chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Based on additional information received on 18 July 2016, this case initially considered as non-serious was upgraded to serious due to event pregnancy terminated. Initial unsolicited pregnancy report received from a nurse on 08 June 2016. This case involves an 18-year-old female patient who was vaccinated with a second dose of MENACTRA (batch number: U5259AA, expiry date: 13 May 2017, dose not reported) intramuscularly in left deltoid on 07 June 2016. It was unknown, if the patient was pregnant at the time of vaccination. Pregnancy information (LMP was unknown, estimated delivery date, pregnancy trimester) was not reported. The patient's medical history and concomitant medications were not reported. By the time of reporting, the patient was not seen by obstetrician HCP. At the time of this report, the patient had not experienced any adverse events. Pregnancy outcome was not reported. Documents held by sender: none. Follow-up information received from a nurse on 18 July 2016. On an unknown date, the pregnancy was terminated. Upon internal review, the company decided to consider the event serious due to important medical event: pregnancy terminated. The outcome of pregnancy terminated was unknown. Sender's Comments: Patient was administered MENACTRA vaccine at that time she was unaware of pregnancy, usually vaccine are not given during pregnancy, and later patient has terminated the pregnancy. Details regarding the gestational age, cause for termination and any anomaly in previous baby are needed to further assess the case. MENACTRA vaccine is not absolutely contraindicated in pregnancy. Based on available information role of vaccine is unlikely.
Information has been received from a RN concerning a 27 month old white male with no past medical history and no known drug allergies who on 02Mar2002, also reported as 21Mar2002, was vaccinated SC in the thigh with a first dose of varicella virus vaccine live. There was not illness at the time of vaccination. There was no concomitant medication. On 03Jun2003, also reported as 02Jun2003, the pt presented to the dr's office with a chickenpox rash. No fever was noted. It was reported that no treatment was required at that time. No other information was provided. There was no product quality complaint. The outcome was reported as not recovered. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the pt or his siblings. Follow  up information indicated that the pt recovered. No further information is expected.
24-72 hours after IM in jection of 5th DTaP, developed warm, tender, swollen erythema 8inches in diameter at site.
Information has been received from a Registered Nurse concerning a 34 year old male patient with no drug reactions/allergies and with no pertinent medical history reported who was vaccinated with three "standard doses" of RECOMBIVAX HB (dates, routes and lot numbers not reported). There was no concomitant medication. The nurse reported that the patient failed to have antibody titer several years after receiving three "standard doses" of RECOMBIVAX HB. "Titer tested last month" (approximately in April 2010). The patient sought unspecified medical attention. No adverse effect reported. Additional information has been requested.
Chills, fever 101.3, very sleepy, fast heart rate. headache, still occurring 01/30/21 @ 11:23 pm.
On the 14th day post vaccine 2 my right arm was sore near area of injection site.  Rest of my arm was fine.  I also felt tired and general malaise.  Within 12 hours and after taking 2 Alleve tablets I felt much better
Flushing, sweating, dizziness, nausea. BP 98/58 (pulse 64), 100%. Crackers, juice, water given. F/u BP 108/95 (pulse 74).
Patient presented for second vaccine. Stated she was told by the health center that she could come in today for her vaccine.
Patient was tested positive for COVID-19 on 4/13/2021. Symptom onset was 4/10/2021. Exposure was from a close contact.
9 days following injection: fever, nausea, loss of appetite, headache, fatigue, body aches
menstral cycle was moved from 5 days a month to 2-3 weeks per month/ this went on for 5 months; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 19-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 30Apr2021 (Lot number: ER8733) at the age of 19 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 01May2021, outcome "recovered" (Oct2021), described as "menstral cycle was moved from 5 days a month to 2-3 weeks per month/ this went on for 5 months". The event "menstral cycle was moved from 5 days a month to 2-3 weeks per month/ this went on for 5 months" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heavy menstrual bleeding.  Additional information: The patient has no known allergies. The patient also received the second dose of BNT162B2, administered in the left arm on 24May2021 (Lot number: EW0171) for COVID-19 immunisation. She did not receive any other vaccines within four weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Apgar score: one minute: 2/Apgar score decreased; Foetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 19-Jun-2019, concerning a female neonate patient.   The patient's mother was 33-year-old with obstetrical history included two previous pregnancies in which both were full term live births and there were no birth defects reported. The patient's mother did not have history of offspring with major congenital malformation and no relevant maternal and paternal medical history. The concomitant medications of the patient's mother included Prenatal vitamins (minerals nos, vitamins nos) for pregnancy as a supplement. The pregnancy status of the patient's mother was collected, and no pregnancy complications were noted.  The last menstrual period (LMP) date of the patient's mother was 07-Sep-2018. The type of pregnancy was singleton. The patient's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   On 14-Nov-2018, the panorama prenatal test of the patient's mother was performed, and no major congenital malformation was noted.  On 24-Jan-2019, at gestational age of approximately 19 weeks, the foetus was exposed to Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: transplacental, batch number: 252675, dose, anatomical location and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for an unknown indication.   On an unspecified date, after the vaccine administration, the patient's mother experienced heartburn and was treated with Prilosec (omeprazole) (dose: 1 tablet, prn, orally from 22-May-2019) and Tums (calcium carbonate) (dose: 1 tablet, prn, orally from 22-May-2019) for heartburn.  At gestational age 39.9 weeks, the mother gave a live birth to a normal female neonate via vaginal method of delivery. The characteristics of the neonate included birth weight: 3690 grams. The head circumference: no data, body length: no data and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 2 (one minute) (explicitly coded as Apgar score decreased), 9 (five minutes). No other pregnancy complications and major congenital malformation (MCM) were not identified at birth.  The estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) of the patient's mother was reported as 14-Jun-2019.  This case is cross-linked to the case: 201903626 (mother case).; Reporter's Comments: A female neonate patient born at 39.9 weeks of gestation was found to have one minute APGAR score of 2, following vaccination with Flucelvax QIVc at 19 weeks. The event can be explained by the delivery related process rather than suspect vaccine. Hence, the causality assessed as not related to suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed this case as serious (medically significant)
Patient said that 1 hour after receiving the Pfizer vaccine she had 1 hive on her chin. She said that it resolved 1 hour after it appeared.
