chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Serum Sickness; Hyper Covid Sensitivity; my ankles are breaking out still so badly; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported), via an unspecified route of administration on 28Apr2021 at 09:00 (at the age of 61-year-old), as DOSE 2, SINGLE for covid-19 immunization. Medical history included high blood pressure (diagnosed around 6 years ago) from an unknown date and unknown if ongoing, Low thyroid from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Concomitant medications included Levothyroxine taken for thyroid, 112 mcg, one tablet, oral, once a day, start and stop date were not reported; Hydrochlorothiazide taken for High blood pressure 25 mg, once a day, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8737, Expiry Date of Covid-19 Vaccine.: Unknown), via an unspecified route of administration on 30Mar2021 at 09:00 AM in the morning, as dose 1, single for covid-19 immunization. On 13May2021, the patient experienced serum sickness, on an unspecified date in 2021, patient experienced hyper covid sensitivity and ankles are breaking out still so badly. Patient stated, she went to saw her doctor on an unknown date (today) because her ankles are breaking out still so badly and he said that she has something called serum sickness. It was something that the doctors are quite afraid, serum sickness and she was unhappy, that was something that the doctors were saying and when she talked to Pfizer and ask them about it, they did not really have anything to say to me, but it was something that her doctors had seen much of that they were calling it serum sickness. So, she wanted to make sure if somebody there curing this (Consumer was crying over the call). She had covid long, her doctor has diagnosed that it was hypersensitivity, hyper covid sensitivity. It has to do also with the vaccine. Clinical outcome of the events was reported as unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Experiencing loss of smell and taste, which started 24 hours or so after the vaccine and progressively getting worse (at day 5 now)
03/31/2022 at around 02:00AM, shortness of breath; cough; runny nose; backache; fever; wheezing. I did a rapid test which was positive. I did tele a health with my doctor and I got monoclonal infusion the same day within 24 hours I started feeling better. After COVID-19 now I am dealing with long COVID. I experience shortness of breath more often than I use to. I went to the Allergist 2 times, my elevation and treatment is going. I have an ENT appoint. next week. My COVID-19 is not going away. I am having more problems than before.
Rash from abdomen up to neck Narrative:  3 days after receiving shingrix vaccine and TDAP shot, patient developed a rash on upper torso of body. Per urgent care provider, the pattern of the rash was consistent with a shingles outbreak, therefore, the determination was  made that the Shingrix vaccine was the cause of the reaction.
This spontaneous report as received from a medical assistant refers to a 15 months old patient. The patient was vaccinated with a dose of ZOSTAVAX (Lot# not reported) on 05-JUL-2012. It was reported that this medical assistant noted she inadvertently administered ZOSTAVAX intramuscularly to this child. No adverse effect was reported. And whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information has been requested.
A spontaneous report was received from a pharmacist concerning an elderly patient, who received the second dose of the Moderna's COVID-19 vaccine (mRNA-1273) 2 days apart. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. Two days later (on an unspecified date) the patient received the second dose of Moderna vaccine (Inappropriate schedule of product administration). No treatment information was provided. The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable. The outcome of the event was considered recovered.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.
Left arm pain at site. Also shoulder pain. This is week 3 of the pain and it is not getting any better. Can't lift arm without it hurting my arm and shoulder
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020. On 9th March 2018 14:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th March 2018, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication were unknown. The patient was administered SHINGRIX in the left deltoid. Pharmacist reported that the patient developed shingles a few days after receiving SHINGRIX. The patient was seen by the physician and got a prescription for VALTREX on 19th March 2018.
Took vaccine directly out of fridge and vaccinated; A spontaneous report was received from a consumer concerning a 68 years-old male patient, who received Moderna (mRNA-1273) and experienced took vaccine directly out of fridge and vaccinated.  The patient's medical history included obesity, diabetes, chronic obstructive pulmonary disorder (COPD) and dementia. Concomitant product use was not provided by the reporter.   On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient's spouse reported upon administering vaccination, they took vaccine directly out of fridge and vaccinated patient. The patient's spouse read that it must be at room temperature before it is administered and inquired if it would be effective. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.  The event took vaccine directly out of fridge and vaccinated was resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of product preparation error for mRNA-1273, lot # 007M20A,  with no associated AEs.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 1:33 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 1:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 45.50 for dose administered on 29-Apr-2021.  No concomitant medications were reported.  Batch number 007C21A underwent temperature excursion on 27-Apr-2021 with temperature 35 degrees Fahrenheit at 09:00 AM, on 28-Apr-2021 with temperature 33 degrees Fahrenheit at 09:00 AM and on 29-Apr-2021 with temperature 33 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 29-Apr-2021. 5 vials from this batch were sent to the clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This is a spontaneous report received from contactable consumer or other non-healthcare professional (patient). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced  gait disturbance/having trouble walking and bone pain/patient's bones hurt, onset 2021, with outcome of unknown. Additional information: Reporter stated he was getting the same symptoms his sister got, his bones were hurting. He also had trouble walking. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This spontaneous report as received from a registered nurse refers to an approximately 17 year old female patient with BACTRIM allergy. The patient received dose one of the GARDASIL injection series about four months ago (in approximately October 2013) (lot #, expiry date, dose and route unknown). Concomitant therapies included amitriptyline (manufacturer unknown) and CARAFATE. The nurse reported that since revealing the GARDASIL, the patient had not felt very well-explained as having a feeling that a hand was around her throat. The nurse reported that because of this sensation, the patient had visited the Ear, Nose and Throat doctor. Patient had CT (computerized tomogram) scans of the area and results were negative. No treatment was given for the event. The patient was not recovered. Additional information has been requested.
