chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling in their arm/ sometime swells up; wants to know what's its making arm felling wrong. tiered of hurting/ arm hurts so bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in their arm/ sometime swells up), LIMB DISCOMFORT (wants to know what's its making arm felling wrong.) and PAIN IN EXTREMITY (tiered of hurting/ arm hurts so bad) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PERIPHERAL SWELLING (swelling in their arm/ sometime swells up), LIMB DISCOMFORT (wants to know what's its making arm felling wrong.) and PAIN IN EXTREMITY (tiered of hurting/ arm hurts so bad). At the time of the report, PERIPHERAL SWELLING (swelling in their arm/ sometime swells up), LIMB DISCOMFORT (wants to know what's its making arm felling wrong.) and PAIN IN EXTREMITY (tiered of hurting/ arm hurts so bad) had not resolved.            Concomitant drugs included cholesterol medicine.  It was reported that patient was planning to take X-rays for the arm and visited orthopedic doctor. It was reported that the events worsened.  Treatment medications were not provided.   This case was linked to MOD-2022-510135, MOD-2022-510205, MOD-2022-510214 (Patient Link).
Shivers, Fever, Severe Headache, Nausea, Muscle Aches and Pains, Soreness at injection site.  Inability to perform daily functions.
Diffuse morbilliform rash over entire body including palms and soles. Antibiotic prescribed the same day. Antibiotic stopped on 4/25/02. Cried X 3 hours on 4/25/02 but dx'd with bilateral otitis and ruptured TM. Rash still faintly present on follow-up exam on 5/8/02.
Breakthrough case admission after 5 vaccines Moderna 3/23/21 Lot# 00B21A;  Moderna 4/20/21 Lot# 043B21A;  Moderna 11/23/21 lot# 012H21B;  Moderna 8/11/22 lot# 055A22A;  Moderna 10/7/22  060F22A
Sx started 2 hrs p/inject pt cried >3hrs & had a high pitched "different" cry the normal cry; was inconsolable; MD was notified & pt was not seen but told that should not recvd pertussis again;
experienced fogginess; fatigue; experienced lethargy; Initial information received on 17-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 76 years old male patient who experienced fogginess, fatigue and experienced lethargy while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included COVID-19 VACCINE. The patient's past medical history, medical treatment(s) and family history were not provided.   On 11-Oct-2022, the patient received 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE once (formulation, strength and lot number not reported) via unknown route in the right arm for prophylactic vaccination.  On 12-Oct-2022, the patient developed non-serious events of experienced fogginess (feeling abnormal), fatigue and experienced lethargy (lethargy) (latency: 1 day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (experienced fogginess, fatigue, experienced lethargy).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events.
Severe muscle pain upper left shoulder and neck followed by muscle spasms. These were followed by tingling of neck and upper shoulder, recurring cycles of spasms.
On 7/16/2018 at 2:45 pm, I received phone call from client's mother, stating her daughter greceived shots last week here, and once she got home that same day, was complaining of pain in her Right arm, woke up next morning, area was reddened and swollen at injection site, and could not lift arm. States arm is warm to touch. Mother applied warm compresses and rubbing alcohol to area. As of this afternoon, client still complains of not being able to lift arm, with pain, still reddened and swollen at site. Encouraged to try cool compresses, and take patient to her PCP for evaluation and mother is to follow up with me after client is seen. I attempted to call client this morning, at 3 different phone numbers that were in the CARES system, 2 numbers were under client's name had no answer and no voicemail set up. Third number was emergency contact number of sister. There was no answer, and no message left as no information available as to okay to leave a message with that number.
small red mark at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per indication The patient had Shingrix three weeks ago, and now had a small red mark at injection site.  The patient asked was this normal.
swelling over lt deltoid down to elbow w/some residual swelling in the hand;no pain, tingling able to use arm w/o problem;improved over 2 days;no residual problem;better 25MAR
blood clots, bilateral pulmonary embolism, thrombectomy Hospital (02/12/2021)
brought to the hospital with difficulty breathing; found to be positive for COVID; admitted; severe hypoxia, lactic acid acidosis, hypokalemia, acute on chronic kidney disease; treated with antibiotics, remdesivir, dexamethasone, heparin drip; pt worsened with an increase in hypoxia and bradycardia; O2 sats worsened and he passed away in the hospital
aches; slight fever; This is a spontaneous report from a non-contactable consumer (patient's father).   A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. It was reported that the patient was out with friends had dinner. The patient received his first dose of the Pfizer covid vaccine Monday morning and got a call Monday night one of his friends tested positive. The patient got shot Monday and had a slight fever, aches, and woke up this morning and is fine. It was reported that they were concerned if he needs to get a test or anything. The outcome of the events was recovering/resolving.  No follow-up attempts were possible. Information about lot/batch number cannot be obtained.