Dose 1: 4 days after vaccine until present (6 weeks), I have experienced dizziness and right knee pain. 7 days after vaccine until around day 28 (3 weeks), I had stabbing pain in right ear when swallowing. Dose 2: 1 day after vaccine until day 3, I had moderate swelling in left ankle. 1 day after vaccine until day 7, I experienced left ankle pain and right arm pain at injection site along with bullseye rash, swelling, warmth, itching and tenderness.
Moderate flu like symptoms on evening of Thursday October 13th lasting for 48 hours.  Rash started developing in groin area on 4 day after Covid 19 booster vaccination.
I am really angry; now I am screwed up,Something is happening that shouldn't be happening; I am upset; soreness of the arm they received the dose in; Unusually bad headache last night; if twisting the muscle, it's tender; menstrual bleeding lightly; headache; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (menstrual bleeding lightly), ANGER (I am really angry), FEELING ABNORMAL (now I am screwed up,Something is happening that shouldn't be happening), DEPRESSED MOOD (I am upset) and PAIN IN EXTREMITY (soreness of the arm they received the dose in) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Postmenopause (reported to be postmenopausal for over 2 years now). Concomitant products included LITHIUM, LAMOTRIGINE, CLONAZEPAM (KLONOPIN), LEVOTHYROXINE SODIUM (SYNTHROID), OLANZAPINE (ZYPREXA) and MELATONIN for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HEADACHE (headache). On 04-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (menstrual bleeding lightly). On an unknown date, the patient experienced ANGER (I am really angry), FEELING ABNORMAL (now I am screwed up,Something is happening that shouldn't be happening), DEPRESSED MOOD (I am upset), PAIN IN EXTREMITY (soreness of the arm they received the dose in), HEADACHE (Unusually bad headache last night) and MYALGIA (if twisting the muscle, it's tender). The patient was treated with ACETYLSALICYLIC ACID, DIPHENHYDRAMINE CITRATE, PARACETAMOL (EXCEDRIN PM HEADACHE) ongoing from 03-Aug-2021 for Headache, at a dose of 1 dosage form. On 03-Aug-2021, HEADACHE (headache) had resolved. On 04-Aug-2021, PAIN IN EXTREMITY (soreness of the arm they received the dose in) had resolved. At the time of the report, INTERMENSTRUAL BLEEDING (menstrual bleeding lightly), ANGER (I am really angry), FEELING ABNORMAL (now I am screwed up,Something is happening that shouldn't be happening), DEPRESSED MOOD (I am upset), HEADACHE (Unusually bad headache last night) and MYALGIA (if twisting the muscle, it's tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up was received. Additional events- anger, depressed mood, myalgia, headache and feeling abnormal were added.
Abnormal and breakthrough menstrual bleeding with IUD present, started to occur after 1 st vaccination and has not stopped.  Prior to the Covid vaccination I experienced no menstrual bleeding after IUD placement.   I have also had significant hair loss and thinning after the Covid-19 Vaccine.
lethargy had to waken to feed inc drooling; refusal to nurse; temp 8-10 hr post immun 99 ax;
#1)Viral-type illness on day #6 after vaccine given; extreme fatigue/myalgias/sent home on quarters #2)cardiac chest pain 2 months later (Apr 03) #3)thyromegaly-diagnosed with Grave's disease 3 months later (May 03)  Nurse follow up on 06/03/04 states: "Complete."
