chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose received at 4 month age and 3rd dose at 7 month age; 1st dose pediarix and 2nd dose pentacel 3rd dose pediarix 4th pentacel; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 7-year-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included PENTACEL for prophylaxis and PENTACEL for prophylaxis.   Previously administered products included Pediarix  (1st dose received at the age of 2 months).   On an unknown date, the patient received the 3rd dose of Pediarix, the 4th dose of PENTACEL and the 2nd dose of PENTACEL. On an unknown date, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received at 4 month age and 3rd dose at 7 month age) and interchange of vaccine products (Verbatim: 1st dose pediarix and 2nd dose pentacel 3rd dose pediarix 4th pentacel). The outcome of the drug dose administration interval too long and interchange of vaccine products were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 26-JUL-2023 The reporter was the medical assistant. The reporter reported that the patient received first dose and third dose of DTaP vaccine was Pediarix at the age of 2nd and 7th month. The reporter stated that the patient received 2nd and 4th dose of DTaP vaccine was pentacle at the age of 4th and 9th month. The patient received 5th dose of DTaP at the age of19 months of unknown brand name. The 5th DTaP dose was administered then because the 4th dose of DTaP the Pentacel vaccine was early and needed to be repeated.  Boostrix was intended to be administered as a catch-up 5th dose. The patient received 3rd dose of Pediarix late than recommended time frame, which led to lengthening of vaccination schedule. The patient was administered with Pediarix vaccine after Pentacel, which led to interchange of vaccine products.
Female Breast Cancer; Migraines; Pain on right side in rib area; Hard to catch breath at times; FACILITATED COLLECT NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not provided). The reporter is the patient. Other Case identifier(s): 21K-163-4209745-00 (AbbVie).  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01May2021 (Batch/Lot number: unknown) at the age of 74 years as dose 1, single and intramuscular, administration date 28Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: BREAST CANCER FEMALE (medically significant) with onset 2021, outcome "not recovered", described as "Female Breast Cancer"; MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "Migraines"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain on right side in rib area"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Hard to catch breath at times". The action taken for adalimumab was unknown. Clinical course was reported as the patient had places on scalp, migraines, breast cancer, had a lot of pain on the right side in rib area, hard to catch her breath at times. Patient agrees to have MD contacted. No concomitant drugs taken. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Female breast cancer, Migraines, Pain on right side in rib area and hard to catch breath at times was not provided. AbbVie's opinion (causality as per Mfr.) is that the event of Female Breast Cancer is not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of Migraines, Pain on right side in rib area and hard to catch breath at times are related to Humira (Adalimumab).  The reporter's causality for the event(s) of Female breast cancer, Migraines, Pain on right side in rib area and hard to catch breath at times to BNT162B2 was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events reported and the suspect drug BNT162B2 is assessed possibly unrelated The case will be reassessed once new information is available.
Patient was nauseous and lightheaded. After 15 minutes patient felt better and left pharmacy. Feels well. Next day - patient follow up - said she is well. Possible anxiety driven symptoms.
Patient described scratchiness to throat and observed a flat red rash on bilateral upper arms and chest shortly after vaccination.  VS BP 122/99, P 72, R 20 . Administered 50 mg Benadryl PO . Rash subsided and patient stated she felt better and had no difficulty breathing  50 minutes post vaccination.  VS at release from clinic BP 118/84, P 72.
12/13/21 presents to ED for "breathing problem". PMHx of "hypertension"
patient received an expired dose of TENIVAC with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional (Reference number- 00572564) and transmitted to Sanofi on 22-Apr-2021.  This case involves a female patient with age 65 or above who was administered with 0.5 mL expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA and expiry date: 19-Apr-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 21-Apr-2021.   Medical history, past medical treatment(s), past vaccination(s), concomitant medication and family history were not provided.   It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter wanted to know if there is a grace period?   At the time of reporting, the patient experienced no specific adverse event.   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.
