chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of infection transmission via personal contact in a 38-year-old female subject whose son was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 16 December 2010 at 10:30 the subject's son received 1st dose of ROTARIX (unknown). On 17 December 2010 at 03:00, 1 day after vaccination with ROTARIX, the subject experienced infection transmission via personal contact, gas and diarrhea. The subject reported that her son received ROTARIX on 16 December 2010 approximately 10:30 and then on 17 December 2010 at about 03:00 she stated experienced the "listed gastrointestinal (GI) side effects". At the time of reporting the outcome of the gas and diarrhea were unspecified.
Information has been received from a physician concerning a 10 year old female who in November 2007, was vaccinated with GARDASIL (lot 658219/0755U).  There was no adverse reaction.  She received her second dose on 20-JAN-2008.  On 24-JAN-2008 she developed an itchy rash with lesions on her trunk which then spread to her extremities.  She was treated with diphenhydramine (BENADRYL).  On 28-JAN-2008 the patient recovered from itchy rash and lesions.  The physician reported she was unsure if it was related to GARDASIL vaccine or if it may be chicken pox despite being vaccinated as a young child.  Additional information has been requested.
little spots, almost hives, they don't itch, around her abdomen; woke up and couldn't go back to sleep; liver swelling/liver is bumping out; Liver pain; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left deltoid on 31Aug2021 at 17:00 (Lot Number: FC3183, unknown expiration; at the age of 45 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing tick bite, allergic to meat (ongoing), and ongoing alpha one complications since she was about 9 or 10 years old; ongoing seizures; immunocompromised; and penicillin allergy. Family medical history included her father has severe cardiac condition. Concomitant medication included topiramate (TOPAMAX) taken for seizures from 2006 and ongoing. The patient previously took morphine and experienced drug hypersensitivity; and influenza vaccine for immunisation and experienced pneumonia (years ago as a teenager). The patient reported that she is having reactions that are not listed. She has been trying to get an appointment with the emergency room or her PCP but couldn't get through, so she decided to call Pfizer. She wanted to report in case others are having the same thing. The patient mentioned that she is having liver swelling. Her side effect developed yesterday (on 01Sep2021). She was recommended the Johnson one, but it is not available. The patient further described the event as liver is bumping out, and it was very painful (liver pain); it started as a light pain. Then about 03:00 am on 01Sep2021, she woke up and couldn't go back to sleep. The pain was unbearable last night. Today (02Sep2021), she noticed little spots, almost hives, they don't itch, around her abdomen. She thinks her liver swelling and pain started about seven hours after the vaccination. All of her symptoms are getting worse. When ask for seriousness she states all her events are medically significant; when ask for causality she states yes, related to the product. She has been unable to get a hold of the ER or the health department, she has not had any treatment yet. No history of previous immunization with the Pfizer vaccine considered as suspect. The patient asked if anyone else had this side effect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient did not receive treatment for the events. No relevant tests. The patient has not yet recovered from the events. The events were assessed as serious (medically significant).   Information on the lot/batch number has been requested.
patient started sweating and feeling dizzy after the shot. she sat down for a while and recovered after sometime.  Paramedics were called. they examined her vitals and everything was ok
Patient recieved Jannsen vaccine 1 week ago. reported shortness of breath x 6 days. arrived at hospital tested c/o shortness of breath. Currently admitted inpatient positive covid test 5/20/21. patient did note exposure to covid  positive person 10 days ago.
Numbness to bottom lip Sensation of puffiness Paresthesias to left temporal/ orbital area
Patient had a typical vasovagal response.  She lost conscious for seconds, then regained consciousness.  She was slightly dizzy but we had her lay on her back with feet elevated.  After 5 minutes she was back to normal.  Patient was observed for 20 more minutes with no issues.
