awful red, burning and itching reactions. Patient was unsure about the second shot of vaccine. Patient's husband was in good health as his arm did not even turned red. Patient reported feeling super achy and fatigued.; Sender's Comments:  US-GSK-US2022AMR139374:same report, other patients
WAS FINE AFTER SHOT, SOAR ARM AND TIRED.  IN EARLY MAY NOTICED MY LEFT SIDE OF FACE WAS NOT ABLE TO MOVE, SEEMED DROOPY.  I WAITED TO SEE IF THE SYMPTOMS WOULD GO AWAY.  ON MAY 28, WENT TO ER.  MY BLOOD PRESSURE WAS HIGH AND ALSO MY SUGAR WAS ALSO HIGH.  THEY BELIVED I HAD BELLS PALSY.
shingles; shivering about 4  5 hours after injection; muscle pain; pain at the  injection site/enderness at the injection site; redness at the injection site; pain on his legs; flu like symptoms; overall skin hurt; low grade fever of 99.9 degrees; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. On 18th November 2019, 4 hrs after receiving Shingrix, the patient experienced shivering, muscle pain, injection site pain, injection site erythema, leg pain, influenza-like symptoms, skin pain and low grade fever. On 27th November 2019, the patient experienced shingles. In November 2019, the outcome of the muscle pain, injection site pain, injection site erythema, leg pain, influenza-like symptoms, skin pain and low grade fever were recovered/resolved. On 18th November 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the shingles was recovered/resolved.   The reporter considered the shingles to be unrelated to Shingrix. It was unknown if the reporter considered the shivering, muscle pain, injection site pain, injection site erythema, leg pain, influenza-like symptoms, skin pain and low grade fever to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had shingles.That was the first time he developed shingles. He realizes that it's unrelated to vaccination. He also experienced shivering about 4 to 5 hours after injection and it lasted about an hour. When he got up the next morning he felt better from the shivering. The patient also noticed the following symptoms the day of the injection muscle pain, pain at the injection site, tenderness at the injection site and redness at injection site, pain on his legs, flu like symptoms, his overall skin hurt, low grade fever of 99.9 degrees. All the symptoms lasted about 24 hours. The reporter consented to follow up.
Arm swelling; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after receiving older Shingrix vaccine experienced swelling in her arm. The patient stated that the older vaccine caused her arm to swell to three times its normal size. This case has been linked with US2019117626, reported by the same reporter.
aches and pains; nausea; some confusion; the patient woke up in the middle of the night on 20Jan; This is a spontaneous report from a contactable consumer  A 79-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on  19Jan2021 in the left arm at 18:00 at SINGLE DOSE for covid-19 immunisation .  Age at vaccination: 79 Years. Facility where the most recent COVID-19 vaccine was administered:Public Health Clinic.The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included history high blood pressure, covid-19 (covid prior vaccination: Yes)  and the patient has a pace maker.  Concomitant medication included hydrochlorothiazide, losartan potassium (HYZAAR), carvedilol (COREG), acetylsalicylic acid (ASPIRIN ,  colecalciferol (D3 VITAMIN).  The patient experienced Sleeplessness on 20Jan2021, Ache , nausea and confusion on 21Jan2021 02:00.Clincal course reported as follows: the patient woke up in the middle of the night on 20Jan with aches and pains, nausea and some confusion, confusion resolved in 15 min, tylenol administered for aches and pains, no issues when patient woke up in the morning.All events reported as non serious . The patient was recovered from confusion on 21Jan2021, while the outcome of the other events was recovered on unknown date .Since the vaccination, the patient had not been tested for COVID-19 information on the lot/batch number has been requested
arm soreness; headache for 7 hours following injection; lethargy following morning; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247), via an unspecified route of administration administered in arm right on 28Jan2021 11:15 AM as single dose for COVID-19 immunization. Medical history was reported as None. No Other vaccine in four weeks. Patient was not pregnant at time of vaccination. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. Concomitant medication included ibuprofen for about two weeks. On 28Jan2021 11:30 AM, the patient experienced arm soreness, headache for 7 hours following injection, lethargy following morning. No treatment for adverse events. The outcome of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
3/13/09, fever 104.5, poor appetite, sleeping 21 hours/day. Fever controlled with TYLENOL and MOTRIN to 100-102 degrees. Afebrile 3/15/09, continued sleeping 18-21 hours/day.
Call to pt, B12 was wnl. She received pneumonia vaccine last week. She had what she describes as an allergic reaction. That afternoon, several hours after getting the injection, she noticed that her right arm was getting sore, which got progressively worse as the day progressed. She took some ALEVE and applied a cold pack. The next am, she had to travel, and noticed that her right arm at injection site started to swell and feel warm to touch. She consulted with nurses/MA's in her family, and they advised her to wrap and hot pack it. When this did not produce relief, she went to urgent care that day. She was told that because she was taking ALLEGRA, SINGULAIR and ALEVE and continued to have reaction, she should be rx'd prednisone and VISTARIL. Her arm is much better since starting these medications. She was told to check the solution ingredients - which I read to her from the insert. She has not had vaccine reaction in the past. She has tolerated flu vaccine in the past. She asked for the lot # and manufacturer and requests a copy of the insert be mailed to her. Added to allergy list. I will report reaction per office policy (reported to supervisor and called the Vaccine Hotline).
Incorrect diluent volume was mixed (the vial contents were diluted with a diluent volume of 0.8 mL instead of 1.8 mL), but a 0.3 mL dose was still administered. We have already talked to Pfizer-BioNtech. They told us that if the dose given in error is the first dose, a second should dose should be administered at the recommended interval of 21 days. If the dose given in error is the second dose, the series is complete, and no additional doses are needed. We have already informed the patients of the potential for local and systemic adverse events.