Dizziness within 10 minutes, but that passed after an hour. The main concern was extreme fluttering heart and rapid heart beat within 3 hours of shot and lasted for several hours, but eventually passed as well.
exp high pitch screaming reaction x 10 hrs of duration; Incident occurred 1 hrs p/vax was given on 12AUG92; also had fever of 102 x 4 hrs;
My left should and upper arm, started becoming sore and stiff the same evening I received the injection which was on a Friday and by Sunday my arm was very painful and I could not move my arm in any direction. Dr. diagnosed it as being a frozen shoulder due to the injection being improperly administered. Currently going through 8 weeks of physical therapy and if my arm and shoulder haven't had significant improvement by the end of June, I may have to have surgery. Constant pain every day now for 3 months, can't sleep well as pain keeps me up at night, difficulty getting dressed and undressed, driving a car and doing my hair, can't lift anything and every time after therapy I suffer from severe pain for two to three days after.
Premature ventricular contractions that lasted two to three days; Dose received: 3/ Dose number=3,; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 32-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 24Nov2021 at 15:00 (Lot number: FJ1620) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8731, Anatomical site: Left arm, Administration time: 15:00), administration date: 20Apr2021, when the patient was 32 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0182, Anatomical site: Left arm, Administration time: 14:00), administration date: 12May2021, when the patient was 32 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 at 15:00, outcome "unknown", described as "Dose received: 3/ Dose number=3,"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 01Dec2021 at 13:00, outcome "recovered" (an unknown date in Dec2021), described as "Premature ventricular contractions that lasted two to three days". Therapeutic measures were not taken as a result of ventricular extrasystoles.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Headache, Sedation, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, chills and fatigue. pain at the injection site.
Splotch pox-like blistery (non-painful) sore on nose; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 18:30 (Lot number: EP6955) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "celiac disease" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; WELLBUTRIN; ESCITALOPRAM. The following information was reported: BLISTER (non-serious) with onset 22Mar2021 08:00, outcome "unknown", described as "Splotch pox-like blistery (non-painful) sore on nose". Therapeutic measures were not taken as a result of blister.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The reported event was considered non-serious (not resulted in death, not life-threatening, did not cause/prolong hospitalization, not disabling/incapacitating, no congenital anomaly/birth defect).  Follow-up attempts completed. No further information expected.
Pt developed a knot in her left arm along with extreme itching, redness and tenderness 12/4, the day after receiving vaccinations. Symptoms reported 12/5. Treated with ice and ibuprofen. Symptoms improved.
I was on a trip and walking a lot and noticed I was having to stop and catch my breath. I wasn't getting dizzy, no chest pain. Some days I just don't have any oomph, and I can never tell when those times will be. Some days I'm completely normal and wondering if everything is just in my head. It feels like if I have a purpose, that I'm walking for, I'm perfectly fine. But if someone wants to go for a walk or something, I can't do it, I'll run out of breath. I was walking on a treadmill for 30 mins everyday but after I started losing my breath I had to stop. My doctor told me to start again, and I tried it yesterday. I was able to get to 30 mins but I wanted to quit. I have spoken to my cardiologist and I am scheduled for a chemical stress test next week. They don't seem alarmed. I also had COVID19 the month before my vaccination. It could be long covid19 but doctors don't seem keen on diagnosing anyone with that.
tired; sore shoulder; headache for only one evening; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6201 and expiration date: unknown), via an unspecified route of administration in left arm on 04Mar2021 at 08:30 as a single for COVID-19 immunisation. The patient's medical history included allergies to any cillin. Concomitant medications were not reported. The patient has not received any other vaccinations in four weeks nor other medications in two weeks. The patient was not diagnosed with Covid prior to vaccination and has not tested for Covid post vaccination. After first dose, on an unspecified date the patient experienced tired, sore shoulder and headache for only one evening. No treatment received for the adverse events. The outcome of the events was reported as recovering.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven years old female patient who received 0.5 mL dose of vaccine FLUZONE QUADRIVALENT lot UJ034AB, expiry date: 30-Jun-2019 via unknown route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to vaccine underdose and exposure via skin contact. It was also case of syringe issue. It was reported that administered fluid was all over the arm of patient. She was unsure if the patient received a complete dose because it looked like most of it was on the patient's arm. Nurse did not note any cracks in the syringes and was unsure if the patient received a complete dose because it looked like most of it was on the patients arm. It was unknown whether patient experienced any adverse reaction after vaccination. 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 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. Documents held by sender: none.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses of M-M-R II (lot # reported as: J013431, expiry date reported as: 24-OCT-2014, therapy type, dosage, route of administration, anatomical location were not reported), which were exposed to 8.5C for 15 minutes. No adverse effect were reported. Thi sis one of several reports received from the same reporter. Additional information has been requested.
