chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a new pediatric nurse administered IMOVAX subcutaneously instead of intramuscularly with no reported adverse event; Initial information received on 03-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient  and it was reported that  a new pediatric nurse administered imovax subcutaneously instead of intramuscularly with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-JUN-2022 , a new pediatric nurse administered imovax subcutaneously instead of intramuscularly with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of RABIES (HDC) VACCINE. The patient received a 1 ml dose of suspect RABIES (HDC) VACCINE, once, ( lot : U1D852M ; expiry date: 31-Aug-2023) via subcutaneous route in unknown administration site for immunization.   Action taken: not applicable.  Outcome: unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Day 0: Vaccine given at ~9:00am. Mild sore arm. Starting 10:30pm, intense chills and shaking. Day 1: Woke up no longer feverish. Moderate mental and physical fatigue. Day 2: Woke up around 7:30/8:00am with moderate to intense pain in the heart area. Patient is unsure if myocarditis or pericarditis, but "it felt like my heart itself was being squeezed, like it was about to explode from the pressure". Heartbeat not abnormally fast, but felt pounding. It felt like I couldn't get as full of a breath. Patient elected not to take methylphenidate that day due to it being a stimulant and concerns about it worsening the intense heart symptoms and patient skipped work due to not feeling safe to drive or walk around. Patient slept most of the day, monitoring heart rate and focusing on breathing as normally as possible. Pain dissipated starting at 9pm that evening. Day 3: No symptoms other than mild lingering fatigue. Day 4: No symptoms.
paresthesia, moderate; This is a spontaneous report from a contactable other hcp (patient). A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0142 and expiry date: unknown), dose 2 via an unspecified route of administration on 18Jan2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient received first dose of bnt162b2 on 28Dec2020 at 08:00 AM for covid-19 immunisation (Lot No: EH9899, Administrator route: Intramuscular, Vaccine location: Right arm). Medical history included sinusitis and seasonal allergy. The patient had no known allergies. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced paresthesia, moderate on 31Jan2021 at 12:00. The patient experienced event at doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not take treatment for the event. Outcome of the event was not recovered.  No follow-up attempts are possible; No further information is expected.
First Paralysis legs 09/15/22, 12 hrs, function returned to legs Grand mal seizure 1 hr at home, grand mal seizure in ambulance 10/31/22 Second Paralysis legs, 12 hrs in hospital, kept in hospital for test
a huge hives adjacent to the injection 2 inches long and 1.5 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (a huge hives adjacent to the injection 2 inches long and 1.5 inches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (a huge hives adjacent to the injection 2 inches long and 1.5 inches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE URTICARIA (a huge hives adjacent to the injection 2 inches long and 1.5 inches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PATIENT MENTIONED SHE WAS NERVOUS, I MADE SURE SHE WAS BREATHING REGULARLY AND NOT HOLDING HER BREATH. AFTERWARDS HAD HER SIT IN WAITING ROOM FOR THE 15 MINUTES. AFTER A COUPLE OF MINUTES SHE APPROACHED COUNTER AND SAID SHE WAS NOT FEELING WELL, I HAD HER SIT BACK DOWN, HAD MY TECHNICIAN CALL 911, AND RETRIEVED THE EPI-PEN. AS I WAS APPROACHING HER SHE SLUMPED OVER. I TRIED TALKING TO HER, THERE WAS NO RESPONSE AND WAS TURNING PALE. I ADMINISTERED THE EPI-PEN AND WITHIN A FEW SECONDS SHE WAS RESPONDING. THERE WAS A NURSE IN THE STORE WHO BEGAN MONITORING THE PATIENTS HEART RATE AND BLOOD PRESSURE. THE PATIENT WAS TALKING TO US BUT STILL NOT FEELING WELL. A COUPLE MINUTES LATER THE EMS ARRIVED AND TOOK HER TO THE HOSPITAL
I had overall pain and low fever (100's F). Pain in my joints, fatigue, Felt very tired. After 4 weeks my right wrist was swallow. Called the doctor and told her about my condition and had difficult time concentrating. He gave me another medicine for the pain. Still have the pain. Contacted a Primary Care Doctor and gave pain medication (Midodrine).
