chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Itching at Injection Site-Mild, Systemic: Complained of \" tingling all over \" at 5:25 PM-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Complained of tingling approx 15 minutes after the injection. No rash noted. Stated some brief itching on left forearm, no rash noted. Refused Benadryl, stated he would  take some at home. Vital signs at 5:30 PM, T 96.2, P 64 Regular, R 18, BP 128/80. No stridor, Vital signs at 5:53 PM, T 96.6 temporal, P 64 regular, R 20, no stridor, BP 110/80, no rash, went home at 5:55 PM. Stated he would take some Benadryl at home. Advised to pull over and dial 911 if any signs of respiratory distress/shock
MMRV and Varicella administered. MMRV should have been MMR. Follow up call made in afternoon by RN, mother stated child/patient is doing fine. Appointment scheduled for Hep A in 5 weeks at time of phone call.
ARM WAS SORE FOR A DAY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: esketamine hydrochloride ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the subject experienced arm was sore for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore for a day. This report was non-serious.
This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A female patient received the 4th dose (second booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jul 6, 2022, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st, 2nd and 3rd dose (first booster) of the COVID-19 vaccine (primary immunization series complete, manufacturer unknown), for immunization. The patient had fatigue/very tired, with outcome of not recovered. Additional information: The patient received her 2nd booster shot on Jul 6. She was still very tired and fatigued. She wanted to know if this was normal? The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
INCORRECT PRODUCT STORAGE; PATIENT RECEIVED THE JANSSEN COVID-19  VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF  EXCURSION.; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 17-FEB-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 17-FEB-2022, the patient experienced patient received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649704, 20220649370, 20220650014, 20220649804, 20220649045, 20220650111, 20220649488, 20220649417, 20220649421, 20220649137, 20220649884, 20220649803, 20220649626, 20220650185 and 20220650933.
Injection area became red and swollen to size of golf ball. Patient has a fever going on 3rd day.
Headache, Myalgia, Arthralgia, Fever, chills, brain fog Narrative:
This patient was provided 0.2 cc of an adult Pfizer vaccine in error. They should have been provided a 0.3 mg dose instead. Staff member previously drew up pediatric Pfizer vaccine, which required different types of reconstitution than the adult Pfizer vaccine. Although, the correct amount of saline was used to dilute the vaccine, the incorrect dose was given to the patient. The staff who drew up the vaccine did not give the patient their vaccine. They should have drawn up the complete amount before providing them to staff for use. These patients were contacted to receive a replace full dose per guidelines.
Notice redding in arm and as the day went on the red spot raised up and was hot. Applied ice pack off and on. I also discovered a lump in my left breast. I had a mamogram in Sept 2020 and nothing was detected.  On October 01,2020  I had surgery on my left arm on my rotator cuff . On 02/22/2021 I saw my primary doctor regarding the lump he indicated that he didnt think it was caused by the injection. I saw him on 01/21/2021 for a physical and didnt notice any lump. I dont know how much of this is associated with the vaccine but wanted to make awareness.
Severe unknown neurological illness, including the following symptoms: dizziness/vertigo, intense visual disturbances, nerve pain within the legs, trouble walking off and on, muscle/bone aching within legs, fatigue and tremors.
This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unknown date, the patient developed shingles after being administered the ZOSTAVAX. At the time of the report, the outcome of shingles was unknown. The reporter's causality assessment between the shingles and the ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
First week of April, patient noted itching on top of both feet with pink discoloration. Then moved up to the outside of both knees where pink circle developed and itching. Then moved up to both arms all over, tops of hands, elbows. Finally moved up to her scalp. Still reports experiencing itching on both elbows.
(ADMINISTRATION ERROR *  49 Y/O MALE RECEIVED SECOND BOOSTER DOSE (PFIZER) BEFORE 50 YEARS OF AGE, RECOMMENDED BY CDC
There was itching and warmth at the injection site initially. Dizziness was noticed two times that week.  The itching continued and became increasingly worse.  Then, in addition to the moderate itching, there was a welt, swollen with redness and warm to the touch.  The welt grew in size.  Treatment included going to an Immediate Care where I received a steroid injection, steroid cream and a Medrol pack.