In the am of 02/14/2002 (10:00) a large swollen red outside of left leg area was noticed . By noon, the swelling had spread. Mom phone both the Health Department and physician and finally went to the ER (HD referred) (see ER notes).
Miscarriage. Shortly after receiving the flu vaccine the baby's heart stopped beating and stopped growing. Ended up being a missed miscarriage found at a routine 9 week ultrasound.
no adverse effect; recieved improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent.   On 23-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005078 and expiration date: 19-FEB-2021) or (lot # R019237 and expiration date: 04-JUL-2020) for prophylaxis (strength, dose, unit, route and anatomical location was not reported). The vaccine was reconstituted with properly stored sterile diluent. It was unknown that which lot # of varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) of both lots experienced temperature excursion between -14ºC to 10ºC (-9.74ºC) for an unknown time frame (product storage error). There was no previous temperature excursion. The call was due to digital data logger. No adverse effect was reported. The outcome of product storage error was unknown.
pt recvd 1st dose of Hep B vax w/no noted problems; Pt recvd 2nd dose of Hep B vax 18AUg92 w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
Patient received first dose of Moderna vaccine. Later that day, patient experienced heavy vaginal bleeding that included blood clots and required the use of a sanitary pad. She had her period the previous week and it had since stopped so she does not believe it's her period. At the time of the call to the pharmacy, 8:30am the following day, patient was still actively bleeding. Advised patient to monitor for other signs and symptoms of bleeding such as excessive bruising, nose bleeds, gum bleeds, and to check her stool for the appearance of coffee grounds. Patient was calling to try to find a doctor nearby who could see her. Advised patient that if she could not find a doctor to go to urgent care if the bleeding continued or worsened.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Moderna COVID-19 vaccine administered to patients post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 92 of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master Case
CLIENT RECEIVED PEDI PFIZER FORMULATION FOR AGES 5-11YO.  CLIENT WAS 4YO AT TIME OF VACCINATION AND SHOULD'VE RECEIVED 6M-4Y FORMULATION OF 3MCG/0.2ML.
About 25-30 minutes after vaccine administration, pt. started coughing, crying, and drooling at the mouth, taken back to exam room. T: 98.2 O2 sats 90%. Received ATROVENT/Albuterol and BENADRYL. O2 sats 94%. Stopped coughing, was talking and walking ok. Monitored for 30 minutes. When in parking lot started coughing/wheezing taken to ED. Received O2 sats 100% dexamethasone.
Pt vaccinated with MMR experienced atonic seizure followed by temp elevation to 102 lasting 3-4hrs. Seizure lasted 2 min.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received BEXSERO (batch number 146101D, expiry date 30th April 2016). On 7th April 2016, the patient received BEXSERO .5 ml. On 7th April 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to BEXSERO. Additional details were received as follows: The reporter called to report that a female adult patient received her second dose of BEXSERO on 7th April 2016 and experienced a painful, hot-to-the-touch two inch in diameter raised red mark below the injection site in the subcutaneous area. The patient called the clinic this morning, and had an appointment with the physician at the clinic on the day of reporting, and the painful event has not yet resolved.
Approx. March 19, I started having headaches under right eyebrow and begin to take some Advil. After a couple weeks of no sign of improvement, I contacted my PCP and she recommended a frontal xray which came back clear. I also started getting headaches in the back of my head, more of a throbbing and they have continued for weeks. On 4/16 I started taking a baby aspirin and still the headaches seem to come and go. I have never really had headaches, I consume lots of water regularly, so no chance of dehydration, am postmenopausal, but this seemed like a potential side-effect from the vaccine, so thought I'd pass along this info.
You had abdominal cramps which elevated to pain to ER- emergency surgery on your colon,perforated colon- removed part of colon
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.