chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. request to be lowered to the ground after she ?felt an attack? coming. Reports to having Mast Cell Activation syndrome causing severe allergic reactions & muscle spasms at random.  VS 128/86, HR-88, O2 - 98%, 18 - Resp, pt. remained A&O able to answer all questions appropriately, no loss of consciousness. Reports she is currently on medications for syndrome, with last ?attack? 12/2020. EMS activated, pt. & husband refused. Pt. assisted up to chair, monitored for additional 15 min. Reassessment - pt. reports no spasms, no spasms assessed by writer. Pt. states she has returned to her ?normal? other than ?weakness? which she reports is ?normal after attack?. Pt. left to home with spouse.
Patient was inadvertently given bivalent booster as first primary series dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was inadvertently given bivalent booster as first primary series dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was inadvertently given bivalent booster as first primary series dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was inadvertently given bivalent booster as first primary series dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was inadvertently given bivalent booster as first primary series dose).    Concomitant product use was not provided by the reporter.   HCP (clinical services manager for pharmacy chain) reports that the patient was inadvertently given bivalent booster as first primary series dose and additional patient details were unknown to the reporting HCP at that time.  Treatment information was not provided.
In January 2023 I initially had a slight cough and body aches.  It progressed to chest congestion and wheezing.  I had mucus when I coughed.  I contacted the doctor on January 31st.  I lost my voice.  I was prescribed Paxlovid and began taking the five-day treatment.  My symptoms progressed for a couple of more days but then started to decline.  I was feeling better after day 8 days.  As of today I have rib pain due to the continuous coughing.
1 day p/vax pt became cranky, temp (not recorded), leg was eythematous  4cm w/eccymosis; when seen on 20MAY erythema had resolved w/2 cm induration;
Initial report received from physician on 17 Dec 2009: A 2 years old child was administered with FLUVIRIN on 16 Dec 2009. No adverse event was reported.
Feel tired; Muscle fatigue; This case was reported by a consumer and described the occurrence of tiredness in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced tiredness and muscle fatigue. On an unknown date, the outcome of the tiredness and muscle fatigue were unknown.   It was unknown if the reporter considered the tiredness and muscle fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had feel tired with muscle pain.
This spontaneous report as received from a physician refers to a patient of unknown age. On 30-OCT-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # HJ001180, expiration date: 18-AUG-2014) (dose, route unknown) which was improperly stored. No adverse event reported. This is one of several reports (1403USA000875; 1403USA001193; 1403USA001194) from the same reporter. Additional information is not expected.
No treatment.  The lymph knot showed a swelling between chest and armpit. It is still swollen a little bit, but much better than this morning and the pain is not there anymore.
At 6 hrs post vaccination I became lethargic. I laid down and my heart was racing. I fell asleep for a few minutes and when my daughter came walking across the wood floors after having left for a few minutes I had auditory issues in which it sounded like she was storming in large boots at a fast speed across the wood floor (pounding in my ears). I became panicked and was afraid of her until I realized who she was. I fell back asleep and had delirious "fever dreams". After 30 min nap, I felt ok. The next day I had vertigo and didn't feel safe to drive so I worked from home on Fri 4/30/21. Every time I moved my head, everything had a "tail". This lasted until the next day, Sat 5/1/21.  I was increasingly becoming confused and scatterbrained (losing things, not being able to "collect my thoughts". On Sunday, 5/2/21,  I was able to play pickleball with family but at the end, felt vertigo again. On Monday, 5/3/21 the vertigo was gone but I continued to feel confused and had a phone conversation with a client in which I involuntarily yelled "UM!" 6 times and was unable to control it.  I continued to work during this time period and those around me felt I appeared more scatterbrained but inside I was increasingly concerned. I also forgot to pick up my 14 year old daughter as arranged.  On Thurs 5/6/21 I had a pre arranged doctor appt in which I was clear headed enough to tell her I had been confused continuously since the last vaccination. Beyond this appt, I continued to have distortion of time in which I would think 10 min passed but an hour or more had passed. Additionally, the following 2-3 weeks involved me undoing the damage I had done to my work files. I had dramatically mis filed almost every piece of paperwork that I touched and forgot to call clients when making changes to schedule, etc.
Local injection site pain and soreness immediately after. Starting about 6 hours later, started feeling nausea, shivers, whole body aches. About half an hour after that, had a bout of vomiting, loss of vision for about 10 seconds after standing up from bed (possibly associated with undiagnosed iron deficiency), and paleness of skin and mucous membranes.