100F fever; very dizzy; nausea; strong headache; body ache (all muscles); body ache (all bones); This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 03Jun2021 at 09:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 13May2021 at 09:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Jun2021 at 20:00 the patient experienced 100F fever, very dizzy, nausea, strong headache, body ache (all muscles, all bones). On 03Jun2021, the patient checked body temperature and the result was 100F fever. The clinical outcome of the events 100F fever, very dizzy, nausea, strong headache, body ache (all muscles, all bones) was recovered with sequelae on 06Jun2021.   No follow-up attempts are possible. No further information is expected
PATIENT FACE TURNED RED shortly after receiving Pneumovax 23. Patient breathing and heart beat were normal. So I provided patient with Benadryl 50 mg and instructed her to wait longer in lounge. 10 minutes later patient reaction was worsening, both face and neck were getting more red. So I gave the patient some cold pads to apply on her face and neck. Ten minutes later patient was somewhat stable, no swelling or difficulty breathing. Another pharmacist followed up with patient and gave her 2*25 mg capsules to take one while waiting in store and take the other 6 hours later. Patient showed up in store next day and she did not have any allergy symptoms.
Fever with temp high of 102.1 and Rash (Generalized red raised rash covering body and face. Consisting of both confluent and discrete spots).
Patient has large itchy red rash on left side of lower back approximately 6-8 inches square. Patient stated it had been warm and"burning "at one point. The rash started at approximately 8:30 am today, 5-14-21.
The evening of the first shot- mild to moderate lower back and sciatic nerve pain. The evening of the second shot- severe lower back and sciatic pain with numbness wrapping around left leg.
Three hours after injection, developed itching all over body.  This is despite the fact I had taken 50 mg of Benadryl and a 24 hour Allegra and Pepcid prior to the appointment per family doctor's instruction.  Took additional 50mg of Benadryl six hours after the first dose.  This stopped the itching for several hours, but about 1:00 a.m. itching returned.
I was diagnosed with Diabetes on 01/25/2022. I didn't have symptoms but it popped as a diagnosis after having bloodwork at a routine annual exam. I was prescribed metformin and, when I went for a 3 month checkup, my bloodwork showed the metformin was not working as well as it should. So, she increased the dosage.
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GH9694) for 1 day for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for 1 day 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: she mentioned her son had COVID-19.  Clinical course: The reporter stated her son received today a dose of the Pfizer COVID-19 vaccine and wanted to confirm he received the Bivalent. Lot number provided was GH9694. After confirming with caller that indeed it was for the Bivalent, she mentioned her son had COVID-19.
13 day post receiving the 1st Prevnar vaccine, patient broke out with moderate erythema multiforme type of rash.
- Patient was seen by cardiology for palpitations and SOB and was diagnosed with pericarditis.
9 days after vaccine administered, I developed Covid Arm at the site.  Itchy rash.  It is still there 4 days after onset.
little tiredness; little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little tiredness) and VACCINATION SITE PAIN (little soreness at the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (little tiredness) and VACCINATION SITE PAIN (little soreness at the injection site). At the time of the report, FATIGUE (little tiredness) and VACCINATION SITE PAIN (little soreness at the injection site) 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.
3/2/21-Low grade fever and headache. 3/3/2021-Itching covering entire body started around 7PM.  3/5-Hives started on face. 3/6- Injection site remained swollen, red, warm and firm to the touch. From 3/6-Present had hives moving all over body. Intense itch/burn at times that have been painful. Have been prescribed Atarax 25mg (3/6/2021) and  increased to 50mg 3/10/2021, 7 day Medrol Dose Pak(3/10/2021), and a steroid injection (3/18/2021). As of today (3/24/2021) there has been no resolution. Hives continue to move over body, intense itching, and some pain.
pt recvd vax & had flu like symptoms next am; tired; edema & redness down right arm fr deltoid inject site;
Left arm sore for 2 days, headache for a day, body chills for 24 hours, low grade fever for 1 day, muscle soreness for 2 days.
Patient woke up with fever of 102 degrees F, severe body aches, and weakness, with intermittent dizziness.  After Tylenol and rest, the fever dropped to 101 degrees, but again went up to 102 after a few hours.  Around 1:00 PM, Advil was taken, and temperature dropped to 99 degrees.  By approximately 5:00 PM, temperature was back to 102 degrees.  Other symptoms persisted throughout the day.  The next day, 09/29/2016, the patient woke up at 5:00 AM with a fever of 102 degrees, and continued aches and weakness.  Around 7:30 AM, patient noticed a large, raised, red bump that was hot to the touch, approximately 2 inches below the injection site and the size of a golf ball.  Fever went down with Advil, and began to raise back to 101 degrees around 1:00 PM.  The red lump continued to spread, now to the size of a large softball.  Patient returned to the doctor at 3:00 PM, where temperature was 101 degrees.  Doctor recommended icing the arm and monitoring to see if it spread.  Blood was drawn to determine if infection was present.  On Friday, 09/30/2016, patient woke up at 5:00 AM to a normal temperature but weak.  The rash had spread very little but began to itch.  As of today, patient is waiting to hear back from the doctor as to whether an allergy pill may help.