Information has been received from a medical assistant concerning an 11 year old female with allergy to penicillin and sulfa who on 06-JUL-2010, was vaccinated with a 0.5 ml IM dose of GARDASIL. On 06-JUL-2010, five minutes post injection, the patient experienced feeling lightheaded, nauseous and faint. The patient was seen by the physician who instructed her to lie down and after ten minutes the patient was released to home. The patient stated she felt better. On 06-JUL-2010, the patient recovered from feeling lightheaded, nauseous and faint. Additional information has been requested.
get really, really sick; muscle aches; fever; my immune system is down; couldn't get out of bed I was too weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly female patient received BNT162b2 (COMIRNATY), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Factor V" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Feb2021, for COVID-19 immunization, reaction(s): "Couldn't get out of bed I was too weak", "Immune system down", "Get really sick", "Muscle aches", "Fever". The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "recovered", described as "couldn't get out of bed I was too weak"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "fever"; MALAISE (non-serious) with onset 2021, outcome "recovered", described as "get really, really sick"; MYALGIA (non-serious) with onset 2021, outcome "recovered", described as "muscle aches"; IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "recovered", described as "my immune system is down". Additional information: the patient stated that her symptoms only last 24 hours, she guessed it was not that bad, the fever and muscle aches start at nighttime after getting the injection. The patient's concomitant medications included blood thinners as her told her that she should get it. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201232892 same patient/drug/AE, different dose;US-PFIZER INC-202201233151 same patient/drug/AE, different dose;
11:30 - 124/82, RR 22, HR 92.  11:56 - 126/82, RR 18, HR 86. Pt was vaccinated with Pfizer COVID-19 (Lot # EW0158) vaccine and went to post-vacc area.  Pt told post-vacc nurses that she was feeling nauseous and anxious.  Pt stated that she has Hx of anxiety and this episode felt "like my normal anxiety attack."  Pt denied any chest pain, SOB, or other pain or discomfort.  Pt was seated outside with post-vacc nurse and given a bottle of water because Pt stated that being outside helps her anxiety.  Pt sat outside for approximately 30 minutes and then stated that she was feeling better.  Pt left with her mother, who was also on-site for vaccination.
Information has been received from a nurse practitioner for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female patient. On 30-JUN-2014, the patient was vaccinated with the first dose of GARDASIL (route and lot # not reported). The nurse reported that 15 minutes after vaccination, the patient's pregnancy test came back and it was positive. The nurse stated that the patient only missed one period, therefore it was not believed to be far along. The LMP and EDD were not known. The pregnancy outcome was pending. Additional information has been requested.
Information has been received from a registered nurse concerning a 67-year-old female with hypothyroidism and an allergy to penicillin allergy and DEMEROL who on 10-DEC-2007 was vaccinated subcutaneous with a dose of Zostavax (Oka/Merck) (lot # 658212/0887U).  Concomitant therapy included SYNTHROID.  On 16-DEC-2007 the patient developed a right upper lip pustule with swelling.  The patient also developed soreness of the right upper cheek and the roof of her mouth.  A pustule developed near her right eye.  The patient was examined in the office on 17-DEC-2007 and a culture of a pustule was taken.  The culture results were negative for virus.  On 21-DEC-2007, the patient was examined in the office again.  The exam revealed tearing of the right eye.  The patient was started on VALTREX and referred to an ophthalmologist for consultation.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
This spontaneous report as received from nurse refers to a 73 years old female patient. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported) on 19-JUL-2012. On 19-JUL-2012 after being vaccinated, the patient developed chest pain and anxiety. It was reported that the patient did an EKG. And the patient sought for medical attention when she was at the office at that time. The physician did not think the AE had anything to do with ZOSTAVAX because the patient was normally anxious. Additional information has been requested.
This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), DECREASED APPETITE (poor appettie) and FATIGUE (extreme fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MACITENTAN (OPSUMIT) for Pulmonary hypertension.    Concurrent medical conditions included Pulmonary hypertension (secondary Pulmonary hypertension). Concomitant products included RIOCIGUAT (ADEMPAS) and APIXABAN (ELIQUIS) for an unknown indication.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 and MACITENTAN (OPSUMIT) (Oral) at an unspecified dose. On 12-Apr-2021, the patient experienced PYREXIA (fever) (seriousness criterion hospitalization prolonged), DECREASED APPETITE (poor appettie) (seriousness criterion hospitalization prolonged) and FATIGUE (extreme fatigue) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 12-Apr-2021 to 19-Apr-2021 due to DECREASED APPETITE, FATIGUE and PYREXIA. At the time of the report, PYREXIA (fever), DECREASED APPETITE (poor appettie) and FATIGUE (extreme fatigue) outcome was unknown.            No treatment medications provided by the reporter.  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.; 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.
