chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bloody/reddish stool; low platelet count; fatigue; nausea; hot flash; legs feel heavy/leg muscles tired; irritability; anxiety; diarrhea; This is a solicited report from a Pfizer-sponsored program contactable other healthcare professional and contactable 66-year-old female patient reported that she received palbociclib (IBRANCE), via oral from 01Apr2021 (Batch/Lot number was not reported) and ongoing, at 125 mg, daily, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 300 mg, twice day for breast cancer; bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included venlafaxine taken for an unspecified indication, start and stop date were not reported. Current dose: ibrance 125 mg (milligram) daily for 21 days and off for 7 days. patient reported she had fatigue, nausea for 2 minutes followed by a hot flash for 3 min and then goes away but occurs sometimes every two hours but has gotten better. legs feel heavy/leg muscles tired like she's been riding a bicycle for a long time. patient also reports when she started ibrance she had her 2nd covid vaccination and is not sure if that has also contributed to her side effects after starting ibrance. md (medical doctor) aware. no further information given. patient reports previously mentioned fatigue continues and remains the same, nausea continues but is better with anti-nausea medication, hot flashes continue and md prescribed venlafaxine (started today) to help out along with helping new report of irritability and anxiety, and previously mentioned legs feeling physically tired continues and remains the same. patient also has a new report of occasional diarrhea after starting ibrance. md aware. no further information given. The patient underwent lab tests and procedures which included platelet count: low. The action taken in response to the events for palbociclib was dose not changed , for bnt162b2 was not applicable. The outcome of events bloody/reddish stool, low platelet count was unknown, for events fatigue, hot flash, irritability, anxiety, diarrhea, outcome was recovering, for event legs feel heavy/leg muscles tired outcome of not recovered and for event nausea it was recovered.   No follow-up attempts are needed. No further information expected.; Sender's Comments: Based on the available information and considering the reported events can be associated with ibrance, its role was considered possible.
Within 24 hours I noticed my daughter had hives around her mouth and on her back. We gave her some Benadryl and they went away. 24 hours later they returned so we repeated the Benadryl. 6-8 hours later the hives returned along with a measles-like rash that started around her neck and spread down her abdomen. I contacted the after hours line at her pediatricians office and was told to continue Benadryl and seek medical attention. The next day my daughter woke up with hives, the measles-like rash and this time the back of her head and neck were bright red and she was scratching at it. The symptoms increased over a course of 3-4 days. We took her to urgent care and they prescribed confirmed that it was an allergic reaction to the MMR vaccination and they prescribed some medicine. It took about 24 hours for the medication to kick in and after that her symptoms decreased. Within 48 hours the rash and hives were more or less gone.
Initial misuse report received from a healthcare professional on 17 July 2013. A child received only the DTaP/IPV portion from PENTACEL vaccine and ACTHIB portion was not administered. No adverse events was reported. Documents held by sender: none.
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 18:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Fever".  Additional Information: Is the patient also the reporter No. Is COVID 19 Vaccine a Pfizer product? Yes. Reason for no lot number: of COVID 19 Vaccine: Other: LOT: Reporter Stated, she had to go find the card. It is somewhere in her room, she do not have it with her. Reporter stated, her daughter was seven. She was starting seven in Jan. she got her first Pfizer dose in the Friday around 6 'O' clock evening and since Saturday she was running a fever. It was being already 4-5 days. she mean how many days this will last. Vaccine Name: Pfizer COVID 19 Vaccine While paraphrasing the concern: Reporter stated, Yes  2-3 days she understand but she started Saturday. Friday evening, she got the vaccine. Saturday she was having fever. Reporter was informed about the role of Pfizer Drug Safety. Reporter was informed about Pfizer Medical Information and provided with the contact information. In response to further probing: Reporter stated, No she do not have time since she did not have the information what to do, so she will call another number. Reporter was unwilling to complete the report. Thus further probing could not be done. Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed. Hence limited information available over the call. Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. The patient was vaccinated with two doses of PNEUMOVAX 23 (dose, route and lot# were unknown) on 10-SEP-2015 and 29-OCT-2015, respectively, which was shorter than the recommended interval (inappropriate schedule of drug administration). No concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
Guillain Barre syndrome; he had severe right foot drop and was taken to the ER; This is a spontaneous report from a contactable consumer and nurse. A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 08Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Jan2021, he had severe right foot drop and was taken to the ER, was seen by an internist and evaluated with an MRI and Xray of the spine and was scheduled for EMG and MRI of the brain at a later date. A stroke was ruled out and now wants to know if he has Guillain Barre syndrome (18Jan2021). Outcome of the events was unknown.  Information about Lot/Batch number has been requested.
