chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE's; The pharmacist stated that a patient was administered a MMR II vaccine via the intramuscular route instead of the subcutaneous route.; This spontaneous report was received from a pharmacist and refers to a 59-year-old female patient (reported as 58-year-old patient, conflicting information). The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's allergies or drug reactions.  On 21-APR-2022, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly instead subcutaneously (incorrect route of product administration), albumin status rHa, lot #U028163, expiration date: 09-SEP-2023, (strength, exact dose were not provided) for prophylaxis; and sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, (strength, exact dose, expiration date, were not reported). Lot #00006468200 is an invalid lot # for sterile diluent (MERCK STERILE DILUENT). Lot #00006468200 does not match any Company product as confirmed by Lot Verification team. No additional adverse events was reported (no adverse events).
Patient developed cellulitis in right arm 24 hours after vaccine administered.  Patient seen in ED and discharged on doxycycline.
VIAL WAS OPENED 3/10/23, REPORTER CHECKED EXPIRATION DATE ON VIAL WHICH WAS 8/24 NO SYMTOMS AT THIS TIME
PATIENT STATES SHE WOKE UP WITH A VERY PAINFUL/STIFF NECK, ESPECIALLY ON THE RIGHT SIDE.  LASTED ALL DAY, THEN WAS GONE THE NEXT DAY. ACCORDING TO THE PATIENT, SHE DOES HAVE A HISTORY OF CHRONIC NECK PAIN.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015 the patient was vaccinated with expired dose of ZOSTAVAX (lot number: J006827 with expiry date of 14-SEP-2014) (dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. A product quality complaint was filed for current administered ZOSTAVAX due to alleged mix. The reporter stated that she administered ZOSTAVAX from a vial that had a different expiration date and lot number from the other nine vials that were present in the box. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. Additional information has been requested.
Arthus reaction 10 hours after administration- erythema, warmth and induration surrounding the administration site.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In April 2016, the patient went to a pharmacy and was administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
positive for Covid 19; Headaches (sinus pressure); Difficult to taste; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (positive for Covid 19), PARANASAL SINUS DISCOMFORT (Headaches (sinus pressure)), TASTE DISORDER (Difficult to taste) and NAUSEA (Nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (positive for Covid 19), PARANASAL SINUS DISCOMFORT (Headaches (sinus pressure)), TASTE DISORDER (Difficult to taste) and NAUSEA (Nausea). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) on 16-Jan-2021 for Adverse event, at a dose of 81 mg once a day; CETIRIZINE on 16-Jan-2021 for Adverse event, at a dose of 10 mg once a day; FAMOTIDINE (PEPCID [FAMOTIDINE]) on 16-Jan-2021 for Nausea, at a dose of 1 dosage form; BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE (BROMFED) for COVID-19, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 26-Jan-2021, COVID-19 (positive for Covid 19), PARANASAL SINUS DISCOMFORT (Headaches (sinus pressure)), TASTE DISORDER (Difficult to taste) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included medication for nausea.  Patient reported that, she was retesting for virus on 05 Feb 2021 and wants to do a rapid test.  Patient also reported that, she was prescribed with vitamin d, zinc, z pack, ibuterol; but she had not taken these medications. She stated her second dose for vaccine on 08-Feb-2021.  Patient had a thermometer to check temperature/oxygen levels.  Treatment of the events included, cocktail injection and steroids.
It was reported that a 57 year old male with stage IV non-Hodgkin's Lymphoma who was vaccinated with pneumococcal vaccine 23 polyvalent at the time of his splenectomy for stage IV non-Hodgkin's. Three years, post vax, the pt developed fevers, chills, hypotension and a generalized seizure. The pt was treated with antibiotics for 4 weeks. He was treated with ceftriaxone, vancomycin and rifampin. Although the pt had been vaccinated against Streptococcus pneumoniae at the time of his splenectomy, he showed a protective antibody response to only 8 of 12 serotypes tested. A Gram's stain of the CSF showed gram-positive organisms in pairs and short chains, but cultures of the CSF were negative. A latex-agglutination test was positive for Streptococcus pneumoniae. During the next several days, disseminated intravascular coagulation and symmetric areas of pallor developed on the back of both hands and the soles of the feet, with overlying bulla. Cultures of the bullous fluid were sterile. The lesions progressed to dry gangrene. All blood cultures remained negative. The arterial supply to each of the arms and legs remained patent. The pt was revaccinated. It was noted that the pt's appearance was typical of symmetric peripheral gangrene associated with Streptococcus pneumoniae bacteremia in a pt whose spleen had been removed. Upon internal review, the pt's experiences were determined to be "Other Medical Events". Additional information has been requested.