Body rash which started at  chin and spread  down  body, per client started 4/15/22 and resolved on 04/18/22. Also had vomiting on 04/15/22.
Headache, Myalgia, Fever, pain at injection site Narrative:  Other Relevant History:
This is a spontaneous report from a contactable pharmacist. A 17-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, Solution for injection, Lot number was ER8731), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant was not reported. Historical vaccine included BNT162B2 for COVID-19 immunization. It was reported that 48 hours after receiving the 2nd Pfizer Biontech COVID vaccine she woke up with chest pains and the next morning went to urgent care where she had an irregular EKG. The sent her to the local hospital where her troponin was 7. The patient underwent lab tests and procedures which included electrocardiogram irregular on 18Apr2021, troponin was 7. Event took place after use of product. The outcome of the events was unknown.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Chest pain.The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Shaking; Chills; Fatigue; Muscle pain; Fever of 102.4 degrees; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Fever of 102.4 degrees) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Fever of 102.4 degrees). At the time of the report, TREMOR (Shaking), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Fever of 102.4 degrees) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.4 (High) fever of 102.4.
Headache, muscle pain, nausea, fatigue, large baseball sized swelling under right armpit
muscle ache in back; Muscle ache in back and abdomen; Shortness of breath / Couldn't breathe at all; Felt bad; Was so scared; could not burp; Nausea; Vomiting; Severe Headache; sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on 02Apr2021 at 15:00 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Apr2021, the patient experienced muscle ache in back and abdomen, shortness of breath / couldn't breathe at all, felt bad, and was so scared; all on 14:38 while could not burp, nausea, vomiting, severe headache and sick on an unspecified time. It was further reported that she felt bad and started to have muscle ache in back and abdomen, shortness of breath, could not breathe at all and was so scared. She was outside at the time, came home and laid down. She was drinking ginger ale since she could not burp. All of the sudden she had nausea and vomiting and a severe headache. She was really, really sick. The patient wanted to know if this have anything to do with the Pfizer vaccination and on what to do about her second dose. She asked if she should get vitamin C or zinc. Therapeutic measures were taken as a result of the event could not burp included ginger ale. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Observer noticed patient eyes glazed ,  Call pharmacist over - pharmacist spoke with  patient, he noticed eyes rolling up and yelled to call 911 -then  asked patient her name And where she was - did Not answer - pharmacist administered epi pen. Paramedics arrived
Infant developed fever when he arrived home from doctors visit - 105 degrees.  10/27/09 Vaccine records received. Medical records received for DOS 10/02. FINAL DIAGNOSIS: Fever, possible bacteremia. Neonate seen for well child exam and immunized. S/P developed fever and reduced intake of formula. Less active. Fever 38.9c. Irritable but easily consoled.  WBC increased. Blood cx abnormal. Urine cx neg. TX with ABX. Discharge to home. follow-up with PCP.
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        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.   No concomitant products were reported. No treatment drugs were reported It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt..  The patient did not experience any adverse events after receiving vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow-up received as additional information to initial version and  I-narrative supplement updated.
Rash located distal to vaccination site approx. 2 inches in length, 1 in width, erythema present with itching and burning sensation, no edema
Patient's wife is covid positive, unvaccinated.  Patient symptomatic with nasal congestion, loss of taste and smell, mild cough, onset 10/20/21. Patient admitted for dialysis.
