chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 05-MAY-2015, the male patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 13-JUL-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the events to be related to ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.
1 day after receiving a ZOSTAVAX injection patient developed 2 cold sores on her upper lip - drug co. called found no correlation in literature - patient ok.
Strong migraines, fatigue, muscle pain, chills. Pain, tenderness, and swelling at vaccine sight.
GENERALIZED ACHING/BODY ACHE; SWOLLEN JOINTS; JOINT PAIN; CHILLS; FEVER; TIREDNESS; This spontaneous report received from other manufacturer, and the patient was enrolled in non-Company sponsored solicited program, consumer concerned an adult female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1)  (suspension for injection, intramuscular, batch number was not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported On an unspecified date, the patient experienced generalized aching/body ache, swollen joints, joint pain, chills, fever, and tiredness (all events with dose number in series 1) . The patient recovered from generalized aching/body ache, chills, and fever, and was recovering from tiredness, swollen joints, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). This report was non-serious.
The period lasted 2 weeks.; After the vaccine, my menstrual period have not been the same. I get it up to two times in a month. My menstrual is now abnormal.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 10:45 (Lot number: EW0167) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaemia" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 25Jun2021, outcome "unknown", described as "The period lasted 2 weeks."; MENSTRUAL DISORDER (non-serious) with onset 25Jun2021, outcome "unknown", described as "After the vaccine, my menstrual period has not been the same. I get it up to two times in a month. My menstrual is now abnormal.". The events "the period lasted 2 weeks." and "after the vaccine, my menstrual period have not been the same. i get it up to two times in a month. my menstrual is now abnormal." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstrual disorder.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was patient was diagnosed with covid, Since the vaccination, patient has been tested for covid.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected. Follow-up(12Oct2021): This is a follow-up spontaneous report from a contactable consumer.This consumer reported in response to Hcp letter sent that included  No follow-up attempts are possible. No further information is expected.
This non-serious spontaneous case, initially received from a pharmacist on 27-Sep-2018, concerns a 54-year-old, adult female patient. On an unspecified date, the patient (under age of 65 years) was administered FLUAD (TIV) [dose, route of administration, anatomical location, batch number and expiry date: not reported]. Follow-up received from the pharmacist on 16-Oct-2018: The patient's age was confirmed as 54-year and gender was updated as female. No other information was obtained.
Severe chills, high fever of 101.7, severe body aches, fatigue Large, painful knot in arm at injection that still has not gone away completely (almost a week)
arm soreness; fever; groggy overall; not feeling too well; lethargy; 25 weeks pregnant and got her 2nd dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant and got her 2nd dose), SOMNOLENCE (groggy overall), MALAISE (not feeling too well), LETHARGY (lethargy) and PAIN IN EXTREMITY (arm soreness) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant and got her 2nd dose). On 24-Feb-2021, the patient experienced SOMNOLENCE (groggy overall), MALAISE (not feeling too well) and LETHARGY (lethargy). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) and PYREXIA (fever). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Pain in arm, at a dose of UNK dosage form. On 15-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant and got her 2nd dose) had resolved. At the time of the report, SOMNOLENCE (groggy overall), MALAISE (not feeling too well), LETHARGY (lethargy) and PYREXIA (fever) outcome was unknown and PAIN IN EXTREMITY (arm soreness) had resolved.
first shot on Jan 25th - fatigue , nausea and headache about 9 days later  my arm is sore and shot area is read and the muscle aches into my shoulder blade for 2 plus days
full dose given for booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (full dose given for booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (full dose given for booster). At the time of the report, ACCIDENTAL OVERDOSE (full dose given for booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Sore arm; Slight headache; Congestion in throat; Slight tickle in throat; Slightly spacey; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 24Feb2021 at 10:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included QT prolonged, heart failure, fruit allergy to kiwi fruit, dairy allergy, gluten sensitivity, food allergy to potatoes, tomatoes and penicillin allergy. 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 vaccination. Concomitant medications included nadolol (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. On 24Feb2021 at 11:00, the patient experienced sore arm, slight headache, congestion and slight tickle in throat and slightly spacey. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event slight headache was recovered on 24Feb2021 while that of the event sore arm was recovered on 26Feb2021. The clinical outcome of the events congestion in throat, slight tickle in throat and slightly spacey was recovering at the time of this report  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Awoke on Day 2 after vaccine with swelling in my leftarmpit (injection arm).; tenderness in left armpit (injection arm); This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration in the left arm on 19Apr2021 at 13:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and sulfonamide allergy. 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 vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 26Mar2021 at 12:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 05:30,  after vaccination the patient woke up on day 2 with swelling and tenderness in her left armpit (injection arm). 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling and tenderness in left armpit (injection arm) were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Headache; Muscle pain; Nauseas; Dizzied; Extremely tired; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0179) via an unspecified route of administration in the arm right on 08May2021 at 11:45 as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm right on 17Apr2021 at 11:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021 at 00:00, the patient experienced headache, muscle pain, nausea, dizzied and felt extremely tired. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not 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 headache, muscle pain, nauseas, dizzied and extremely tired were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Patient stated she got her first two doses of Pfizer COVID-19 vaccine in March & April 2021 and didn't have any issues.  Months later, she started developing severe pain in the area of injection and still is dealing with it.  She came in for her booster and that was the first we had heard of her complaint.  She did her booster dose in the right arm.