Patient alert oriented with no signs of distress noted. Dad had child sitting on lap during administration of multi vaccines. Child responsive, pleasant after immunization. Dad and child sill in room observing sibling getting immunization when child fainted, fell backward, hit floor. Dad carries child, child immediately began to cry. No signs/symptoms of shortness of breath noted. EMS assessed patient vital signs normal. Father took child to ER for observation due to fall.
arm is sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details reported were as follows: This case was reported by the patient. The age at vaccination was not reported. Few days ago, from reporting date, the patient received Shingles vaccine and Covid vaccine. After vaccination, the patient's arm was sore. The patient mean that the Covid shot was nothing like this soreness and not.  The patient stated that then need to get back before six months and to get two more mixes in one shot. The follow-up would not possible as no contact details were available.
On 12/26/2022, during the evening, I started to notice I had a runny nose. I tested on 12/26/2022, because my husband was already testing positive. On 12/27/2022, I woke up with a runny nose, a general feeling of not feeling well and fatigue. I tested myself again on 12/27/2022, and the test came back positive. I am in a risk factor category and that is why I sought care from my doctor. I contacted my doctor and went in to see if I could start on PAXLOVID. I was prescribed PAXLOVID and started taking it on 12/27/2022. I feel that PAXLOVID did help reduce the symptoms I was experiencing and could have experienced. I ended up with Covid rebound after PAXLOVID on 01/03/2023. I tested negative up to 01/04/2023, and finally tested positive on 01/05/2023. I experienced a runny nose and a slight cough. The second time, it seemed that my symptoms were more pronounced.
It feels like swollen; sore in the eyes; head is haunted; high blood pressure; severe head ache between the neck and the head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (It feels like swollen), EYE PAIN (sore in the eyes), FEELING ABNORMAL (head is haunted), BLOOD PRESSURE INCREASED (high blood pressure) and HEADACHE (severe head ache between the neck and the head) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (It feels like swollen), EYE PAIN (sore in the eyes), FEELING ABNORMAL (head is haunted), BLOOD PRESSURE INCREASED (high blood pressure) and HEADACHE (severe head ache between the neck and the head). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (It feels like swollen), EYE PAIN (sore in the eyes), FEELING ABNORMAL (head is haunted), BLOOD PRESSURE INCREASED (high blood pressure) and HEADACHE (severe head ache between the neck and the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant medications were not provided by reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 at 16:45 as dose 1, single (Lot number: EJ1685), in left arm, on 11Jan2021 at 12:00 as dose 2, single (Lot number: EL0142), in left arm and on 22Jul2021 at 16:45 as dose 3 (booster), single (Lot number: EW0175) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: The patient previously received a COVID-19 Vaccine. The patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
A few minutes after receiving the flu vaccine, the patient passed out and fell to the floor hitting her head. Unresponsive for short time, approx 1 minute, skin was cool, clammy and diaphoretic. Mother called 911 and thought patient had lump on back of head. Had patient continue to lie down as we waited for EMT. 6:40 PM BP=101/66, POX 98%. 6:45 PM client is responsive and is being brought to ER. ER evaluated and said her head was fine and didn't find a lump on back of head. No further treatment was necessary.
Caller experienced fatigue within 2 hrs of rcvding the vaccine on 3/23/2021, and she experienced mild body achiness within 24 hrs of rcvding the vaccine. The fatigue and mild bod yachiness has subsided. Upon waking this morning on 3/24/2021, she have the following symptoms in her left eye: redness, runny, burning sensation and blurry vision.