covid test type post vaccination:Blood test, covid test result:Positive; covid test type post vaccination:Blood test, covid test result:Positive; Torn retina in left eye; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at the age of 80-years-old) (Batch/Lot Number: E19262) as DOSE 2, SINGLE for covid-19 immunisation. There was no medical history and were no concomitant medications. On 10Feb2021, the patient experienced BNT162B2 for COVID-19 immunisation (Dose Number: 1, Batch/Lot No: EN6208, Location of injection: Arm Left). On 11May2021, the patient experienced torn retina in left eye (disability, life threatening). On 04Oct2021, the patient covid test type post vaccination:Blood test, covid test result:Positive (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Oct2021. Therapeutic measures were taken as a result of torn retina in left eye (retinal tear). The outcome of the event Torn retina in left eye was not recovered, while unknown for the other events.   Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a contactable pharmacist via a sales representative. This pharmacist reported similar events for two patients. This is the second of the two reports. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date as a single dose for immunization at the pharmacy/drug store. The patient's medical history was not reported. Concomitant medication included influenza vaccine for immunization. The patient experienced swelling at the injection site that lasted 5 to 7 days on an unspecified date. It was reported that the patient also had a flu shot that was administered to her on the same day at a different injection site. Outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017427753 different patient, same product, same event.
dose of Pediarix already expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number MG92G, expiry date 3rd May 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 4th May 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows:  On 4th May 2021, patient received Pediarix vaccine which was already expired on 3rd May 2021. The reporter consented to follow up.
Mild shingles; Few lesions; 1st dose earlier this year, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, skin lesion and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the skin lesion was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles and skin lesion to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comment: The reporter was a patient. The patient reported that she received 1st dose of Shingrix vaccine in early 2022. The patient stated that few days ago after received Shingrix vaccine she experienced mild case of shingles, The patient stated that the symptoms were getting better, but she still had few lesions. The patient reported that she did not receive the 2nd dose of Shingrix vaccine and she confirmed that it had been greater than 6 months since the received first dose. The reporter requested to consent to follow up. She had no further information regarding the vaccine itself or when she got the vaccine.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Pt had generalized rash, maculopapular than vesicular less than 50 lesions.
You already have the information about the arm pit swelling from the maderna vacines. This report is for new symptoms that started about 2 weeks after the J&J booster.   I started having irregular heartbeats.  My heart would jump around at random times.  It did not make any difference if I was active or resting.  I have no previous cardiac history.  It would just be a few odd beats now and then for some days then it started getting worse.  Then it would start jumping for a few minutes at a time.  Then near the end of december it started having these things for more than half hour at a time.  Then just after christmas I had several episodes that lasted for several hours.  I went to the hospital.   I went to the hospital.  They did EKG and blood tests.  They confirmed I did not have a heart attack.  The said I had a very irregular heartbeat and enlarged left atrium.  They put me on a heart monitor for 3 days which showed irregular heartbeat.  I have been having fewer and fewer of these episodes of heart jumping around.  As of  today 3-5-2022 I am only having a few short episodes (several odd beats at a time) every few days.  I am occasionally starting to feel a little pressure in my chest from time to time but no real pain or shortness of breath.