Notes from my visit with him: May 17th 2021-- "Got his second dose of Moderna vaccine a week ago. Had some SOB afterwards, and then felt improved. But then yesterday started to have similar symptoms, as well as chest pressure, hurts to breathe all the way in, feels a twinge feeling on the inside. Also noticed a muscular pain as well in the same area, hurts to move down the middle of his chest. Also having pain on the right side. Symptoms are persistent, will wax and wane slightly but doesn't go away completely. Feels better when he is standing if feels better, has not noticed food triggers, no difficulty eating or swallowing. A few weeks ago also started a higher fat intake diet. No fevers or chills, no diarrhea, no rash, no sore throat, no runny nose. No known muscular injury that he can think of." May 20, 2021-- "Today is feeling some decrease in symptoms, but still feels like he needs to take deep breaths. Feels like "something is erratic" once in a while. Not feeling increased improvement. Laying down does seem to make it worse. One time he was leaning forward and then sitting up made it worse." May 26, 2021 -- "he reports that he is still feeling some chest pain, but overall is feeling better, symptoms are up and down. Feels like a "tiredness" in the chest wall area. The most pain is from twisting. Not worsening with acidic or greasy foods. Feels like pain is mostly in the muscle now. No SOB at all with increased exertion."
COVID ARM PRESENTED ON 4/22 WITH REDNESS ON ARM BUT PAIN STARTED ON DAY  AFTER VACCINATION (4/20/21). PAIN INCREASED ON 4/21/21 BUT HAS SUBSIDED AS OF 4/22/21. PT STATED ITCHINESS STARTED ON 4/22 AND WAS TOLD TO TAKE BENADRYL TO  ABATE SYMPTOMS
Tingling in lower legs, sometimes in feet also started morning after vaccine. Periods of dizziness started 2nd day after vaccine.
Patient broke out in hives on face, stomach, back and chest. Very swollen and red on face area and around the eyes. Decardron 4ml was administered to the patient. The redness got somewhat better that evening and the swelling finally went away 2 days after steroid was given.
Patient had possibly received an extra COVID Booster, too soon and also shows that he already had the Bivalent booster.  He had received COVID shots on the following dates:  02/11/21, 03/11/2021, 11/29/21, 03/30/2021, 09/7/22 (Bivalent) and then possibly on 10/7/22 (Bivalent). Pt's wife had informed us that this was an extra and wanted to make sure things would be fine. There have been no reported issues since then.
High heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (High heart rate) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEART RATE INCREASED (High heart rate). At the time of the report, HEART RATE INCREASED (High heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Site: Pain at Injection Site-Medium, Additional Details: Patient received a flu shot on sept 02 2021. A couple of months later he comes in to tell me his arm hurts and started to hurt a couple weeks after the vaccine & his doctor thinks it was because he received 3 vaccines in 1 arm (moderna on april 21 2021 and again on may 19 2021)  He comes back months later and tells me his arm still hurts with certain movements. I dont believe it was due to the vaccine as the pain didnt happen right away and shots were months apart but reporting just in case
Muscle soreness/muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness/muscle pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced MYALGIA (Muscle soreness/muscle pain). At the time of the report, MYALGIA (Muscle soreness/muscle pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The muscle pain was not severe and in about 2 weeks they were getting less painful.   This case was linked to MOD-2021-259101 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received contains significant information of Patient demographics and vaccine start date were updated. Batch number, event start date, vaccination facility information were added.