Painful , very enlarged lymph nodes in right Axilla, Collarbone area, right side of neck and right breast. Extremely painful and swollen. Started approx 26 hours after injection - came on suddenly; Painful , very enlarged lymph nodes in right Axilla, Collarbone area, right side of neck and right breast. Extremely painful and swollen. Started approx 26 hours after injection - came on suddenly; This is a spontaneous report from a contactable nurse. A 41-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (anatomical location: arm right) from 07Jan2021 14:00 to 07Jan2021 14:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, pancreatitis, If-covid-prior-vaccination: Yes and allergies sulfa meds. Concomitant medication included paracetamol (TYLENOL) and metoprolol. The patient previously took codeine for allergies. The patient had first vaccine of BNT162B2 from 18Dec2020 to 18Dec2020 for COVID-19 immunization. On 08Jan2021 at 16:30, the patient had painful, very enlarged lymph nodes in right axilla, collarbone area, right side of neck and right breast. extremely painful and swollen. Started approx 26 hours after injection - came on suddenly. Outcome of the events was not recovered.
Vaccination for COVID19 Pfizer 4th dose/booster was administered to patient by a certified technician with a 1inch, 1ml vanishpoint safety syringe/needle.  After administration, the technician activated the safety feature by retracting needle into syringe, a small amount of liquid came out of the patient's arm. The patient stated that there was a "bubbling." Patient does not feel that she received the entire dose.  I assured patient during a phone call after the vaccination date, that I believe she received the entire dose, as the syringe requires the entire dose to be administered. There may have been some that came out from the retraction, but the entire dose was administered. No adverse event has occured but that patient believes she may not receive full protection.
Within minutes of getting the vaccine I had a head rush not long after and up with a headache it has now been over a week I can not get rid of the headache my head is so full of pressure at times it feels like it is too much pressure. It?s causing neck discomfort. I have tried excedrin Tylenol midol and tramadol and nothing helps. As soon as I wake up in the morning and stand up it comes right back. The only thing that relieves pressure is laying down. I am getting a tingly type feeling in my face and random chill type feelings in my face. I have also been just feeling over all blah and some weird pains behind my arm like shooting pains.
Headache, followed by stiff neck, in addition on 10/6/2012 101 fever, fatigue, upset stomach lasting until 10/07.
I have generally felt bad; Erythema Nodosum; tired and sluggish; left side of my face went numb; low energy for a couple of days; sore left injection site arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA NODOSUM (Erythema Nodosum) and HYPOAESTHESIA (left side of my face went numb) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced HYPOAESTHESIA (left side of my face went numb) (seriousness criterion medically significant), ASTHENIA (low energy for a couple of days), MYALGIA (sore left injection site arm) and CHILLS (chills). On 01-Jun-2021, the patient experienced ERYTHEMA NODOSUM (Erythema Nodosum) (seriousness criterion medically significant), FEELING ABNORMAL (I have generally felt bad) and FATIGUE (tired and sluggish). At the time of the report, ERYTHEMA NODOSUM (Erythema Nodosum), HYPOAESTHESIA (left side of my face went numb), FEELING ABNORMAL (I have generally felt bad), ASTHENIA (low energy for a couple of days), MYALGIA (sore left injection site arm), CHILLS (chills) and FATIGUE (tired and sluggish) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant or treatment medication has been reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Company comment - This case concerns a 60-year-old female patient with no relevant medical history, who experienced the unexpected events of hypoaesthesia and Erythema nodosum. The event hypoaesthesia occurred on the same day after first dose of Spikevax. The event erythema nodosum occurred 4 months and 3 days after second dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected.   This case was linked to MOD-2021-322417 (Patient Link).; Sender's Comments: This case concerns a 60-year-old female patient with no relevant medical history, who experienced the unexpected events of hypoaesthesia and Erythema nodosum. The event hypoaesthesia occurred on the same day after first dose of Spikevax. The event erythema nodosum occurred 4 months and 3 days after second dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected.
it's really strange this cyst mysteriously goes away AFTER getting the second vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (it's really strange this cyst mysteriously goes away AFTER getting the second vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ganglion cyst (about 3/4 of an inch in size, on her wrist, for over a year).   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (it's really strange this cyst mysteriously goes away AFTER getting the second vaccine.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (it's really strange this cyst mysteriously goes away AFTER getting the second vaccine.) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The patient additionally reported that as expected, Friday (6/4) was a rough day.  Concomitant medications were not provided.  No treatment information was provided.
Syncope and alleged seizure as reported by mother and bystanders  (Pharmacist did not witness event)
Tinnitus-like ringing in both ears, becoming more prominent in right ear over time,  reduced hearing in right ear.
11 x 2 cm of erythema on LT upper arm; fever x 1 day
Increased seizure frequency 10/08/07-DC summary included with VAERS report for DOS 7/31-8/3/07-DC DX: Infantile Spasms. Increased seizures. EEG demonstrated infantile spasms. Echo normal.  11/1/07-records received for DOS 7/30/8/3/07-DC DX: Infantile spasms. Presented to ER with increased frequency and duration of seizures manifested as extensor posturing.  Follow-up: Pt still has seizures, mother states seizures are no different now than they were prior to vaccine. Pt has epilepsy.
Pt was give Tdap on 7/17/2015 and was seen back in our office on 7/20/2015 with a indurated erythematous rash 11 by 18 cm at site of injection. Evaluated at our office by Dr.