Patient received 4 month immunizations on 1/18/08. Over weekend, parents noticed streaks of blood in diaper which worsened 1/22/08 am. Patient went to ER for evaluation. Petechia and bruising were noted in ER. Platelet count was zero. Patient was transferred to tertiary care center PICU and idiopathic thrombocytopenic purpura was diagnosed. Patient received IVIG, steroids and platelet transfusion.  02/12/2008 MR received for DOS01/22-25/2008 with DX: ITP likely viral/immunization related.  Infant presented with  bloody stools and petechiae/bruising noted on extremities. (+) epistaxis. On PE infant noted to be pale with numerous petechiae. TXd with platelet transfusion, IVIG, and steroids. Peds Hemotolgy impression:  Probable Immune Thrombocytopenia
Breast feeding/first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; She was also breast feeding; first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; Fever of 101.7/ temp is still a little elevated at 99.5; full body aches; Chills; Headache; Breast feeding and experienced painful let down; This is a spontaneous report from a non-contactable nurse (patient) reported for herself. This Nurse reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL1283) via an unspecified route of administration on 11Jan2021 07:30 at single dose for COVID-19 immunization. The patient received the first dose on 24Dec2020 14:30 at age of 33 years old at single dose for COVID-19 immunization, and only had a sore arm and maybe fatigue.  Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever of 101.7, full body aches, chills, headache. She was also breast feeding and experienced painful let down at the time (she did not have mastitis). She had all these symptoms on 11Jan2021 16 hrs after receiving second dose. Now at 24 hours all symptoms have resolved except her temp is still a little elevated at 99.5. No treatment was received for the adverse event. Events outcome of full body aches, chills, headache, painful let down at the time (breast feeding) was recovered, for fever was recovering, while for others was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
Carpopedal spasm, chest pain, heart palpations, trachycadia, dizziness, light headedness, anxiety, panic attacks, paricarditis. 2 ambulance rides, 5 ER visits, 3 clinic visits, halter monitor for one week and cardiologist apt. Treatments included in fluids, 3 chest x-ray, Ativan, beta blocker for rapid heart rate, MRI of brain, various blood lab tests, 6 EKGs, and echocardiogram. Treatment is Ativan and beta blocker medication persribed.
Pt. states had burning pain down upper arm to elbow at time injection given.  Over the last 6 weeks she states she is having increasing weakness, decreasing ROM of left arm/shoulder and pain in left arm.
Pneumonia; cough; headache; chills; fever; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycemia and Fibromyalgia. Concomitant products included DULOXETINE, METHOCARBAMOL, AMITRIPTYLINE and GABAPENTIN for Fibromyalgia, VERAPAMIL and GLUCAGON for Hypoglycemia.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced COUGH (cough), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache). On 21-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date for Pneumonia, at a dose of 1 dosage form. On 19-Apr-2021, COUGH (cough), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache) had resolved. On 30-Apr-2021, PNEUMONIA (Pneumonia) had resolved.        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.   The other concomitant medication provided by the reporter was Rescue inhaler, Epi pen and Air duo Inhaler. It was reported that the consumer took allergy shot about 1.5 weeks after receiving the first dose. Treatment medication provided was antibiotics.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-200079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Non-significant Follow up appended for AE Doc Attachment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The vasovagal episode almost immediately after vaccination.  The patient reports that this happens with most needles and anytime blood is drawn.  At the time of my arrival, he is drinking juice and reports he is feeling at his baseline.  No further intervention required.
felt a little tired; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Feb2021 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 24Feb2021, outcome "unknown", described as "felt a little tired". Additional Information: The patient had the 1st one and felt a little tired on the 2nd day.  No follow-up attempts are possible. No further information is expected.
feel well; Gastrointestinal distress; Fatigue; Headache; spent the whole day in bed; This case was reported by a consumer via call center representative and described the occurrence of distress gastrointestinal in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2020, the patient received the 2nd dose of Shingrix. On 10th November 2020, less than a day after receiving Shingrix, the patient experienced distress gastrointestinal, fatigue, headache and loss of personal independence in daily activities. On 12th November 2020, the patient experienced unwell. On an unknown date, the outcome of the distress gastrointestinal, fatigue and headache were not recovered/not resolved and the outcome of the loss of personal independence in daily activities and unwell were unknown.   It was unknown if the reporter considered the distress gastrointestinal, fatigue, headache, loss of personal independence in daily activities and unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her 2nd shot of Shingrix and 6-8 hours after the symptoms presented. The reporter had every symptom except shivering and fever. The patient confirmed gastrointestinal distress, fatigue to the point where she spent the whole day in bed and headache. The patient abruptly ended the call because she did not feel well. The reporter did not consent to follow up.
Flu like symptom's, cold and had a fever, but the next day participant stated she fine. Did not see a doctor, not that serious.
Headache, fatigue, fever, chills, joint pain, pain at injection site and rash near injection site