chrisvoncsefalvay/vaers-outcomes huggingface dataset:
also found to have high rate of PVCs a couple of days after her second Pfizer covid dose; This is a spontaneous report from a contactable other health care professional.   A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 01May2021 as dose 2 single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reported that patient had no covid prior vaccination and not tested covid post vaccination, no known allergies reported. Reported that patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received other medications within 2 weeks of vaccination. patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on unspecified date as dose 1 single for covid-19 immunisation. it was reported that after a couple of days of receiving second dose of covid vaccine, patient experienced very high rate of premature ventricular contractions PVCs - cardiologist found normal echocardiogram but 7-day cardiac ambulant EKG monitor showed PVCs at 6% of the time. patient biological parent (mother, 71yrs) was also found to have high rate of PVCs a couple of days after her second Pfizer covid dose. On 05May2021, the patient experienced also found to have high rate of PVCs a couple of days after her second pfizer covid dose. AE resulted in doctor or other healthcare professional office/clinic visit, no treatment received for events. device time stamp: 22Jun2021. The patient underwent lab tests and procedures which included echocardiogram resulted as normal, cardiac ambulant EKG monitor resulted as PVCs at 6% of the time (7-day cardiac ambulant EKG monitor showed PVCs at 6% of the time) on an unspecified date. The outcome of event was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: The event of Premature Ventricular systole is assessed as possibly related to the suspect product  BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's familial medical history. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt received wrong dose of vaccine.  Pt received 5-11 yr covid vaccine instead of 6 month - 4 yr vaccine. No symptoms at this time.
vaccinated and boostered but I tested positive yesterday for covid; very limited symptoms or anything; basically have no symptom; vaccinated and boostered but I tested positive yesterday for covid; very limited symptoms or anything; basically have no symptom; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 49 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 31May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "vaccinated and boostered but I tested positive yesterday for covid; very limited symptoms or anything; basically have no symptom". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Follow-up attempts have been completed and no further information is expected.
48 hrs p/recvd 1st dose of Engerix-B devel nausea & vomiting; sx lasted for 1 wk & abated w/o tx;
Headache, nausea, fever, extreme muscle and joint pain (can?t even move body), chills
No adverse rxn at time of administration. On 12/5/05 pt called to report pain and tingling in left arm. Pt seen in clinic 12/7/05 and given rx for pain.  10/9/07 Received vax record from pcp which confirms lot #. 10/19/07 Reviewed neurology medical records of 4/11/07 which reveal patient experienced pain in left arm x 18 mos s/p flu shot  FINAL DX: radial neuropathy.
Due to communications from patient and patient having CDC COVID Vaccination card that had the original COVID vaccination series (03/12/2021 and 04/02/2021) but was not updated with the booster dose received by the patient on 11/02/2021 at the time of vaccination, since the patient did not having vaccination card on-hand when receiving the booster of the vaccine, the patient erroneously received a second booster dose for a cumulative fourth dose of the Pfizer (Comirnaty) SARS-COV-2 vaccine on 12/03/2021. When following-up with the patient, no ADR was identified and the patient was educated on potential ADRs.
MODERATE SWELLING, REDNESS AND TENDERNESS AT IMMUNIZATION SITE AND EXTENDING DISTALLY INTO L ARM OCCURING WITHIN HOURS OF THE IMMUNIZATION. NO FEVER, RESPIRATORY SYMPTOMS.
Second day after vaccine had fever, chills, aches & fatigue for 2-3 days.   Two weeks after vaccine  had intractable nausea, vomiting repeatedly over a 14 hour span, accompanied by diarrhea and headache.  48 hours in, still feeling weak and unable to eat much.
PT reports headache x 2 days, nausea, muscle & joint aches, dizziness & fatigue. Also reports sore arm and left leg. Felt like had a fever. Started w/in hrs after 1st dose of Anthrax vax.
Fever 100 degrees. Induration redness 8 x 4 cm > 48 hr.
bad reaction to the first one painful hives all over one side of his face; bad reaction to the first one painful hives all over one side of his face; Initial information was received on 18-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient's mother or father) via social media.  This case involves adult male patient (age not specified) who had bad reaction to the first one painful hives all over one side of his face (urticaria and pain), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history or risk factor were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bad reaction to the first one painful hives all over one side of his face (urticarial and pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  Laboratory data was not provided.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown for both events.  There will be no information available on the batch number for this case.
Headache, Body aches,Dry mouth,Back pain,tired,Cold/hot feeling,sweating.