Information has been received from a physician concerning a female who on 12 Dec 2006 was vaccinated with a "full" dose of Gardasil. At the time of administration, a small amount of bleeding was reported at the injection site. The bleeding was controlled prior to the patient leaving the physician's office on 12 Dec 2006. The patient called the office the day (13 Dec 2006) and reported that she had bled from the injection site and that the "blood had run down her arm". The patient feels that she did not get the full vaccination because of the bleeding problem. It was reported that the patient sought unspecified medical attention. As of 13 Dec 2006, the patient had recovered from bleeding at the injection site. Additional information has been requested.
First, I am a physician and was required to get this vaccine due to the vaccine mandates, otherwise I would have been fired and I was having difficulty obtaining another job. Within 24 hours of this vaccine I had a new onset Right-sided facial redness, tingling, and droop.  I went to urgent and was diagnosed as Bell's palsy and started on prednisone 60mg.  It become incredibly painful and acutely worse by the next week and I was sent to the ER, which resulted in increase in prednisone and 1 week of Valtrex.  In short, I had incredible right ear pain, right retrorbital pain, mild facial droop, swelling of the right face.  I required high dose prednisone for 3.5 months. I was also bed-ridden, unable to drive, and out of work for 3 months.  I was seen by PCP, ophthalmology, neurology, ENT, Rheumatology without any other findings aside from a vaccine reaction.  I had extensive negative blood work and negative brain MRI. It is now 6 months later and I continue to have right sided facial pain, redness, swelling,  Tinnitus which started as I tapered the prednisone, and my vision has not yet returned to baseline (I am a dermatologist).
A few minutes after receiving vaccine, patient became unresponsive and was frozen in a seizure-like trance. She then vomited and became responsive but remained disoriented. Blood pressure was elevated but she was stable. EMS arrived and she was taken to local ED
CLIENT RETURNED AFTER 40 MINUTES WITH ITCHING, GENERALIZED RASH INCLUDING WHELPS. NO RESPIRATORY SYMPTOMS. BP 132/72.INITIAL TREATMENT WITH COOL CLOTH AND ICE.  HEALTH DEPT PHYSICIANN CONTACTED BENADRYL 50 MG ORDERED.THIS WAS ADMINISTERED AND CLIENT OBSERVED FOR 30 MINUTES. ITCHING AND RASH RESOLVING. CLIENT RELEASED WITH FAMILY.
Fever up to 102 for 2 days and periodically for 2 weeks after bone ache for first two days and a severe flare up 2 weeks later diarrhea for first week Chills for two days and off and on after Brain fog ongoing since shot
breakthrough case or not; breakthrough case or not; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "breakthrough case or not".Reporter was on the phone with someone and was reminded that at some point (Name initials withheld) had Covid, and reporter cannot remember if it was a breakthrough case or not may have been initially told this prior to my time at Pfizer. Regardless, reporter do believe she has recovered and has been back at work for a while. Additionally the case was mild - she did not think she had Covid. Cannot remember exact details but believe case was extremely minor. Reporter believe she is vaccinated, likely with Moderna or Pfizer and at least fully vaccinated, but reporter cannot re-member when this happened. I report this because it may have been a breakthrough case at the time but reporter unsure. She may have also reported side effects at one point, but cannot re-member. Again, reporter may have been told before my time at Pfizer. She is in her 40s I believe.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Tingling in feet; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in feet) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PARAESTHESIA (Tingling in feet). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in feet) outcome was unknown.            No relevant concomitant medications reported. Treatment information include gabapentin. Action taken with mRNA-123 is not applicable.
Already had tinnitus, was suddenly noticeably worse the day after 2nd dose. Has not improved, has gotten worse.
Patient had syncopal episode followed by vomiting within 15 minutes of vaccination.  Patient continued to feel "sleepy" and first refused to go to ER, then agreed to be transported to the ER by EMS.
Patient received dose #1 of Pfizer vaccine on 6/6/2021 @ Vaccination site and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Re-administered dose on 6/24/2021 as recommended. No adverse reactions identified on site.