BLOOD CLOT IN LEGS/DVT; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (BLOOD CLOT IN LEGS/DVT) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (BLOOD CLOT IN LEGS/DVT) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (BLOOD CLOT IN LEGS/DVT) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient received Humira as Solution for injection in pre-filled pen.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns an adult male patient with use of Adalimumab for Ulcerative colitis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Deep vein thrombosis (reported as blood clot in legs/DVT) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as the vaccination date and  date of event onset were not provided. No information on any other doses of COVID-19 vaccination was provided. The use of Adalimumab  could be considered confounding to the case as leg thrombosis was reported to be one of its serious hematologic adverse effects. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with use of Adalimumab for Ulcerative colitis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Deep vein thrombosis (reported as blood clot in legs/DVT) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as the vaccination date and  date of event onset were not provided. No information on any other doses of COVID-19 vaccination was provided. The use of Adalimumab  could be considered confounding to the case as leg thrombosis was reported to be one of its serious hematologic adverse effects. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Severe cramping in the legs; 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 MUSCLE SPASMS (Severe cramping in the legs) 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 06-May-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) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MUSCLE SPASMS (Severe cramping in the legs). At the time of the report, MUSCLE SPASMS (Severe cramping in the legs) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Pt experienced a bruise the size of a quarter. Pt received the vaccine on 8/17/99.
Agonizing pain in right arm and shoulder, nausea, Teeth chattering, chills, weakness.
After dose 1 of the Moderna vaccine on day 7 I got a severe headache, nausea and vomiting    After dose 2 of the Moderna vaccine the following morning I had a severe headache, nausea, vomiting, and major body aches. I also had  severe stabbing stomach pain, sweating, vomiting and pain in my back. Day 2-6 most of the symptoms cleared up except the headache and stabbing stomach pain. I am currently on day 6 and I have severe  stomach pain every time after I eat food. I am going to see a gastro doctor to rule out gallbladder inflammation.
Received the vaccine on 04/02 and got the Shingles on 05/12.  I got the vaccine to prevent the Shingles, Not to Give me the Shingles.  I had the Shingles 25 years ago and got the medicine and it was much less severe then the Shingles outbreak this month from the vaccine.   I  also got sick after getting the vaccine with fever, aches, tiredness for a week.  That was listed as a possible side effect. I kept telling myself "this is better than getting Shingles" and then I got the Shingles. I did not see anything about the possibility of getting Shingles from the vaccine.    I did get Famciclovir on 05/14 which helped but I still had the Shingles.  I don't want a vaccine to give me a disease to get over.
Approximately 3 days after having received Johnson and Johnson vaccine for first time on 8/4/2022, I started to have louder more consistent tinnitus in my ears louder than I ever have experienced before. I now am waking up with very loud ear ringing in middle of night and cannot sleep well. Tinnitus is still continuing to this day.
This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A male patient in his 50's received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Consumer tested positive for 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. Clinical Course: Reporter also reported as he has been vaccinated and received Pfizer booster and tested positive for COVID 19, symptoms mild. He receiving treatment with Paxlovid and is responding well. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Skin hurt, bones hurt, muscles hurt, ever hair hurt.  Waves of pain going thru my body all night.  Low grade fever
fell on 2april at a local Walmart; started itching last night in my hands after I took Oxycodone/Every time I take opioids, I have itching; woke up with hives on my torso, knees, and my arms/hives are most likely related to oxycodone; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (tripped over a pallet and fell) and FALL (fell on 2april at a local ) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (surgery to repair my elbow) on 08-Apr-2021. Concurrent medical conditions included Allergy. Concomitant products included CITALOPRAM and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced SYNCOPE (tripped over a pallet and fell) (seriousness criterion medically significant) and FALL (fell on 2april at a local ) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRURITUS (started itching last night in my hands after I took Oxycodone/Every time I take opioids, I have itching) and URTICARIA (woke up with hives on my torso, knees, and my arms/hives are most likely related to oxycodone). The patient was treated with Surgery for Fall. At the time of the report, SYNCOPE (tripped over a pallet and fell), PRURITUS (started itching last night in my hands after I took Oxycodone/Every time I take opioids, I have itching) and URTICARIA (woke up with hives on my torso, knees, and my arms/hives are most likely related to oxycodone) outcome was unknown and FALL (fell on 2april at a local  was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment drugs included, Oxycodone , Zyrtec, Benadryl. Patient went to see doctor and they put on a new brace called T-form. It was reported that these hives are most likely related to oxycodone.; Sender's Comments: Based on reporter's causality (Tripped over a pallet and fell) the event is assessed as unlikely related to mRNA-1273.
INJECTION SITE VERY WARM TO TOUCH; BODY ACHING; CHILLS; FEVER; HEADACHE; INJECTION SITE RED; INJECTION SITE SWOLLEN; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAY-2021, the subject experienced injection site very warm to touch. On 17-MAY-2021, the subject experienced body aching. On 17-MAY-2021, the subject experienced chills. On 17-MAY-2021, the subject experienced fever. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced injection site red. On 17-MAY-2021, the subject experienced injection site swollen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aching, chills, fever, and headache on 19-MAY-2021, and had not recovered from injection site red, injection site swollen, and injection site very warm to touch. This report was non-serious.
Initial misuse report received from a healthcare professional on 05 September 2013. A patient received only diluent from the Act-Hib vaccine. No information was provided regarding the patient. List of documents held by the sender: None.