Sneezing, eyes swollen, scratching all over body, Pulse 166, BP 84/60 and crying. Was given 3ml Benadryl PO. Called ambulance to transport to ER for evaluation and treatment. Code Blue called. Ice applied to eyes. Called CCU at Medical Ctr and child is doing well this AM. Plans to be discharged today after 24 hours of observation. Diagnosis: anaphylaxis
Patient is a 78 y.o. male patient of PA-C with history of  diabetes mellitus, HTN, hypothyroidism, sleep apnea presented to Hospital with  shortness of breath and fatigue, has been on ventilator for respiratory failure, status postcardiac arrest on 9/11   Acute Hypoxemic Respiratory Failure Multifocal Pneumonia Secondary to COVID 19 Sepsis Status post cardiac arrest Shock Critical care managing, was on a ventilator support and multiple IV pressor support Remains on multiple pressor support Blood cultures no growth =.  Urine antigen negative Sputum cultures pending Discussed with critical care team-possible plan for withdrawal of care later today and transition to comfort Eventually patient was transition to withdrawal of care and comfort and per chart was pronounced dead at 1937 on 9/13   AKI Worsening with poor urine output Nephrology following-high risk for RRT   Acute VTE Lower extremity Dopplers positive for DVT On heparin drip   Diabetes Mellitis type 2 Continue sliding scale    Hypothyroidism Continue Synthroid   Hypertension Meds on hold    Elevated liver enzymes  Probably Shock liver Continue to monitor
Client verbalize feeling hot and sweaty after taking the vaccination.  Client was evaluated by onsite Fire Rescue and released to go home at 2:38 pm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 at 16:00 as dose 4 (booster), single (Lot number: PP4554) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The other medications the patient received within 2 weeks of vaccination. The device date was reported as 25Jun2022.  No follow-up attempts are possible. No further information is expected..
A nurse reported the occurrence of injection site cellulitis in a 6-month-old male who received diphtheria and tetanus toxoids and acelular pertussis vaccine adsorbed (Infanrix).  The subject's medical history, concurrent conditions, and concurrent medications were not specified.  On 03/20/2002, the subject received his third injection of Infanrix.  Two days later, the subject developed injection site cellulitis.  The reporter considered the event to be probably related to Infanrix administration.  The outcome of the event was not known.
mom reports child devel a red raised rash on chest, arms, & underarms immed p/vax;rash lasted x2 days;denied itching;denied resp distress;
belly pain; diarrhea; redness and swelling at the site of injection; redness and swelling at the site of injection; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (belly pain), DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness and swelling at the site of injection), VACCINATION SITE SWELLING (redness and swelling at the site of injection) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN for Diabetes, FLUOXETINE HYDROCHLORIDE (PROZAC) and LISINOPRIL for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ABDOMINAL PAIN (belly pain), DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness and swelling at the site of injection), VACCINATION SITE SWELLING (redness and swelling at the site of injection), HEADACHE (headache) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN (belly pain) had not resolved and DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness and swelling at the site of injection), VACCINATION SITE SWELLING (redness and swelling at the site of injection), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            Concomitant product use was provided by the reporter as allergies pill OTC. Treatment information was not provided. The action taken with the drug was Not applicable.
4 days after Receiving chicken pox vaccine at clinic developed Red-warm tender edema at injection site. 2 inch diameter ice; Tylenol x 2 days on day 7 after vaccine swelling at injection site bruise-Red area-Non tender-Non itchy-Resolving
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: bp 148/114 after injection drove a vacination card then explained to pt the side effects then about 4 sescond pt said that cannot breath cried and removed her mask, gave epiphen then called 911
Experienced severe redness that lasted 1 week; This is a spontaneous report from a contactable pharmacist via Pfizer Sales Representative, who reported events for two patients. This is one of the two reports.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date at single dose for immunisation .The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe redness that lasted 1 week; event is non-serious and recovered on an unknown date. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020076486 same reporter/drug, different patient
pt recvd vax;itchy, red spots on forehead, cheeks & shoulder area pain/stiffness in joints, all began approx 11 days p/ recving vax;no tx;no MD visit;
Taken into emergency with sudden onset of seizure at 3 :30am while sleeping at home. Had another seizure when arrived at the hospital. After multiple exams abs tests, diagnosed as subarachnoid hemorrhagic stroke. Don?t know if it?s related to the vaccine received 2 weeks prior
1/23/2021 Arm soreness, tenderness, swelling at vaccine site 1/24/2021 12am woke with chills, headache, took 2 Tylenol, felt nauseated/"queasy" so took a peptobismol chewable and then vomited. Remained "very cold". 8am temp 100.2, could not get warm, started Zofran and held down soup. Vomited this evening again. 1/25/2021 Vomited again, headache persists, taking Tylenol and Zofran, thinks she had fever. 1/26/2021 Vomiting and diarrhea, headache, abdominal pain, thinks she had fever. 1/27/2021 Today - vomiting and diarrhea have stopped, headache is still present but has improved. Afebrile. She still does no feel well overall.