This case was reported by a other health professional via call center representative and described the occurrence of burning oral sensation in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced burning oral sensation, numbness oral and inadvertent exposure to vaccine. On an unknown date, the outcome of the burning oral sensation, numbness oral and inadvertent exposure to vaccine were unknown. It was unknown if the reporter considered the burning oral sensation and numbness oral to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that she was giving an injection to the patient and she thought she might have got some vaccine in her mouth. The reporter thought she must have had some of the vaccine on my fingers from the bottle. She experienced burning sensation and numbness in her mouth. She could not have ingested much but she still had a funny sensation in her mouth/throat. She flushed her mouth with water, lots and lots of water.
In mid June I became very tired and not feeling well for no known reason at all. I didn't see a physician because I didn't have any actual symptoms of anything. At the end of July I went to see an internal medicine doctor. I had nauseas, loss of appetite, pain in the gastric area, and I felt more tired. The doctor prescribed protonix and sucralfate which I am no longer taking. Two weeks later I became more ill, nauseas, and tired. I went to doctor and had testing did. I was referred to see a gastroenterologist for my elevated liver enzymes. I saw the doctor and multiple testing was done. They ruled out hepatitis A, B, C, and multiple other causes. My enzymes have been coming down, but they are still elevated. The tiredness has improved but its still present. My immune system seems to be down because I am catching more colds. I am still tired, and I don't have any energy.
Arm pain in her left arm / never resolved / still ongoing; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd May 2018, the patient received the 2nd dose of Shingrix. On 2nd May 2018, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient she developed arm pain in her left arm, that has never resolved and was still ongoing. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248587:same reporter US-GLAXOSMITHKLINE-US2020248574:Same reporter US-GLAXOSMITHKLINE-US2020248580:Same reporter US-GLAXOSMITHKLINE-US2020248583:Same reporter
Patient and her father both say that only complaint was a sore arm. They deny any further signs or symptoms after vaccine.
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB was 06/11/2004. Guardian, consented to the vaccination. The Department of Health verified with statistical records that the patients actual DOB is 06/11/2005 which made the vaccine a contraindication.  No known adverse reactions noted.
Information has been received from a physician concerning an 18 year old female who on 16-JAN-2007 was vaccinated with the first dose of Gardasil.  The patient received the second dose on 13-MAR-2007 and the third dose on 06-AUG-2007.  On 06-AUG-2007, after receiving the third injection of Gardasil, the patient passed out for about 10 seconds.  The patient recovered the same day.  The patient did not experience the same event after the first two doses.  Medical attention was sought.  No further information is available.
got the vaccinegot shingles/suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and got shingles any way and the patient stated god awful. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Dense swellings under the skin of shoulder; skin became red; Skin became itchy; Case reference number MOD-2021-012194 is a spontaneous case report sent by a Other on 22-JAN-2021 00:00:00. .  The patients past medical history included: No adverse event   . .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some    later,  the patient developed Dense swellings under the skin of shoulder. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed skin became red,Skin became itchy. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Swelling . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Other did not declare any relatedness between Dense swellings under the skin of shoulder and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Other,  Age-  ,  Sex-  ,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Started with lower back progressing into thighs and having difficulty walking a lot of joint pain. Started next day and also had rash on left thigh, continuing to get worse.
The patient came in for a visit and was scheduled to have a flu vaccine. There was no record of a previous flu vaccine in his EMR. When Nursing staff went to administer the vaccine, they noticed there was a band aid on his R upper arm. He was asked if her recently had a vaccine and he replied he didn't know.  His daughter also stated the same. The vaccine was administered. After the fact, the Provider looked in database and found that he had one on 10/2/23 when he was seen in an Urgent Care.
Sudden hearing loss. Oral steroids and steroid injection. Recovered after 3 weeks.
baby developed severe diaper rash that lasted for 2 weeks and experienced some blood in stool intermittently during the 2 week period.  No treatment was administered other than topicals for rash.
started period couple days early after first vaccine,second period since the vaccine and is on Day 16 of period; heavy bleeding along with clots and things; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 01Mar2021as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. On Mar2021 the patient experienced heavy bleeding along with clots and things and started period couple days early after first vaccine, second period since the vaccine and was on Day 16 of period. It had gotten worse but did subside. States she had another small period in between the first and second vaccine, but that only lasted for a day. She had the second dose 3 weeks after the first dose on 22Mar2021 and a couple days after that her period started early on 03May2021 and she is now on her period and on Day 16 and it's gotten worse.  She had issues with both doses and enquired if prolonged bleeding with periods was a side effect of the vaccine and how long these periods last and if they ever end. She stated she knew there were other women with these things. She got the first Pfizer BioNTech vaccine in 01Mar2021 and shortly a day or two afterwards her period started, which was a couple days early and did not stop for 10 days. It was really, really heavy bleeding along with clots and things. She was tested for anemia in Apr2021 and her iron was low and was found to be anemic. She went to a specialist and was suggested a biopsy to rule out that there was nothing else going on. They suggested for doing an ablation to stop the bleeding or a partial hysterectomy if nothing else worked. She did not had any energy and it was hard to breath with no oxygen in blood. The outcome of the event heavy bleeding along with clots and things and started period couple days early after first vaccine, second period since the vaccine and is on Day 16 of period was unknown.
