chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delivered her baby early at 35 weeks pregnancy; delivered her baby early at 35 weeks pregnancy; he was 4 pounds 14 ounces; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the parent.  A male patient was exposed to BNT162b2 (COMIRNATY), transplacental, administration details for the mother: as dose number unknown, single (Lot number: Unknown) for covid-19 immunisation. The mother was 35 weeks pregnant at the event onset. The mother is expected to deliver one baby(s). The mother's relevant medical history and concomitant medications were not reported. The following information was reported: FOETAL EXPOSURE DURING PREGNANCY (non-serious), PREMATURE BABY (non-serious), outcome "unknown" and all described as "delivered her baby early at 35 weeks pregnancy"; LOW BIRTH WEIGHT BABY (non-serious), outcome "unknown", described as "he was 4 pounds 14 ounces". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The mother had the covid vaccine during pregnancy. She delivered her baby early at 35 weeks pregnancy. Baby boy was healthy, although he was 4 pounds 14 ounces. She believes the early delivery was due to covid vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200108785 Mother/Baby;
he tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 10Jan2022, outcome "recovered" (Jan2022), described as "he tested positive for Covid". Relevant laboratory tests and procedures included covid positive on 10 jan2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Occurred 4-5 min after administration, C/O mild light headedness, Slt flush. Recovered in approximately 5 min after lying down.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: Approximately 1-2 minutes after IM administration patient developed redness on his face, flushing, blackout and felt the need to lie down on the floor. Patient remain concious during the incidence, asked for water and was provided, fan. After 15-20 minutes, patient feel better and left the store.
diarrhea; Headache; muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HEADACHE (Headache), MYALGIA (muscle pain) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced DIARRHOEA (diarrhea), HEADACHE (Headache), MYALGIA (muscle pain) and FATIGUE (fatigue). At the time of the report, DIARRHOEA (diarrhea), HEADACHE (Headache), MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Reporter did not allow further contact
I had a sore arm, a headache and weakness after receiving the vaccine for a couple of days. I have an autoimmune disease and I have blood work drawn often. In 01/2023, I went to my doctor for bloodwork and my liver enzymes was elevated. On 05/12/2023, I had a liver biopsy and waiting for results.
WEAKNESS,  TINGLING AND NUMBNESS, UNABLE TO WALK, SHAKING, APPEARS ANXIOUS, TINGLING IN TONGUE
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with ZOSTAVAX. One week after the patient received the vaccine developed symptoms of chickenpox. On an unspecified date, the patient recovered from the symptoms of chickenpox. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
I have been itching systemically since 4/20/21. I had second dose end of February.  March 15th or so I started Latuda for my Bipolar. By May 20th or so I started to itch. It got worse over the next two weeks. Went to ER was given depo Medrol 60mg IM injection, and prednisone for 5 days.  days after the prednisone the itching came back, a few weeks after first ER visit I went back and was given Decadron IM 10MG, that didn't work at all. The next day my lip began to swell. I had been off of Latuda at this point for 10 days. I was given prednisone again for 6 days with a taper off 2 days 20mg BID, 2 days 20MG QD, and 2 days 10g QD. A friend told me about fematode, zantac, etc for acid reflux has anti histamine properties which I looked up and figured it wouldn't hurt to try it. I had already done rounds of Benadryl for weeks. Benadryl would work a little. The zantac generic seemed to work and has been up until the last few days. This itching moves from my face to my hands, feet, butt, thighs, chest. Each time it just varies were it flares up at, when it flares up, and how intense. Besides the Latuda which I stopped over 3-4 weeks ago the only other change is the covid vaccine.
Case PHEH2016US025812, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to an 51 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618521) at a dose of 1 ml intramuscularly on 26 Sep 2016. The nurse stated that, she discovered that 9 patients received 1.0 ml of FLUVIRIN rather than 0.5 ml. No adverse event was reported after this maladministration. The case was lost to follow up at initial.
measles; morbilliform rash over trunk, face and some extremities; This spontaneous report was received from a consumer via a company representative and refers to a 14 year old patient of unknown gender. The patient's medical history included stem cell transplant and it was reported the patient was well. No information regarding the patient's concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, frequency, route and site of administration, lot number and expiration date were not provided).  On an unknown date, 7 days after the vaccination, the patient developed morbilliform rash over trunk, face and some extremities. It was stated that it looked like measles. It was unknown if there was any treatment given for the adverse events. The patient was being seen by the dermatology team and would have a biopsy. The outcome of the events was not provided.  The reporter was concerned that the events were related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  Upon internal review, the event of measles was considered to be medically significant.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
Have observe some pain at the injection site at the moment of the vaccine administration/burning like pain; The pain was described as a burning like pain; This is a spontaneous report received from contactable Pharmacist from information team and a sales representative.  A 65 year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as single dose for immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Have observe some pain at the injection site at the moment of the vaccine administration/burning like pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "The pain was described as a burning like pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
complained of dizziness soon after receiving the vaccine. As per the worker BP went up to 190/90 and later came down to 140/?. Felt better and went home. during night had swelling of lips and eye lids, felt feverish, with soreness of left upper arm,pain 10/10 on a pain scale of 10. Felt better with Benedry and Tylenol. Came to Occupational health Servic ein the morning complaining of feeling foggy, feverish,blurred vision and head ache. Referred to Er for evaluation and management.