This spontaneous report was received from a male patient of unknown age. On an unknown date in SEP-2013 (reported as last Wednesday), the patient was vaccinated with ZOSTAVAX, (lot number, expiry date was unknown). On an unknown date, the patient experienced side effects. The outcome of side effects was unknown. Additional information is not expected.
hives; nausea; diarrhea; vomiting; she felt this was an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 28 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown, Dose number: 1), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "she felt this was an allergic reaction".  Additional information: This patient received the second dose of the adult Pfizer COVID-19 Vaccine last year and experienced side effects 2 days later. The symptoms were hives, nausea, diarrhea and vomiting, then the caller added that she felt this was an allergic reaction. Caller's inquiry was if the booster dose of the Pfizer COVID Vaccine would be recommended after her patient suffered this side effects.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a medical assistant referring to a currently 62 year old (also reported as a 33 years old) male patient. The patient's concurrent conditions included diabetes and Crohn's disease. He was allergic to metformin, WELLBUTRIN, hydrochlorothiazide and acetone. No concomitant therapies or medical history was provided. On an unknown date (when he was 15 month old), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) subcutaneously (lot number, dose, recombinant human albumin (HSA), expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). The lot number and expiration date of the sterile diluent (manufacturer unknown) used for reconstitution was unknown by the reporter too. On an unspecified date in 2017 (reported as ''recently''), the patient experienced measles antibody negative, rubella antibody negative and mumps antibody test negative as he drew MMR titers and they were negative for immunity to measles, mumps, and rubella even though it was "likely that the patient received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine when he was a child". It was reported that the immunization status of the patient was not known or which MMR vaccine he received. The outcome of the events was reported as not resolved and no additional information provided. No treatment was given to the patient due to the events. The reporter did not assessed the causal relationship of the events and the M-M-R II vaccine.
Having rashes all over the body (It started in my face, around my ears and neck. Now it is on my arms, stomach and legs); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Having rashes all over the body (It started in my face, around my ears and neck. Now it is on my arms, stomach and legs)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced RASH (Having rashes all over the body (It started in my face, around my ears and neck. Now it is on my arms, stomach and legs)). At the time of the report, RASH (Having rashes all over the body (It started in my face, around my ears and neck. Now it is on my arms, stomach and legs)) outcome was unknown.            No concomitant medication were reported.  Patient stated having rashes all over the body. It started on face, around ears and neck. Now it is on arms, stomach and legs. The symptoms started about a week ago. The patient took pain pills only.
Sharp pain in left shoulder blade; gradually became weakness & tingling in left arm & hand; Tingling in left arm & hand; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 04Mar2021 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol and the patient's family had plenty of unspecified medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included testosterone (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE) and unspecified antihistamine; all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 04Feb2021 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced sharp pain in left shoulder blade, gradually became weakness and tingling in left arm and hand. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sharp pain in left shoulder blade, gradually became weakness and tingling in left arm and hand was not resolved at the time of this report.
Pt started with redness and pain in the left upper arm was diagnosed with Cellulitis on 7/26/2017 was prescribed BENADRYL 25mg 2 tabs every 8 hrs x 10 days, Ibuprofen 400mg 1 tab every 6 hrs x 10 days, and BACTRIM DS 800-160mg 1 tab twice a day x 10 days.
Testicular pain on left side after exposure to COVID vaccinated individuals, often severe. This has happened over a dozen times, pain disappearing for weeks then coming back within a day of exposure to COVID vaccinated.
Approximately 15 minutes post vaccination at 1155 client complained of throat tightness and swelling, at that time client received 0.5mL 1:1000 aq. epinephrine IM LVL and 50mg Benadryl IM RVL, oxygen applied via NC at 2L, transported to ER for evaluation at 1200-patient A+O x 4 and vital signs stable during episode. Care handed off to ER staff, patient received Prednisone 60mg in ER and observed for 2hrs, discharged at 1400 with RX for prednisone, ER physician advised follow up with PCP for 2nd dose of COVID19 vaccine for pretreatment with prednisone and Benadryl prior to receipt of vaccine.