Information was received on 03-JUL-2017 from a medical assistant. concerning a male patient of unknown age. No medical history or concomitant medications were reported. On 03-JUL-2017, the patient received a dose of PROQUAD (Lot # N013865, expires 31-OCT-2018) that was improperly stored and properly stored sterile diluent (N001543, expires 30-JUL-2019). No adverse effects reported. The vaccine PROQUAD (lot N013865, expires 31-OCT-2018) was at a temperature range of 15 degrees F  to 46 degrees F for 4 hours via a data logger. No previous temperature excursion. Additional information has been requested.
3/25/21- 6:30 pm vaccine shot 3/26/21 ~ 9:30- 10:00 am Chills, high fever reaching 103 (rising steadily throughout the day after injection), fatigue, confusion, wiped out, couldn't move for 7-8 hours, unable to stay awake or focus/function on anything,   Fever broke about 6 pm after taking Tylenol a couple hours earlier.  Nausea, and weak  3/27/21- fatigue, body aches  (lower back hurt, head hurt), night sweats 3/28/21 fatigue, body aches  (lower back hurt, shoulders and neck hurt, stiff neck, body temperature dropped to 96
Muscle fatigue; Soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue) and PAIN (Soreness) 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 01-Jun-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced MUSCLE FATIGUE (Muscle fatigue) and PAIN (Soreness). At the time of the report, MUSCLE FATIGUE (Muscle fatigue) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.
Localized itching, pain, redness, swelling Narrative:  Other Relevant History:
This spontaneous report was received from an office manager, via company representative and refers to a currently 19-year-old female patient. The patient did not have any medical history and drug reactions or allergies. Her concomitant medications included an unspecified meningococcal vaccine. On 16-AUG-2018, the patient was vaccinated with a dose of GARDASIL 9 (dose not reported) lot # N035032 with expiration date: 24-SEP-2020, intramuscularly for prophylaxis. On an unknown date, the patient experienced tingling and poking sensations in her upper body. She contacted her physician but did not receive any treatment. None laboratory diagnostics nor studies were performed. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and (GARDASIL 9) was not provided.
My oxygen levels dropped below what they had been previously as I am recovering from Covid infection  tested positive 20 October 2020.  If I do anything at all other then set my oxygen levels would drop into the low 80's.  I have also been monitoring my sugar levels.  I am not diabetic but did so because in ICU was using steroids which elevated sugar levels.  I continued to monitor it at home because I had to do injections for several weeks after leaving the hospital.  Have not had to use insulin til the other day.  Vision is very blurry.  Had that problem in the hospital but it has gone away but since I had the first vaccine everything is now blurry.  Left leg hurts to put weight on the heel. I have nerve damage to the left leg but this is a unique issue.  I'm running a low grade fever 100.2 - in the morning it is normally 96.5-97.6 and this temperature was in the morning the day after the shot.  Neck is very sore.  I have rods from C3-C6 and the pain is in the muscle glands closer to the surface.  It is almost like it is attacking all areas of the body I previously had issues.  I spent October 25 - November 13 in Hospital, majority of time in ICU.
could not move lt arm, sweating profusely, T102, chills, aches, pains, could not sleep, inj item sore w/hard not;cont w/T100-102, chills, body aches;
Initial unsolicited report received from nurse on 23 September 2016. This case involves 13-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE QIV (batch number: UI658AA, expiration date, dose and dose in series, route of administration were not reported) on 21 September 2016. The patient's Medical history and Concomitant medication were not reported. On 22 September 2016, in night, one day following the vaccination the patient had symptoms (unspecified). On 23 September 2016, two days following vaccination, the patient had developed 101 (unit not reported) fever, red swollen sore hot arm. Lab data and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Patient received her Covid-19 vaccination  and waited in the store for about 30 minutes.  She then approached me and stated she had mild SOB but was not sure if it was due to her anxiety about the vaccine or if it was a reaction.  She had no other complaints of dizziness, throat swelling, hives, sweating, etc.  She was able to speak without hesitation or difficulty, but I asked her to remain in the store a little longer to be monitored and not to drive home.  Her BP was 123/68 and HR was 66.  She decided to take a alprazolam tablet which she uses for her anxiety.  About 15 minutes later, she did not feel any improvement in breathing, but was still able to speak.  Her BP was 122/68 and HR was 70.  I decided to call paramedics to be safe and evaluate the patient.  The paramedics arrived in about 5 minutes and assessed her.  They stated all her vitals were stable and felt she did not need further intervention unless her symptoms worsened.    She was advised to follow up with her physician.