pt recv vax & next day devel redness @ inj site;this event was dx as an allerg rxn;pt recovered;this is 1 of 2 residents from this facility to have an adverse exp p/pnu immune 23 lot#444070;
Soreness at the injection site/at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site/at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site/at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site/at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a healthcare worker concerning a female (age unk) with unk medical history and unk drug reactions/allergies, who on an unspecified date was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot 651321/1036P). Subsequently, on an unspecified date the pt experienced pain at the injection site, fever, chills and fatigue, after receiving the vaccination. The pt's status was not reported. Additional information has been requested.
NASAL CONGESTION, RUNNY NOSE, COUGH, HEADACHE, SHORTNESS OF BREATH, FEVER,      PT ADMITTED TO HOSPITAL
arm sore; tired; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 28Dec2020, the patient experienced arm sore and tired a couple of days. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter.  Information on the lot/batch number has been requested.
Patient received Pfizer COVID vaccine on 1/21/21 (lot # EL3302), 2/10/21 (lot # EN6201), and 9/27/21 (unknown lot #, data from pharmacy per file).  On 2/1/22, patient admitted to our inpatient facility with acute hypoxic respiratory failure secondary to possible community acquired pneumonia, COPD exacerbation, and CHF exacerbation. She also tested positive for COVID on 2/4/22 during admission.  As of today (2/8/22), patient is still admitted in our med/surg unit.
Chills, fever, splitting headache, nausea, extreme fatigue.  24 hours
On the seventh day an inflammation began, the area was red very itchy. That reaction started from my upper arm to almost the elbow. It is wide. At first I thought it was an insect bite but after the third to fourth day, it would not go away and it was very itchy. I decided to apply aloe vera gel however the itching continued. Today is March 14th and it is the first day that the itching has decreased but not the inflammation neither the size of the red spot on my arm.
I95.9 HYPOTENSION 4/14/2023 HYPOGLYCEMIA
passed out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  An 81-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure", start date: 2012 (unspecified if ongoing); "passed out" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Primary Immunization series completed), for Covid-19 immunization; Bnt162b2 (dose number unknown (booster), single), for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 15Nov2023, outcome "unknown", described as "passed out". Clinical course: Reporter and his wife got both Covid 19 vaccines since it started including the booster. His wife passed out three times within the past 1.5 years. Most recently that day. Had heard that this was a possible side effect of the vaccine. Wanted to report the experience and find out if this was indeed coming from the vaccine. Reporter stated his wife passed out that day and the first time she was age 81 when it happened first and she was then age 82. The dates his wife passed out were 15Jul2022, 16Dec2022, and that day 15Nov2023. The only date of the Pfizer covid vaccine he had was for her last booster shot that was on 14Nov2023 at (Withheld) and he had no other dates of her other doses and no lots, expiry dates or NDC numbers to provide for any of her covid vaccines. One time when she went to the hospital, they said they did not know what it was and it might be her heart so they went to a heart specialist who said it was probably not and to keep checking it and the last thought was that she might be dehydrated. When the patient went to the hospital she was there for a day and was there overnight and then the next day they went home.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Syncope; Flushing; Blurred vision; Felt like is going to pass out; A spontaneous report was received from a pharmacist concerning a 67-year-old, female patient, and experienced syncope, flushing, blurred vision (vision blurred) and felt like she is going to pass out (presyncope).  The patient's medical history, was diabetes type 2, high blood pressure and anxiety. Concomitant medications reported included non specified medications to diabetes type 2, high blood pressure and to anxiety.  On 04 Mar 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced syncope, she was flushing and had blurred vision. She felt like she is going to pass out.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, syncope, flushing, blurred vision (vision blurred) and felt like she is going to pass out (presyncope) were considered as unknown.; Reporter'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.
I developed fever of 101.7, had rigors, sweats, bone and muscle ache. I experienced a zapping sensation in my head that traveled down to my jaw. It felt like an electric shock that lasted a few seconds .It went from top of my head to my left jaw and ear. If felt the pain in my back molars.  This happened at least 15 times. In a 24 hour period. It was not a headache.
sudden onset of extreme pallor. Somnolent, went to sleep for several hours, awoke appearing normal and back to baseline.