weakness/my strength Has Been Sapped; Slight Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness/my strength Has Been Sapped) and PYREXIA (Slight Fever) 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 07-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced ASTHENIA (weakness/my strength Has Been Sapped) and PYREXIA (Slight Fever). At the time of the report, ASTHENIA (weakness/my strength Has Been Sapped) and PYREXIA (Slight Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
She got her vaccine, she was OK at first.  Then in the middle of the morning of Sunday, 10/16/22 she got pain in the upper arm in the muscle, as she can feel the muscle.  She couldn't raise her arm up over her head to comb her chair.  She was trying to get together to go to service and could not get dressed and comb her hair.  It is just the upper part of her arm.  This pain has not gone away, and the pain comes and goes, has slowed down a little bit but does off and on.  She took some Excedrin with no relief.  She gets tired lifting her arm up as there is pain.
2 hours after injection left leg from the knee down started to swell and the muscle turned rock hard Severe pain made it impossible to walk The swelling is not going down and is causing great discomfort went to the doctor yesterday and it was determined there is a blot clot
It started as a tinging in my hand and when up to my chest. It be numb and it's non stop. I had a headache and it has stopped. I am weak in my left leg. Everything is on the left side of my body.
Fever, chills, starting at 8:30 pm 4/6/21 and at 1am VOMITING and unable to keep food/liquids down
This spontaneous report as received from a healthcare professional refers to unspecified number of patient of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with PEDVAXHIB (Lot# L002867, Expiry date: 11-NOV-2017, Lot# L030869, Expiry date: 08-JUN-2018, Lot# L014426, Expiry date: 08-MAR-2018, Lot# L012837, Expiry date: 11-MAR-2018) which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse event were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Patient called pharmacy complaining of itchy, heat-rash-like bumps over his entire body. He denied any other changes regarding diet or lifestyle (no new laundry detergent, body lotion, etc). I recommended he take oral Benadryl and see his primary care physician. I also recommended topical hydrocortisone for itch relief if he couldn't take Benadryl due to drowsiness during the day but warned that it wasn't ideal for a wide-spread rash. He said he would call his doctor.
7/24/07 woke up 10:30 pm fever approx 103 deg Tympanic/crying/inconsolable. Acting like had much pain lt. leg. 7/25/07 rash all over lt. leg and spreading to abdomen. Diaper rash/diarrhea. To ER 7/25/07 AM. Given acetaminophen/ibuprofen and sent home. Some fever that nite and next day 7/26/07. Fussy "not herself" much improved 7/27/07 "Gave only 1 dose Tylenol" on 7/27/07
This spontaneous report as received from a physician's assistant refers to a 12 years old female patient. The patient was vaccinated intramuscularly in the right arm with dose 2, 1 ml dose of RECOMBIVAX HB (lot # not reported) on 07-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Fever, muscle ache, joint pain, injection site soreness, headache, fatigue,
red blotch below injection site,  right leg very difficult walking almost as if foot not attached to leg
Approximately a week after my 3rd shot (Booster) I experienced the following symptoms: Extreme raising heart beat. I felt like my chest was buzzy. I did not get it to calm down. I went to the doctor the next day and was prescribed with metoprolol and it did help to subside my condition after 2 weeks of taking it. I went back to the doctor but she said my blood pressure was still too high so she added another medication; hydrochlorothiazide and by taking both medications it did improve my condition.
Wheezing, coughing, eyes were blood shot, coughing up mucus, chest hurting, nausea, dizziness.