Very brief moments of losing equilibrium.  Lasted no more than a second, but felt like the world tilted.  This occurred 5 different times after the second dose about 2 weeks after the second shot.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9206) via an unspecified route of administration in the arm left on 13Feb2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. 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 vaccination. Concomitant medications included probiotics nos (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and multivitamin (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the arm left on 19Jan2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 22Feb2021, the patient experienced very brief moments of losing equilibrium.  Lasted no more than a second, but felt like the world tilted.  This occurred 5 different times after the second dose about 2 weeks after the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No 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 event equilibrium loss was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Wthin 12 hours post vax, pt developed a fever of 101, extreme muscle aches and spasms, chills, headache and light sensitivity. He was treated with Motrin and cool bath to bring fever down. Symptoms lasted 3 days.
Patient described a knot under the band aid where vaccine was administered.  She removed band aid and noticed area was red and slightly swollen.  Patient returned to pharmacy on 01/14/2015 and noticed vaccine was given in deltoid region of arm and was red.  Then told patient to continue to observe the area and if got any worse to call pharmacy or doctor.
Patient stated her (L) arm swelled from her shoulder to her elbow for 2 days and then had severe itching. Area was red and slightly warm to touch.
Hospitalized from 10/12/08 to 10/15/08 for new onset atrial fibrillation, which resolved itself. According to patient there was no treatment and during her hospitalization she was offered flu immunization (admitting physician was unaware she had already received it).
Developed some spots, red and itchy on 9/16/04 followed by onset of fine red rash to body lasting until 9/22/04. No fever. Was lethargic and "cranky." History of Varicella Disease. Mother also reported his feces "smelled funny." No diarrhea or constipation.
No further AE; HCP calls to report PROQUAD administered to patient after expirations date.  No further AE.  No PQC.; This spontaneous report was received from a nurse, referring to p5-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 16-JUN-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status rHa (1 dosage form, subcutaneously in right upper arm, lot #u039955, expiration date 14-JUN-2023) for prophylaxis (Expired vaccine used). No further adverse event (AE) (No adverse event). No product quality complaints (PQC).
Birth in 1988, 7 lbs 5 .5 ounces  Developed a bruise approximately the size of a quarter at the injection site that lasted 3 weeks. No other symptoms and did not seek any treatment.
I caught COVID; I caught COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "I caught COVID". The patient was hospitalized for drug ineffective, suspected covid-19 (hospitalization duration: 90 day(s)). Clinical course: During the phone call received regarding reenrollment in PAP for Celontin, the patient stated, "I caught Covid and misplaced all of my paperwork here. I was in the hospital for 3 months. It was a bad one and I had all of my shots from Pfizer. I am due for the next booster."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
High fever, 105.3 for the second dose and along with major body aches,high fever over 105; High fever, 105.3 for the second dose and . Along with major body aches; Patient took vaccine 5 milliliter; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (High fever, 105.3 for the second dose and along with major body aches,high fever over 105), PAIN (High fever, 105.3 for the second dose and . Along with major body aches) and ACCIDENTAL OVERDOSE (Patient took vaccine 5 milliliter) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Penicillin (Healthy person). Past adverse reactions to the above products included No adverse event with Penicillin.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 5 milliliter once. On an unknown date, the patient experienced PYREXIA (High fever, 105.3 for the second dose and along with major body aches,high fever over 105), PAIN (High fever, 105.3 for the second dose and . Along with major body aches) and ACCIDENTAL OVERDOSE (Patient took vaccine 5 milliliter). At the time of the report, PYREXIA (High fever, 105.3 for the second dose and along with major body aches,high fever over 105), PAIN (High fever, 105.3 for the second dose and . Along with major body aches) and ACCIDENTAL OVERDOSE (Patient took vaccine 5 milliliter) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PYREXIA (High fever, 105.3 for the second dose and along with major body aches,high fever over 105) and PAIN (High fever, 105.3 for the second dose and . Along with major body aches) to be related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Patient took vaccine 5 milliliter).    Treatment information were not reported. Concomitants medications were not reported. It was reported that the patient's body temperature was reduced by laying in a bathtub with water at 101 deg for extended periods and patient was penicillin healthy person.   This case was linked to MOD-2022-459276 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2022: Follow up received and reporter qualification updated consumer to other health.
This case was reported by a lawyer and described the occurrence of mental fog in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix, for prophylaxis. A physician or other health care professional hs not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced mental fog, arthralgias, myalgias, headaches, burning and tingling, eye problems, muscle spasms, ear pain , difficulty concentrating, shooting and stabbing pains, joint stiffness and weakness, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. He also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.