She had the virus (was hospitalized and released after the treatment and receiving the antibodies); She had the virus (was hospitalized and released after the treatment and receiving the antibodies); This is a spontaneous report from a non-contactable consumer. A 95-years-old (95 and a half years) female patient (Mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the virus (was hospitalized and released after the treatment and receiving the antibodies) (Hospitalized, Medically Significant). She was told she needs the covid vaccine. Reporter stated his mother received the first dose of the Pfizer Covid vaccine after some time from getting the antibodies. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache that felt like fire was running through my brain for 1-2 days. Leg pain and soreness especially when standing for ~10 days
10-9-13 Pt. seen because of swelling to left upper arm that began several hours after injection on 10-7-13. 8.5 cm x 14 cm have on left upper arm. Non tender. Mild erythema.
Vaginal bleeding (Medium blood flow, Not Spotting); panicking; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 3:47 PM, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) (seriousness criterion medically significant) and PANIC REACTION (panicking). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) and PANIC REACTION (panicking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not taking any blood thinners and had no Chronic Medical conditions.  Concomitant medications and treatment information was not provided.  The patient reported that it was not Hemorrhoids and was panicking because she heard someone died from bleeding after receiving the vaccine.  This case concerns a 72-year-old female with a serious unexpected event of vaginal hemorrhage, and nonserious unexpected panic reaction. Latency 3 days after first mRNA-1273 dose. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 72-year-old female with a serious unexpected event of vaginal hemorrhage, and nonserious unexpected panic reaction. Latency 3 days after first mRNA-1273 dose. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
About 4 hours after the shot I had a mild allergic reaction on both of my arms - they both became red and blotchy and itchy. The left arm was worse than the right. Then I had some nausea and achey-ness the rest of the day, and then the day after I was achey, had a headache and ran a fever
This spontaneous report as received from a consumer refers to her niece. May be a week ago approximately on 11-DEC-2012 the patient was vaccinated subdermally with the first dose of GARDASIL (lot # not reported). 3 injections would be given over 6 months. May be a week ago approximately on 11-DEC-2012 after getting the first dose of vaccination the patient felt dizzy. No treatment was given for the event. The patient did not seek medical attention. The outcome of dizzy was unknown. Additional information is not expected.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. In April 2017 the patient was inadvertently administered a dose of PNEUMOVAX 23 instead of PREVNAR 13 (wrong drug administered). No adverse effects reported.
Initial and follow up information has been received from a nurse and a certified medical midwife for the Pregnancy Registry for GARDASIL, concerning a 23 year old female patient who smokes cigarettes, who in 17-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot No 658563/1063U). In approximately 2008, the patient was vaccinated with the second dose of GARDASIL, 0.5 mL. Concomitant therapy included Depo-Provera on 17-DEC-2007 for contraception. On 17-DEC-2007, the patient took a pregnancy test which came back negative. Patient came back approximately a week later and was pregnant. The last date of menstrual period was on 22-NOV-2008 and the estimated delivery date was on 02-SEP-2008. On 11-JAN-2008, 17-APR-2008, 23-JUL-2008, 08-AUG-2008 some ultrasounds were performed to check the dates, survey and bleeding was found it. On 04-APR-2008 a serum alpha-fetoprotein test performed with negative results. The certified medical midwife reported that on 04-SEP-2008 the patient delivered a normal male baby, with no congenital anomalies, and with no known complication during labor/delivery. The patient had an obstetric history of one previous pregnancy with an spontaneous abortion and history of yeast during pregnancy. There was a complication during the patient's pregnancy with a vaginal bleeding at 36 weeks. Other medication used during pregnancy were prenatal vitamins (PVN), ferrous sulfate for anaemia, and Diflucan for yeast. The baby's weight was 6 pounds with 8 onz, with length of 18 1/2 cm a head circumference of 32 cm and an Apgar score of 9/9. No further information is expected.
HOSPITALIZATION; This spontaneous report received from a patient via social media via a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced hospitalization. Hospitalization date, duration of hospitalization and discharge information were not reported. It was reported "The j and j shot put me in hospital. It was really bad". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220816754-covid-19 vaccine ad26.cov2.s-Hospitalization. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Shots given approx 1400 hrs, 1Aug07.  Patient noticed hives on chest,under arms,groin,back upon waking up 2Aug07, approx 8:00 am.  Reported the hive outbreak to the vaccination administrator at approx 1400hrs 2Aug07. Self-treated with benedryl cream which helped reduce the hive outbreak.
dose number: 3; Arm was very sore; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: EW0196) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 04Mar2021, when the patient was 49 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 24Mar2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "recovered" (2021), described as "dose number: 3"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2021, outcome "recovered" (2021), described as "Arm was very sore"; PYREXIA (non-serious) with onset 16Nov2021, outcome "recovered" (2021), described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, pain in extremity, pyrexia.  Additional information: Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.   No follow-up attempts are possible. No further information is expected.