Woke up the next morning with periodic headaches randomly on left and right temple areas and feeling like my face was flushed. Not lasting more then 3 or 4 mins at a time. Still continuing so scheduled appt with medical provider. Blood pressure at office was 124/79. Recommended to continue monitoring blood pressure and headaches to see if get better or worse. Scheduled for my second vaccine on the 15th of Nov.
Blistering  burning, skin peeling rash, started  on collarbone spread across chest, then down back, then to thighs then lower legs and feet from Oct until present. That Rash slowly left leaving red rash  with scaly skin over entire body.
I experienced similar symptoms the day before the first vaccine - (Just the pain in the chest- like something sticking in my chest. More severe stuff was experienced after the second vaccine.  After second vaccine, I had pain in my chest. I had a dull ache - like a broom stick stuck in chest - sometimes front and sometimes back and sometimes both. Goes up my spine into my neck sometimes. Sometimes it comes with shortness of breath. One point when it went down my left arm and into my hands. Dull pain. I have gone to medical center - Urgent Care twice and two different doctors and they haven't found anything yet. I woke up gasping for air - one time last weekend. That lasted for two hours - I was only getting 50% of breath when I breathed in. Today I woke up at 6 am (two hours earlier for me) and again had shortness of breath.  The doctors have no idea what is going on. I have never had anything like this before. I'm not particularly stressed so I don't think it's anxiety like one doctor suggested. It's very physical and disturbing so I doubt it's anxiety. Muscular - Skeletal relaxant to take - and that didn't help and I stopped taking it because it didn't feel good to stay on it.
Flu like symptoms; Weakness; Red circle at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), VACCINATION SITE ERYTHEMA (Red circle at injection site) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), VACCINATION SITE ERYTHEMA (Red circle at injection site) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. On 24-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), VACCINATION SITE ERYTHEMA (Red circle at injection site) and HEADACHE (Headache) had resolved.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up information was  received  contains significant information, the outcome of the events were changed from unknown to recovered.
Pt vaccinated with MMR developed red spots on lt arm from elbow to axilla & lt side of upper body from axilla to waist. Family DR dx as "shingles".
Immediate warm tingling started in my arm and then went through my whole body and left me feeling week. Then my heart started racing (between 90-110 and I tried to stay relaxed and take deep breaths then my mouth got very dry and my tongue felt like it swelled slightly. By then it had been 10 minutes and nothing was getting worse and I had no problems breathing and didn't feel dizzy so I stayed and waited 10 more minutes and nothing changed so I went home. Symptoms continued for another 45 minutes then I had diarrhea and then slowly my heart rate started going back down to normal my tongue went back to normal and I stopped feeling weak. (about 1 1/4 hours after shot).  Its been 2 days and no new problems.  Usually allergic reactions stay in my body much longer and I continue to have symptoms for at least 24 hours so that was odd too.
Pain in arm; I feeling tired; High fever last night on day of vaccination; Feeling under the weather; Bit weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 82-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Oct2021 16:00 (Lot number: 30130BA) at the age of 82 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Weakened immune system" (unspecified if ongoing). Concomitant medication(s) included: B12 [CYANOCOBALAMIN] taken for supplementation therapy, start date: 1980 (ongoing). Vaccination history included: Bnt162b2 (First dose, Lot Number: EL3249, Time: 2pm, Anatomical site of Injection: left arm, Route of administration: Intramuscular, Expiry date: 31May2021), administration date: 15Jan2021, when the patient was 82 years old, for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (Second dose, Route of administration: Intramuscular, Lot Number: EM9810, Time: 3pm, Anatomical site of Injection: left arm, Batch/Lot number: EM9810), administration date: 06Feb2021, when the patient was 82 years old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PYREXIA (non-serious) with onset 01Oct2021 23:00, outcome "recovered" (02Oct2021 08:00), described as "High fever last night on day of vaccination"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2021, outcome "recovered" (02Oct2021), described as "Pain in arm"; FATIGUE (non-serious) with onset 02Oct2021, outcome "recovered" (02Oct2021), described as "I feeling tired"; ASTHENIA (non-serious) with onset Oct2021, outcome "recovered" (02Oct2021), described as "Bit weak"; MALAISE (non-serious) with onset 01Oct2021, outcome "recovered" (02Oct2021), described as "Feeling under the weather". Therapeutic measures were not taken as a result of pyrexia, pain in extremity, fatigue.  Additional information: The patient had high fever last night after taking booster and pain in arm and was feeling tired its almost over now. The patient woke up at midnight 1-2 o'clock and had the high fever. The patient did not receive any prior vaccinations to Covid vaccine. No relevant lab tests were performed. The patient did not receive treatment for fever and just rested.  No follow-up attempts are possible. No further information is expected.
started to have heavy periods every 10 -17 days instead of my normal cycle of  27 days.