Initial case retrieved via the scientific literature on 01 February 2010. This involves a case of misuse (drug administration error). Summary of article: On 27 March 2009, blood products were collected from 89 active duty military donor/trainees during a blood drive. On 10 April 2009, a routine record review in connection with a subsequent blood drive learned of breach in the deferral protocol for blood products collected from 89 donor/trainees. Further investigation revealed that the blood obtained from the donor/trainees was from donor/trainees who had been vaccinated with yellow fever vaccine 4 days prior to donating blood. All the blood products had already been processed and incorporated into the inventory at the hospital blood bank. Additional investigation showed that, between 31 March and 09 April 2009, 5 patients had received a total of 6 blood products (3 platelets, 2 fresh frozen plasma, and 1 packed red cell unit) from 6 of the 89 donor/trainees. One of 5 blood recipients had underlying diffuse large B cell lymphoma and prostate carcinoma, and died 20 days after receiving the blood product. Of the other 4 surviving blood recipients, 3 had VFV-IgM antibodies confirmed by plaque reduction neutralization test. This case contains information for 1 of the 5 blood product recipients. Information regarding the other 4 blood recipients is reported in cases 2010-00827, 00841, 00842, and 00843. Information regarding the 6 blood donor/trainees is recorded in case 2010-00844. An 82-year-old male patient was discharged to inpatient hospice for terminal prostate cancer and end-stage, transfusion dependent, B-cell lymphoma, and received on an unspecified date, 1 unit of irradiated platelets that was from blood products that had been donated by one of the active duty military donor/trainees who had received yellow fever vaccination 4 days prior to donating blood. The blood donor/trainee had no previous history of vaccination or travel history consistent with exposure to wild-type YFV. Testing for pre-transfusion serologic status of the patient could not be performed because banked sera were not available. The patient died (death not related) 20 days after receiving the blood transfusion of irradiated platelets. It was noted the patient had previously been vaccinated with yellow fever vaccine in 1959 and again in 1965. No autopsy was performed on the patient; and cause of death was not provided. No pre-mortem blood specimens were available for testing, and residual blood products from the patients transfusion was discarded. Documents held by sender: None.
Pronounced red streaks appeared on both arms while showering. Marks faded within an hour or so.
arm sensitivity; had some side effects that are on your package insert; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (arm sensitivity) and ADVERSE EVENT (had some side effects that are on your package insert) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HYPERSENSITIVITY (arm sensitivity) and ADVERSE EVENT (had some side effects that are on your package insert). At the time of the report, INJECTION SITE HYPERSENSITIVITY (arm sensitivity) and ADVERSE EVENT (had some side effects that are on your package insert) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Herpes outbreak; A spontaneous report was received from a nurse concerning herself, a 50-year old, female patient who received Moderna's COVID-19 vaccine and experienced herpes outbreak.   The patient's medical history included herpes. Concomitant medications reported included gabapentin, ibuprofen, and celecoxib.   On 28 Dec 2020 at 2:00 pm, approximately several hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (LOT# 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Dec 2020, in the middle of the night, the patient reported starting to feel like she was going to have a herpes outbreak. On 29 Dec 2020, the next morning, she was sure she was starting to have an outbreak. The patient reported having an outbreak after receiving the flu vaccine and wanted to know if she could take Zorivax antiviral in response to the event. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event herpes outbreak was unknown.; Reporter's Comments: This case concerns a 50-year old female nurse who experienced a nonserious event of herpes outbreak. The event occurred one day after she received the first of two planned doses of mRNA01273 (Lot # 025L20A). The patient's past medical history includes herpes. The concomitant medications included gabapentin, ibuprofen, and celecoxib. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of mRNA-1273 and the event, a causal relationship cannot be excluded. Additional information is required for further assessment.
Initial unsolicited report received from a consumer (patient herself) on 20 Oct 2017. This case involves a 51-year-old female patient who was vaccinated with one dose of FLUZONE QUADRIVALENT (Batch number: UT5954KA, Expiry date: 30-Jun-2018, dose and dose in series was not reported) intramuscularly in left deltoid on 11-Oct-2017. Patient medical history was not reported. The patient denied injury or previous history of back issues. Concomitant medications were not reported. (It was reported as no other vaccines were administered by the patient). On 13-Oct-2017, two days following the vaccination, the patient developed incapacitating back pain, the pain was limited to lower back and lower extremities. Relevant lab tests were not reported. Patient received corrective treatment with ibuprofen (Advil), naproxen sodium (Aleve), paracetamol (Tylenol), ice, heat and foam roller but had no relief from any of those medications. The outcome of the event Low back pain was recovering (reported as back pain has remained, improved, but is still noticeable) and the outcome of Pain of lower extremities was unknown. Documents held by sender: none.