Body aches; Fever; Chills; Sore arm; Diarrhoea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN), both from an unknown dates for an unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 04Mar2021 at 16:45 (at the age of 54-year-old) 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 diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 11:00 after the second dose of vaccination, the patient experienced fever, chills, body aches, sore arm, diarrhea and headache. The patient did not receive any treatment for the reported events. The clinical outcome of the events of fever, chills, general body pain, pain in arm, diarrhea and headache was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 19-DEC-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Headache; Fatigue; Nausea; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 10:30 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced headache, fatigue, nausea and chills. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fatigue, nausea and chills were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
32yo pt went to ER w/a cut finger; no sutures required but was given TTOX & six hrs later had a seizure (observed by family member); required ER visit;
Pt stated he had body aches, headache, chills, neck and back pain, redness, warmth, and pain at injection site.
No symptomatic side effects; Inbound call from HCP stating that a patient was inadvertently administered PNEUMOVAX 23 past it's expiration date.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 25-APR-2023, the patient was inadvertently vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (formulation prefilled syringe, 0.5 mL, lot #U026796, expiration date 28-JAN-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No symptomatic side effects reported during time of a call. No additional adverse event (AE) details or product quality complaint (PQC).
1 day later under arm pain on arm with injection site started. Pain described as shooting rated at a 8. Take ibuprofen/APAP prn Went to see physician for other complaints and mentioned it, but nothing was done at that time. lasted approx 2 weeks and abated at that time. Week of second vaccine (2/9/21) pain started prior to receiving second injection (which was given in the right arm rather than the left) at the current time pain is still occuring. Has not sought medical care directly related to this complaint currently.
pt recv vax & "thinks" is preg;LMP was 7/25/98;estimated date of delivery 5/1/99;f/u recv indicated fetus was found to have trisomy 18 at 31 wks gestation;preg terminated 3/13/99;
Received Fluzone 0.5 ml IM (L) thigh on 9/18/20.  Mom reports that night Fever 101 degrees and redness & swelling around shot site. Mom called office 9/24 states she looks fine now. Temp was 99-100 over  weekend 9/19 - 9/20. Fever gone 9-21 PM.
couldn't eat or taste; arm swollen the size of a cantaloupe; felt like she had covid; out of breathe; couldn't walk; excruciating pain in feet and hands; shoulder feels heavy; shoulder feels like bumblebees are inside; chills; muscle pain in right shoulder; fever; head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (head cold), AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid) and DYSPNOEA (out of breathe) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, VITAMIN D [VITAMIN D NOS] and BIOTIN for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced NASOPHARYNGITIS (head cold). On 30-Apr-2021, the patient experienced AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid), DYSPNOEA (out of breathe), GAIT DISTURBANCE (couldn't walk), PAIN IN EXTREMITY (excruciating pain in feet and hands), MUSCULOSKELETAL DISCOMFORT (shoulder feels heavy), MUSCULOSKELETAL DISCOMFORT (shoulder feels like bumblebees are inside), CHILLS (chills), ARTHRALGIA (muscle pain in right shoulder) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 02-Apr-2021, NASOPHARYNGITIS (head cold) had resolved. On 05-May-2021, AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid), DYSPNOEA (out of breathe), GAIT DISTURBANCE (couldn't walk), PAIN IN EXTREMITY (excruciating pain in feet and hands), MUSCULOSKELETAL DISCOMFORT (shoulder feels heavy), MUSCULOSKELETAL DISCOMFORT (shoulder feels like bumblebees are inside), CHILLS (chills), ARTHRALGIA (muscle pain in right shoulder) and PYREXIA (fever) had resolved.            This case was linked to MOD-2021-201287 (Patient Link).