GuillainBarre syndrome; patient received seasonal influenza vaccine early in the first trimester of pregnancy; Initial information received on 07-Jun-2019 regarding an unsolicited valid serious pregnancy case issued from a literature article.   Abstract: Guillain-Barré syndrome (GBS) is an adverse event of interest after vaccination, yet few data are available for background rates during pregnancy. We confirmed 2 cases of incident GBS and estimated an incidence of 2.8 confirmed GBS cases per million person-years (95% confidence interval, 0.5-9.3), indicating rare occurrence. Our findings will help inform safety assessments of Zika vaccines in pregnant populations.  This case involves a 26 years old female patient who developed Guillain-Barre Syndrome, while she received vaccine INFLUENZA VACCINE, while she was pregnant.   Data regarding this pregnancy were received retrospectively, i.e. after pregnancy outcome was known. The reported Guillain-Barre syndrome occurred at 22 Weeks of pregnancy.  The date of last menstrual period and actual date of delivery were not reported.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had previous pregnancies.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (formulation: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient presented with a serious Guillain-Barre Syndrome (guillain-barre syndrome) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was case of vaccine exposure during pregnancy. The patient was 22 weeks pregnant when she received vaccine.  (Other relevant tests included No lab data.) Final diagnosis was guillain-barre syndrome.   It was not reported if the patient received a corrective treatment.  The reporter did not believe that this represents a case of vaccine-associated GBS.  Outcome of the event GBS was not reported.  Additionally, at time of reporting, the birth type and delivery type were not reported. Gestation period at delivery: 39 weeks.  There will be no information available on the batch number for this case.  List of document held by sender; none; Sender's Comments: This case concerns a 26 years old pregnant female patient who presented with Guillain-barre syndrome after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Mixing error occurred, patient may have received only diluent. re-vaccinated 5/5.
I tested positive for COVID on February 28, 2023. I tested because I was having nasal symptoms and I was high risk from international travel. I was prescribed PAXLOVID on the 28th and took the full 5 days, I tested again and was negative at first then positive, my symptoms are more mild now. No adverse event to vaccination just tested positive for COVID.
Moderna vaccine: Red swollen arm , redness spread 6" from vaccination site and was 4" wide. Still visible today 3/15/21 Starting 3/11/21, fatigue, muscle pain, joint pain, chills, nausea, diarrhea, and fever 101.7. unable to get out of bed 3/11 and 3/12.  3/13/21, no fever but fatigue persisted with frequent naps required.  3/15/21, finally feel symptom free.
Initial and follow up information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the approximately second dose of GARDASIL (lot #, route and site of administration not reported). Subsequently, the patient developed hives, joint pain and muscle aches. The patient was having debilitating problems and now dependent on steroids. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Hives, joint pain, muscle aches and debilitating problems were considered to be disabling by the reporter. Additional information has been requested.
The day after vaccine 4/6/2012, patient was more hyper, less attentive, less affect, less eye contact, and some strange facial expressions. Low temp of 99. All within normal side effects for vaccine assuming they were temporary and self limiting; no concern at this point of reaction. Upon waking, patient was lethargic, irritable, flushed. Temperature reading at 8:00 was 103. Patient had never experienced a fever higher than 102 in his life, or lethargy, despite having several viruses in his young life. Patient was taken to doctor this day, thought to be virus, however the next morning awoke perfectly well. This is when the immune activation is thought to have begun. On 4/29/2012 mild leg pain and fatigue; extremely unusual for patient. This is when the Encephalopathy is thought to have begun.  4/30/2012 Awoke at 5:30 screaming, afraid, nightsweat. Irritable, flushed, lethargic. Similar to previous event with 103.5 fever this time. This time however, he looked, felt, acted, seriously ill. Was unable to eat, would not drink, scared, skin hurt. This is when suspected Encephalomyelitis began. On the way to the doctor's office, his pupils were as large as his iris, shivering, aching knees, leg muscles, breathing was labored. Dr. that he saw observed that he was very ill and did bloodwork for mono, EBV, strep. All turned out to be negative. He woke up "well" the next morning. Another episode on 5/2/2012 in which he had headache, small bumpy rash on his ears, arms, and legs, completely lethargic, diarrhea. This is the day that the neurological symptoms became more noticable. For the next 7-10 days, patient loss cognitive abilities, memory loss, muscle pain, sensory sensations, nightmares / possible febrile seizures, hearing, vision changes, urination accidents, loss of coordination, unable to pronounce words, unable to follow directions, unable to express himself the way that he had always been able to so well.