Pt in for a well child exam, provider wrote for a PEDIARIX, IPV and PREVNAR to be given, nurse did not realize that PEDIARIX had IPV in it, Pt received 2 IPV vaccines.
pt recv vax 23APR96 3PM & same day 7PM pt t spiked to 103 & pt began having screaming spells lasting 30min which lasted through the noc fever also the next day;mom called clinic advised to take to MD mom took pt to ER 430PM dx ear infect
Patient with 2 Moderna vaccinations, last dose 04/28/21, who admitted after a fall who incidentally tested detected for COVID.  No COVID complications noted during stay.  Provider discharge note below:  "Medically complex vaccinated elderly man presents with fall and left arm laceration secondary to reported postural near syncope.  Patient is on a number of hypotensive medications.  ER evaluation noted hypotension and incidentally discovered the patient to be PCR positive for COVID-19; he is chronically immunosuppressed with steroids for myasthenia gravis.  He was admitted to telemetry and noted to be in paced rhythm, his PM was interrogated and noted no corresponding rhythm changes.  He did not developed hypoxemia or respiratory symptoms.  Medication reconciliation noted chronic Elavil use, and it was noted that his blood pressure was low after taking this medication in the evening.  His Elavil was stopped and his episodes of postural dizziness improved and he requested discharge home with the assistance of his son.  He had no evidence of exacerbation of his myasthenia.  COVID antibodies revealed that he was immune from vaccination and not infection; this was interpreted to suggest that he was unlikely to develop severe pneumonitis from COVID-19."
Mom called to report that following vaccines on 4/5/12 (at 1625) baby screamed for a little over 1 week. Since this weekend (April 14/15, 2012), he is almost back to normal but not quite. Following his 2 month vaccines on 2-2-12, he screamed overnight and then was fine.
I was told her reaction is rare and happens in about 5% of children. But she is presenting with the rash portion of the illness no fever or itchiness so far (day 2 of rash)
This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot #, expiry not reported). No adverse effects reported. The nurse stated that the vaccine was exposed to warmer temperatures. However, she had to research to determine if the vaccines were administered. This is 1 of several reports received from the same reporter. Additional information has been requested.
Severe inflammation at injection site - redness, pain, tenderness. Started to improve over 3 days, but has taken 7 days for full resolution
SORE THROAT; CONGESTED; NIGHT SWEATS; CHILLS; HEADACHE; FEVER; MULTIPLE JOINT PAIN; REALLY TIRED; NAUSEA; HIGHER BODY TEMPERATURE; BODY ACHE; HEAVY HEAD; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritic pain, penicillline drug allergy and wellbutrin drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 Expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:45 in left arm for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride/paracetamol. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced heavy head. On 24-MAR-2021, the subject experienced multiple joint pain. On 24-MAR-2021, the subject experienced really tired. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced higher body temperature. On 25-MAR-2021, the subject experienced congested. On 25-MAR-2021, the subject experienced night sweats. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced fever. On 28-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 26-MAR-2021, had not recovered from really tired, body ache, chills, sore throat, multiple joint pain, nausea, higher body temperature, and heavy head, and the outcome of night sweats, fever and congested was not reported. This report was non-serious.
I did not have an adverse reaction to the vaccine.  This time of year, I have seasonal allergies every year. I had to be tested for COVID-19 prior to a medical procedure.  I went home and took a home test and it was positive on 09/27/2022. I went to the next level and had a NATT test and it confirmed COVID-19 positive on 09/27/2022.  My symptoms felt more like allergies, so I would never think I had COVID-19. I did not obtain a prescription due to my liver cirrhosis. As of today, I continue to test positive.
Intermittent vaginal bleeding - spotting. Has been on norethindrone acetate 10 mg daily for over a year with no spotting
This spontaneous report was received from a female patient (age unknown) referring to herself. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On an unspecified date, the patient received a dose of injectable ZOSTAVAX for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). The reporter stated that, she had a bad skin reaction after receiving ZOSTAVAX. At the time of reporting, the outcome for the event and the relationship between ZOSTAVAX and the event of skin reaction were not provided. There was no product quality complaint (PQC) involved. Additional information is not expected because the reporter did not consent for further follow up.