I had fuzzy throat and cough with fatigue from 01/05 and went to get a COVID test 01/14. This came up positive and because the cough persisted until after my quarantine, I went to see my doctor. At the doctor's office on 2/22 I had an x-ray (normal), blood work (normal) and COVID test. The doctor called it a "viral cough" and was given prednisone and a albuterol inhaler. It took until mid-March for my fatigue and cough to break. I have recovered and no other maladies.
Hive - 36 h after first vaccine dose, mild hives on arms/legs. Resolved with oral Benadryl.
Injection site has developed a raised welt and very itchy.  Noticeable increase in fatigue
Starting 6 hrs post immunization, pt has urticaria on trunk and extremities and face, no breathing issues, examined 24 hr later still had scattered urticaria, no joint swelling no mucosal.
This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a(n) 27-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Left arm pain when moving arm over your head. Hives to body. Cellulitis to left foot and ankle.
The shingles shot gave me the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and gave him/her the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Headache, Fever, NauseaVomiting, FATIGUE Narrative:
the patient developed redness, swelling and tenderness at the site of VARIVAX injection; the patient developed redness, swelling and tenderness at the site of VARIVAX injection; the patient developed redness, swelling and tenderness at the site of VARIVAX injection; a patient received a dose of VARIVAX via the intramuscular route; This spontaneous report was received from a registered nurse, concerning a none pregnant 23 -years-old female patient. The patient had none medical history, concurrent conditions, drug allergies or reactions. Her concomitant therapies included vitamins (unspecified) and hormonal contraceptives (unspecified).  On 25-OCT-2019, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, intramuscularly (incorrect route of product administration), to prevent chickenpox (lot number S007076 with expiration date on 10-MAR-2021).  On 26-OCT-2019, the patient developed redness (injection site erythema), swelling (injection site swelling) and tenderness (injection site pain) at the site varicella virus vaccine live (Oka/Merck) (VARIVAX) injection. The patient sought medical attention (reported as patient called the physician). However, no laboratory diagnostics or studies were performed, and no treatment was given for the adverse events.  On 28-OCT-2019, the patient recovered from the events redness, swelling and tenderness at the injection site.  The causal relationship between the aforementioned events and therapy with varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Red and hot rash, felt sick to her stomach the day after receiving the immunizations. These symptoms lasted about 3 days.
Pt. had a 2 day history of fever and upper respiratory systems and presented to the emergency department with signs of shock (cyanosis, decreased perfusion).  Responded to fluid resuscitation and was started on Cefotaxime and admitted to the Ped. ICU for a sepsis work up.  Currently afebrile and doing well.  Nurse follow up on 08/30/04 states: "Complete."
numbness of left side of face, involuntary  twitching/jerking movements of the whole body.
1:30 pm after shot at 11:30  heart started to beat rapidly and erratic. Wouldn?t stop after an hour. Went to emergency part of hospital. Took ekg, drew blood to see if anything was not correct, had chest X-ray. All came out fine  except ekg. Did not settle down.  ER doctor called my doctor and he said other AFib patients have had this happen also. Er doctor agreed with my doctor. Also had no chest pains or shortness of breath or dizziness. Told to take Tylenol for a couple days and was released. The erratic and fast pace of my heart has eased some but still persists.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown) On 04-JUN-2009, patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 663710-0219Y expiry date: 13-FEB-2011. No adverse effect were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received Pfizer COVID vaccine on 5/24/21 and 6/15/21. On 8/10/21 patient began to develop symptoms of GI upset and subjective fevers and chills.  Patient  then had progressive respiratory distress and therefore seen at ED on 8/20/21 with thrombocytopenia and positive COVID status. Patient discharged in stable condition.  Patient was called at home and told to present to the ED  (our facility) for infusion of REGEN-COV (which was completed).  However patient was noted to be shaking with chills, afebrile, mildly tachypneic.  And upon further evaluation was noted to be satting as low as 89% on room air about exertion.  Patient also required 2 L nasal cannula to maintain ox saturations greater than 94%.  Patient admitted to our facility for acute hypoxic respiratory failure secondary to COVID-19 pneumonia on 8/23/21. As of today (8/31/21), patient is still in the inpatient setting.